TREATMENT PROTOCOL COMPUTER SYSTEMS AND METHODS

INVENTORS: Kelsey Leigh Ramsden and Frank Mark Geoffrey Belair

CROSS-REFERENCE

[01] This application claims priority under PCT Article 8(1) and PCT Rule 4.10 to U.S. Provisional Application No. 63/167,611, and Canadian Application No. 3,113,414, each filed March 29, 2021, and both of which are incorporated by reference for all purposes as if fully set forth herein.

TECHNICAL FIELD

[02] The present invention relates to computer-implemented methods and systems for nervous system disorder treatment protocols.

BACKGROUND OF THE INVENTION

[03] Mental health conditions are the leading cause of disability worldwide, and are estimated to lead to over a million lives lost to suicide. Additionally, they are estimated to cost the global economy over $1 trillion in lost productivity each year. Nervous system disorders are also highly correlated with substance abuse, poor educational attainment, unemployment, homelessness, and incarceration, and are associated with a 40% higher risk of developing cardiovascular and metabolic diseases, as well as other comorbidities. In the United States, mental health disorders are estimated to affect 1 in 5 adults and 1 in 6 children aged 6-17, totaling nearly 50 million people. Moreover, their incidence has been increasing over recent decades in all age groups, and is expected to continue that trend.

[04] Despite the high prevalence and increasing incidence of nervous system disorders, current first-line treatments are largely inadequate, a major factor being the substantial variations in how each disorder presents and the lack of personalization inherent to the prior art. Herein, Applicant discloses methods, devices, and uses thereof useful in tailoring therapies to individual patients with the granularity and specificity necessary to enable personalization of a treatment protocol for a given patient, thereby increasing patient compliance and treatment efficacy.

INCORPORATION BY REFERENCE

[05] Each patent, publication, and non-patent literature cited in the application or in the section entitled References is hereby incorporated by reference in its entirety as if each was incorporated by reference individually. Unless specifically stated otherwise, reference to any document herein is not to be construed as an admission that the document referred to or any underlying information in the document is prior art in any jurisdiction, or forms part of the common general knowledge in the art.

BRIEF SUMMARY OF THE INVENTION

[06] The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[07] In some aspects are disclosed methods for treating at least one nervous system disorder, which comprise: confirming a patient is diagnosed with at least one nervous system disorder; enrolling the patient into a treatment protocol useful in treating the at least one nervous system disorder comprising a plurality of components, wherein the therapy protocol is embodied in a physical computer-readable storage medium integrated with a technological device comprising a processor, random access memory, and a storage medium, and is in data communication with at least one other technological device; obtaining at least one biometric measure from the patient; delivering to the patient at least one component of the plurality of components; and modifying the treatment protocol in response to changes in the at least one biometric measure.

[08] In some embodiments of the methods for treating at least one nervous system disorder, the nervous system disorder is any of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, depression, atypical depression, postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, anxiety, phobia disorders, binge disorders, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, substance-related disorders, substance use disorders, alcohol use disorder, substance-induced mood disorder, a mood disorder related to another health condition, disruptive behavior disorders, eating disorders, impulse control disorders, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), personality disorders, attachment disorders, dissociative disorders, Alzheimer’s disease, ataxia, Huntington’s disease, Parkinson’s disease, motor neuron disease, multiple system atrophy, progressive supranuclear palsy, migraines, cluster headaches, short-lasting unilateral neuralgiform headaches, fibromyalgia, traumatic brain injury, and mild traumatic brain injury (mTBI). [09] In some embodiments of the methods for treating at least one nervous system disorder, the technological device is a server.

[10] In some embodiments of the methods for treating at least one nervous system disorder, the at least one other technological device includes a patient device and a clinician device.

[11] In some embodiments of the methods for treating at least one nervous system disorder, the patient device is any of a cellular phone, a wearable technological device, a laptop, a tablet, and a desktop computer.

[12] In some embodiments of the methods for treating at least one nervous system disorder, the clinician device is any of a cellular phone, a wearable technological device, a laptop, a tablet, and a desktop computer.

[13] In some embodiments of the methods for treating at least one nervous system disorder, the at least one biometric measure is obtained from the at least one other technological device.

[14] In some embodiments of the methods for treating at least one nervous system disorder, the at least one biometric measure is at least one of body temperature, skin temperature, heart rate (HR), resting heart rate, oxygen saturation (Sp02), breathing rate, blood oxygenation, blood pressure (BP) and its variables, including systolic (SBP), diastolic (DBP), mean arterial (MAP), and pulse (PP); continuous non-invasive beat-by-beat blood pressure (CNIBP); measurements from an electrocardiogram (ECG), including RR interval or its variability, QT interval or its variability, heart rate variability (HRV) (or measured by devices other than an ECG); sleep patterns, hemodynamic response (HR), and levels of glucose, cortisol, serotonin, dopamine, cholesterol and electroencephalography (EEG) measures, present emotions, rumination, negative affect, and positive affect.

[15] In some embodiments of the methods for treating at least one nervous system disorder, the at least one other technological device has a graphical user interface.

[16] In some embodiments of the methods for treating at least one nervous system disorder, the plurality of components are chosen at random by the processor of the technological device, based on weights assigned to each component.

[17] In some embodiments of the methods for treating at least one nervous system disorder, the at least one component is delivered to the patient device via the technological device.

[18] In some embodiments of the methods for treating at least one nervous system disorder, the at least one component is delivered to the patient device as a suggestion, and the patient may accept or reject the suggestion via the graphical user interface of the patient device.

[19] In some embodiments of the methods for treating at least one nervous system disorder, the acceptance or rejection of the suggestion by the patient is delivered to the clinician device as a missed-event notification.

[20] In some embodiments of the methods for treating at least one nervous system disorder, the weights assigned to each component are determined by the treatment protocol that the patient is enrolled in.

[21] In some embodiments of the methods for treating at least one nervous system disorder, repeated rejection by the patient of the component causes the weight assigned to the component to decrease, lowering the frequency with which the component is suggested.

[22] In some embodiments of the methods for treating at least one nervous system disorder, the patient device is capable of determining the patient’s geographic location and transmitting said geographic location to the technological device.

[23] In some embodiments of the methods for treating at least one nervous system disorder, the clinician may monitor the patient’s geographic location by requesting and receiving the patient’s geographic location from the technological device.

[24] In some embodiments of the methods for treating at least one nervous system disorder, the patient restricts the plurality of components available for a given geographic location.

[25] In some embodiments of the methods for treating at least one nervous system disorder, the technological device determines the geographic location of the patient and modifies the weights assigned to each of the plurality of components according to the restriction of the plurality of components by the patient for the geographic location.

[26] In some embodiments of the methods for treating at least one nervous system disorder, the weights assigned to each of the plurality of components are increased or decreased based on the restriction of the plurality of components by the patient for the geographic location.

[27] In some embodiments of the methods for treating at least one nervous system disorder, the technological device determines the geographic location of the patient; if the geographic location is one wherein the patient has restricted the plurality of components available for the geographic location, the technological device increases or decreases the weights assigned to each component according to the restriction; and wherein the technological device delivers a suggested component to the patient device reflective of the increase or decrease in the weights assigned to each component.

[28] In some aspects are disclosed methods of increasing the safety of a patient undergoing a treatment protocol, the method comprising: enrolling the patient into at least one treatment protocol comprising a plurality of components, wherein the treatment protocol is embodied in a physical computer-readable storage medium integrated with a technological device comprising a processor, random access memory, and a storage medium that is in data communication with at least one other technological device, wherein the at least one other technological device includes a patient device capable of determining the location of the patient and monitoring at least one biometric of the patient; and a clinician device, wherein the clinician device is capable of requesting and receiving the patient’s geographic location and the at least one biometric monitored by the patient device from the technological device; the technological device comparing the biometric data obtained from the patient device to an established range for the patient wherein at the upper and lower terminus of the safe range is a threshold to which the biometric data is compared, wherein such comparison determines whether the biometric data is in the safe range or the unsafe range; when at least one biometric measure crosses the threshold between the safe range and the unsafe range, the technological device delivers an alert to the clinician device; and in response to the alert, the clinician modifies the treatment protocol.

[29] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the at least one biometric measure is at least one of body temperature, skin temperature, heart rate (HR), resting heart rate, oxygen saturation (Sp02), breathing rate, blood oxygenation, blood pressure (BP) and its variables, including systolic (SBP), diastolic (DBP), mean arterial (MAP), and pulse (PP); continuous non-invasive beat-by-beat blood pressure (CNIBP); measurements from an electrocardiogram (ECG), including RR interval or its variability, QT interval or its variability, heart rate variability (HRV) (or measured by devices other than an ECG); sleep patterns, hemodynamic response (HR), and levels of glucose, cortisol, serotonin, dopamine, cholesterol and electroencephalography (EEG) measures, present emotions, rumination, negative affect, and positive affect.

[30] In some embodiments, the therapy protocol is for the treatment of at least one nervous system disorder.

[31] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the nervous system disorder is any of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, depression, atypical depression, postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, anxiety, phobia disorders, binge disorders, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, substance-related disorders, substance use disorders, alcohol use disorder, substance-induced mood disorder, a mood disorder related to another health condition, disruptive behavior disorders, eating disorders, impulse control disorders, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), personality disorders, attachment disorders, dissociative disorders, Alzheimer’s disease, ataxia, Huntington’s disease, Parkinson’s disease, motor neuron disease, multiple system atrophy, progressive supranuclear palsy, migraines, cluster headaches, short-lasting unilateral neuralgiform headaches, fibromyalgia, traumatic brain injury, and mild traumatic brain injury (mTBI).

[32] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the treatment protocol includes psychedelic dosing.

[33] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the treatment protocol includes dosing of a non-psychedelic agent.

[34] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is a modification in the dose of the psychedelic agent or non-psychedelic agent.

[35] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is a reduction in the dose of the psychedelic agent or the non-psychedelic agent.

[36] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is an increase in the dose of the psychedelic agent or the non-psychedelic agent.

[37] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the treatment protocol does not include dosing of an active agent.

[38] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, at least one of the plurality of components is suggested to the patient at random by the processor of the technological device based on weights assigned to each component.

[39] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, a component is suggested to the patient when the at least one biometric enters a predefined range that borders the threshold of the unsafe range. [40] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the component is useful in preventing the at least one biometric from crossing the threshold into the unsafe range.

[41] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, a component is suggested to the patient when the at least one biometric is beyond the threshold of the unsafe range.

[42] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the component is useful in returning the at least one biometric to the safe range.

[43] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, at least one component is delivered to the patient as a suggestion via the patient device, and the patient may accept or reject the suggestion via a graphical user interface operably connected to the patient device.

[44] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the acceptance or rejection is delivered to the clinician device as a notification via a graphical user interface operably connected to the clinician device.

[45] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is an adjustment of the weights assigned to each component.

[46] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is an increase or a decrease in the weights assigned to each component.

[47] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is an addition of components or a removal of components.

[48] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is the addition of a psychedelic dosing protocol.

[49] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is the removal of a psychedelic dosing protocol.

[50] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is the addition of a non-psychedelic dosing protocol.

[51] In some embodiments of the methods of increasing the safety of a patient undergoing a treatment protocol, the modification is the removal of a non-psychedelic dosing protocol. [52] In some aspects disclosed systems for structuring the treatment of a nervous system disorder with a distributed network, the system comprising: a technological device configured to store a treatment protocol database, wherein the treatment protocol database is comprised of a plurality of treatment protocol records and each treatment protocol record is comprised of a plurality of components; and a communication network comprising at least one patient device and at least one clinician device in data communication with the technological device, wherein patient biometric and geographic location data is stored on the at least one patient device, a treatment protocol stored on the technological device can be assigned by the at least one clinician device to the at least one patient device, patient biometric and geographic location data stored on the at least one patient device can be requested by the at least one clinician device, and the at least one clinician device can do any of adding, removing, altering, lengthening, shortening, and modifying a component of the treatment protocol assigned to the at least one patient device.

[53] In some aspects are disclosed non-transitory computer-readable storage mediums storing executable instructions that, when executed by a processor, cause the processor to perform steps comprising: confirming a patient is diagnosed with at least one nervous system disorder; enrolling the patient into a treatment protocol comprising a plurality of components useful in treating the at least one nervous system disorder; obtaining at least one biometric measure from the patient; delivering to the patient at least one component of the treatment protocol; and modifying the treatment protocol in response to changes in the at least one biometric measure.

[54] The foregoing has outlined broadly some pertinent features of certain exemplary embodiments of the present disclosure so that the detailed description of the invention that follows may be better understood and so that the present contribution to the art can be more fully appreciated. Additional features of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the disclosed specific methods and structures may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. It should be also realized that such equivalent structures do not depart from the spirit and scope of the invention as set forth in the appended claims. Hence, this summary has been made with the understanding that it is to be considered as a brief and general synopsis of only some of the objects and embodiments disclosed herein, is provided solely for the benefit and convenience of the reader, and is not intended to limit in any manner the scope, or range of equivalents, to which the claims are lawfully entitled. BRIEF SUMMARY OF THE DRAWINGS

[55] To further clarify various aspects of the invention, a more particular description of the invention will be rendered by reference to certain exemplary embodiments thereof which are illustrated in the included figures. It should be understood and appreciated that the figures depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. They are simply provided as exemplary illustrations of certain concepts of some embodiments of the invention.

[56] Certain aspects of the invention are therefore further described and explained with additional specificity and detail, but still by way of example only, with reference to the accompanying figures in which:

[57] FIG. 1: is a schematic illustration of an exemplary computer system according to a first embodiment of the invention that is in communication with a plurality of patients, a plurality of associated medical health professionals, and a plurality of associated clinicians.

[58] FIG. 2: is a tabular representation of an exemplary treatment protocol record stored in a treatment protocol database of the computer system of FIG. 1.

[59] FIG. 3: is an exemplary flow chart of an illustrative treatment protocol structuring method performed by a processor of the computer system of FIG. 1.

[60] FIG. 4: is an exemplary visual representation of a form where administrators may establish protocol authors.

[61] FIG. 5: is an exemplary visual representation of a form where administrators may add, remove, and provide additional information about authors.

[62] FIG. 6: is an exemplary visual representation of a form where administrators may update the author’s details, including their first and last names, and their identifying photo.

[63] FIG. 7: is an exemplary visual representation of a form that administrators and practitioners may access outlining critical information for each protocol in the protocol catalog.

[64] FIG. 8: is an exemplary visual representation of a form administrators may use to add additional protocols to the protocol catalog, specifically information for the protocol claims and criteria.

[65] FIG. 9: is an exemplary visual representation of a form administrators may use to add additional protocols to the protocol catalog, specifically information for the protocol activities. [66] FIG. 10: is an exemplary visual representation of a form administrators may use to add additional protocols to the protocol catalog, specifically information for protocol training and support.

[67] FIG. 11: is an exemplary visual representation of a form wherein administrators and practitioners are able to view available protocols at various clinics.

[68] FIG. 12: is an exemplary visual representation of a form wherein practitioners may assign a protocol to a patient.

[69] FIG. 13: is an exemplary visual representation of a form illustrating the various protocols available for assignment, compared to all protocols listed in the protocol catalog.

[70] FIG. 14: is an exemplary visual representation of a form wherein practitioners may be assigned to patients.

[71] FIG. 15: is an exemplary visual representation of the transmission of geographic location data of the patient from the patient device to the clinician via the clinician device.

[72] FIG. 16: is an exemplary visual representation of the flow of data from the patient via the patient device to the clinician via the clinician device, wherein the patient device and clinician device are in data communication with the technological device.

DETAILED DESCRIPTION

[73] While various aspects and features of certain embodiments have been summarized above, the following detailed description illustrates several exemplary embodiments in further detail to enable one of skill in the art to practice such embodiments, and to make and use the full scope of the invention claimed. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention or its applications. It will be understood that many modifications, substitutions, changes, and variations in the described examples, embodiments, applications, and details of the invention illustrated herein can be made by those skilled in the art without departing from the spirit of the invention, or the scope of the invention as described in the appended claims, and the general principles defined herein may be applied to a wide range of aspects. Thus, the invention is not intended to be limited to the aspects presented, but is to be accorded the widest scope consistent with the principles and novel features disclosed. The description below is designed to make such embodiments apparent to a person of ordinary skill, in that the embodiments shall be both readily cognizable and readily creatable without undue experimentation, solely using the teachings herein together with general knowledge of the art.

[74] While the methods described and illustrated herein may include particular steps, it should be apparent that other methods including fewer, more, or different steps than those described and shown are also within the spirit and scope of the invention. The methods and uses of any device or apparatus discussed and associated steps shown herein therefore should be understood as being provided for purposes of illustration, not limitation. It should be further understood that the specific order or hierarchy of steps in the methods and uses of a device disclosed are only exemplary approaches. Based upon user and design preferences, the specific order or hierarchy of steps in the methods and uses of a device may be rearranged while remaining within the spirit and scope of the present disclosure. The accompanying claims present elements of the steps in a sample order, and are not meant to be limited to the specific order presented.

[75] Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, locations, orientations, configurations, and other specifications that are set forth (either expressly or impliedly) in this specification, including in the figures and in the claims that follow, are approximate, and not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

A. General Definitions and Terms

[76] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a treatment protocol” includes reference to a combination of two or more treatment protocols, and reference to “a processor” includes reference to a combination of two or more processors. While the term “one or more” may be used, its absence (or its replacement by the singular) does not signify the singular only, but simply underscores the possibility of multiple components in particular embodiments.

[77] The terms “comprising,” “including,” “such as,” and “having” are intended to be inclusive and not exclusive (i.e., there may be other elements in addition to the recited elements). Thus, the term “including” as used herein means, and is used interchangeably with, the phrase “including but not limited to.” The term “or” is used herein to mean, and is used interchangeably with, the term “and/or,” unless context clearly indicates otherwise.

[78] Unless otherwise indicated, all numbers expressing quantities of components, time, dosages, etc., used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. [79] In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[80] Unless defined otherwise, all technical and scientific terms herein have the meaning as commonly understood by one having ordinary skill in the art to which this invention belongs, who as a shorthand may be referred to simply as “one of skill.” Further definitions that may assist the reader in understanding the disclosed embodiments are as follows; however, it will be appreciated that such definitions are not intended to limit the scope of the invention, which shall be properly interpreted and understood by reference to the full specification (as well as any plain meaning known to one of skill in the relevant art) in view of the language used in the appended claims. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[81] Generally, the nomenclature used and procedures performed herein are those known in fields relating to that of one or more aspects of the invention, such as those of biology, pharmacology, neuroscience, psychology, computer science, electrical engineering, organic chemistry, synthetic chemistry, or medicinal chemistry, and are those that will be well-known and commonly employed in such fields. Standard techniques and procedures will be those generally performed according to conventional methods in the art.

[82] Herein, a “protocol” “protocols,” or “treatment protocol” (herein used interchangeably with “treatment plan” and “patient workflow,” refers to a process (i.e., a series of steps) that has shown efficacy when executed. Further, “protocol,” “protocols,” or “treatment protocol” herein include protocols that may or may not include psychedelic dosing or dosing of non-psychedelic compounds. Thus, reading of “protocol,” “protocols,” or “treatment protocol” should not be construed as limiting to any such embodiment.

