BACKGROUND

[Oil The following information is provided to assist the reader to understand the technology described below and certain environments in which such technology can be used. The terms used herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the technology or the background thereof. The disclosure of all references cited herein are incorporated by reference.

[02] Current patient monitoring systems and/or methods are expensive, difficult to implement, and usually are reactive to changes in the patient's condition. As a result, remote caregivers are alerted of a problem with the patient only in the event of an acute attack or when the patient initiates an alert, typically by pressing a button.

[03] Currently available personal emergency response systems (PERS) provide a wearable communicator actuatable by the user. Clinical monitoring systems can, for example, be used to monitor physiological parameters, such as blood pressure, blood glucose levels, weight, etc. A number of home or office remote monitoring systems are based upon security technology. Such systems involve significant installation expense and expertise.

SUMMARY

[04] In one aspect, a system for monitoring wellness of a person includes a monitoring system at a residence of the person including at least one sensor at the residence to monitor change caused by activity of the person and a communication system in communicative connection with the sensor. The system further includes at least one processing system remote from the residence and adapted to be in at least periodic communication with the communication system to receive data from the sensor.

[05] The monitoring system can, for example, include a plurality of sensors at the residence. Each of the sensors can, for example, be adapted to monitor change in the state of a device in which the sensor is in operative connection. Each of the plurality of sensors can, for example, be in operative connection with a different device.

[06] Each of the sensors can, for example, be in communicative connection with the communication system via a wireless network to transmit data to the communication system.

[07] In a number of embodiments, at least one the sensors measures whether an electrically powered device is in an "on" state or an "off state, at least one of the sensor measures if the person is in a bed, at least one of the sensors measures water flow, at least one of the sensors measures if a refrigerator door is opened, at least one of the sensors measures if a room is occupied, or at least one of the sensors measures a state of a phone.

[08] At least one of the sensors can, for example, include an impedance sensor. At least one of the sensor can, for example, include a current sensor that includes a plug operative to be connected to an electrical outlet and a receptacle to accept a plug from the device operatively connected to the current sensor. The current sensor can further include circuitry or electronics to determine a state of the operatively connected device. The current sensor can, for example, be adapted to determine a type of electrically powered device to which it is operatively connected. The current sensor can, for example, determine the type of electrically powered device to which it is operatively connected via at least one of current frequency, current amplitude or Fourier transform pattern.

[09] The communication system can, for example, transmit data from the sensors on a periodic basis. The communication system can, for example, transmit event-based data from the sensors on a periodic basis.

[10] The processing system can, for example, apply rules to the data transmitted by the communication system to determine if action is required (for example, via computer software). The processing system can, for example, be operative to communicate an alert to a caregiver in the case that it is determined that action is required. The alert can, for example, be communicated via at least one of interactive voice response, short message service, email, instant messaging or smart phone application. [11] The monitoring system can, for example, include a system to determine if data from at least one of the sensors should be communicated to the processing system prior to a next scheduled periodic communication.

[12] The processing system can, for example, be adapted to modify at least one rule depending upon the date. The at least one rule can, for example, be modified on the basis of whether the date is a weekday, a weekend or a holiday.

[13] The processing system can, for example, be adapted to delay an alert until an attempt is made to communicate with the person. The processing system can, for example, be adapted to automatically communicate with the person being monitored prior to communicating an alert to a caregiver of the person.

[14] In a number of embodiments, the processing system is adapted to correlate data from more than one sensor to determine if an action is required.

[15] In a number of embodiments, the processing system is adapted to determine if one of the sensors or the communication system is communicating from a location different from the residence. The processing system can, for example, identify a phone number, an IP address and/or other data indicating a location from which communication is made or originated to determine if there has been a change in location.

[16] At least one sensor can, for example, be adapted to monitor compliance with use of a medical device. The medical device can, for example, be a device adapted to treat a dental condition or a device to treat a sleep apnea condition.