[83] In some embodiments, a “protocol” or a “treatment protocol” may include a plurality of stages, non-limiting examples of which include a cleansing stage, a medicine stage, and/or an integration stage, as described infra. In some embodiments, the treatment protocol includes only a cleansing stage, only a medicine stage, or only an integration stage; any two of a cleansing stage, a medicine stage, and an integration stage, or all three of a cleansing stage, a medicine stage, and an integration stage. Meaning, a treatment protocol may include any one of, any two of, or all of a cleansing stage, a medicine stage, and an integration stage, in any such conceivable combination, and in any such order specified by the specific treatment protocol assigned to the patient, and still be within the scope and spirit of the invention as disclosed herein.

[84] That said, the invention is not limited to cleansing, medicine, and/or integration stages. There may be a plurality of stages instead of, or in addition to, the cleansing, integration, and medicine stages such that, in some embodiments, a treatment protocol may contain a total of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 stages which may or may not include any of cleansing, integration, or medicine stages. Furthermore, the stages could have different names, but still be within the scope and spirit of the invention as disclosed herein. In some embodiments, the “cleansing” stage may be referred to as, e.g., the “detoxification” stage and/or the “preparation” stage; the “integration” stage may be referred to as, e.g., the “therapy” stage; and/or the “medicine” stage may be referred to as, e.g., the “dosing” and/or “administration” stage. Moreover, in some embodiments, the cleansing, integration, and/or medicine stages may be combined with one another, such that the cleansing stage includes components of the cleansing, integration, and/or medicine stages; the integration stage includes components of the cleansing, integration, and/or medicine stages; and/or the medicine stage includes components of the cleansing, integration, and/or medicine stages.

[85] Likewise, a patient may be enrolled by a clinician into any such stage of the treatment protocol, and the stages may be completed in any order. Meaning, in embodiments wherein a treatment protocol contains a cleansing, medicine, and integration stage and is structured to be completed in that order, a clinician may determine the patient need not complete the cleansing stage, and instead instructs them to begin the protocol at the medicine stage. Or, in some embodiments, the clinician may instruct the patient to begin at the integration stage, if the clinician determines the patient need only that stage of the protocol.

[86] Finally, in embodiments wherein a treatment protocol contains a cleansing, medicine, and integration stage and is structured to be completed in that order, a clinician may determine it would be more fruitful for the patient to complete the stages in a separate order, to omit certain stages, replace certain stages, or to add additional stages. Thus, in some embodiments, a patient may first complete the medicine or integration stages, followed by the cleansing stage. Or, the patient may complete only one or two of the cleansing, medicine, and integration stages; or the patient may complete more stages than the cleansing, medicine, and integration stages. Non-limiting examples of stages in addition to the cleansing, integration, and medicine stages include an activity stage, a spiritual stage, a meditation stage, a counseling stage, a physical therapy stage, an observation stage, a secondary dosing stage, a tertiary dosing stage, or support group stage.

[87] The upshot being, the stages associated with each protocol are defined by the protocol, and the scope and spirit of the invention as disclosed herein encompasses any such number or type of stage. Moreover, a clinician may choose to add, remove, or instruct a patient to complete the stages in any such order, including enrolling the patient in a specific stage that is not normally the first stage of the treatment protocol. Thus, discussion of the cleansing, integration, and medicine stages herein is merely exemplary and illustrative, so as to enable one of skill to practice the invention, and should not in any way be construed as limiting the scope and spirit of the invention.

[88] Moreover, as will be discussed infra, any such changes made by the clinician to the protocol structure during the course of treatment may be recorded in the “history” tab of the protocol forms, and may be later accessed by administrators and clinicians to ascertain how the modifications affected the patient. Such is one of many attributes of the invention that allow for increased granularity, and personalization for a given patient, or patient population.

[89] Herein, “biometric data” refers to any data illustrating the physiological state of a patient (herein termed physiological biometric data), including body temperature, skin temperature, heart rate (HR), resting heart rate, oxygen saturation (Sp02), breathing rate, blood oxygenation, blood pressure (BP) and its variables, including systolic (SBP), diastolic (DBP), mean arterial (MAP), and pulse (PP); continuous non-invasive beat-by-beat blood pressure (CNIBP); measurements from an electrocardiogram (ECG), including RR interval or its variability, QT interval or its variability, heart rate variability (HRV) (or measured by devices other than an ECG); sleep patterns, hemodynamic response (HR), and levels of glucose, cortisol, serotonin, dopamine, cholesterol and electroencephalography (EEG) measures; as well as any data illustrating the psychology of a patient (herein termed psychological biometric data), such as but not limited to present emotions, including happiness, disgust, fear, anger, sadness, surprise, and joy; sleep history, rumination, negative affect, and positive affect.

[90] Thus, herein, “biometric data” generally encompasses physiological biometric data, psychological biometric data, or a combination thereof, as the context indicates. For ease of reading, and to enable of one skill, reference to “biometric data” should generally be construed to include both physiological and psychological biometric data, unless the context clearly dictates otherwise, or if “biometric data” is modified by “psychological” or “physiological” in particular. B. Advances Over Current Treatment Paradigm

[91] There is a need for patient-specific treatment methods that are not only tailored to a given patient, or patient population, but those capable of adapting and changing to meet the demands of the same. Not only that, but current treatment options are limited to the information gathered at clinical checkups. According to the Cleveland Clinic, there are a plurality of factors that may affect such data, including stress, smoking, weather (whether it is cold, warm, mild, rainy, etc.), exercise regimen (including whether or not the patient arrived at the consultation prior to, or after, working out), whether or not the subject has a full stomach, full bladder, has consumed alcohol, caffeine, tobacco, certain medications; is gaining or losing weight, their current salt intake, etc.

[92] The upshot: there is necessarily a substantial fluctuation in one’s general homeostatic environment. As a result, a clinical visit is merely a snapshot of the conditions of the patient on that given day, at the time the measurements were taken. Given the complex nature of nervous system disorders and mental health conditions, in particular, it is no wonder that conditions are often misdiagnosed or improperly treated.

[93] With the rise of telemedicine, the “meta-verse,” and other such technological advances, mental health diagnostics and treatment will fall behind without advancements. Applicant herein discloses a means of advancing the discipline with an integratable technological application capable of monitoring, in real time, the conditions of a patient and altering a treatment protocol to match the needs of the same. Further, through progressive data aggregation and platform expansion, the technology is able to assist clinicians in treating subsequent patients more efficiently, as the data obtained can be extrapolated for separate patient populations.

[94] The technology of the invention also offers advances in patient safety — spanning both the treatment phase and day to day life — via the continuous collection of biometric data from a technological device (in some embodiments, as disclosed herein), and automated messages to a practitioner when said data exceeds a given safety threshold.

[95] For purposes of ease of description, but without being bound by theory, the sum of these improvements broadly fits into two categories: technological improvements to treatment efficacy, and technological improvements to patient safety, both of which would not be possible without the technology of the invention, as disclosed herein.

C. Technology Overview

[96] Herein, the technology of the invention refers to the system that accumulates, stores, organizes, manages, manipulates, processes, and analyzes patient, clinician, and protocol-specific information. Through novel methods of data organization that amount to tangible technological improvements to standard distributed network architecture, the technology of the invention is able to increase patient safety, and treatment efficacy, as described herein.

[97] In some embodiments, the technology of the invention is integrated with a technological device as illustrated as in FIG. 1, 100, wherein the technological device is in data communication with at least one patient device (132 and/or 134) and at least one clinician device (142 and/or 144), wherein the at least one patient device may further be in data communication with at least one satellite (as illustrated in FIG. 15).

[98] As used herein, the “technology of the invention” will broadly refer to the invention’s accumulation, storage, processing, organization, manipulation, and analysis of information, such that the “technology of the invention” may refer to the technology integrated with technological device 100, the manner in which a patient and a clinician interact, the improvements to patient safety, treatment efficacy, and/or distributed network architecture; the distribution of components to a patient undergoing treatment, the modification of said components due to biometric and/or geographic location data; or a combination thereof, as the context of its usage necessarily implies.

[99] As it relates to the technology of the invention specifically, it functions in some embodiments as a companion to a technological device, including mobile devices such as smartphones and other cellular devices capable of establishing an internet connection and transmitting data using said internet connection; wearable devices, such as smart watches, fitness bands, smart glasses, smart bracelets, wearable chest monitors, electronic rings, smart shoe inserts, smart belts, and smart clothing; tablets, desktop computers, laptops, smart mirrors, and any other such technological devices capable of downloading information from, and uploading information to, at least one other technological device via a network that, in some embodiments, includes the internet; that allows a clinician to assign at least one treatment protocol to a patient, and the patient to utilize the technological device to interact with the treatment protocol.

[100] In some embodiments, the technology has three levels of organization, the highest being the global administration console (herein referred to generally as “administrator”), which is accessible by the Applicant; the organizational portal, which is accessible by each healthcare provider using the technology of the invention and provides the same with an administrative interface for employee access that includes billing, legal documents, and subscription setup that facilitates access to patient management tools, patient personal information (which is tokenized for anonymity) including demographic data, intake workflow, assessment workflow, and questionnaire workflow; reporting and analytics, templates (including assessments and questionnaires), protocol execution and optimization tools, and automated email services; and a patient portal (accessible by the patient via a patient device) that offers a welcome dashboard with summary information based on the patient’s assigned protocol and progress indicators (including cumulative progress), and a menu with access to the creation and management of diary notes (i.e., journaling), data collection and control, content links, communication services, and emergency services; and will be the main means of communication between the patient and clinician.

[101] In some embodiments, a patient will be enrolled into/assigned a treatment protocol. Herein, enrolling a patient into a treatment protocol and assignment a treatment protocol to a patient and/or assignment a patient to a treatment protocol should be construed as equivalent. As it relates to enrollment/assignment specifically, in some embodiments, a patient may seek consultation from a clinician concerning at least one nervous system disorder, and the clinician may, in turn, determine the patient may benefit from at least one of the technology of the invention’s treatment protocols. The clinician may then, in some embodiments, instruct the patient to access the technology of the invention on at least one patient device and, in some embodiments, do the same with at least one biometric monitoring device, so that the patient may receive protocol-specific information via the patient device.

[102] Once a patient is enrolled into/assigned at least one treatment protocol, the patient will interact with the technological device integrated with the technology of the invention via a patient device. In some embodiments, such interaction may include, but is not limited to, completing at least one “component” of the treatment protocol. In some embodiments, a “component” of the protocol refers to a patient-engaged event reflective of, and necessitated by, the specific treatment protocol the patient is enrolled in. Said another way, each component is tailored to a given protocol, and is integral to its completion. Non-limiting examples of components are those that suggest the patient complete an activity, such as but not limited to preparing for a dosing session by ceasing all eating and drinking at a certain time, or, conversely, instructing the patient to eat or drink a certain amount prior to the dosing session — depending on the active agent involved; or may suggest the patient complete at least one mindfulness activity, such as but not limited to journaling, breath work, meditation, etc.

[103] As will be discussed further herein, in embodiments wherein the treatment protocol contains at least one component, the patient will have the option to either accept or reject a component suggestion when prompted via a graphical user interface operably connected to the patient device. In some embodiments, regardless of whether or not the patient accepts or rejects the component of the protocol, the technological device integrated with the technology of the invention will alert the clinician as to the patient’s decision — via a graphical user interface operably connected to a clinician device — so that the clinician is intimately aware of the patient’s progress within the treatment protocol. In addition, the technology of the invention is capable of learning and adapting to each patient’s patterns and can, in turn, increase or reduce the frequency of a component depending on whether it was accepted or rejected, respectively (as discussed in greater detail infra).

[104] Further, through patient scheduling built into the technology, the technology will automatically reduce or cease certain components as necessary. For instance, at a time wherein the patient is at work, the technology will refrain from suggesting the individual perform a component not conducive to that patient’s specific work environment — suggesting instead, in some embodiments, a component better suited for the patient’s occupation and location. Likewise, in some embodiments, the technology of the invention will refrain from sending any component suggestions to the patient device via the technological device when the patient is at work/working. As would be apparent to one of skill, the frequency and type of components contained within each protocol is dependent upon the specific treatment protocol in which the patient is enrolled.

[105] The technology of the invention also allows clinicians and patients to engage in one-on-one voice, text, and/or video chat sessions via clinician and patient devices in data communication with one another via their data communication with the technological device within which the technology of the invention is integrated. This allows the clinician and patient to remain tethered for the duration of the treatment protocol, to facilitate discussion of any patient questions, to provide immediate assistance, or to conduct routine checkups.

[106] In some embodiments, the patient device will also continuously monitor at least one biometric of the invention. In such embodiments, the biometric measures include at least one of body temperature, skin temperature, heart rate (HR), resting heart rate, oxygen saturation (Sp02), breathing rate, blood oxygenation, blood pressure (BP) and its variables, including systolic (SBP), diastolic (DBP), mean arterial (MAP), and pulse (PP); continuous non-invasive beat-by-beat blood pressure (CNIBP); measurements from an electrocardiogram (ECG), including RR interval or its variability, QT interval or its variability, heart rate variability (HRV) (or measured by devices other than an ECG); sleep patterns, hemodynamic response (HR), and levels of glucose, cortisol, serotonin, dopamine, cholesterol and electroencephalography (EEG) measures, present emotions, including happiness, disgust, fear, anger, sadness, surprise, and joy; sleep history, rumination, negative affect, and positive affect.

[107] To enable one of skill, EEG devices include quantitative EEG (qEEG), magnetoencephalography (MEG), electrocorticography (ECoG), functional magnetic resonance imaging (fMRI), positron emission tomography (PET), nuclear magnetic resonance (NMR), spectroscopy (or, equivalently, magnetic resonance spectroscopy — MSR), single-photon emission computed tomography (SPECT), near infrared spectroscopy (NIRS), functional NIRS (fNIRS), and event-related optical signal (EROS).

[108] Broadly, EEG is a well-established tool which has been used for over a hundred years to measure rhythmic electrical activity emitted by the brain. It is widely used as the method is noninvasive and the technology is cheap and portable (consisting essentially of a cap studded with electrodes that sit on the surface of the scalp, an amplifier to amplify the signal, and a computer to read the activity). In these electrical emissions (visualized as brain waves), one can identify patterns determined by specific events and conditions (e.g., when the brain is in a resting state and the eyes are closed, the brain-wave activity changes from high-frequency rhythms to slower-frequency rhythms).

[109] In some embodiments, wherein biometric measures are collected, safe ranges of such biometric measures may be established on a patient-to-patient basis. At the terminus of the upper and lower limits of the safe range is a threshold, wherein crossing the threshold places the patient in an “unsafe” range. In some embodiments, if any of the biometrics referenced herein are found to be in the unsafe range, a clinician is duly notified. In some embodiments, the clinician then may either contact the patient, emergency services, or a combination thereof.

[110] In some embodiments, such continuous communication between the patient device and the technological device facilitates additional granularity in the treatment of nervous system disorders through modifying, in real time, the treatment protocols (and components thereof) to meet the needs of the patient. As a purely non-limiting example, a patient going through a particularly stressful situation may have biometrics reflecting that (e.g., increased heart rate, blood pressure, respiration rate, etc.) and, as a result, the technology of the invention may propose a component designed to lower stress levels (e.g., meditation or breathwork) or may offer affirming sentiments, such as messages that let the patient know the clinician is only a phone call away, that the situation they are currently in will pass, that they are strong and capable of dealing with whatever they are facing, or other such messages designed to prevent the at least one biometric measure from entering its established “unsafe” range, return the same to its established “safe” range, or return the same to its basal level.

[111] This is a significant technological improvement over traditional medical technology in that it allows real-time monitoring of a patient and provides insights into the physiological and psychological progress of the same as they progress through a treatment protocol — which would not be possible without the technology of the invention. Moreover, such information enables the alteration to/modification of a treatment protocol — including activities to be completed throughout the duration thereof, and/or dosing, in embodiments wherein administration of an active agent is part of the treatment protocol — by a clinician based on such information gathered by the technology of the invention (as will be discussed infra).

[112] For instance, in embodiments wherein a patient undergoes periodic dosing sessions of an active agent which, in some embodiments, may or may not be a psychedelic agent, a clinician may carefully review the biometric data obtained by the patient device (132 and/or 134) in data communication with the technological device (100) for a time period prior to the dosing session, such as but not limited to between about 24 to about 96 hours prior to the dosing session (including values in between), and may titrate the dose of the active agent accordingly. In some embodiments, the clinician may then monitor the patient’s biometric data after the dosing session to better inform dosing decisions for the next dosing session.

[113] In a purely exemplary, non-limiting example, in embodiments wherein biometric data includes measurements of monoamines in the patient’s blood plasma, a clinician may determine the half-life for the administered compound is longer than expected, or that the maximum concentration (C _max ) is higher than expected, indicating poor metabolism (for instance, poor first-pass metabolism by liver enzymes including, but not limited to CYP2D6) and may, as a result, reduce the dose administered to the patient in subsequent sessions.

[114] Likewise, in some embodiments, continuous biometric monitoring prior to, or after a dosing session may aid the clinician in determining that, e.g., a different dosage, method of administration, timing of administration, active agent, or combination of active agents is more appropriate for a given patient.

[115] Moreover, in some embodiments, wherein the treatment protocol assigned to the patient includes administration of a psychedelic agent at a psychedelic dose, the clinician may determine administration at a sub-psychedelic (“microdose”) is more beneficial.

[116] Suffice to say, the additional granularity and individualized approach offered by the technology of the invention is among the significant improvements over traditional medical practices, which aids in increasing the efficiency and effectiveness of medical treatment for nervous system disorders. Further, the continuous monitoring made possible by the technology of the invention may increase the safety and security of the patient both in the treatment process, and beyond. Meaning, such continuous monitoring may allow a practitioner to observe, in real time, adverse events unrelated to the treatment protocol, such as but not limited to car crashes, falls, heart attacks, strokes, physical altercations, violent attacks, etc., and would allow the clinician to immediately establish contact with the individual, and/or call emergency services.

[117] These, as well as other various technological improvements made possible by the technology of the invention as disclosed herein (i.e., those in which a human alone could not achieve in absence of the technology of the invention) are made possible by the system that powers the technology of the invention, as disclosed below.

D. System Overview

[118] Referring to FIGS. 1 and 2, a technological device according to an exemplary embodiment of the invention is shown generally at 100 in FIG. 1. In some embodiments, the technological device (100), which may be any of a computer, including a desktop computer, a server, or a laptop, a tablet, a mobile device, a smart watch, or any other such machine known to those in the art having hardware characteristic of a computer, includes a treatment protocol database 102 embodied in a physical computer-readable storage medium.

[119] In some embodiments, the technological device (100) may be a plurality of devices, including 1, 2, 3, 4, 5, 6, 7, 8, 9 or more than 9 devices, wherein the technology of the invention is distributed between the plurality of devices and is accessed through a hard-wired connection. In some embodiments, the technological device (100) may be a plurality of devices, wherein the technology of the invention is distributed between the plurality of devices and is accessed via the internet. In some embodiments, technological device 100 is a device owned and operated by the clinician, or the organization to which the clinician belongs.

[120] As would be apparent to one of skill, but is specifically disclosed for ease of reading, when discussing the hardware that makes up technological device 100, reference is necessarily also being made to technological device 100. Meaning, in exemplary, non-limiting embodiments wherein processor 110 is in data communication with at least one of patient device (132 and/or 134) and/or clinician device (142 and/or 144), it may also be said that technological device 100 is in data communication with the same. So, if an embodiment discloses processor 110 delivering a given component of a treatment protocol to patient 130 via patient device 132 and/or 134, the scope of such an embodiment extends to technological device 100 delivering the same component to patient 130 via patient device 132 and/or 134.

[121] The treatment protocol database (102) stores a plurality of treatment protocol records such as that shown at 200 in FIG. 2. The protocol records define the respective treatment protocols for a plurality of patients (130), and each of the protocols includes a plurality of “components,” as described in greater detail herein.

[122] Moreover, technological device 100 includes a processor 110 in communication with the treatment protocol database (102), and a computer-readable medium 104 in communication with the processor (110). The computer-readable medium (104) stores instructions which, when executed by the processor (110), cause the various methods described herein (referred to throughout as the “technology of the invention”) to be carried out. Technological device 100 further includes a medical database (106), a memory (108) in communication with processor 110, and is in communication with network 120 which, in some embodiments, includes the Internet (i.e., either a cellular network with internet access, a WiFi connection, a satellite internet connection, a physically tethered internet connection, e.g., an ethemet connection; or any other such network capable of downloading information from, and/or uploading information to, the internet). Technological device 100 is in further communication with, via network 120, a plurality of patients (130), and a plurality of clinicians (140).

[123] As used herein, “clinician” refers to a healthcare professional, including nurses (nurse practitioners, licensed practical nurses, licensed vocational nurses, and registered nurses) physicians (medical doctors and doctors of osteopathic medicine), physician assistants, certified nursing assistants, psychologists, psychiatrists, therapists, and any other such medical professionals wherein the technology of the invention would be useful in increasing the efficacy of treatment or patient safety. Meaning, in non-limiting, exemplary embodiments wherein psychedelic dosing is included in the treatment protocol, “clinician” may refer to the practitioner administering the psychedelic dose, the physician or psychiatrist diagnosing the patient/prescribing the psychedelic agent, the therapist(s) observing the patients, or the physician assistants and nurses working with the physician.

[124] In some embodiments, as will be disclosed herein, technological device 100 is additionally in data communication with at least one other technological device, wherein the at least one other technological device includes, but is not limited to, mobile devices such as smartphones and other cellular devices capable of establishing an internet connection and transmitting data using said internet connection; wearable technological devices, such as smart watches, fitness bands, smart glasses, smart bracelets, wearable chest monitors, electronic rings, smart shoe inserts, smart belts, and smart clothing; tablets, desktop computers, laptops, smart mirrors, and any other such technological devices capable of being in data communication with technological device 100.

[125] In some embodiments, the at least one other technological device includes a patient device (132 and/or 134), which, in some embodiments, continuously monitors at least one biometric of the patient and may or may not be in further data communication with at least one satellite and thus capable of determining the geographic location of the patient (as described and illustrated in Fig. 15); and a clinician device (142 and 144) capable of, in some embodiments, requesting and receiving the geographic location of the patient and, in some embodiments, the status of the at least one biometric obtained via the patient device (132 and/or 134), from the technological device (100).

[126] In some embodiments, each of the patients (130) is undergoing or scheduled to undergo a treatment protocol which, in some embodiments, includes dosing of an active agent. In some embodiments, the active agent may or may not be a psychedelic agent. In some embodiments, regardless of whether the active agent is or is not a psychedelic agent, the portion of the treatment protocol wherein the active agent is procured (either through prescription by a clinician or obtaining without a prescription) and administered (either by the clinician, the patient, or a third party who is not a clinician or the patient), is termed the “medicine stage,” or an equivalent thereof.

[127] In conjunction with the medicine stage, the treatment protocol for each patient may, in some embodiments, further include a “cleansing stage” to precede the medicine stage, and an “integration stage” to be followed concurrently with or after completion of the medicine stage. However, embodiments containing no cleansing stage, medicine stage, and/or integration stage are still within the spirit of the invention. Likewise, in embodiments that do include any one, any two, or all of a cleansing stage, medicine stage, and/or integration stage, the order in which they are conducted is determined by the specific treatment protocol to which the patient is assigned, and thus any such order recited herein should not be construed as limiting. Finally, as mentioned supra, the components are defined by the treatment protocol and, as a result, a given treatment protocol may contain components in addition to or instead of the cleansing, integration and/or medicine stages.

[128] In some embodiments, each of the patients (130) has a personal technological device (132) such as a smartphone, a smart-home device, a smart scale, a smart mirror, a laptop, a tablet, or any other such device from which data can be obtained and/or a biometric monitoring device (134), referred to herein together as “patient device 132 and/or 134” that are, in some embodiments, in data communication with technological device 100 via network 120. As mentioned, but reiterated so as to ensure a person of skill is enabled to carry out the invention, “in data communication” refers to communication between at least two devices, wherein such communication facilitates the transmission of data between the same. In some embodiments, such data transfer utilizes a network (120), wherein the network (120) facilitates the transfer of data between the devices in data communication with one another. Herein, “data transmission” or “data transfer” refers to the downloading or uploading of data. Such that, for devices in data communication with one another via a network (120), the devices are capable of transmitting data by uploading and downloading the data via the network (120).

[129] If desired, each of the patients (130) may additionally or alternatively communicate with technological device 100 via a desktop computer, tablet or any other device capable of establishing data communication with technological device 100 via network 120. Similarly, each of the clinicians (140) may use a smartphone/tablet (142) and/or a desktop computer (144) to communicate with technological device 100 via network 120.

[130] In some embodiments, the patient (130) and the clinician (140) may communicate with one another via the technology of the invention (as illustrated in FIG. 16). Meaning, in some embodiments, the patient (1601/130), via the patient device (132 and/or 134) or the clinician (1605/140) via the clinician device (142 and/or 144), may initiate communication with the other party (e.g., patient 130 may initiate conversation with clinician 140, as illustrated via 1602, or clinician 140 may initiate communication with patient 130, as illustrated via 1604), through the use of technological device 100 (1603), and network (120), as illustrated by 1602 and 1604, respectively.

[131] In such embodiments, the party initiating communication will send a message, e.g., a text message, a voice message, a video message, or a combination thereof (herein “message”), to the other party. As mentioned, the patient device (132 and/or 134) are in data communication with the clinician device (142 and/or 144) via network (120) and technological device (100). So, when the party initiating communication (either patient 130/1601, as illustrated via 1602; or clinician 140/1605, as illustrated via 1604) sends a message, such communication is routed by technological device 100 from the sending device (either patient device 132 and/or 134, or clinician device 142 and/or 144), to the receiving device, via network 120. Meaning, in a purely exemplary non-limiting embodiment wherein the patient (130) were to send a message to the clinician (140), the message would travel from the patient (130/1601) via the network (120/1602) to the technological device (100/1603) which would then route the message via the network (120/1604) to the clinician

(140/1605)

E. Treatment Protocol Records

[132] Referring to FIGS. 1 and 2, an illustrative treatment protocol record is shown generally at 200 in FIG. 2. As illustrated, the treatment protocol database (102) is embodied in a physical computer-readable storage medium within technological device 100, and stores one or more protocol records (200) for each patient (130) — each protocol record defining a respective protocol for the patient. More particularly, for each of the patients (130), the treatment protocol database (102) stores, in some embodiments, records for at least one medicine stage and, in some embodiments — which may or may not be the same embodiments — a cleansing stage and/or an integration stage that accompanies the medicine stage.

[133] In some embodiments, the treatment protocol database (102) stores a plurality of treatment protocol records defining a plurality of respective “default” protocols that can be readily selected by a clinician (140) for use by a patient (130). As a purely exemplary, non-limiting example, database 102 may store records defining a plurality of default medicine stages that correspond to the dosing of an active agent which, in some embodiments, may or may not be a medicine stage for the administration of each respective one of a plurality of psychedelic compounds which, in some embodiments, include any of psilocybin, DMT, LSD, mescaline, MDMA, 5-MeO-DMT, ibogaine, ketamine, and numerous others, which may have hallucinogenic, “entheogenic,” “entactogenic” or “empathogenic,” dissociative, and other effects, and which may be used in “psychedelic”-assisted psychotherapy, whether or not termed “psychedelics,” and including various analogs and derivatives of any of the above, or novel chemical compounds having similar structures, effects, and uses. Alternatively, in some embodiments, medicine stages may be defined for other psychedelic compounds, non-psychedelic compounds, and combinations thereof.

[134] In some embodiments, wherein dosing of an active agent — which may or may not be a psychedelic agent — is a component of the treatment protocol, for each default medicine stage, the treatment protocol database (102) stores at least one corresponding default cleansing stage and at least one corresponding default integration stage. Alternatively, larger numbers of default protocols may be stored in the database (102) if desired.

[135] Or, as a further alternative, rather than selecting from among a plurality of “default” protocols, a protocol be customized for a particular patient (130) by the patient’s clinician (140), through their respective interactions with technological device 100 to effectively add, remove, alter, lengthen, shorten, or otherwise modify certain components in the protocol. In some embodiments, as described supra, the resultant protocol may or may not contain at least one of a medicine stage, a cleansing stage, or an integration stage; or may include additional stages other than the cleansing, integration, and medicine stages, as disclosed supra.

[136] As mentioned, in embodiments wherein more than one of a medicine stage, cleansing stage, integration stage and/or stage(s) other than, or in addition to, the medicine, cleansing, and integration stages are included in the treatment protocol, they may be completed in any such order that the specific treatment protocol assigned to the patient requires. Regardless, any such changes made to the treatment protocol for each individual patient is recorded in a “history” record accessible by administrators and clinicians which, as disclosed infra, may aid in modifying the treatment protocol to increase its efficacy for certain patients, or populations thereof, over time — which is among the significant technological advancements offered by the technology of the invention.

[137] In some embodiments, the medicine stage may include the administration of an active agent to a patient (130) by the patient (130) or a third party which may or may not be a clinician (140), and which may or may not be supervised by a clinician (140).

[138] In some embodiments, the medicine stage may not include administration of an active agent. In some embodiments, the cleansing stage may comprise components that amount to methods of medical treatment, which includes but is not limited to detoxification. In some embodiments, the integration stage may comprise components that amount to methods of medical treatment, such as but not limited to therapy, psychotherapy, and physician-assisted therapy. In other embodiments, the cleansing and/or integration stages comprise components that do not amount to methods of medical treatment.

[139] Likewise, in some embodiments, the medicine stage may or may not include the administration of an active agent, the cleansing stage may or may not include components that amount to methods of medical treatment, and the integration stage may or may not include components that amount to methods of medical treatment.

[140] Attention should now be paid to FIG. 2, which shows an illustrative, non-limiting example of a treatment protocol record (200). In some embodiments, the record generally includes a plurality of fields for storing different types of data, including protocol definition fields (210), patient fields (220), diet fields (230), components fields (240), psychological biometrics fields (250), physiological biometrics fields (260), and history fields (270). Broadly, a protocol record will be created for each patient for each stage of the treatment protocol. Meaning, in non-limiting, exemplary embodiments wherein a patient is enrolled in a treatment protocol containing a medicine, integration, and cleansing stage, there will be three treatment protocol records established for that patient. Likewise, if a patient is enrolled in a treatment protocol containing two of the aforementioned three stages, one of the aforementioned three stages, more than three of the aforementioned three stages, or any number of stages other than the aforementioned three stages, the number of treatment protocol records created for the patient will reflect this.

[141] In some embodiments, the protocol definition fields (210) include a protocol type field (212) and a protocol ID field (214). The protocol type field (212) stores an identification of a type of treatment protocol which, in some embodiments, contains at least one stage of the treatment protocol. The protocol ID field (214) stores a unique ID for each unique protocol, although each protocol can be assigned to more than one patient, resulting in more than one treatment record (200) for the unique protocol (i.e., one record for each patient). The protocol ID fields (214) may also store identifications of related protocol records. As a purely illustrative, non-limiting example, the protocol ID fields (214) for any of the stages for a particular patient (130) also store identification records for all additional stages (in embodiments including more than one stage). Meaning, in such an illustrative, non-limiting example, an ID field (214) containing identification of a medicine stage would also contain information regarding the accompanying cleansing and/or integration stages, if that treatment protocol required a cleansing and/or integration stage accompanying the medicine stage.

[142] Thus, while there may be three separate treatment records for a patient assigned a treatment protocol containing each of a medicine, a cleansing, and an integration stage, ID field 214 may, in some embodiments, contain information pertaining to the other stages. So, in a non-limiting, illustrative example, wherein a patient is enrolled in a treatment protocol containing each of a medicine, a cleansing, and an integration stage, and a clinician is viewing the treatment protocol record (200) for the cleansing stage, ID field 214 may also have information pertaining to the medicine and integration stages.

[143] In some embodiments, the patient fields (220) include a patient ID field (222) and a patient calendar field (224). The patient ID field (222) stores an identification of the patient (130) to whom the record (200) relates. In some embodiments, the patient ID field (222) stores either a unique number identifying the patient or an encryption of information identifying the patient, rather than storing information that legibly identifies the patient. Alternatively, the patient’s name can be stored with appropriate permissions and security. Broadly, if the record (200) pertains to a cleansing or integration stage, the patient calendar field (224) stores a plurality of times that the patient (130) is available for cleansing or integration activities or assessments. Alternatively, the patient calendar field (224) may store a schedule for a medicine stage which, in some embodiments, may be a psychedelic or non-psychedelic dosing protocol.

[144] In some embodiments, the diet fields (230) include a plurality of diet-related protocol components, including food fields (232), water fields (234), and abstinence fields (236). As a non-limiting, illustrative example, if the treatment protocol record (200) defines a cleansing stage preceding a psilocybin medicine stage (with the corresponding medicine stage being identified as a related stage in the ID fields (214) of the treatment protocol record (200), the food and water fields (232) and (234), respectively, may contain instructions to eat a meal and drink water three hours before a scheduled component of the corresponding psilocybin medicine stage. Alternatively, other medicine stages may require abstinence from alcohol, nicotine, other drugs (including recreational drugs, pharmaceutical drugs prescribed to the patient, or pharmaceutical drugs not so prescribed), or combinations of drugs for a predetermined period of time preceding a component of the medicine stage, in which case the abstinence fields (236) of the corresponding cleansing stage record (200) may specify such abstinence requirements.

[145] In some embodiments, the components fields (240) define a plurality of components that can form part of a particular protocol, said components fields including, but not limited to, breathwork fields (241), meditation fields (242), journaling fields (243), music fields (244), yoga fields (245), muscle relaxation fields (246), and guided curiosity fields (247). In some embodiments, the components fields (240) allow the clinician (140) and patient (130) to select or deselect each of the components (241) to (247), and to set a relative weight of each component. In some embodiments, the patient (130) must receive permission from the clinician (140) prior to making any adjustments to the assignable components, and frequency weights thereof

[146] Regardless, in some embodiments, the relative weight can range from zero (for a component that is omitted from the protocol) to as high as one (for a component that is the sole component of the protocol). As a non-limiting example, if a particular integration stage contains five components intended to be performed with equal frequency, then each component would have a relative weight of 0.2. As would be apparent to one of skill, components are not limited to a single stage, but can be completed during any stage of the treatment protocol. Meaning, while there may be certain components generally reserved for one or more stages, this should not be construed as a limitation — as any component may be completed during any stage.

[147] In some embodiments, the psychological biometrics fields (250) define psychological biometric assessment components of the protocol defined by the record (200). More particularly, in some embodiments, the psychological biometrics fields (250) include sleep review fields (251), cognitive dissonance (CD) fields (252), mood report fields (253) and values clarification fields (254). More particularly still, in some embodiments, the sleep review fields (251) store information defining questions or sets of questions for the processor (110) to pose to a patient (130) regarding the patient’s sleep or sleep patterns. Similarly, in some embodiments, the CD fields (252) store information defining cognitive dissonance questions or sets of questions for the processor (110) to pose to the patient (130), and the mood report fields (253) store information defining mood-related questions for the processor (110) to pose to the patient (130). In some embodiments, the values clarification fields (254) store information defining questions for the processor (110) to pose to the patient (130) to clarify the patient’s values on a range of topics, which in some embodiments include the following illustrative list of topics: family, career, spirituality, love, fun, nature, wealth, loyalty, friendship, fairness, and peace. Generally, the psychological biometrics fields (250) allow the clinician (140) and the patient (130) to select or omit each of these types of assessment from the protocol, and to select a frequency with which each type of assessment should be repeated. As a purely illustrative, non-limiting example, in some embodiments, the values clarification fields (254) are included in each “default” cleansing stage to obtain an initial or baseline assessment of the values of the patient (130) before commencing a medicine stage. Likewise, in some embodiments, the values clarification fields (254) are included in each “default” integration stage to mandate one or more subsequent reassessments of the patient’s values.

[148] In some embodiments, the physiological biometrics fields (260) specify one or more types of commonly available biometric inputs to be included in, or omitted from, the protocol. More particularly, in some embodiments, the physiological biometrics fields (260) include resting heart rate fields (261), heart rate variability fields (262), skin temperature variability fields (263), breathing rate fields (264), oxygen saturation (Sp02) fields (265), and sleep pattern fields (266). In some embodiments, the fields 261 to 265 correspond to biometric data that can be obtained from commonly available biometric monitoring devices (134), such as those disclosed supra, and the field 266 relates to data that can be obtained from a typical smartphone (132), such as those disclosed supra. Alternatively, other types of biometrics may be added or substituted. The physiological biometrics fields (260) allow the clinician (140) and the patient (130) to select or omit each of these types of biometric data from the protocol for the patient (130), and to indicate times and any conditions for obtaining these biometric data.

[149] Prior to execution of the protocol structuring routine (300) by the processor (110), the patient (130) and the clinician (140) will have created one or more protocol records (200) defining one or more respective treatment protocols for the patient (130). As mentioned, in some embodiments, a treatment protocol record (200) is created for each stage of the treatment protocol for which a patient is enrolled. Thus, the treatment protocol records created for each patient will, in some embodiments, correspond to the number of stages the treatment protocol they are enrolled in contains.

[150] Note, as it relates to general assessment (e.g., assessment of physiological and psychological biometrics), as well as delivering of protocol components, the frequency of such may be completed at any of a fixed interval, in response to a fixed event, a variable interval, in response to a variable event, or continuous. Meaning, in some embodiments, assessment or component delivery may be completed at a fixed interval, wherein a set amount of time dictates when an assessment/component delivery occurs, such as but not limited to occurring at a specific time of day, or occurring in response to a set schedule, including once every 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 120, 150, 180, 240, 360 minutes, etc.