[17] In a number of embodiments, one of the sensors can, for example, be a flow sensor in operative connection with a positive airway pressure or PAP device to determine flow in the positive air pressure device. The flow sensor can, for example, be positioned in the vicinity of an intake of the positive airway pressure device or elsewhere in a flow path. Any type of flow sensor can be used. In a number of embodiments, a thermistor-type flow sensor (that is, a flow sensor including a thermistor) such as a thermistor-type anemometer is used. Other examples of suitable flow sensors include, but are not limited to, impingement devices or vane-type flow sensors. A pressure sensor can, for example, be placed in operative connection with the positive airway pressure device to be in fluid connection with the airway of the person. The pressure sensor can, for example, be placed in fluid connection with an outlet of the positive airway pressure device or in fluid connection with a mask connected to the outlet of the positive airway pressure device. The flow sensor and the pressure sensor can, for example, be used to determine an apnea-hypopnea index of the person. In a number of embodiments, the flow sensor alone is used to determine an apnea-hypopnea index of the person.

[18] In a number of embodiments, the processing system is operative to modify an at least partially automated communication to the person regarding a health condition of the patient on the basis of data from one or more of the sensors. The health condition can, for example, be sleep apnea. The at least partially automated communication can, for example, be modified in at least one of content or timing on the basis of data from one or more of the sensors.

[19] In another aspect, a positive airway pressure system includes a blower including an intake, an outlet, a mask in fluid connection with the outlet and adapted to be worn by a person, and a thermistor in fluid connection with the intake to measure flow. The system can further include a pressure sensor in fluid connection with the outlet or the mask. Data from the thermistor and the pressure sensor can, for example, be used to determine an apnea-hypopnea index. The system can, for example, further include a data acquisition system in communicative connection with the thermistor and/or the pressure sensor. The system can also, for example, include a communication device in communicative connection with the data acquisition system.

[20] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[21] Figure 1 A illustrates an embodiment of a system for collecting data from a plurality of devices for remote patient wellness monitoring.

[22] Figure IB illustrates another embodiment of a system for collecting data from a plurality of devices for remote patient wellness monitoring. [23] Figure 1C illustrates a circuit diagram of an embodiment of a current sensor for use in connection with any one of a plurality of electronic devices.

[24] Figure 2A illustrates an embodiment of a screen for login and for device rule settings.

[25] Figure 2B illustrates an embodiment of a screen summarizing set rules for alerts and an embodiment of a screen summarizing resident information.

[26] Figure 2C illustrates an embodiment of a screen summarizing caregiver information.

[27] Figure 2D illustrates an embodiment of a screen setting forth an activity summary derived from event-based sensor data.

[28] Figure 2E illustrates an embodiment of a screen setting forth entertainment activity derived from event-based sensor data.

[29] Figure 2F illustrates an embodiment of a screen setting forth activity derived from event-based kitchen device sensor data.

[30] Figure 2G illustrates an embodiment of a screen setting forth sleep activity derived from event-based sensor data.

[31] Figure 2H illustrates an embodiment of a screen setting forth water use derived from event-based sensor data.

[32] Figure 3A illustrates an embodiment of a system for monitoring PAP device usage including a thermistor sensor for measuring flow.

[33] Figure 3B illustrates an embodiment of a circuit diagram for measuring flow in a PAP device.

[34] Figure 3C illustrates an embodiment of a system for monitoring PAP device usage including a thermistor sensor for measuring flow and a pressure sensor for measuring pressure change. [35] Figure 4A illustrates an embodiment of a computer screen listing PAP device users being monitored.

[36] Figure 4B illustrates an embodiment of a screen for entry of patient-specific information.

[37] Figure 4C illustrates an embodiment of a screen summarizing patient compliance with PAP device usage.

[38] Figure 4D illustrates an embodiment of a screen for entry of device information for a PAP device being monitored.

[39] Figure 4E illustrates an embodiment of a screen summarizing referrer information.

[40] Figure 4F illustrates an embodiment of a screen summarizing device information for a PAP device being monitored.

[41] Figure 4G illustrates an embodiment of a screen for setting forth and verifying an identification for an origin of data transmitted from a PAP device (for example, caller ID, IP address, etc.).

[42] Figure 5A illustrates an embodiment of a report of patient information and compliance summary data for a patient using a PAP device.

[43] Figure 5B illustrates an embodiment of a report of data including daily PAP device usage time and runtime for a period of time from March 9 ^th through May 26 ^th .