[151] Likewise, assessment/component delivery may occur in response to a fixed event, wherein the specific event determines what assessment and/or component is delivered. In such an embodiment, a purely illustrative non-limiting example may include a patient completing a component that requires the patient to complete aerobic exercise. When the patient notifies the technology of the invention that the patient is beginning to complete the component by, e.g., interaction with a graphical user interface operably connected to patient device 132 and/or 134, the technology of the invention may begin assessment of patient biometrics. Similarly, when finished, the technology of the invention may deliver an interactive notification to the patient device (132 and/or 134) asking the patient how the patient feels. Finally, an “event” may also include biometric measures exceeding a threshold that is characteristic of a “dangerous condition” as disclosed herein, or that of a “safe” range, necessarily making the value an “unsafe” measure. In such an embodiment, said event may cause the technological device (100) to deliver a component to the patient device (132 and/or 134) useful in returning the measure to the “safe” range or altering it such that it is no longer characteristic of a dangerous condition. In an exemplary embodiment, in a situation wherein biometric measurement captured a heart rate above that characterized as “safe” for that specific patient — indicative of a stressful event or other such dangerous situation — technological device 100 may deliver to patient device 132 and/or 134 a component designed to reduce one’s heart rate, such as but not limited to meditation and/or breathwork.

[152] Variable interval frequency of assessment/component delivery occurs after a random amount of time has elapsed, and is centered around an average. Meaning, the device is programmed to complete an assessment/deliver a component an average number of times over a given amount of time. Meaning, in some embodiments that should not be construed as limiting, the technology of the invention may be programmed to randomly assess a patient’s mood three times throughout the day, and may be programmed to suggest a component revolving around exercise two times per week. Because such assessment/component delivery is not based on a fixed amount of time, nor event driven, its frequency is necessarily variably interval.

[153] Variable event frequency, on the other hand, involves delivering a component of the treatment protocol or beginning assessment after a random number of events based on an average; wherein the average number of events may include an average number of a single event (e.g., one event occurring three times) or a cumulative average number of separate events (e.g., three events occurring one time each). As would be apparent to one of skill, the number of events encompassing the average may be any positive integer, so “three” and “one” above are purely exemplary, and should not be construed as limiting the scope or spirit of the invention. Meaning, in some embodiments, the component delivery and/or assessment may be in response to a single event occurring, or a cumulative number of events occurring once, twice, three times, four times, five times, six times, seven times, eight times, nine times, etc.

[154] Finally, frequency may be continuous. In such embodiments, continuous frequency is generally limited to assessment; however, in some limited circumstances, component delivery may also be continuous. Regardless, continuous assessment is generally in the form of physiological or psychological monitoring, wherein at least one biometric is continuously monitored.

[155] That said, none of the disclosed frequency interval types should be construed as limiting the scope or spirit of the invention and, as would be apparent to one of skill, may be deployed in combination with one another in any such embodiment described herein. Meaning, in some embodiments, components and/or assessments may be completed in a fixed interval frequency, in a fixed event frequency, in a variable interval frequency, in a variable event frequency, in a continuous frequency, or as two of, as three of, as four of, or as all of the above. Thus, as a purely exemplary, non-limiting illustration, “heart rate” may be measured in a fixed interval (e.g., once every five minutes), in response to a fixed event (e.g., prior to, during, or after beginning a component; a biometric measure exceeding a threshold associated with a dangerous condition, or a biometric measure exceeding a threshold at the terminus of a “safe” range for that biometric, thus making the measure an “unsafe” measure), in a variable interval, wherein heart rate is collected an average of, e.g., 5 times per day between the hours of 8:00 am and 10:00 pm; in response to a variable event, wherein heart rate is collected an average of 3 times after the completion of two components; and/or may be continuously collected. In such an embodiment, heart rate may be collected in all of, or some of the means disclosed above. As mentioned, “heart rate” is merely an exemplary measurement disclosed in this illustrative example, and any such biometric measure, as disclosed herein, may be substituted for the same. Likewise, any such component of the treatment protocol may be substituted as the clinician, and protocol guidelines see fit.

[156] Finally, protocol history may be tracked via history fields 270. The history fields (270) may include past instances fields (272) identifying the locations of other records in the database (102) of past instances of the same protocol (having the same protocol ID 214). The history fields (270) may further include outcome scores fields (274), including an outcome score for the current protocol record (200), for the current patient (130), and an average of outcome scores for the past instances of the same protocol. Protocol history fields (270) may also include any alterations, modifications, or general changes to the protocol, as well as the outcome achieved for the patient wherein the changes were made. As disclosed in more detail below, this enables maturation of the protocol catalog with additional data collection, and improved treatment efficacy for specific patients, or populations thereof, in the future.

[157] Such stored changes include changes to the stages, including addition of other stages not initially within the protocol, removal of stages within the protocol, modification of the stages, so that the stages are lengthened or shortened; and modification to the components, including the timing of delivery, the amount of components delivered, the rate at which the patient completed the components, the amount of components completed by the patient, any components the patient neglected to complete, the success rate of successful delivery and completion by the patient, the fail rate, wherein a component was delivered to a patient but the patient declined to complete the component; general patient compliance with each stage, the maimer in which the components were delivered, and the frequency thereof; and the overall success the patient had using the protocol — wherein success is measured by the reduction in at least one symptom of the nervous system disorder the patient is diagnosed with. Such success metrics may be obtained through the use of clinical outcome assessments (COAs) which may be completed by the patient prior to, and after protocol completion. However, this is but one non-limiting way to measure success. Other success metrics known to those of skill are necessarily also within the scope and spirit of the invention, and may contribute to the success metrics stored in the history fields (270).

[158] As will be discussed more infra, such granularity allows practitioners to obtain new insights into the efficacy of a given treatment protocol, and what modifications may better treat different patients, and populations thereof. Moreover, because patient information also contains a listing of each of the protocols the patient was enrolled in, and when the patient was enrolled in them, clinicians may further extrapolate information as to how to effectively “chain” multiple protocols together to find novel protocol regimens comprising of a first protocol, followed by a second protocol and optionally a third, fourth, or fifth protocol that begins concurrently with, or after the previous protocol, to better and more effectively treat a nervous system disorder. In such embodiments, patients may discover a more significant decrease in the amount and severity of symptoms, or may have a more prolonged cessation of the same. Regardless, such granularity affords clinicians a more thorough understanding of how to effectively treat a given disorder than would be possible without use of the technology of the invention.

[159] Please note, while the treatment protocol record and personal health information (PHI) has been discussed supra, one of skill should also be made aware that personally identifiable information (PII) is additionally stored, but is stored separately from PHI and the treatment protocol records (which are themselves stored separately), and that PII and PHI are both encrypted to ensure patient security is upheld.

[160] Note, although a specific structure of a protocol record (200) has been described above, it is merely for illustrative purposes, and should not be construed as limiting the invention. As would be appreciated by one of skill, alternative structures may be substituted, and are necessarily still within the spirit of the invention as it is disclosed herein.

F Protocol Structuring Routine

[161] Referring to FIGS. 1-3, the protocol structuring routine is shown generally in FIG. 3. It will be appreciated that the protocol structuring routine (300) described below merely provides one illustrative example of a routine in accordance with an embodiment of the invention. In some embodiments, different functions and routines may be added or substituted.

[162] In some embodiments, the protocol structuring routine (300) begins with blocks 302 and 304 of codes, which direct the processor (110) to automatically select, at each of a plurality of times specified by an integration or cleansing stage, one component of the protocol, and to send the patient a notification including a suggestion to perform the one component.

[163] To achieve this, block 302 first directs the processor (110) to determine whether it is time to suggest a component of an integration or cleansing stage to a patient (130). It will be recalled that the patient calendar fields (224) of each treatment protocol record (200) may store indications of available times for the particular patient (130) to perform various components of a given stage. As a non-limiting example, the calendar fields (224) for an integration stage for a particular patient (130) may indicate that the patient (130) is available weekday evenings at 7 pm, or weekend afternoons. Block 302 directs the processor (110) to search through the database (102) to locate any treatment protocol records (200) that are identified in their protocol type fields (212) as being either cleansing or integration stages, and having patient calendar fields (224) indicating that the patient (130) has become currently available to participate in a component of the protocol. For each such identified integration or cleansing stage record (200) for which a patient (130) is currently available, the processor is directed to blocks 304 to 334 below.

[164] Following location of such a record (200) at block 302, in some embodiments, block 304 directs processor 110 to automatically select one component of the protocol to which the record (200) pertains, and to send to the relevant patient (130) a notification including a suggestion to perform the one selected component of the protocol. To achieve this, in some embodiments, block 304 directs the processor (110) to randomly select one of the plurality of components of the protocol, according to the selection weights stored in the relevant activities fields (240) for the respective components. For example, an illustrative integration stage for a particular patient (130) might involve only four of the possible components (e.g., yoga, breath work, music, and journaling), but might specify a preference for the particular patient to do yoga twice as often as each of the other three components. In this example, the breathwork fields (241), journaling fields (243), music fields (244), and yoga fields (245) would store selection weights of 0.2, 0.2, 0.2, and 0.4, respectively, and block 304 would direct processor 110 to make a weighted random selection with a 40% chance of selecting yoga, a 20% chance of selecting breathwork, a 20% chance of selecting journaling, and a 20% chance of selecting music.

[165] Upon making a weighted random selection of a component of the protocol record (200), block 304 further directs the processor to send to the patient (130) a notification including a suggestion to perform the selected component. In some embodiments, block 304 achieves this by directing the processor (110) to transmit a push notification to patient device 132 and/or 134, wherein the notification is readable and, in some embodiments, interactable via a graphical user interface operably connected to said device of the patient (130) to whom the located record (200) pertains. In such embodiments, the notification displayed via the graphical user interface operably connected to patient device 132 and/or 134 displays to patient 130 a suggestion to perform the selected component of the protocol. As a purely exemplary, non-limiting example, if the selected component was “yoga,” block 304 may direct the processor (110) to construct a notification displaying the message, “How about some yoga now?” in conjunction with displayed option buttons such as “yes” or “no,” wherein patient 130 may acquiesce by selecting the former, or decline by selecting the latter.

[166] In response to patient actuation of a displayed ‘Yes” or “No” button, in some embodiments, patient device 132 and/or 134 transmits an appropriate “acceptance” or “rejection” signal to processor 110 via network 120 which, in some embodiments, is additionally transmitted to clinician device 142 and/or 144 to notify the clinician (140) of the patient’s decision. In some embodiments, in addition to a notification that may or may not display a visual, text, or visual and text message, patient device 132 and/or 134 may also open an activity dashboard in the form of a visual graphical user interface displayed on patient device 132 and/or 134 that allows patient 130 to select and perform components of the treatment protocol in addition to, or instead of, the components that are prompted to the patient (130) via patient device 132 and/or 134. In some embodiments, a patient (130) may additionally choose to open the activity dashboard on their own volition, and choose components of the treatment protocol to complete without being prompted to do so.

[167] If at block 304 a “Yes” (acceptance) response is received from patient device 132 and/or 134 by processor 110, in some embodiments, block 306 then directs the processor (110) to increment an acceptance counter in the relevant one of the components fields (240) for the currently selected and suggested component of the protocol record (200), and to proceed to block 314 below.

[168] If at block 306 a “No” response is received from patient device 132 and/or 134 by the processor (110), or if no response is received within a predefined interval, in some embodiments, block 310 directs the processor (110) to determine whether the patient (130) has selected an alternative component of the protocol record. In some embodiments, in response to a patient selection of “No,” or a failure to respond, patient device 132 and/or 134 may use the activity dashboard to ask the patient (130) if they would like to perform a different component specified in the protocol record (200). In response to input from patient 130 selecting a different component of the protocol record (200), patient device 132 and/or 134 transmits a message to processor 110 via the network (120), including an identification of the different component selected by the patient (130). In such embodiments, block 312 may or may not direct processor 110 to increment an acceptance counter in the relevant one of the activities fields (240) for the different component of the protocol selected by the patient (130), and to proceed to block 314 below.

[169] In some embodiments, block 314 directs the processor (110) to obtain and store baseline biometric data for the patient (130), as the patient (130) begins the selected component of the treatment protocol. In some embodiments, the actual biometric input data received from the patient (130) is stored in a separate corresponding record in a medical database (106), and the patient identification number stored in the patient ID field (222) acts as a cross-reference between the protocol record (200) and the corresponding record in the medical database (106). Alternatively, if desired, the biometric data may be stored in the treatment protocol database (102), provided appropriate privacy and confidentiality safeguards are adopted.

[170] Block 314 first directs the processor (110) to begin receiving and storing each of the biometrics specified in physiological biometrics field 260 and psychological biometrics field 250 of the currently addressed protocol record (200). As a purely exemplary, non-limiting embodiment, in a “default” integration stage record (200), the contents of the resting heart rate fields (261), heart rate variability fields (262), skin temperature variability fields (263), breathing rate fields (264), and oxygen saturation (Sp02) fields (265) may all be set to “active” so that said biometric data are included in the integration stage.

[171] In some embodiments, block 314 directs the processor (110) to receive any of a plurality of biometric data, as disclosed supra from patient device 132 and/or 134, and also directs the processor (110) to receive the most recent sleep pattern data from the same, as specified by “active” contents of the sleep pattern data fields (266) of the current protocol record (200). Block 314 may then, in some embodiments, direct the processor (110) to store each of these biometric data in a record in the medical database (106) corresponding to the currently addressed protocol record (200). [172] In some embodiments, block 316 then directs the processor (110) to monitor the biometric data received from patient device 132 and/or 134 and to compare the received data to predefined thresholds associated with dangerous conditions, as well as personalized, patient-specific ranges. Meaning, as disclosed supra, the technology of the invention stores biometric information for each patient (130) including a “safe” range for each biometric that is either inputted by a clinician (140) or obtained through continuous monitoring of the patient (130), wherein the upper and lower bounds of the “safe” range contain a threshold which, when crossed, places the value in an “unsafe” range.

[173] Thus, in some embodiments, patient (130) biometric data may either be compared to a predefined threshold associated with a dangerous condition, to patient-specific safe, and unsafe values for each biometric, or a combination thereof. Herein, a biometric value is said to be indicative of a “dangerous condition” if it is within a range associated with a given physiological condition and/or indication. Non-limiting examples of such include hypoxia, hypothermia, hyperthermia, heart failure, hypoglycemia, hyperglycemia, ketoacidosis, dehydration, and other such conditions, as will be known to physicians, nurses, and other clinicians, and others of skill in the art.

[174] As a purely exemplary, non-limiting example, the patient identification fields (220) may store a maximum heart rate for the particular patient (130) (e.g., 220 minus the patient’s age), in which case block 316 may direct the processor to monitor the heart rate data received from patient device 132 and/or 134 to determine whether the current heart rate of the patient (130) exceeds the maximum heart rate stored for the patient (130). As a further example of a dangerous condition, block 316 may also direct the processor (110) to monitor skin temperature data received from patient device 132 and/or 134 and compare the received skin temperature to a predefined threshold associated with hyperthermia (e.g., 39 or 40 degrees Celsius).

[175] If at block 316 either a dangerous condition is detected from the biometric data, or a value is collected outside the “safe” range established for patient (130), block 318 directs the processor (110) to, in some embodiments, generate and send appropriate alerts to either the patient (130), the clinician (140), or both; alert the patient (130) to cease the current component, and alert both the patient and the clinician (140) to the occurrence of the dangerous condition and/or unsafe biometric measure.

[176] Block 318 directs the processor (110) to determine whether the current component of the protocol has been completed by checking each of a plurality of predefined conditions, non-limiting examples of which including block 318 directing the processor (110) to determine whether it has received a message from patient device 132 and/or 134, and/or that the patient (130) has used the activity dashboard accessible via the graphical user interface operably connected to patient device 132 and/or 134 to mark the current component of the protocol as completed. Alternatively, it may be assumed that each type of component has been completed when a predetermined characteristic time interval has elapsed since their commencement.

[177] If the current component of the protocol has not yet completed, block 322 directs the processor (110) to continue monitoring and storing biometric data received from patient device 132 and/or 134, and the processor is directed back to blocks 316 to 320 to continue monitoring the biometric data for dangerous conditions until the current component of the protocol is completed.

[178] If at block 320 it is determined that the current component of the protocol has completed, block 324 directs the processor (110) to obtain further psychological biometric data. For example, in some embodiments, the components fields (240) for each component of the protocol specify specific questions to be posed to the patient (130) upon completion of an instance of the component of the protocol, such as, “Do you feel better now?” Alternatively, block 324 may direct the processor (110) to pose further questions to the patient selected from those stored in the psychological biometrics fields (250) of the current protocol record (200).

[179] In some embodiments, block 326 then directs the processor (110) to automatically reduce a frequency at which the particular component is selected and suggested to the patient as discussed at block 304 above, in response to the processor determining that the biometric data associated with the currently completed component of the protocol satisfies a predefined adjustment condition. In this regard, the components fields (240) for each of the components of the protocol may specify specific expected ranges for physiological and psychological biometric data to satisfy for the particular component. As a non-limiting example, for a “journaling” component of the protocol, it may be expected that the patient’s resting heart rate should remain below a threshold rate and not increase by more than a threshold amount associated with an onset of anxiety, so a departure from this expectation is an example of a biometric adjustment condition.

[180] Similarly, it may be expected that the patient’s mood or disposition will not suddenly worsen after completion of the component of the protocol, so a departure from this expectation (by comparing the psychological and physiological biometric data obtained at blocks 324 and 314 above) is an example of a psychological/psychological biometrics adjustment condition. If at block 326 a physiological/psychological biometrics adjustment condition is detected, block 326 further directs the processor (110) to readjust the selection weights of the components as stored in their respective components fields (240) of the currently addressed protocol record 200. Meaning, if the journaling fields (243) of the current protocol record (200) initially specified a selection weight of, e.g., 0.2 representing a 20% chance of journaling being randomly selected and suggest at block 304, block 326 may direct the processor (110) to update the selection weights of the components fields (240) for the various components of the protocol, by reducing the selection weight of the journaling component by, e.g., 0.20 to 0.16, and then redistributing the difference of 0.04 among the suggestion weights of the other components of the protocol. Following execution of block 326, the processor is directed back to block 302.

[181] If at block 310 above the patient (130) declined to choose any component of the protocol, then block 328 directs the processor (110) to generate missed-event notifications. In some embodiments, block 328 directs the processor (110) to send such a missed-event notification only to the clinician (140) and not directly to the patient (130), in an attempt to avoid agitating and/or shaming the patient (130), either of which might deter the patient’s compliance with the protocol. In some embodiments, the processor (110) sends a missed-event notification message to the clinician (140) via a graphical interface operably connected to clinician device (144 and/or 142). In such embodiments, the graphical interface may present the clinician (140) with options, such as but not limited to whether to telephone the patient, or manually adjust the selection weights of the components of the protocol.

[182] Block 330 then directs the processor (110) to increment a rejection counter stored in the relevant activities fields 240 for the component that was suggested to the patient above at block 304.

[183] In some embodiments, blocks 332 and 334 then direct the processor (110) to automatically reduce a frequency at which a particular component is selected and included in the suggestion at block 304 in response to the processor (110) detecting repeated non-completion of the particular component. Said another way, in some embodiments, repeated rejection by the patient (130) of a particular component causes the weight assigned to the component to decrease, lowering the frequency with which the component is suggested.

[184] In some embodiments, this is accomplished by block 332 directing the processor (110) to determine whether a rejection threshold has been exceeded for the component that was suggested to the patient at block 304. More specifically, block 332 directs the processor (110) to compare an acceptance counter and a rejection counter stored in the components fields (240) of the component that was suggested to the patient at block 304. In some embodiments, if the total rejection percentage exceeds a first threshold, or if the rejection percentage in the most recent time period exceeds a second threshold, block 332 directs the processor (110) to decrease the selection weight of the component that was suggested at block 304. This reduction may be achieved in the same way as described above in connection with block 326, for example. Following a reduction of the selection weight of the rejected component at block 334, the processor (110) is directed back to block 302.

[185] If at block 302 there are no more current component suggestions to be made to patients 130, block 336 then directs the processor (110) to determine whether it is time for one or more psychological and/or physiological biometric assessments. In this regard, for a particular protocol record (200), the psychological biometrics fields (250) for one or more of the available types of psychological biometric assessments may be set active so that they are included in the protocol, and the patient’s calendar (224) may include an indication of times at which the patient (130) should be prompted to provide specific psychological biometric input for each one of the selected assessment types. Block 336 directs the processor (110) to search the database (102) for any records (200) for which it is time to solicit psychological biometric inputs from the patient, and upon locating any such records at block 336, block 338 directs the processor (110) to prompt the patient (130) to provide the specified psychological biometric inputs, such as answers to specific questions.

[186] In some embodiments, if at block 336 no further records (200) are identified for which it is time to request psychological biometric input, block 340 directs the processor (110) to determine whether any medicine stage components are commencing or are in progress. As a purely exemplary, non-liming embodiment, a medicine stage requiring administration of an active agent may involve the patient (130) visiting one of the clinicians (140) to undergo administration of the active agent by the clinician and within the supervised confines of the clinic.

[187] Upon detecting such a medicine stage component commencing or in progress at block 340, block 342 directs the processor (110) to begin receiving and storing, in the treatment protocol database (102), physiological and psychological biometric data representing at least one biometric of the patient (130) while the patient is participating in the medicine stage component. In some embodiments, the processor (110) receives the biometric data from patient device 132 and/or 134. [188] Block 344 then directs the processor (110) to detect any one of a plurality of predefined conditions from the received biometric data. In some embodiments, detecting a predefined condition may include determining that the current biometric data deviates from a desired range for the current component of the medicine stage by more than a predefined threshold. Thus, as a non-limiting example, detecting predefined conditions may include detecting any of the dangerous conditions described above in connection with block 316, such as critically high heart rate or skin temperature; or may include at least one biometric measure crossing the threshold at the terminus of the “safe” range of biometrics into the “unsafe” range. Additionally, the predefined conditions may include conditions which, though not “dangerous,” or categorized as “unsafe,” may nevertheless warrant intervention by the clinician (e.g., a heart rate elevated above rest levels but also below the patient’s maximum heart rate may suggest patient anxiety, suggesting that a calming intervention may be desirable).

[189] Upon detecting any such predefined condition at block 344, in some embodiments, block 346 directs the processor (110) of technological device 100 to automatically alert a clinician (140) overseeing the current component of the medicine stage, in response to the processor (110), and sending an alert message to the clinician device (142) and/or (144) via the network (120). In some embodiments, the alert includes an identification of the cause of the alert (e.g., elevated heart rate), and a predefined suggested intervention corresponding to the identified cause (e.g., reassure the patient verbally, or change to more soothing background music).

[190] Block 348 directs the processor (110) to determine whether the medicine stage component has concluded and, if not, the processor (110) may be directed back to block 342 to continue monitoring psychological and physiological biometric data and checking for intervention conditions as described at blocks 344 and 346.

[191] If at block 348 it is determined that the medicine stage component has completed, block 350 directs the processor (110) to determine whether all protocols in the database (102) have been fully completed. If not, the processor is directed back to blocks 302, 336 and 340 to continue structuring various components and assessments while continually monitoring the patient’s (130) biometrics, as described above.

G. Geographic Location Identification

[192] Attention should now be directed to FIG. 15, which illustrates an exemplary flow of information from the patient (130/1501) and the patient device (132 and/or 134) to the clinician (140/1508) and the clinician device (142 and/or 144), wherein geographic location data is obtained from patient 130/1501 and transmitted to clinician 140/1508.

[193] Herein, “geographic location” or “geolocation” refers to the precise coordinates of the patient within a standard of error known to those of skill. Meaning, the patient’s geographic location is the most precise location of the patient possible given certain characteristics, including satellite availability, cloud cover, clearance (e.g., in areas with tall buildings, many trees, etc.). Further, herein, “geographic location” or “geolocation” refers to location obtained via GPS, and assisted GPS (AGPS), as is discussed in more depth infra. Meaning, when referencing geolocation data, said data may be obtained via GPS, AGPS, a combination thereof, or location services that are neither GPS or AGPS. Thus, all such location services capable of determining one’s geographic location are within the scope and spirit of the invention as disclosed herein.

[194] In some embodiments, the patient device (132 and/or 134) continuously monitors the geographic location of patient 130/1501 via data communication between the patient device (132 and/or 134) and satellite 1502, illustrated via 1506. In such embodiments, clinician 140/1508 may query technological device 100 (1504) via network 120 (as illustrated via 1505), and request the geographic location data from patient 130/1501. To do so, technological device 100 (1504) — which is in data communication with both clinician device 142 and/or 144 and patient device 132 and/or 134 — requests the geographic data obtained via satelite 1502 from patient device 134 and/or 132 via network 120 (as illustrated via 1503), and transmits said information to clinician 140/1508 via network 120, (as illustrated via 1505)

[195] In some embodiments, patient 130/1501 must allow clinician 140/1508 to obtain the patient’s geographic location. In such embodiments, the patient may either approve of continuous location tracking, wherein clinician 140/1508 may query patient 130/1501’s location at any time; or may elect to approve each individual location-request query that clinician 140/1508 initiates. In some embodiments, the initial location-tracking approval may appear as a notification on a graphical user interface operably connected to the patient (130/1501)’s device (134 and/or 132), in embodiments wherein patient 130/1501’s device (134 and/or 132) contains such a graphical user interface.

[196] In embodiments wherein patient 130/1501’s device (134 and/or 132) does not contain a graphical user interface, the patient may approve or decline continuous location tracking when enrolling in the treatment protocol, using the technology of the invention. Likewise, in embodiments wherein patient 130/1501’s device (134 and/or 132) does contain a graphical user interface, patient 130/1501 may also approve of or reject continuous tracking when enrolling in the treatment protocol, using the technology of the invention.

[197] Regardless of whether or not patient 130/1501 approves of or rejects continuous geographic location tracking, patient 130/1501 will, in some embodiments, be alerted via a notification viewable on the graphical user interface of patient device (132 and/or 134) so long as patient device (132 and/or 134) contains a graphical user interface, if/when clinician 140/1508 attempts to query geolocation data from patient 130/1501 via network 120 (1503 and 1505) and technological device 100 (1504).

[198] The difference is that, in embodiments wherein patient 130/1501 approves of continuous geolocation tracking, either when enrolling in the treatment protocol, or upon the first such location query initiated by clinician 140/1508, patient 130/1501 will merely see a notification alerting patient 130/1501 that clinician 140/1508 is monitoring their current location.

[199] In contrast, in embodiments wherein patient 130/1501 rejects continuous monitoring either when enrolling into the treatment protocol, or upon the first-such geolocation query attempt made by clinician 140/1508; when clinician 140/1508 requests to track the location of patient 130/1501, patient 130/1501 will receive a notification requesting approval for geolocation tracking via the graphical user interface operably connected to patient device 132 and/or 134, in embodiments wherein a graphical user interface is operably connected to patient device 132 and/or 134.

[200] In such embodiments, the patient may then either approve of or deny the request for geolocation monitoring. If the patient approves of geolocation monitoring, the geographic location of the patient — determined by satellite 1502 in data communication with patient device 132 and/or 134 (as illustrated via 1506) — will be sent via network 120 (1503) to technological device 100 (1504) and then from technological device 100 (1504) to clinician 140/1508 via network 120 (1505).

[201] If the patient (130/1501) denies the request, clinician 140/1508 will be unable to track the geographic location of patient 130/1501 unless certain criteria are met. Likewise, in embodiments wherein patient 130/1501 rejects continuous monitoring when enrolling in the treatment protocol, or rejects continuous monitoring upon the first-such geolocation query attempt made by clinician 140/1508, clinician 140/1508 will be unable to query the geographic location of patient 130/1501 unless certain criteria are met.

[202] As it relates to such criteria, in some embodiments, wherein at least one biometric is continuously monitored by patient device 132 and/or 134, and said biometric is outside of the “safe” range determined for that patient, or is characteristic of a “dangerous condition,” as disclosed supra, clinician 140/1508 may override patient 130/1501’s refusal to allow clinician 140/1508 to view patient 130/1501’s geographic location. In such embodiments, if patient device 132 and/or 134 contains a graphical user interface operably connected to the same, such graphical user interface will display a notification that alerts patient 130/1501 that at least one biometric is currently in a range deemed “unsafe” for the patient (130/1501), or is characteristic of a dangerous condition and, as a result, clinician 140/1508 will have access to patient 130/1501’s geographic location. In such embodiments, patient 130/1501 may be reassured via the same notification that once the at least biometric returns to a value within the “safe” range for patient 130/1501, clinician 140/1508 will again be unable to view patient 130/1501’s geographic location without patient 130/1501’s consent.

[203] In embodiments wherein patient device 132 and/or 134 does not have a graphical user interface capable of communicating notifications to patient 130/1501, patient 130/1501 may receive a text message and/or email — so long as patient 130/1501 provided a valid phone number and/or email address when enrolling for the treatment protocol — alerting patient 130/1501 that clincican 140/1508 may currently be monitoring patient 130/1501’s geographic location due to at least one biometric being in the “unsafe” range, or characteristic of a dangerous condition, and that clinician 140/1508 will have the ability to monitor patient 130/1501’s geographic location until the at least one biometric returns to a value within the safe range for the patient, or that is no longer characteristic of a dangerous condition (130/1501)

[204] Note, while FIG. 15 illustrates geographic location determination via patient device 132 and/or 134 being in data communication with a single satellite (1502), this is merely for illustrative purposes. As would be apparent to one of skill, to obtain accurate geographic location data, a plurality of GPS satellites may be utilized, including at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or more than 9 satellites. Furthermore, to obtain geographic location data in real time, patient device 132 and/or 134 may, in some embodiments, utilize AGPS.

[205] As would be apparent to one of skill, assisted global position system (AGPS), refers to geographic location determination via a combination of a device’s cellular network-determined location, in addition to traditional GPS data gathered by triangulation from satellites in orbit (Hildenbrand, 2020).

[206] Broadly, and without being limited by theory, location determination on a cellular network works similarly to that of GPS. Both enable location tracking through triangulation, wherein an individual is monitored by at least three separate structures in data communication with the individual’s GPS/cellular-enabled device. As would be apparent to one of skill, in the case of cellular triangulation, the “structures” are cellular towers; while, in the case of GPS, the “structures” are satellites.

[207] The main difference is the distance between the individual and the triangulating “structures,” as well as the signal sent between the same. GPS satellites send radio signals that travel at a specific frequency and are receivable by a GPS-enabled device. Through the use of the internal atomic clock inherent to all GPS satellites, a set of at least three satellites may accurately determine the position of a device based on the time it took each signal to reach the device, and what specific satellites it received said signal from (Hildenbrand, 2020).

[208] However, while necessarily a powerful tool, the accuracy of GPS location tracking is limited by time, and the number of unobstructed satellites in data communication with the device. As it relates to the former, GPS satellites run on rechargeable batteries and, as a result, must conserve energy to the most practical extent. So, the signals transmitted to compatible devices are of a lower speed and, because of this, it may take up to 60 seconds to accurately determine one’s geographic location through the use of GPS alone (Hildenbrand, 2020).

[209] Using GPS alone to locate a moving target can thus be inefficient. To increase the speed and granularity of the process, if a device is in data communication with at least one cellular tower, that data can assist GPS satellites (AGPS) in locating the device. This effectively works via software on the device feeding the cellular triangulation data (i.e., information regarding which towers the device is connected to and the signal strength of the same) to the GPS receiver on the GPS satellite, which will utilize that data to periodically switch between cellular network data and GPS location data in attempt to accurately determine the device’s location in real time.

[210] As mentioned, as used herein, “GPS” broadly refers to the use of GPS, AGPS, and geographic location services that are neither GPS, nor AGPS. Thus, in some embodiments, “GPS” refers to patient device 132 and/or 134 utilizing only GPS, only AGPS, using both GPS and AGPS, using GPS and another service, using AGPS and another service, or using neither GPS nor AGPS, depending on a plurality of factors. In such embodiments, the plurality of factors may include, but are not limited to, whether or not the device is in range of cellular towers of a sufficient strength and number to triangulate the device and offer sufficient location data to a GPS receiver, any battery optimization that restricts location services, device-specific settings set by the user to restrict/expand certain functions of the device based on certain privacy, security, power-optimization, or other such concerns; and any other such factors known to those of skill.

H. Alternatives

[211] As stated, the above description is merely illustrative, and should not be construed as limiting. As would be appreciated by those of skill, other ways of structuring cleansing and integration stages, as well as other ways of monitoring the medicine stage, may necessarily be substituted, and are certainly within the spirit of the invention.

[212] Although blocks 342 to 346 describe generating alert notifications during a medicine stage component containing an active agent in response to biometric information, such notifications may, alternatively, be generated in response to physiological biometric and/or psychological biometric information in a manner similar to that described above in connection with block 326.

[213] Although the above-described embodiments involve psychological biometric information being extracted from patients (130) primarily through questioning, other means of obtaining psychological biometric data may be substituted. As a non-limiting example, journal entries or recorded audio speech or video recordings of the patient may be analyzed by a Machine Learning (ML) algorithm to automatically detect a sentiment or mood of the patient 130.

[214] Note, as mentioned, the integration and cleansing stages discussed above are applicable to treatment protocols including, or not including, dosing of an active agent which may or may not be a psychedelic agent. As a result, one should not read the foregoing disclosure as limiting the invention to treatment protocols including, or not including the same.

[215] In one aspect, reference to the technology of the invention delivering to the patient specific information related to an assigned protocol, including the beginning of particular stages, completion of components, or any other such instructions, is a reference to the clinician instructing the technology of the invention to deliver such information. Meaning, the technology of the invention will independently deliver suggestions to the patient to, e.g., complete components of a specific protocol or stage thereof, or may automatically restrict the components able to be delivered to the patient via the patient device when geographic location data necessitates such. However, in some embodiments of the aspect, all modifications, alterations, restrictions, additions, etc., are first approved by the clinician for a specific patient assigned to a specific treatment protocol. Moreover, in some embodiments of the aspect, all such protocol assignments, and terminations thereof, including the specific stage in which the patient is enrolled into, and if/when the patient may move from one stage to the next, is made by the clinician.

[216] Thus, in some embodiments of the aspect, while the technology of the invention may be programmed to leam a patient’s habits, routines, and preferences; and modify its component delivery based on such acquired knowledge (including the specific components delivered, and the frequency thereof), the clinician will determine, prior to beginning the treatment protocol and at any subsequent point therefrom, the degree to which the technology of the invention is able to make modifications, and what modifications the technology of the invention is able to make.

[217] Specifically, in some embodiments of the aspect, after enrolling a patient into at least one treatment protocol and assigning them to a stage within the protocol with pre-selected components, the clinician may determine the frequency of component delivery, and how such delivery is determined (e.g., whether they are event-driven, scheduled, etc.). The technology of the invention may then, in some embodiments, be programmed to additionally take into consideration additional data — including physiological and/or psychological biometric data, and geographic location data — to modify the established component delivery routine. However, the technology of the invention will not assign a protocol to a patient, move a patient from one stage of a protocol to another, or deliver to the patient component not selected by the clinician as a component that may be delivered without express consent and instruction by the clinician.

[218] As mentioned, the embodiment above is but one aspect of the invention disclosed herein, and should not be construed as limiting the full scope and spirit of the invention in any way.

[219] In addition to the embodiments described above, it is contemplated that any one or more features of any particular embodiment may be combined with any one or more features of any other embodiment, except where such features have been explicitly described as mutually exclusive alternatives.

[220] Again, while specific embodiments of the invention have been described and illustrated, such embodiments should merely be considered illustrative, and not as limiting the invention as construed in accordance with the accompanying claims.

I. Form Building and Creation

[221] As described supra, the technology of the invention may be integrated in at least one technological device, such that a patient may be continuously monitored, a practitioner may access information to view patient progress, and/or a system administrator may review, add, remove, and modify treatment protocols and practitioner information. Below, such backend management is expanded upon and further detailed. Attention should now be paid to FIGS. 4-14, which illustrate views of the technology of the invention’s forms, as would be viewed by a clinician and/or global administrator on a screen reproducing information from a technological device integrated with the technology of the invention.

[222] As illustrated in FIG. 4, a global administrator is capable of viewing, editing, removing, and searching the protocol database. FIG. 4 specifically illustrates a form detailing protocol authors (401), wherein a table in the center of the form contains information pertaining to the protocol ID (402), which is a unique identifier for each individual protocol; the author’s legal name (403), and the company sponsoring the protocol (404), which is also likely where the author works. As is evident by viewing FIG. 4, a global administrator may add new information to the aforementioned table (405), may edit the information within the aforementioned table (406), may delete information in the aforementioned table (407), and may search for additional information (408).

[223] Administrators also have the ability to modify information much more granularly, including which information is viewable by practitioners/patients, as well as what that information entails. As highlighted in FIG. 5, the “Edit Author” form (501) allows administrators to modify the author’s name (503), their unique identifier (502), the company name (504) the end user legal agreement (EULA) (505), information about the authors themselves in a “meet the authors” section (506); a preview window, illustrating the author name, and whether a photo has been uploaded (507), the company logo (508), and whether the information is viewable by a practitioner/patient. Specifically, whether or not the company name (509), EULA (510), meet the authors section (511), and/or company logo (512) is viewable outside of the administrator portal.

[224] As it relates to author information specifically, the preview box of 507 is editable specifically in the form highlighted in FIG. 6, titled the “new author details” form (601), wherein an author’s first name (602), last name (603), and photo (604) may be uploaded from a file stored on the technological device integrated with the technology of the invention (i.e., technological device 101) (605).

[225] Protocols themselves are detailed in FIG. 7 (701), and are accessible to a global administrator via a form containing general protocol information, including the unique ID for the given protocol (702), the protocol name (703), the active drug (704) involved in the protocol, as well as its corresponding dosage (705), if applicable; the author name (706), the account number (707), the internal protocol ranking (708), and the protocol status (709). As would be apparent to one of skill viewing the form illustrated in FIG. 7, such information can be added (710), edited (711), and/or deleted (712). Specific information may also be searched for (713), and the history (714) of the protocol, including any changes over time, who was assigned to the protocol, successes, etc., may also be assessed.