DETAILED DESCRIPTION

[44] As used herein and in the appended claims, the singular forms "a," "an", and "the" include plural references unless the content clearly dictates otherwise. Thus, for example, reference to "a sensor" includes a plurality of such sensors and equivalents thereof known to those skilled in the art, and so forth, and reference to "the sensor" is a reference to one or more such sensors and equivalents thereof known to those skilled in the art, and so forth. [45] In a number or representative embodiments, a remote wellness monitoring system monitors basic day-to-day patient activities or lack of activity, such as sleeping behavior, television usage, eating habits, water consumption, etc. The system provides real time monitoring of parameters indicative of the overall well being of the resident and provides timely alerts designed to help prevent an acute episode. The system can, for example, be used in conjunction with a personal emergency response system (PERS) or as a standalone system, to provide relatively comprehensive remote monitoring for a remote caregiver at a price and ease of installation that is currently not available.

[46] In a number of embodiments, monitoring systems hereof operate using a wireless local area network (LAN). In that regard, a plurality of sensors can, for example, be connected to daily used equipment, devices or appliances, such as beds, ranges, refrigerators, televisions, toilets, etc. Data from the sensors can, for example, be networked and uploaded to, for example, a remote central or remote distributed processing system that can, for example, include a server or server system via a communication system (for example, landline telephones, wireless telephones, the internet and/or other communication systems). An embodiment of such a system is, for example, illustrated in Figure 1A. Software of the processing system analyzes the data and, for example, assists a care-giver with a long-term care plans, alerts, use of additional sensors etc.

[47] In a number of embodiments, a processing system or server system receives data from a residence, household or other abode and, for example, uses/processes the data to implement a long-term care plan. The server system can, for example, apply predetermined rules and/or logic defining alert thresholds, alert methods, appointed caregivers, associated reports for trending etc. in implementing a care plan. Remote alerts can, for example, be activated in the case of predetermined events (or series or groups of events) or at predetermined levels so that caregivers can respond in a proactive manner to changes in patient behavior. The alerts can, for example, be dispatched in any number of ways including, but not limited to interactive voice response or IVR, short message service or SMS, email, internet communications (for example, instant messaging), and/or smart phone/client applications. Compared to currently available monitoring systems, the monitoring systems hereof provide more proactive/timely alerts, while significantly reducing cost and complexity of installation. Caregivers can also transmit inquiries to the processing system via one or more communication channels as described above to, for example, inquire of the current "status" of a patient. Further, the system can transfer information to third parties (for example, physicians etc.) on the patients instructions as part of an overall care plan. For example, a physician (or other authorized third party) portal can be provided.

[48] The plurality of sensors used in the systems hereof can, for example, be used in connection with the patient, the patient's living space, a variety of medical devices, appliances, equipment, utilities etc. to monitor the patient's wellbeing by, for example, monitoring patient activity/inactivity. Table 1 provides a non-exhaustive listing of a number of representative devices and/or systems that can be monitored and representative sensor types for use in monitoring such devices and/or systems.

[49] Table 1

Ambient Light

Acoustic

ultrasonic,

microwave

Kitchen - Oven IR thermometer

Current sensing (microwave,

Kitchen - other Fridge, toaster, coffee maker, other electrical)

Phone usage / problem Off-hook monitor

Water (Flow) Pipe Temperature

Water Level (float in tank)

Ultrasonic flowmeter

positive displacement flowmeter

Water Leakage Conductivity

Thermistor / Silicon, IR,

Water Temperature

thermocouple, scald protection

Freeze protection

All sensors - inexpensive to implement, diagnostics, implicit

Temperature (room / area) trending, correlate with local

outside temperature to assess HVAC operational status

Temperature sensors - May not be

Temperature (outdoor) needed if correlated with web temperature info

Doorbell Acoustic

Intrusion, Glass Breakage Acoustic, ultrasonic, microwave

Shower Humidity (delta)

230V systems, high-current Amp-clamp. (DW, dryer, furnace, systems A C)

Garage door open Tilt

Ambient Light Sensing ex: door open switches, alarm

Universal interface (I/O - other

systems, HVAC controls, doorbell, systems)

3rd party sensors CO Alarm / Natural Gas Alarm Electrochemical etc.

Sn-oxide

Shock (bottom of steps, other likely

Accelerometer

fall locations)

Walker issues Tilt

Accelerometer

(Other sensor applications)

Falls off commode

Lift assist (general)

Mailslot / Mail Presence (mailbox)

Door / knock sensor

Loss of Power (AC Mains)

Low Voltage (Brownout or failure

tripping - 3 cycles and out)

UPS Status

Barometric pressure (can detect

HVAC operation, opening & closing

of doors)

Particulate detection (smoke

detection - cheap Motorola smoke

detector chips)

Furnace blower (airflow)

Barcode reader.