[226] New protocols can be added and modified in the “new protocol template,” which is first detailed in FIG. 8, and continues through FIG. 10. Each of the three figures outline a separate component of the protocol template (801) form, including claims and criteria (802) and FIG. 8, protocol activities (803) and FIG. 9, and training and support (804) FIG. 10. On the claims and criteria form (802 and 805) and FIG. 8, a global administrator may add in protocol claims (810), screening criteria (811) to determine whether or not a patient may participate in that specific protocol, including, e.g., medical history, psychiatric evaluation, substance misuse history, comorbid conditions, prescribed medication use, nursing, pregnancy, and physical fitness; outline specialized therapist skillsets necessary or advantageous for that specific treatment protocol (812), e.g., experience with psychedelic-assisted therapy, experience with administering active agents, experience guiding patients through an active agent dosing session, experience working with vulnerable populations, experience working with those with comorbid conditions, experience working with those diagnosed with nervous system disorders, and experience working with those with addictions; common side effects experienced by other patients undergoing the treatment protocol (813), e.g., dry mouth, constipation, irritability, indigestion, drowsiness, dizziness, diaphoresis, insomnia, fatigue, mood swings, increased appetite, decreased appetite, decreased libido, increased libido, headache, chest pain, elevated heart rate, increased blood pressure, decreased blood pressure, altered heart rate variability, painful urination etc., and — as with FIG. 5 detailed supra, whether or not the various information is visible to a practitioner/patient, including the protocol claims (806), the screening criteria (807), the specialized therapist skillset (808), and the common side effects (809). Finally, a system administrator may either move on to the next form (814) detailed in FIG. 9, or save a draft outlining the current information (815).

[227] In FIG. 9, the protocol activities form (903), allows system administrators to edit the protocol name (917), add in information as to when the protocol was created (906), its internal ranking (905), whether it is billable or not (907), the protocol icon (908), which is an identifying image associated with the protocol; the author of the protocol (909), information pertaining to the specifics of the protocol (910), including the components associated with that protocol, the protocol’s duration, the specific treatment steps and a target schedule for completing the same, etc.; any conditions particularly well suited for treatment under that protocol (911), the active drug administered during the protocol, if applicable (912), the status of the protocol, i.e., whether it is active or inactive (where “active” refers to whether or not it may be assigned to a patient); and the protocol agenda (914).

[228] Additionally, as illustrated by 918, 919, and 920, FIG. 9’s form highlights three of the stages discussed supra — the cleansing stage, medicine stage, and integration stage, respectively, which can be further expanded and wherein a practitioner may specify certain requirements/suggestions to accompany the protocol. As a non-limiting, purely illustrative example, the cleansing stage (918) may include, in some embodiments, a list of medication or substances that should either be avoided or abstained from, including tobacco, alcohol, painkillers/opiates, SSRIs, and other such prescription and non-prescription substances. In addition, the cleansing stage (918) may include, in some embodiments, activities that can accompany the cleanse, such as but not limited to yoga, aerobic exercise, music, and breathwork.

[229] The medicine stage (919), on the other hand, may include information regarding the date of the appointment, the time at which the individual should arrive, the expected duration of the appointment, and, in some embodiments, may additionally include a test dosage, a therapeutic dosage, and notes regarding a dosing protocol. In embodiments wherein dosing or a medical visit is required, the medical stage (919) further includes information for set and setting, wherein the specific location — be it clinical or non-clinical, as would be apparent to one of skill and specified by the treatment protocol assigned to the patient — is outlined. Additionally, separate “setting conditions” are present which include, but are not limited to, music, aromatherapy, snacks/beverages, water, eyeshades, sheets, blankets, and pillows; emesis bin, facilitator forms, dark room, additional towels, pre-dosing bathroom break, writing and art supplies, audio recording of the session, headphones, and availability of rescue medication. When accessed by a clinician, the medical stage (919) information section will provide guidance for each of the above metrics, and more in some embodiments, which will in turn instruct a clinician to create the proper setting for the patient during the active agent, or non-active agent (regardless of whether the active agent is or is not a psychedelic active agent) dosing session.

[230] As mentioned, information regarding the integration stage (920) may also be found, which, in some embodiments, includes information regarding integrating a medical dosing stage with the treatment protocol assigned to the patient via, inter alia, techniques to promote mental wellbeing and prolong the effects of the treatment. Such techniques include, but are not limited to, yoga, aerobic exercise, music, and breathwork. When viewing the integration stage information tab (920), a clinician will also have the ability to schedule a time for each technique, and may integrate those into components of the treatment protocol to be completed by the patient through suggestions delivered via technological device 100 to patient device 132 and/or 134, as disclosed supra.

[231] However, it should be noted, as would be apparent to one of skill, the specific techniques, requirements, etc., for each of the cleansing (918) medicine (919) and integration (920) stages should not be construed as mutually exclusive to those stages. Each treatment protocol a patient is enrolled in has, by definition, been shown to be efficacious in treating at least one nervous system disorder. However, as each patient is different and has their own unique circumstances and requirements, a clinician may add, remove, modify, mix-and-match, or otherwise alter the techniques/requirements of each stage. Meaning, in some embodiments, it may be beneficial to include requirements for the cleansing protocol during the integration stage. Likewise, it may be prudent to incorporate integration techniques into either of, or both of, the medicine and cleansing stages. Such is ultimately at the discretion of the clinician and their expertise.

[232] As with FIG. 8, once the administrator completes the form, they may either save a draft containing the information already filled in for that part of the new protocol template form (916), or may move on to the next form (915).

[233] Finally, as it relates to the new protocol template (1001), the last form is the training and support form (1003 and 1005). This form details information about opportunities for clinicians to receive training relevant to that specific therapy protocol, and how to best help their patients. Specifically, preparation support (1011), information pertaining to guiding the psychedelic journey (1012), how to better prepare the patient for integration (1013), means of better supporting integration as a whole (1014), various additional educational resources (1015), and whether or not to include the aforementioned items in the protocol — including whether to include preparation support (1006), guiding the psychedelic journey (1007), preparing the patient for integration (1008), integration support (1009), and education resources (1010). Lastly, once the administrator has completed such actions, the administrator may then save a draft of the protocol template (1017), and/or save the completed protocol.

[234] FIG. 11 further illustrates protocol management/organizational tools (1101), wherein a clinician may select a clinic (1102 and 1113) and review its available protocols (1103). Specifically, details include the protocol name (1107), its amount of active users (1108), the amount of lifetime users (1109), whether or not it is billable (1110), the expiry date (1111), and protocol assignment (1112). An administrator may then review the available information and assign a protocol to a given clinic (1104), unassign the same (1106), or search for additional protocols (1105).

[235] FIG. 12 offers the ability to assign a protocol (1201). Administrators will be able to choose the protocol they would like to assign (1202), select an expiration date for the protocol (1203), and save the selection (1204). FIG. 13, on the other hand, illustrates the protocol catalog (1301), including available protocols (1302), which includes the protocol name, the authors, and information about the authors; as well as a listing of all protocols (1303), which offers the same view as the available protocols section (1302), while additionally containing information (protocol name, authors, and information about the authors) for all of the protocols. Finally, FIG. 14 allows an administrator to add a clinician (termed “practitioner”) (1401). At step 1402, a clinician may be chosen, while an expiration date may be chosen for such assignment at 1403. The administrator may then either save (1404) or cancel (1405) the assignment.

./. Patient Information Security

[236] In all embodiments discussed herein, if at any point patient personal identifiable information (PII) is collected and stored by the technology of the invention, as mentioned, such information is tokenized for anonymity so that a threat actor will be unable to identify the patient and/or their personal information. As mentioned, this information is stored separately from personal health information (PHI) and the treatment protocol records — which are themselves also stored separately. Further, any such collected data is completed within HIPAA and GDPR standards, the patient’s data is always stored in the patient’s country, and the technology of the invention only collects the data necessary to provide the best care and user experience. In some preferred embodiments when any such data is allowed to be processed and/or analyzed, for example by or within machine learning algorithms for the optimization of one or more tools or procedures disclosed herein, federated database systems (FDBS), federated data models (FDM), and/or federated learning models are utilized.

K. Uses in Treatment of Nervous System Disorders

[237] As mentioned, the technology of the invention allows a practitioner to enroll a plurality of patients into at least one treatment protocol, and to continuously monitor the progress of the patient as they traverse the same. Such protocols can be tailored to the treatment of nervous system disorders, which refer to any disease of the central nervous system (CNS) (brain, brainstem, spinal cord, and cerebellum), the peripheral nervous system (PNS) (including cranial nerves), and the autonomic nervous system (ANS) (parts of which are located in both central and peripheral nervous system). Neurodegenerative disorders refer to a type of neurological disease marked by the loss of nerve cells, including, but not limited to, Alzheimer's disease, Parkinson's disease, frontotemporal dementia, multiple sclerosis, amyotrophic lateral sclerosis, tauopathies (including frontotemporal dementia), multiple system atrophy, and Huntington's disease. Examples of neurological diseases include, but are not limited to, headache, stupor and coma, dementia, seizure, sleep disorders, trauma, infections, neoplasms, neuro-ophthalmopathy, movement disorders, demyelinating diseases, spinal cord disorders, and disorders of peripheral nerves, muscle and neuromuscular junctions. Addiction and mental illness, include, but are not limited to, bipolar disorder, depression and schizophrenia, are also included in the definition of CNS diseases. Further examples of neurological diseases include acquired epileptiform aphasia; acute disseminated encephalomyelitis; adrenoleukodystrophy; agenesis of the corpus callosum; agnosia; Aicardi syndrome; Alexander disease; Alpers' disease; alternating hemiplegia; Alzheimer's disease; amyotrophic lateral sclerosis; anencephaly; Angelman syndrome; angiomatosis; anoxia; aphasia; apraxia; arachnoid cysts; arachnoiditis; Amold-Chiari malformation; arteriovenous malformation; Asperger syndrome; ataxia telangiectasia; attention deficit hyperactivity disorder; autism; autonomic dysfunction; back pain; Batten disease; Behcet's disease; Bell's palsy; benign essential blepharospasm; benign focal amyotrophy; benign intracranial hypertension; Binswanger's disease; blepharospasm; Bloch Sulzberger syndrome; brachial plexus injury; brain abscess; brain injury; brain tumors (including glioblastoma multiforme); spinal cord tumor; Brown-Sequard syndrome; Canavan disease; carpal tunnel syndrome (CTS); causalgia; central pain syndrome; central pontine myelinolysis; cephalic disorder; cerebral aneurysm; cerebral arteriosclerosis; cerebral atrophy; cerebral gigantism; cerebral palsy; Charcot-Marie-Tooth disease; chemotherapy-induced neuropathy and neuropathic pain; Chiari malformation; chorea; chronic inflammatory demyelinating polyneuropathy (CIDP); chronic pain; chronic regional pain syndrome; Coffin Lowry syndrome; coma, including persistent vegetative state; congenital facial diplegia; corticobasal degeneration; cranial arteritis; craniosynostosis; Creutzfeldt-Jakob disease; cumulative trauma disorders; Cushing's syndrome; cytomegalic inclusion body disease (CIBD); cytomegalovirus infection; dancing eyes-dancing feet syndrome; Dandy-Walker syndrome; Dawson disease; De Morsier's syndrome; Dejerine-Klumpke palsy; dementia; dermatomyositis; diabetic neuropathy; diffuse sclerosis; dysautonomia; dysgraphia; dyslexia; dystonias; early infantile epileptic encephalopathy; empty sella syndrome; encephalitis; encephaloceles; encephalotrigeminal angiomatosis; epilepsy; Erb's palsy; essential tremor; Fabry's disease; Fahr's syndrome; fainting; familial spastic paralysis; febrile seizures; Fisher syndrome; Friedreich's ataxia; frontotemporal dementia and other “tauopathies”; Gaucher's disease; Gerstmann's syndrome; giant cell arteritis; giant cell inclusion disease; globoid cell leukodystrophy; Guillain-Barre syndrome; HTLV-1 associated myelopathy; Hallervorden-Spatz disease; head injury; headache; hemifacial spasm; hereditary spastic paraplegia; heredopathia atactica polyneuritiformis; herpes zoster oticus; herpes zoster; Hirayama syndrome; HIV-associated dementia and neuropathy (see also neurological manifestations of AIDS); holoprosencephaly; Huntington's disease and other polyglutamine repeat diseases; hydranencephaly; hydrocephalus; hypercortisolism; hypoxia; immune-mediated encephalomyelitis; inclusion body myositis; incontinentia pigmenti; infantile phytanic acid storage disease; Infantile Refsum disease; infantile spasms; inflammatory myopathy; intracranial cyst; intracranial hypertension; Joubert syndrome; Keams-Sayre syndrome; Kennedy disease; Kinsboume syndrome; Klippel Fed syndrome; Krabbe disease; Kugelberg-Welander disease; kuru; Lafora disease; Lambert-Eaton myasthenic syndrome; Landau-Kleffher syndrome; lateral medullary (Wallenberg) syndrome; learning disabilities; Leigh's disease; Lennox-Gastaut syndrome; Lesch-Nyhan syndrome; leukodystrophy; Lewy body dementia; lissencephaly; locked-in syndrome; Lou Gehrig's disease (aka motor neuron disease or amyotrophic lateral sclerosis); lumbar disc disease; lyme disease-neurological sequelae; Machado-Joseph disease; macrencephaly; megalencephaly; Melkersson-Rosenthal syndrome; Menieres disease; meningitis; Menkes disease; metachromatic leukodystrophy; microcephaly; migraine; Miller Fisher syndrome; mini-strokes; mitochondrial myopathies; Mobius syndrome; monomelic amyotrophy; motor neurone disease; moyamoya disease; mucopolysaccharidoses; multi-infarct dementia; multifocal motor neuropathy; multiple sclerosis and other demyelinating disorders; multiple system atrophy with postural hypotension; muscular dystrophy; myasthenia gravis; myelinoclastic diffuse sclerosis; myoclonic encephalopathy of infants; myoclonus; myopathy; myotonia congenital; narcolepsy; neurofibromatosis; neuroleptic malignant syndrome; neurological manifestations of AIDS; neurological sequelae of lupus; neuromyotonia; neuronal ceroid lipofuscinosis; neuronal migration disorders; Niemann-Pick disease; O'Sullivan-McLeod syndrome; occipital neuralgia; occult spinal dysraphism sequence; Ohtahara syndrome; olivopontocerebellar atrophy; opsoclonus myoclonus; optic neuritis; orthostatic hypotension; overuse syndrome; paresthesia; Parkinson's disease; paramyotonia congenita; paraneoplastic diseases; paroxysmal attacks; Parry Romberg syndrome; Pelizaeus-Merzbacher disease; periodic paralyses; peripheral neuropathy; painful neuropathy and neuropathic pain; persistent vegetative state; pervasive developmental disorders; photic sneeze reflex; phytanic acid storage disease; Pick's disease; pinched nerve; pituitary tumors; polymyositis; porencephaly; Post-Polio syndrome; postherpetic neuralgia (PHN); postinfectious encephalomyelitis; postural hypotension; Prader-Willi syndrome; primary lateral sclerosis; prion diseases; progressive; hemifacial atrophy; progressive multifocal leukoencephalopathy; progressive sclerosing poliodystrophy; progressive supranuclear palsy; pseudotumor cerebri; Ramsay-Hunt syndrome (Type I and Type II); Rasmussen's Encephalitis; reflex sympathetic dystrophy syndrome; Refsum disease; repetitive motion disorders; repetitive stress injuries; restless legs syndrome; retrovirus-associated myelopathy; Rett syndrome; Reye's syndrome; Saint Vitus Dance; Sandhoff disease; Schilder's disease; schizencephaly; septo-optic dysplasia; shaken baby syndrome; shingles; Shy-Drager syndrome; Sjogren's syndrome; sleep apnea; Soto's syndrome; spasticity; spina bifida; spinal cord injury; spinal cord tumors; spinal muscular atrophy; stiff-person syndrome; stroke; Sturge-Weber syndrome; subacute sclerosing panencephalitis; subarachnoid hemorrhage; subcortical arteriosclerotic encephalopathy; sydenham chorea; syncope; syringomyelia; tardive dyskinesia; Tay-Sachs disease; temporal arteritis; tethered spinal cord syndrome; Thomsen disease; thoracic outlet syndrome; tic douloureux; Todd's paralysis; Tourette syndrome; transient ischemic attack; transmissible spongiform encephalopathies; transverse myelitis; traumatic brain injury; tremor; trigeminal neuralgia; tropical spastic paraparesis; tuberous sclerosis; vascular dementia (multi-infarct dementia); vasculitis including temporal arteritis; Von Hippel-Lindau Disease (VHL); Wallenberg's syndrome; Werdnig-Hoffman disease; West syndrome; whiplash; Williams syndrome; Wilson's disease; and Zellweger syndrome; and mental health conditions which include, but are not limited to, anxiety disorders (e.g., acute stress disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, separation anxiety disorder, social phobia, and specific phobia), childhood disorders, (e.g., attention-deficit/hyperactivity disorder, conduct disorder, and oppositional defiant disorder), eating disorders (e.g., anorexia nervosa and bulimia nervosa), mood disorders (e.g., depression, bipolar disorder I and II, cyclothymic disorder, dysthymic disorder, and major depressive disorder), personality disorders (e.g., antisocial personality disorder, avoidant personality disorder, borderline personality disorder, dependent personality disorder, histrionic personality disorder, narcissistic personality disorder, obsessive-compulsive personality disorder, paranoid personality disorder, schizoid personality disorder, and schizotypal personality disorder), psychotic disorders (e.g., brief psychotic disorder, delusional disorder, schizoaffective disorder, schizophreniform disorder, schizophrenia, and shared psychotic disorder), substance-related disorders (e.g., alcohol dependence or abuse, amphetamine dependence or abuse, cannabis dependence or abuse, cocaine dependence or abuse, hallucinogen dependence or abuse, inhalant dependence or abuse, nicotine dependence or abuse, opioid dependence or abuse, phencyclidine dependence or abuse, and sedative dependence or abuse), adjustment disorders, autism, Asperger's disorder, delirium, dementia, multi-infarct dementia, learning and memory disorders (e.g., amnesia and age-related memory loss), tic disorder and Tourette's disorder.

[238] In some embodiments, nervous system disorders include mental health conditions and neurodegenerative conditions. In such embodiments, mental health conditions are selected from the group consisting of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, depression, atypical depression, postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, anxiety, phobia disorders, binge disorders, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, substance-related disorders, substance use disorders, alcohol use disorder, substance-induced mood disorder, a mood disorder related to another health condition, disruptive behavior disorders, eating disorders, impulse control disorders, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), personality disorders, attachment disorders, and dissociative disorders; while neurodegenerative conditions are selected from the group consisting of Alzheimer’s disease, ataxia, Huntington’s disease, Parkinson’s disease, motor neuron disease, multiple system atrophy, progressive supranuclear palsy, migraines, cluster headaches, short-lasting unilateral neuralgiform headaches, fibromyalgia, traumatic brain injury, and mild traumatic brain injury (mTBI).

[239] In some aspects, the technology of the invention herein may be used to facilitate the treatment of nervous system disorders in a subject or patient in need thereof. In some aspects, the technology of the invention may be used to treat at least one nervous system disorder. In some aspects, the technology of the invention may improve the treatment of at least one nervous system disorder.

[240] As used herein, the terms “treating” or “treatment” include preventing or delaying the appearance of clinical symptoms of a disease or condition developing within a subject afflicted with, or predisposed to, the disease or condition but who does not yet experience or display clinical or subclinical symptoms of the disease or condition; inhibiting the disease or condition, i.e., arresting or reducing the development of the disease or condition, or at least one clinical or subclinical symptom thereof; and relieving the disease or condition, i.e., causing regression of the disease or condition or at least one of its clinical or subclinical symptoms.

[241] As used herein, “effective,” “an effective amount,” “effective dose,” “sufficient amount,” “sufficient dose,” “therapeutically effective,” “a therapeutically effective amount,” “a therapeutically effective dose,” “therapeutically sufficient amount,” “therapeutically sufficient dose,” or “a pharmacologically effective amount” refer to an amount of an active agent that is sufficient to provide the desired therapeutic effect. An effective amount will vary depending upon the subject, the specific therapeutic protocol, and the disease/condition being treated or health benefit sought, the weight and age of the subject, the severity of the disease condition or degree of health benefit sought, the manner of administration, and the like, all of which will be readily determined by one of skill.

[242] As used herein, “therapeutic effect” or “therapeutic efficacy” refer to the responses(s) in a mammal, and preferably a human, after treatment that is judged to be desirable and beneficial. Hence, depending on the disorder to be treated, therapeutic protocol, or improvement in physiological or psychological functioning sought, and depending on the particular constituent(s) in the compositions of the invention under consideration, those responses shall differ, but would be readily understood by those of skill. In preferred embodiments, the mammal is a human.

[243] As would be apparent to one of skill, therapeutic outcome measures will vary depending on the disease/condition to be treated, specific treatment protocol assigned to the patient, and a variety of other factors. However, general measures of therapeutic effect include outcome measures (primary or secondary), endpoints, effect measures, and measures of effect within clinical or medical practice or research which can be used to assess an effect (positive and/or negative) of an intervention or treatment, whether patient-reported (e.g., questionnaires); based on other patient data (e.g., patient monitoring); gathered through laboratory tests such as from blood or urine; through medical examination by a doctor or other medical professional, or by digital means, such as by using electronic tools such as online tools, smartphones, wireless devices, biosensors, or health apps.

[244] In some embodiments, clinical outcome assessments (COAs) may be used to determine the efficacy of a given treatment protocol. In such embodiments, COAs may include, but are not limited to the Addiction Severity Index (ASI), which assesses 30-day and lifetime alcohol and drug use, as well as medical, psychiatric, legal, and family issues; Beck Depression Inventory (BDI), which is a 21 -item measure used to assess depression, involving self-reporting or verbal administration by an administrator, with a possible range of 0-63; the Clinician-Administered PTSD Scale (CAPS), which is a 30-item structured interview administered by a trained individual that corresponds to the DSM-IV criteria for PTSD, and discusses one of the past week, the past month, or the worst month since trauma, with a scale of 0-136; the Davidson Trauma Scale (DTS), which is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD and rates them based on frequency and severity, having a scale of 0-136; the Global Appraisal of Individual Needs (GAIN), which includes an assessment of background information, substance use, physical health, risk behaviors, and mental health; the Global Assessment of Functioning (GAF), which is a clinician administered scale used to assess the social, occupational, and psychological functioning of adults, with a score range of 0-42; the Hospital Anxiety and Depression Scale (HADS), which is a 14-item self-report measure designed to assess anxiety and depression in non-psychiatric populations, and has a range of 0-42; the Hamilton Anxiety Scale (HAM-A or HAS), which is a 14-item clinician-administered measure used to assess the severity of anxiety symptoms having a scale of 0-56; the Hamilton Depression Scale (HAM-D) which, similar to HAM-A/HAS, is a clinician-administered scale used to measure the severity of depressive symptoms, having a scale of 0-54; the Impact of Event Scale (IES), which is a 15-item self-reported measure used to assess the frequency with which experiences of “intrusions,” “avoidance,” and emotional numbing related to stressful events occurring within the last week, and has a scale of 0-75; the Maudsley Addiction Profde (MAP), which measures substance use, health risk behavior, physical and psychological health, and social functioning; the Montgomery-Asberg Depression Rating Scale (MADRS), which is a 10-item clincian rated measure that assesses the severity of depression, having a scale of 0-60; the Mississippi Scale for Combat-related PTSD, which is a 35-item self-report questionnaire used to assess DSM-III combat-related PTSD and related features, having a scale of 35-175; the Modified PTSD Symptom Scale, which is a 17-item self-report measure assessing the 17 DSM-III-R symptoms of PTSD, with a scale of 0-68 for intensity and 0-51 for frequency; the Posttraumatic Diagnostic Scale (PTDS or PDS) which is a 49-item self-report measure for severity of PTSD symptoms related to a single identified traumatic event, assessing all DSM-IV criteria in the past month (although the timeframe may be adjusted), having a scale of 0-51; the PTSD Checklist (PCL), which is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD, having a scale of 17-85; the PTSD Symptom Scale Interview (PSS-I), which is a 17-item semistructured interview that assesses the presence/severity of DSM-IV PTSD symptoms related to single identified traumatic event in individuals with a known trauma history, with a scale of 0-51; the PTSD Symptom Scale Self-report Version (PSS-SR), which is a 17-item self-report scale used to diagnose PTSD according to DSM-III-R criteria, having a scale of 0-51; the Structured interview for PTSD (SI-PTSD or SIP), which assesses the 17 PTSD symptoms as well as survival and behavioral guilt, having a scale of 0-68; the Structured Clinical Interview PTSD Module (SCID), which is a semi-structured interview used to assess the prevalence, absence, and subthreshold presence of PTSD used across trauma populations; the Short PTSD Rating Interview (SPRINT), which is an 8-item self-report measure that assesses the core symptoms of PTSD (intrusion, avoidance, numbing, and arousal) with a scale of 0-32; and the Treatment Outcome Post-Traumatic Stress Disorder Scale (TOP-8), which is an 8-item measure based on all three clusters of posttraumatic stress disorder, having a scale of 0-32 (Forman-Hoffman, Middleton, and Feltner, 2018; Deady, 2009).

[245] In embodiments wherein at least one of the COAs as discussed above are used, a patient may complete an assessment prior to beginning an assigned protocol to determine a baseline measure, and then repeat the process at set points during the course of the protocol, at the conclusion of the protocol, and/or at one or more predetermined periods of time following the protocol, to objectively measure the effectiveness of the protocol, or one or more aspects of the protocol and its efficacy, wherein a decrease or increase in an overall score (e.g., as measured by a test’s “scale”) may determine whether the severity and/or frequency of symptoms has increased, stayed the same, or decreased. As apparent to those of skill, a reduction in score generally indicates symptom improvement, but in some scales, such as GAF, an increase in score indicates improvement.

[246] In some embodiments, the at least one protocol assigned to a patient seeking treatment of at least one nervous system disorder will include at least one “dosing protocol” wherein dosing protocol refer to a therapeutic treatment regimen comprising the administration to a patient in need thereof of an effective amount of at least one active agent.

[247] In some embodiments, the active agent is a “psychedelic agent,” wherein psychedelic agent refers to any compound capable of eliciting psychedelic cognitive effects in a patient, as would be known to one of skill. Likewise, in some embodiments, the active agent is a non-psychedelic agent, i.e., an active agent that does not elicit psychedelic cognitive effects in a patient.

[248] Finally, in some embodiments, the active agent may be a psychedelic agent, but may be prescribed, obtained, and/or administered in a dose that is not a psychedelic dose (termed herein as a “microdose”). [249] Regardless of whether or not the active agent is a psychedelic agent, in embodiments wherein administration of an active agent is required, dosing protocols may include administration to the patient alone, with another patient as in couples therapy, or as part of group therapy; and may or may not be in the presence of one or more therapists (including two therapists, which may or may not be a dyadic therapist team) in a therapeutic setting to facilitate psychotherapy. As those of skill would immediately recognize, numerous such treatment protocols have been described in the art, using terms such as psychedelic-assisted psychotherapy or drug-assisted therapy (see, e.g., Sessa, 2019). Drug-assisted therapy, broadly, includes a range of related approaches that involve at least one session where the patient ingests a psychedelic compound or substance and is monitored, supported, and/or otherwise engaged by one or more trained mental health professionals while under the effects of said substance (see, e.g., Schenberg 2018).

[250] Further, in embodiments wherein a dosing protocol is assigned to a patient, the patient may be administered a compound or composition and be monitored, a patient may be administered a compound or composition and receive psychological support, and a patient may be administered a compound or composition and receive psychotherapy, and such may take place for example with a psychiatrist, medical doctor, clinical psychologist, or other trained clinician, as well as with a “guide” or non-clinical practitioner. In such embodiments, the patient may be administered an active agent, wherein the active agent may or may not be a psychedelic agent, in a controlled environment to facilitate the monitoring (e.g., a treatment room, such as but not limited to a traditional practitioner’s office; an inviting space, wherein temperature, lighting, scent, music, the display of symbolic items, and/or other aspects of “setting” are tailored to the patient undergoing the dosing session, etc.). In some embodiments, monitoring may be completed in person or remotely, for example, over the telephone (e.g., telemedicine), through video conferencing (e.g., Zoom, Teams, Skype, FaceTime), with the use of virtual reality (VR), including both synchronous and asynchronous means, or otherwise through software or an app.

[251] Likewise, in some embodiments, a patient assigned a dosing protocol may administer the active agents to themselves, or be administered by a third party who does not monitor the patient, or provide the patient psychological support (including psychotherapy). Meaning, in some embodiments, the protocol may include periodic dosing (e.g., a dosing regimen on a set, or flexible schedule) without monitoring or psychotherapeutic guidance. In such embodiments, the patient, or the third party administering the dose of the active agent to the patient may do so in a location of the patient’s choosing. Moreover, in such embodiments, the patient may or may not be supervised, and may or may not be instructed on how to self-administer the active agent. In embodiments wherein instruction is provided, it may be in the form of physical instructions that accompany the pharmaceutical composition, through software or an app, or through publicly available information.

[252] In some embodiments, the protocol assigned to a patient may not require, or may forbid dosing of any substances during the course of the treatment protocol. In such embodiments, the treatment protocol may incorporate components such as mindfulness, journaling, yoga, meditation, breathing exercises, etc.

[253] In some embodiments, whether or not the treatment protocol assigned to the patient is one that includes psychedelic or non-psychedelic dosing, the protocol may incorporate therapy, or the use of one or more therapeutic techniques. Non-limiting examples of therapy or therapeutic techniques include acceptance and commitment therapy (ACT), psychoanalytic therapy, cognitive behavioral therapy, and other similar practices.

[254] In some embodiments, whether or not the treatment protocol assigned to the patient is one that includes psychedelic or non-psychedelic dosing or therapy, the patient completes one or more remote consultations with a care provider (e.g., by phone, by video conference, or in virtual reality) prior to being assigned a treatment protocol. In some embodiments, the one or more remote consultations may be used by the care provider to determine what treatment protocol is appropriate for the subject. In some embodiments, the one or more remote consultations may be used by the care provider to determine and/or confirm diagnosis of a condition, such as but not limited to a nervous system disorder, which can be treated by at least one protocol in the protocol catalog of the invention as disclosed herein. In some embodiments, the one or more remote consultations is conducted via the technological device within which the technology of the invention is integrated.

[255] In some embodiments, whether or not the treatment protocol assigned to the patient is one that includes psychedelic or non-psychedelic dosing, or therapy, the patient completes one or more remote preparatory sessions with a care provider (e.g., by phone, by video conference, or in virtual reality) prior to administration of a compound provided herein. In such embodiments, the preparatory session comprises preparing the subject for treatment protocol. Non-limiting examples of preparation include describing what the subject can expect, how to overcome physical and emotional challenges that may arise, such as describing harm reduction techniques, and providing methods to adopt a mindstate that will enhance the therapeutic potential of the assigned protocol. In some embodiments, the one or more preparatory sessions is conducted via patient device 132 and/or 134, which is in data communication with the technological device (100) within which the technology of the invention is integrated.

[256] In some embodiments, whether or not the treatment protocol assigned to the patient is one that includes psychedelic or non-psychedelic dosing, or therapy, the integration stage is completed remotely with a care provider (e.g., by phone, by video conference, or in virtual reality). In some embodiments, the remote integration stage is conducted via patient device 132 and/or 134, which is in data communication with the technological device (100) within which the technology of the invention is integrated.

[257] In some embodiments, whether or not the treatment protocol assigned to the patient is one that includes psychedelic or non-psychedelic dosing, or therapy, the treatment protocol assigned to the patient will include at least one meeting between the patient and the clinician during the course of the treatment protocol. In such embodiments, the at least one meeting may facilitate open communication between the clinician and the patient, wherein the clinician asks for and receives feedback from the patient that will aid the clinician in determining the progress of the patient within the overall treatment protocol framework. As would be apparent to one of skill, such meetings may occur on a set schedule, as needed, or a combination thereof. In addition, such meetings may be conducted via the technological device within which the technology of the invention is integrated.

[258] Note, in embodiments wherein a patient is assigned at least one treatment protocol useful in treating a nervous system disorder, including mental health disorders, as disclosed herein; and neurological disorders, as disclosed herein; the clinician may necessarily modify, truncate, prolong, alter, or otherwise change the treatment protocol at any time. In fact, as disclosed herein, the flexibility and personalization offered by the technology of the invention is one of its core strengths — especially over that of the prior art. For instance, a clinician may initially enroll a patient into a given treatment protocol only to realize, based on the real-time data aggregation and analysis, that a separate treatment protocol may be more appropriate. As a purely exemplary non-limiting example, a clinician may determine, based on the data obtained through continuous monitoring from patient device 132 and/or 134, that the patient requires a less intensive, or in other embodiments, a more intensive treatment protocol. Likewise, in other purely exemplary, non-limiting embodiments, a clinician may determine a patient no longer requires, or would benefit from, a protocol containing psychedelic or non-psychedelic dosing regimens.

[259] Moreover, in embodiments wherein at least one biometric measure is monitored, and the at least one biometric measure contains a “safe” range and an “unsafe” range, and wherein at the upper and lower terminus of the safe range is a threshold to which the biometric data is compared, and crossing such threshold places the biometric measure in the “unsafe” range, a clinician may be alerted. In response to said alert, a clinician may modify the treatment protocol as the clinician deems appropriate. In some embodiments, such modification may include an addition of components or a removal of components, the addition of a psychedelic dosing protocol, or the removal of a psychedelic dosing protocol, the addition of a non-psychedelic dosing protocol, or the removal of a non-psychedelic dosing protocol.

[260] Additionally, in some embodiments, the safe range associated with each biometric measure has a predefined range at the terminus of the safe range that borders the threshold of the unsafe range. In such embodiments, when the biometric measure enters the predefined range that borders the threshold of the unsafe range, a clinician may be alerted. In some embodiments, regardless of whether or not the clinician is alerted, the treatment protocol may be modified. In such embodiments, said modification may include an addition of components or a removal of components, the addition of a psychedelic dosing protocol, or the removal of a psychedelic dosing protocol, the addition of a non-psychedelic dosing protocol, or the removal of a non-psychedelic dosing protocol.

[261] In some embodiments, wherein the safe range associated with each biometric measure has a predefined range at the terminus of the safe range that borders the threshold of the unsafe range, the predefined range may be a given percentage of the safe range, such as 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or less than 1%, wherein the range is inclusive, and is modified by the term “about.” As an exemplary embodiment, if a safe range for a heart rate measure is between 50 bpm, and 150 pm, and the predefined range is 5% of the safe range, the predefined range would be between 55 bpm and 50 bpm, and between 145 bpm and 150 bpm, wherein 55 bpm and 150 bpm illustrate the threshold between the lower and upper bounds of the safe range, respectively, so that values of 54 bpm and below, and 151 bpm and above would all be in the unsafe range.

[262] Regardless of what protocols are employed, and whether or not they include psychedelic or non-psychedelic dosing, or therapy, the technology of the invention, in some embodiments, is used to treat nervous system disorders, including mental disorders, neurodegenerative conditions, and behavioral addictions. a. Mental Health Conditions

[263] “Mental health conditions” refer to disease conditions that generally involve negative changes in emotion, mood, thinking, or behavior, and include, but are not limited to, those disclosed supra. Broadly, mental health conditions include those characterized by the DSM-5, Merck Manual, ICD-11, or other such diagnostic resources known to those of skill.

[264] In some embodiments, mental health conditions are selection from the group consisting of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, depression, atypical depression, postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, anxiety, phobia disorders, binge disorders, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, substance-related disorders, substance use disorders, alcohol use disorder, substance-induced mood disorder, a mood disorder related to another health condition, disruptive behavior disorders, eating disorders, impulse control disorders, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), personality disorders, attachment disorders, and dissociative disorders.

[265] A variety of methods for screening or assessing a subject for a mental health disorder exist. In some embodiments, a diagnosis of a mental health disorder is facilitated with use of the Diagnostic and Statistical Manual of Mental Disorders, such as the DSM-5. In some embodiments, diagnosis of a mental health disorder is facilitated with use of self-reported or observer-report surveys or questionnaires. Non-limiting examples of such questionnaires include the Patient Health Questionnaire 9 (PHQ-9), the Generalized Anxiety Disorder 7 (GAD-7), PTSD Checklist for DSM-5 (PCL-5), The Alcohol Use Disorders Identification Test (AUDIT), Binge Eating Scale (BES), Obsessive-Compulsive Inventory (OCI), the Personality Disorders Questionnaire (PDQ-IV), Dissociative Experiences Scale (DES), Drug Use Questionnaire (D AST-20), The Mood Disorder Questionnaire (MDQ), and other similar questionnaires. In some embodiments, alternative questionnaires, such as the Clinical Global Impression - Improvement scale (CGI-I), may be used to assess improvement of a subject’s mental health state, such as by comparing baseline responses to responses after a treatment intervention. In some embodiments, any of the diagnostic manuals and assessments described, and other similar tools, may be used to confirm a reduction in symptoms, a reduction in symptom severity, or elimination of symptoms and/or a previous diagnosis.

[266] In some embodiments, the technology of the invention is used to treat a patient diagnosed with at least one mental health condition. In some embodiments, a patient diagnosed with at least one mental health condition will be assigned at least one treatment protocol designed to treat the at least one mental health condition of which the patient is diagnosed. In some embodiments, the treatment protocol will require one or more psychedelic dosing sessions. In some embodiments, the treatment protocol will require administration of one or more non-psychedelic substances. In some embodiments, the treatment protocol will incorporate at least one method of therapy. In some embodiments, the treatment protocol will require a combination of psychedelic dosing sessions, therapy, and the administration of non-psychedelic substances. In some embodiments, the treatment protocol will require none of psychedelic dosing sessions, therapy, and the administration of non-psychedelic substances.

[267] As previously stated, if the treatment protocol assigned to the patient requires administration of a substance, whether or not that substance is a psychedelic agent, the administration may be completed by a clinician (e.g., a doctor, therapist, mental health professional, pharmacist, nurse, etc.), a third party (i.e., someone who is not the patient nor falls into the category of “clinician” as stated above), or the patient; and thus may or may not be supervised, may or may not include therapy, and may or may not occur on a regular, defined schedule. Such variances are dependent on the specific protocol to which the patient is assigned, as would be apparent to one of skill.