Memory Card (SD, SDHC, xD, CF)

local storage?

Put status lights on each plug-in

box - power on, (can include L-N- G), connectivity, sensor activated),

bar-graph for current

Pendant (PERS)

Wrist band (Velcro, two-button)

Wander-off detection (out of range

- where's Henrietta)

Wheelchair apps - battery powered

or running off (powered) wheelchair

/ scooter

iPod / iPhone / Droid Apps for alert

/ monitoring / control

[50] Several types of representative sensors for use in the systems hereof are discussed in further detail below. One type of sensor used in the systems hereof is a current sensor that can be used in connection with devices such as appliances etc. attached to an electrical outlet of an abode. A representative embodiment of a modular or universal current sensor is, for example, illustrated in Figure IB. Such a current sensor can, for example, be used in connection with monitoring of many electrically powered devices (for example, televisions, radios, computers, kitchen appliance, other appliances etc.). The current sensitive sensor is, for example, plugged into a wall power receptacle and receives a power cord from the monitored device, such that the current flows through the current sensitive sensor (see, for example, Figure 1A). The existence of current draw through the power cord indicates, for example, that the monitored device is in use, and the duration of use.

[51] To monitor refrigerator usage, a light sensitive sensor or a current based sensor in electrical connection with the refrigerator light bulb can be used. For example, a current sensitive sensor can be used in connection with the electrical outlet of the refrigerator light. The existence of current draw through the refrigerator light bulb indicates that the refrigerator door has been opened, and for what duration.

[52] The current sensor set forth in Figures 1A and IB can, for example, be standardized for universal use in connection with devices using, for example, 110 volt power. In the case of devices or appliances that use current other than 110 volts (for example, an electric range), an impedance sensor can be used. For example, a current sensitive/impedance sensor can be placed in operative connection with (for example, fit around) the power cord of the electric range or other device. The existence of current draw through the power cord will indicate that the range is in use, and for what duration.

[53] Various sensors can also be used to measure utility usage such as water, heating and air conditioning, sewage etc. By, for example, measuring the water intake of a household (or other abode) at the input pipe of the household, a remote caregiver has the ability to track whether a patient and/or monitored person is using the bathroom, taking showers, washing dishes, washing clothes, etc. These behaviors are, in part, an indication of the wellbeing of the patient or monitored person.

[54] Water consumption can, for example, be measured using a variety of methods including, for example, a mass flow sensor that clips around the intake pipe of the household water supply and senses water flow and/or water volume consumed, a temperature sensor that senses temperatures different than room temperature as well as other methods.

[55] One or more sensors can, for example, be used to measure the duration of time that a patient or monitored person is lying in bed, which is an important parameter for monitoring the wellbeing of the person.

[56] Monitoring of bed usage can, for example, be accomplished in various manners including, for example, use of a pressure sensitive pad placed on or under the mattress of the bed to indicate the presence of a person in bed, or the use of a pressure sensor located on or under a leg of the bed and designed to monitor change in weight, thereby indicating the presence of a patient in bed.

[57] Other sensors for sensing the presence of a person in a bed include piezo resistive films, thick film strain sensors, infra red sensors and/or body temperature sensors.

[58] Sensors can also be used in connection with one or more devices (for example, medical or dental devices) used in connection with the monitored person's body. For example, dental appliances are sometimes used to treat patients suffering from obstructive sleep apnea. Patient compliance with dental device therapy is, on average, less than 60% in the United States. One or more sensors can, for example, be used to monitor patients using dental appliances, and track the hours of usage of such devices.

[59] A sensor can, for example, be placed on the side of the dental device, which, when in use, resides in the patient's mouth and senses the use of the dental device by, for example, sensing changes in temperature or conductivity in the patient's mouth. The data can then be transmitted to a processing or server system for compliance tracking purposes.

[60] In another embodiment as described further below, one or more sensors can, for example, be placed in operative connection with a continuous positive airway pressure or CPAP device (or other positive airway pressure of PAP device) often used by patients suffering from obstructive sleep apnea to monitor, for example, patient compliance. [61] In a number of currently available monitoring system for various uses, one or more monitoring devices stream analog-based data to a central server or software device which then converts the streamed data to meaningful information. Analog data is by its nature memory intensive and network intensive, thereby increasing the cost of transmitting the data, slowing the transmission of the data, and limiting/consuming network bandwidth.