[268] In some embodiments, the technology of the invention is efficacious in reducing at least one symptom of a mental health condition within a patient diagnosed with the same. As would be apparent to one of skill, symptoms for each mental health condition will be different, however, through medical monitoring (such as monitoring of objective measurements, as described herein), patient reporting (such as, but not limited to journaling), completion of questionnaires, etc., one will be able to objectively determine if a symptom has reduced in its frequency and/or magnitude. b. Neurodegenerative Conditions

[269] Neurodegenerative conditions encompass a wide range of disorders that result from progressive damage to cells and nervous system connections essential for at least one of mobility, coordination, strength, sensation, and cognition; and encompass those disclosed supra. Symptoms of neurodegenerative diseases include any of reductions in mobility and balance, abnormal movements, difficulty swallowing, abnormal bladder and bowel movement function, wide variations in blood pressure, difficulty sleeping, difficulty breathing, abnormal heart function, reduced memory and cognitive abilities, alterations in mood, and changes to speech (UT Southwestern Medical Center, 2022).

[270] In some embodiments, neurodegenerative conditions are selected from the group consisting of Alzheimer’s disease, ataxia, Huntington’s disease, Parkinson’s disease, motor neuron disease, multiple system atrophy, progressive supranuclear palsy, migraines, cluster headaches, short-lasting unilateral neuralgiform headaches, fibromyalgia, traumatic brain injury, and mild traumatic brain injury (mTBI).

[271] In some embodiments, the technology of the invention is used to treat a patient diagnosed with at least one neurodegenerative condition. In some embodiments, a patient diagnosed with at least one neurodegenerative condition will be assigned at least one treatment protocol designed to treat the at least one neurodegenerative condition of which the patient is diagnosed. In some embodiments, the treatment protocol will require one or more psychedelic dosing sessions. In some embodiments, the treatment protocol will require administration of one or more non-psychedelic substances. In some embodiments, the treatment protocol will incorporate at least one method of therapy. In some embodiments, the treatment protocol will require a combination of psychedelic dosing sessions, therapy, and the administration of non-psychedelic substances. In some embodiments, the treatment protocol will require none of psychedelic dosing sessions, therapy, and the administration of non-psychedelic substances.

[272] As previously stated, if the treatment protocol assigned to the patient requires administration of a substance, whether or not that substance is a psychedelic agent, the administration may be completed by a clinician (e.g., a doctor, therapist, mental health professional, pharmacist, nurse, etc.), a third party (i.e., someone who is not the patient nor falls into the category of “clinician” as stated above), or the patient; and thus may or may not be supervised, may or may not include therapy, and may or may not occur on a regular, defined schedule. Such variances are dependent on the specific protocol to which the patient is assigned, as would be apparent to one of skill.

[273] In some embodiments, the technology of the invention is efficacious in reducing at least one symptom of a neurodegenerative condition within a patient diagnosed with the same. As would be apparent to one of skill, symptoms for each neurodegenerative condition will be different, however, through medical monitoring (such as monitoring of objective measurements, as described herein), patient reporting (such as, but not limited to journaling), completion of questionnaires, etc., one will be able to objectively determine if a symptom has reduced in its frequency and/or magnitude.

L. Technological Improvements over the Prior Art

[274] As mentioned, there are a plurality of advances over the prior art that the technology of the invention allows, some of which include increasing the efficacy of treatment, increasing patient safety, in both treatment and generally; and increasing patient confidence in seeking and following through with treatment. CL Improvements to Treatment Efficacy

[275] Because the technology of the invention allows for more granular data collection, classification, and extrapolation, clinicians are more capable of appropriately diagnosing and carrying out an effective treatment plan. As mentioned, the treatment protocol assigned to each patient will include a variety of components that will periodically suggest to the patient the completion of a given activity. Because the technology of the invention is capable of learning the patient’s preferences and modifying the protocol accordingly, the patient is more likely to positively interact with the technology of the invention. This ensures the patient is completing the tasks necessary to proceed through the treatment protocol, and improve their health condition.

[276] In contrast, traditional nervous system disorder treatment merely instructs a patient to complete a myriad of tasks as part of the treatment program. Often, there is a set schedule wherein the patient is instructed to complete each task (e.g., do yoga for ten minutes each day), but there may also be situation-specific tasks wherein an individual is instructed to complete a task if necessary (e.g., in situations where stress feels overwhelming, do ten minutes of meditation, or breathwork). The flaw in such an approach, however, is that often — when one is feeling significant levels of stress — that level of cognitive thought is nearly impossible. One is often unable to assess the situation and consciously decide that meditation, breathwork, etc., would be efficacious in relieving some of the stress they feel.

[277] However, through the technology of the invention’s integration with a technological device capable of continuous biometric monitoring (patient device 132 and/or 134), in some embodiments, physiological signs of extreme stress, such as but not limited to increased blood pressure, heart rate, respiration rate, and body temperature will be observed in real time and, as a result, a patient may be instructed to complete a component of the invention useful in alleviating stress and returning the patient to a basal mental state.

[278] As mentioned supra, such continuous monitoring also allows a clinician to obtain a holistic view of the patient’s wellbeing, and how they are responding to the treatment protocol assigned to them. Also mentioned supra, the technology of the invention includes a plurality of protocols capable of treating a multitude of nervous system disorders and/or promoting general wellness. Thus, in some embodiments, wherein a clinician determines a patient is responding poorly to treatment through, e.g., stagnation/regression of collected biometric data over a given period of time when improvement was expected, the clinician may seamlessly switch to a protocol more suited to the patient’s specific needs, or may merely incorporate elements from the same. As would be readily apparent to one of skill, such a level of insight into patient-specific treatment efficacy would be impossible without the technology of the invention.

[279] Moreover, as would be apparent to one of skill, treatment efficacy is also heavily dependent on patient compliance. Because the technology of the invention gives the patient options as to which components they will choose to complete at a given time, and distributes that information to a clinician, the clinician will necessarily have a deeper understanding of the patient, including what treatment protocol, or components thereof, may fit their overall needs. The clinician may then utilize the information gathered — which would be impossible without the technology of the invention — to assign a protocol and/or components thereof more tailored to the specific individual, which necessarily increases treatment efficacy.

[280] Additionally, through the use of geospatial data (such as but not limited to GPS and/or AGPS information), the technology of the invention will have the ability to determine the geographic location of the patient assigned to a given treatment protocol and can, as a result, determine which components of the protocol to serve to the patient.

[281] Meaning, in a purely exemplary, non-limiting embodiment wherein the components assigned to the patient include breathwork, meditation, yoga, and journaling; and each of the four components listed normally have an even suggestion weight of 0.25, the weights will automatically change based on a patient’s geospatial data. This is completed through communication established between technological device 100, and patient device 132 and/or 134, which is further in communication with satellite 1502, as disclosed in FIG. 15. In some embodiments, prior to suggesting a treatment protocol component, the processor of the technological device (100) queries available geospatial data from patient device 132 and/or 134. If present, the processor then determines if the location of the patient is one wherein the protocol components have been restricted by the patient. If yes, the processor then chooses a component from the remaining list of components after filtering out (i.e., assigning a weight of 0.0 to) the restricted components.

[282] Thus, in such an embodiment, when the patient is, for example, at work, the technology of the invention will suggest “meditation” instead of “yoga.” Likewise, in some embodiments, the technology of the invention uses artificial intelligence (AI) technology to automatically restrict the component pool. In such embodiments, if, perhaps, the patient is driving (evidenced by geospatial data that divides the distance traveled over the time it has taken to travel such a distance), the technology of the invention will not suggest a component during the duration of driving, to decrease distracted driving. Additionally, in some embodiments, after a patient is administered an active agent as part of the treatment protocol, if within a given duration post-administration the patient is determined to be driving, and the duration is within a limit defined by the treatment protocol as being unsafe to drive, the treatment protocol may alert the clinician.

[283] Moreover, in some embodiments, if the patient is located within a known building/location (e.g., one the technological device (100) recognizes as being marked for a specific purpose/as a specific venue such as, but not limited to, a mall, shopping center, grocery store, pharmacy, hospital, dentistry, school, university, restaurant, gym, etc.), the AI technology of the invention may automatically alter the component weights to reflect the location of the patient. In such embodiments, if the patient is in a location wherein physical activity is not possible, components such as, but not limited to, yoga and aerobic exercise would be restricted. In contrast, if the person is located in one of a gym, dance studio, or athletic club; yoga and aerobic exercise may receive a higher component weight than their baseline component weights.

[284] Finally, because the technology of the invention stores each individual change made to the treatment protocol in history fields (270), each protocol will continuously improve for a given patient population as data is obtained. For example, when a patient with a specific nervous system disorder consults a clinician about treatment options, the clinician may review information stored by the technology of the invention and filter that information by nervous system disorder and patient population so that, if, e.g., a 24 year old man is the person seeking treatment, the clinician may filter the stored data accordingly and determine which protocol, and components thereof, has previously been most effective in treating such an individual.

[285] Further, because patient compliance is additionally tracked, the clinician may also illustrate to the patient the importance of compliance with specific stages/components of the treatment protocol. Meaning, as a non-limiting example, a clinician may convey to the patient that, “for individuals in your patient population undergoing this treatment protocol for your specific indication, only 60% realized desired results when not fully completing the integration stage.” Or, a clinician may determine which components appeared to be most effective for those in that patient population who had a similar line of work (e.g., primarily sedentary jobs vs. active, physically demanding jobs, shift work, swing shift, etc.) and will alter the available components, or the delivery thereof, accordingly. While each of the aforementioned examples are purely illustrative, and non-limiting, such illustrate the power of the technology of the invention in both collecting and conveying critical data for treatment efficacy, and how that data can in turn better inform patients, and lead to increased treatment efficacy.

[286] As would be apparent to one of skill, the integration between the technology of the invention and at least one technological device enables tailoring of treatment protocols to the specific user which, in turn, increases treatment efficacy and the likelihood of patient buy-in and, as a result, the successful completion of the treatment protocol. b. Improvements to Safety

[287] As mentioned, the same functionality that increases treatment efficacy in a manner impossible without the technology of the invention also yields increases in safety — both over traditional medical practices, and in day to day life.

[288] As with treatment efficacy, this is possible through the real-time monitoring that is offered in some embodiments of the invention as disclosed herein. As discussed supra, a patient may, in some embodiments, utilize a technological device (patient device 132 and/or 134) that continuously monitors various biometric measures of the patient. In such embodiments, the technology of the invention will determine baseline measures for the patient, and will use those measures to establish an acceptable range for the biometric measures to be within. If, in some embodiments, the biometric measures exceed a threshold and match a value characterized as “unsafe,” or that is indicative of a “dangerous condition,” the technology of the invention will promptly alert a clinician who, as a result, may reach out to the patient, and/or may contact emergency services.

[289] As it relates to treatment specifically, this is a significant advance over the prior art, as the technology of the invention enables a practitioner to see, in real time, how the treatment protocol is affecting the patient. This can, in turn, better inform the clinician as to dose titration (in embodiments wherein the treatment protocol assigned to the patient includes a dosing component), and can also enable better monitoring of symptoms generally, so as to inform the clinician of possible chronic conditions that are normally difficult to diagnose due to the diagnostic “snapshot in time” discussed previously, that plagues traditional medicine.

[290] Regarding the former, as mentioned supra, such information could indicate to a clinician that the dose administered to the patient is too high, or too low to be therapeutically effective. In embodiments wherein the patient device (132 and/or 134) is capable of determining plasma monoamine concentrations, such information may indicate that a patient has a particularly fast, or particularly slow, metabolism of such substances, which could also impact appropriate dosing. As would be apparent to one of skill, certain polymorphisms or mutations in various enzymes, including CYP liver enzymes, may substantially increase the maximum plasma concentration (C _max ) of certain agents that are typically metabolized in the liver. As would be apparent to one of skill, certain psychedelic and non-psychedelic agents can have adverse effects when administered at improper doses, including valvulopathy in those agonizing 5-HT _2B , hypertension/cardiotoxicity (compounds such as, but not limited to MDMA), neurotoxicity, etc.

[291] While the dose administered or prescribed by the clinician may not be a dangerous dose in and of itself, it very well could be if the agent is not properly metabolized due to an aforementioned mutation/polymorphism. Thus, having the ability to administer/prescribe a “test dose,” in some embodiments, and then monitor the patient’s biometrics — with an effective dose thereafter administered/prescribed — is a substantial improvement to safety over the prior art.

[292] Additionally, the technology of the invention offers numerous improvements to safety in daily life as well. As mentioned, in some embodiments, the technology of the invention is integrated into a technological device capable of monitoring at least one of the patient’s biometrics (patient device 132 and/or 134). In such embodiments, the technology of the invention has the capability of determining when the patient is undergoing an adverse event, such as but not limited to those associated with a health condition unrelated to the treatment protocol assigned to the patient, such as but not limited to a heart attack, a stroke, an aneurysm, diabetic ketoacidosis, inflammation, infection, hyperglycemia, hypoglycemia, allergic reaction, asthma, a brain bleed, respiratory distress, illness, including viral infections, parasitic infections, bacterial infections, fungal infections, and other such adverse health conditions known to those of skill; as well as other traumatic events having the potential to cause bodily harm, such as but not limited to car accidents, arguments, abuse, assault, falls, electrocution, hypothermia, hyperthermia, poisonous ingestion, inhalation injuries, such as but not limited to carbon monoxide inhalation and smoke inhalation; drug overdose, and other such traumatic or otherwise dangerous events that may lead to bodily harm.

[293] Regardless of the specific traumatic event, as mentioned, once at least one biometric measure exceeds a terminal threshold between a safe and an unsafe range, or is indicative of a dangerous condition, a clinician is alerted to the change in biometrics. As in embodiments wherein the adverse event is related to treatment, the clinician may then attempt to establish communication with the patient to inquire about the safety of the same. In such embodiments, if necessary, the clinician may then contact emergency services. c. Increasing Patient Confidence

[294] The technology of the invention also is capable of increasing patient confidence in the treatment protocol, which increases both treatment efficacy and patient safety, as the patient will be more inclined to follow the protocol of the invention and consult a clinician if problems were to arise.

[295] As mentioned, in some embodiments, the technology of the invention will be integrated into a technological device (patient device 132 and/or 134) capable of continuously monitoring patient biometrics and providing direct access to a clinician through, in some embodiments, a text chat function and/or a video chat function. As would be apparent to one of skill, the schematic of traditional medicine — i.e., infrequent visits to a clinician with minimal interaction with a healthcare professional outside of that time — necessarily opposes forming a foundational connection necessary to build trust in the clinician-patient relationship. This is ever-more present in minority communities, wherein a 1999 study revealed that African American patients considered their clinician visits as significantly less participatory than whites in models adjusting for age, gender, marital and health status, and length of the patient-clinician relationship (Cooper-Patrick, Gallo, and Gonzales, 1999).

[296] This disconnect between practitioners and their patients often leads to patients feeling alienated, and necessarily reduces the likelihood that they will follow through with, or at the very least have confidence in, their diagnoses and treatment protocol(s).

[297] However, by allowing direct communication between the patient and clinician, and thereby establishing a trusting relationship, instead of feeling alienated, the patient feels empowered — which will greatly increase the likelihood that the patient completes the treatment protocol and realizes effective results.

[298] In some embodiments, wherein the technology of the invention is incorporated in a technological device (100) capable of communication with at least one other technological device (patient device 132 and/or 134, and clinician device 142 and/or 144), and wherein a patient is suggested at least one component of a therapy protocol, the patient may therein accept, or reject the suggestion. As mentioned supra, regardless of whether the patient accepts or rejects the suggestion, a clinician is alerted to the decision. In some embodiments, the clinician may then have automated messages sent to the patient depending on whether the patient accepted or rejected the suggestion.

[299] For instance, in some non-limiting, exemplary embodiments, if the patient rejects the component, the clinician may send an encouraging message to the patient stating “I hope you’re having a great day! I see you were unable to complete [[COMPONENT]] at this time; no worries, we can try again later!” Likewise, in other non-limiting exemplary embodiments, wherein the patient accepts the component, the clinician may send an automated message that reflects the component chosen such as, but not limited to “I hope this meditation session brings you relaxation and peace!” or “Take the opportunity during today’s yoga session to reflect on today’s challenges and how you overcame them.”

[300] Regardless, such affirming statements sent by the practitioner to the patient via clinician device 142 and/or 144 being in data communication with patient device 132 and/or 134 via technological device 100 will inevitably increase the sense of community and trust between the same and, as a result, will increase the confidence the patient has in the treatment protocol. Moreover, through building a system of trust, the patient will be more likely to reach out to the practitioner and give honest feedback regarding the treatment protocol. Thus, in some embodiments, the patient may suggest additional components, or a restriction of the ones currently utilized. For instance, as a non-limiting and purely illustrative example, if the patient has trouble expressing their thoughts through written word, the patient may suggest an audio journal, rather than a written one. Or, if the patient knows, for example, that they will be supervising children at a certain time each day, and will be unable to meaningfully meditate, for instance, they may instead suggest yoga be completed during that time, so that they can do the yoga with their children and bond with them through that experience while completing the treatment protocol assigned to them.

[301] In any event, such active communication between the patient and the clinician will aid in boosting the confidence of the patient in the efficacy of the treatment protocol and will, as a result, increase the likelihood of the patient completing the treatment protocol assigned to them.

[302] Having now described various embodiments, the following is provided to further clarify the scope of the disclosure. First, it should be noted that the steps or stages of a method, process, or algorithm described in connection with embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of both and/or other components. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, means, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the spirit or scope of this disclosure.

[303] Thus, the various illustrative components, blocks, modules, means, and steps described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. In some implementations, processors may be communication processors or other such processors specifically designed for implementing functionality in communication devices or other mobile or portable devices.

[304] A software module may reside in RAM memory, flash memory, ROM memory, EPROM or EEPROM memory, registers, hard drive, a SSD, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC, which may reside in a user terminal. The processor and the storage medium also may reside as discrete components in a user terminal.

[305] Embodiments may also take the form of a computer storage product with a computer-readable medium having computer code thereon for performing various computer-implemented operations, such as operations related to functionality as describe herein. The media and computer code may be those specially designed and constructed for the purposes of the present invention, or they may be of the kind well known and available to those having skill in the computer software arts, or they may be a combination of both.

[306] Examples of computer-readable media within the spirit and scope of the present invention include SSDs, magnetic media such as hard drives; optical media such as CD-ROMs, DVDs and holographic devices; magneto-optical media; and hardware devices that are specially configured to store and execute program code, such as programmable microcontrollers, ASICs, programmable logic devices (PLDs), and ROM and RAM devices. [307] Examples of computer code may include machine code, such as produced by a compiler or other machine code generation mechanisms, scripting programs, PostScript programs, and/or other code or files containing higher-level code that are executed by a computer using an interpreter or other code execution mechanism. Computer code may be comprised of one or more modules executing a particular process or processes to provide useful results, and the modules may communicate with one another via means known or developed in the art. For example, some embodiments of the invention may be implemented using assembly language, Java, C, C#, C++, scripting languages, and/or other programming languages and software development tools as are known or developed in the art. Other embodiments of the invention may be implemented in hardwired circuitry in place of, or in combination with, machine-executable software instructions.

[308] The foregoing description, for purposes of explanation, uses specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practice the invention. Thus, the foregoing description of specific embodiments of the invention is presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed; obviously, many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, through the elucidation of specific examples, and to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated, when such uses are beyond the specific examples disclosed. Accordingly, the scope of the invention shall be defined solely by the following claims and their equivalents.

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