[62] In several embodiments of the methods and systems hereof, a plurality of sensors as described above monitor a set of parameters indicating the operational use of, for example, medical devices and/or any household device. The sensors collect analog data and record the data as (or convert the data into) event-based data or as discreet values. Rather than transmitting a stream of analog operational data, the event-based data or values (for example, time of use/state change, duration, level of use etc.) are transmitted periodically (for example, hourly, daily etc.) to the processing or server system via the communication network. Different events or values can be transmitted with different periodic frequencies depending upon the nature of the event or value. Some processing of data can, for example, occur at the residence or other abode of the patient in, for example, the current sensor, the communication hub or other processing system before transfer of data to the remote processing or server system.

[63] For example, a CPAP sensor can transmit data of the on time, the off time, the usage time, and the average pressure rather than transmitting a stream of analog data, which is then interpreted on the server side. Transmitting event-base or value-based data (for example, periodically) reduces cost, lowers bandwidth usage, and requires less memory. In the case of some type of device such as medical or physiological devices which monitor movement or physiological parameters (for example, temperature, heart rate etc.) it may be desirable to transfer data at very short periods or even continuously. For such monitoring system it may be desirable to include a second communication device for continuous transmittal of data to the remote processing system or server system. Table 2 provides a summary of several devices describing the functions or activities monitors, the data type to be transmitted to the remote processing center and whether the transmission of such data can, for example, be periodic or continuous. Table 2

[64] Figures 2A through 2H illustrate representative embodiments of computer screen captures from sever-based programming of the remote processing or server system which are representative of the setup and function of a number of aspects of the systems and methods hereof. Figure 2 A illustrates an embodiment of a screen for login and for device rule settings. In that regard, Figure 2A sets forth a number of rules for the monitored persons sleep activity and associated alerts. Figure 2B illustrates an embodiment of a screen summarizing rules for alerts to caregivers and an embodiment of a screen summarizing resident information. Figure 2C illustrates an embodiment of a screen summarizing caregiver information. Figure 2D illustrates an embodiment of a screen setting forth an activity summary screen derived from event-based sensor data. The system can, for example, include logic or learning algorithms to notify an operator of possible modifications (for example, rule changes) that might be desirable to improve operation based upon past actions or experiences (for example, excessive alerts, false alerts etc.) Different categories of activities can, for example, be categorized for ease of viewing and/or analysis. As illustrated in Figure 2D, a type or category of activity can be selected for viewing and/or analysis from a menu. Figure 2E illustrates an embodiment of a screen setting forth entertainment activity derived from event-based sensor data. Figure 2F illustrates an embodiment of a screen setting forth activity derived from event-based kitchen device sensor data. Figure 2G illustrates an embodiment of a screen setting forth sleep activity derived from event-based sensor data. Figure 2H illustrates an embodiment of a screen setting forth water use derived from event-based sensor data.

[65] A plurality of sensors working in concert as part of a larger network monitoring system and designed to upload data on, for example, a predetermined period leave open the possibility that a meaningful event can occur in the household that does not generate an alert or alerts until the data is uploaded to the server. This can reduce the effectiveness of a monitoring system and potentially result in negative clinical benefits to the patient if it results in delay of an appropriate reaction to a clinical need or problem.

[66] As described above, however, transmission of real time streams of monitored data is expensive, requires substantial network bandwidth and requires a substantial amount of memory.

[67] In a number of embodiments of an event-based or value-based system hereof, predetermined events, thresholds, or business logic, can be established for data to be periodically uploaded which, when exceeded or violated, trigger an automatic upload of data to the processing system or server system regardless of predetermined upload cycles. Such triggering events result in more timely and effective monitoring of the patient. Software or logic to determine such a trigger can, for example, be resident on a sensor itself, on the communication hub or on a separate processor system located at the residence.

[68] When monitoring the wellness of a patient or monitored person, it is necessary to track their behavior on a day to day basis. Such behavior, however, can change from day to day, based upon, for example, whether it is a weekend or a weekday, a holiday or a workday etc. If a wellness monitoring system is designed to generate alerts based upon patient behavior using the same alert thresholds or triggering events every day, the probability is significant that alerts will be falsely issued or missed on "special" days such as weekends or holidays.

[69] In a number of embodiments, one or more sensitivity settings can be adjusted for specific classifications of days such as weekends, holidays, or even seasons of the year. For example, a sensitivity setting can involve a high, medium, or low setting, and corresponding thresholds which change based upon the sensitivity setting and corresponding alerts. Such sensitivity settings result in more accurate alerts (for example, less false positives/negatives.)

[70] Regardless of system settings, and depending upon patient behavior and monitoring characteristics, there is always the possibility of false alerts being generated. Such false alerts can result in false alarms, lost productivity, and unnecessary expense.

[71] In a number of embodiments of the systems and methods hereof, the patient or monitored person can, for example, receive an automatic verification phone call and/or other communication prior to the generation of an alert to one or more remote caregivers. Such a phone can, for example, verify that the patient or monitored person is in need of assistance to reduce false positives or false alarms.

[72] Monitoring various parameters, devices or appliances individually does not take into account information that can be derived by looking at multiple devices at the same time and correlating data therefrom. For example, in the case of a patient who has been in bed for a predetermined extended period while the kitchen range is on, or the case that lights are illuminated during off hours for an extended period of time, a patient might require assistance. Monitoring of one of these parameters alone or collectively with no correlation of the resultant data may not result in identification of the patient's needs.

[73] In a number of embodiments of the systems and methods hereof, an array or network of sensors operate in concert with each other and data therefrom can be correlated such that the wellbeing of the monitored person can be tracked and alerts can be generated based upon events or values from multiple sensors or parameters, tracked in parallel. The data for a plurality (including at least two) sensor is thus monitored and correlated using predetermined rules and/or logic to determine if the combination of data from the plurality of sensors indicate the need for an alert. More accurate alerts are thus possible over the case of non-correlated data from individual sensors.

[74] In the systems and methods hereof, use of a monitoring technology designed to track usage of a variety of household items and/or appliances is simplified with the use of a universal sensor technology such as the current sensor module described above and in connection with Figure IB. Because such a universal sensor may be used in connection with more than one type of device, the identification of the exact device being monitored can be problematic.

[75] If the device being monitored is assigned incorrectly, the result may be false positives or negatives, thereby reducing the effectiveness of the system in monitoring the well being of a patient. The universal sensor can, for example, be provided with a selector via which the user/patient identifies the type of device to which the sensor is attached. However, such a selector leaves open the possibility of user error.

[76] A universal sensor designed to monitor the use of various devices (for example, electric ranges, refrigerators, televisions, microwave ovens, coffee pots, oxygen concentrators, compressor nebulizers) can, for example, use the existence of unique current draw characteristics to determine if the sensor is being used in connection with a particular appliance. In that regard, each monitored device/appliance has unique current draw characteristics which may be used to either indentify the appliance, or, at a minimum, rule out certain appliance possibilities. Examples of parameters to be monitored to determine an attached device include current frequency, current amplitude, Fourier transform pattern, etc. Variables other than can current- related variables can, for example, be monitored by such a universal sensor device or system. For example, the device or system can also be used to monitor environmental signals such temperature etc., ambient light, motion etc.

[77] When data is transmitted to the remote processing system or server system, a logic check can, for example, be performed to ensure that current draw characteristics are consistent with the device assigned to a given monitor. If the current characteristics do not match the assigned appliance, the associated data can, for example, be flagged as suspect. Such a device recognition system can, for example, reduce errors and simplify installation.

[78] Sensors designed to monitor patient behavior which use a dial up modem, an internet modem or another communication device to transmit data can, for example, be tracked and linked to a specific patient based upon a pre-assigned identification code. While such a code identifies the modem or communication device, it does not prevent the device from mistakenly being moved from one location to another. Data transmitted via such a modem or other communication device could be assigned errantly to one patient when it actually belongs to another. Because healthcare providers, in the normal course of business, typically move monitoring devices from one patient to another, the possibility of errors and errant data transmissions exists.

[79] In a number of embodiments, in addition to the use of a unique identifier associated with a modem or other communication device, the systems and methods hereof incorporate the collection of phone number, IP address etc. from which a modem or other communication device is transmitting data. This information can, for example, be collected in software associated with the device and is linked to an existing patient within a database. In the event that a matching phone number, IP address and/or other indication of origin cannot be identified and paired with an existing COM device serial number, the data can, for example, be stored in a staging status until a time when phone number, IP address etc. can be linked to an existing patient. Such identifying data can, for example, reduce patient errors and reduce or eliminate the potential for errors in data transmission between healthcare providers or caregivers

[80] As described above, in a number of embodiments, one or more sensors are used in connection with a CPAP device to, for example, monitor patient compliance in the use thereof. Compliance to PAP therapy hovers in the area of 50%. The most important time in the treatment of OSA is the first few weeks when the patient is first becoming accustomed to using the therapy. It has been shown that if the provider can intervene at the time that the patient is first having difficulties tolerating the therapy, there is a much higher likelihood of the patient staying on therapy and receiving the clinical benefit desired. Furthermore, payers for PAP therapy are increasingly looking for quantitative evidence that the patient is using the therapy as a condition for paying for the therapy.

[81] A number of existing system and methods of monitoring compliance are proprietary to a particular PAP device manufacturer. In that regard, such manufacturers use proprietary sensors and/or software. Often such proprietary systems are inefficient in the manner in which they provide data to, for example, the home healthcare provider.

[82] For example, removable memory devices (smart cards, flash memory sticks etc.) can be inserted into the PAP device, loaded with compliance data and subsequently used to upload data to proprietary software provided by the PAP manufacturer. The measured data used by the software is derived from one or more sensors embedded in the PAP device itself.

[83] Modem modules which are inserted into the PAP device can transmit the compliance data either through a wired modem or over wireless devices such as the pager or cellular networks. Once again, the data itself is derived from sensors embedded in the PAP device itself.

[84] U.S. Patent No. 6,910,481, for example, discloses a method of tapping into the patient airway and measuring flow or pressure using an inline sensor device. This approach allows any PAP device to be monitored regardless of the manufacturer of the device. The data can be uploaded to one common software product. However, by intruding on the patient circuit, interference with the proper delivery of the PAP therapy is possible. Moreover, special tubing or fittings can be required.

[85] In a number of embodiments hereof, a flow sensor such as a thermistor-based flow sensor is, for example, placed near the intake filter for a PAP device and is used to monitor flow, which is indicative of the PAP device being in an on state and of the patient breathing. A thermistor can, for example, be used as a flow rate sensor, because the dissipation constant increases with the rate of flow of a fluid past the thermistor. Any type of flow sensor can be used. In a number of embodiments, a thermistor-type anemometer is used. Other examples of suitable flow sensors include impingement devices or vane-type flow sensors. Such a device can, for example, be used independently of a system such as illustrated in Figure 1A or within the system of Figure 1 A. In a number of embodiments, it is not required to make an accurate measurement of flow, but rather simply to measure the existence of flow and the relative velocity and direction of flow. Thus, the thermistor device or other flow sensor can be manufactured in such a way that it is very inexpensive to make and sell, thereby providing a deposable sensor. An example of a thermistor suitable for use herein is the 192-222LET-A01 discrete thermistor available from Honeywell.

[86] An embodiment of a circuit diagram for an air flow sensor is, for example, provided in Figure 3B. The components of Figure 3B are summarized in Table 3.

Table 3

[87] The data derived from the sensor can, for example, be stored in a data acquisition device (MSDAQ) in communicative connection with (for example, wired directly to) the device and containing memory and battery power sufficient to collect and save compliance data (sec, for example, Figure 3A). The compliance data can then, for example, be transmitted via, for example, a telephonic modem unit utilizing, for example, a LAN or local area network (Zigbee, Bluetooth, etc.) as illustrated in Figures 1 A and 3A. The modem unit subsequently uploads the compliance data to, for example, remote server-based software.

[881 By not intruding on the patient circuit, the sensor system does interfere with the proper delivery of the PAP therapy. Moreover, the sensor system requires no special tubing or fittings and is universal in that it can be used to monitor any PAP device regardless of manufacturer, tubing/fitting requirements, etc. Still further, the sensor unit is inexpensive to manufacturer and has a low temperature of operation.

[89] The apnea hypopnea index (AHI) is a measure of the existence of severity of obstructive sleep apnea. It is measured by the number of times that a patient stops breathing for more than 10 seconds during sleep and the average number of times in an hour and is used to gauge the severity of the disease.

[90] Currently the only devices performing such measurements are built into PAP devices directly. However, an external monitor can provide such capability regardless of brand or manufacturer. Existing devices require the measurement of flow to and from the patient by inserting a sensor in line with the patient tubing or by embedding the sensor in the pap blower device.

[91] By measuring flow on the filter intake of the PAP blower device, one can monitor the absence of breathing (for, for example, 10 seconds) and use the data to track the AHI (apnea- hypopnea index) on any PAP blower device regardless of manufacturer or brand and without intruding on the patient circuit.

[92] In several embodiments, two sensors were used to track AHI. The first sensor is a flow sensor (for example, a thermistor sensor) placed, for example, in proximity with the intake filter of the PAP device as described above. The second sensor includes a pressure sensor which communicates with the patient airway either at the output of the PAP device or at the mask itself

[93] By combining both sensors and monitoring signals from each simultaneously, one can detect the absence of patient flow for the necessary ten seconds while the pressure signal, used in tandem with the flow signal will verify the absence of breathing while the PAP device us on and delivering therapy. The system allows for the measurement of AHI on any PAP device regardless of manufacture or brand.

[94] In the case of some types of flow sensors, the need for a pressure sensor to measure AHI is obviated. For example, an impingement device (for example, a flap that moves with flow and includes a strain gauge in operative connection therewith) can measure flow presence (PAP on) and breathing changes ) PAP being used).

[95] Figures 4A through 4G illustrate representative embodiments of screen captures from remote software for monitoring PAP device usage/compliance. Figure 4A illustrates an embodiment of a computer screen listing PAP device users being monitored, the set-up date of monitoring, the last upload date, whether the user has met a threshold compliance and a calculated percent compliance. Figure 4B illustrates an embodiment of a screen for entry of patient-specific information or data. Figure 4C illustrates an embodiment of a screen summarizing patient compliance with PAP device usage. Figure 4D illustrates an embodiment of a screen for entry of device information for a PAP device being monitored. Figure 4E illustrates an embodiment of a screen summarizing referrer information. Figure 4F illustrates an embodiment of a screen summarizing device information for a PAP device being monitored. Figure 4G illustrates an embodiment of a screen for setting forth and verifying an identification for an origin of data transmitted from a PAP device (for example, caller ID, IP address, etc.). An unverified upload of data can, for example, be held until the origin identification data (for example, caller ID, IP address, etc.) is reconciled.

[96] Figure 5A illustrates an embodiment of a report (or a portion of a report) of patient information and compliance summary data for a patient using a PAP device. Figure 5B illustrates an embodiment of a report (or a portion of a report) of data including daily PAP device usage time and runtime for a period of time from March 9 ^th through May 26 ^th . [97] Patients undergoing treatment for chronic or other health conditions in the home such as obstructive sleep apnea (OSA) and other conditions require frequent monitoring. A comprehensive monitoring program involves the collection of both quantitative and qualitative metrics. While quantitative metrics are most easily collected using sensors and associated devices, qualitative methods generally require an interaction with the patient using a variety of systems and/or methods, including conversations over the phone, internet, SMS methods, or via mail.

[981 Using conventional manual methods, a nurse or healthcare provider typically reviews the output of quantitative metrics from sensors and modifies a conversation with the patient accordingly to collect the most appropriate qualitative data possible. When utilizing automated or semi-automated methods, however, such as IVR, web-based surveys, or similar methods, it is difficult to dynamically change the qualitative data collection based upon sensors, thereby reducing the effectiveness of the qualitative monitor and increasing the number of questions and/or surveys required of the patient (which contributes to patient dissatisfaction).

[99] In a number of embodiments, a medical device monitoring device or system (for example, a PAP monitoring device) collects usage, compliance, and clinical efficacy data. The device can be used in conjunction with a patient management tool that is, for example, at least partially automated to contact the patient (utilizing, for example, IVR, SMS, email, and/or internet communication methods) whereby the questions asked and the data collected via the patient management tool are changed based upon the data being collected from the PAP monitoring device.

[100] For example, current OSA patient management technology asks the patient how long and how frequent they have been using their therapy. With the incorporation of the PAP monitoring device, rather than asking how long they've been using their therapy, the patient management tool can tell them how long they've been using it and offer feedback (positive or negative) to the patient. Such a methodology provides a more effective monitoring with higher patient satisfaction.

[101] The foregoing description and accompanying drawings set forth a number of representative embodiments at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope hereof, which is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.