COMMUNICATIONS DEVICE AND METHOD FOR INTERCONNECTING AN INFORMATION MANAGEMENT SYSTEM WITH AN ELECTRICAL

APPLIANCE

Technical field

This invention relates to a communications device and method for interconnecting an information management system of a hospital or testing laboratory with at least one electrical appliance set up to provide as output a plurality of health care parameters.

In general terms, this invention relates to the health care sector and, more specifically, to the sector of communications between information systems for the computerized management of testing laboratories (LIS) or of electronic health records (EHR) and the electrical (or electronic) appliances connected with these information systems, that is, laboratory testing appliances or medical appliances used in hospitals, respectively.

Background art

As regards the interfacing of testing instruments present in clinical and microbiological testing laboratories with information management systems, it should be noted that there are two main reasons why in vitro diagnostic devices, and more specifically, test instruments (test sets) present in clinical and microbiological testing laboratories, are connected to the information systems of the laboratories via software procedures.

A first reason is the need to program the testing appliances based on the medical test requests entered in the information system (as a function of the doctor's prescriptions).

A second reason lies in the need to acquire and transmit to the information system the results of the tests performed by the device; these results are then used by the information system to prepare a report to be printed and delivered to the patients who requested the test.

The diagnostic appliances used in testing laboratories, come in diverse kinds, are made by different manufacturers and are connected to the laboratory management systems by software procedures which vary according to the specific type of appliance and management system, both characterized by specific communications protocols (standard or nonstandard).

These communications protocols vary according to testing appliance manufacturers and management system developers.

Thus, each time a testing appliance has to be connected to an information system for the first time, a new communications software needs to be implemented, with consequent costs of development and installation.

The development of clinical laboratory automation over recent years has led to the introduction of highly sophisticated automation systems. Indeed, in addition to the laboratory information system, these automation systems are governed by software that has come to be known as middleware which, besides managing device connectivity, have a data handling management system dedicated to the management of a complex workflow.

One solution for transmitting data within a network of appliances and servers for hospital use is known, for example, from patent document US2010299517A1.

However, these systems for the overall management of the data flow in a complex network do not solve the problem of simplifying and generalizing the connectivity between the laboratory information system (LIS/LIMS) and the related testing appliances; nor does it allow solving a similar existing problem regarding the connectivity between the information system for the management of electronic health records (EHR) and the electrical appliances used in hospitals.

As regards the problem of the connectivity between the information system and the related appliances, it should also be noted that there is a significant implementation cost in the field of communication between the appliance and the information system because, normally, the same output parameters from the appliances are identified by different codes in the software of the appliances and in the software of the information system.

Disclosure of the invention

This invention has for an aim to provide a communications device and method which can be used to interconnect an information management system of a hospital or testing laboratory with at least one electrical appliance set up to provide as output a plurality of health care parameters and which are capable of overcoming the above mentioned disadvantages of the prior art.

More specifically, the aim of the invention is to provide a device and a method which can, in a simple, fast and economical manner, achieve connectivity between an information management system of a hospital or testing laboratory and the related appliances.

These aims are fully achieved by the device and method according to the invention as characterized in the appended claims.

More specifically, the device according to the invention is a communications device for interconnecting an information management system (of a testing laboratory or a hospital) with at least one electrical appliance set up to provide as output a plurality of health care parameters. The device essentially has two applications, both in the context of health care.

The first application regards communications between the information management system of a testing laboratory (generally known as LIS, Laboratory Information System, or LIMS, Laboratory Information Management System) and the (one or more) testing appliances used in the laboratory itself (these appliances being generally known as IVD devices, IVD standing for "in vitro diagnostics").

The second application regards communications between the information management system used for the management of electronic health files (generally known as electronic health records or EHR, or electronic medical records, or EMR) and one or more of the electrical (or electronic) appliances used in a hospital (for example, vital parameter monitors, or ventilators or infusion pumps. These appliances are collectively referred to as "medical devices" and sometimes denoted by the acronym "MD").

Preferably, the device according to the invention can be used in both applications.

The device is a "plug and play" device. It has embedded hardware which implements dedicated software for the management of the communications.

The device preferably comprises a box-shaped body whose function is to contain and protect the electronic components inside the device.

The device is equipped with an electronic card having a memory and a processor. The card is housed in the box-shaped body.

The memory is preferably a read and write memory. The processor is preferably programmable.

The device also comprises at least a first communications port for transferring input and output data between the device and the information system and at least a second communications port for transferring input and output data between the device and the electrical appliance.

These ports are formed on the box-shaped body.

Preferably, the second ports are serial and/or ethernet ports. Preferably, the device comprises a plurality of second ports.

Preferably, the first port is a TCP/IP port, that is, a network port.

It should be noted that, in principle, the device also comprises a single network port acting both as first port and second port. This configuration is suitable if the appliances which must be connected to the device are accessible through the network defined by the information system.

The device also comprises an interface connected to the card and designed to place the card in communication with at least one external peripheral unit to allow a person to set up the card itself, that is, to program it (the interface might even by constituted by the network port itself).

Preferably, the peripheral unit is one which allows input and output data to be transferred into and out of the device. For example, this peripheral unit consists of a monitor and a keyboard.

The interface comprises, for example, one or more USB ports.

As to electrical power supply, the device comprises a power pack connectable to an external electrical power supply and/or to a battery which the device might be provided with.

The device memory contains (natively) information relating to a plurality of health-care appliances and information relating to a plurality of communications protocols for the information system.

In light of this, the memory of the device preferably contains a plurality of drivers, each being a specific communications driver for one appliance.

Thus, the memory contains a plurality of drivers of testing appliances

(IDV). In addition, or alternatively, the memory contains a plurality of drivers of electrical (or electronic) hospital appliances.

It should be noted that these drivers are preferably stored in the memory of the device. Alternatively, the drivers might be stored in a remote server accessible to the memory of the device through an Internet connection of the device itself.

The processor is programmed to define a communications engine configured to translate and interpret messages travelling from the information system to the appliance (or appliances) and vice versa.

More specifically, the memory of the device contains a software (that is, a sequence of instructions) which, when run by the processor, constitutes the communications engine.

More specifically, the communications engine is configured to translate, in real time, messages in any format (including non standard formats) from an appliance of any type (of a type not known to the information management system) into messages in standard format able to be understood and interpreted by any information management system (that is to say, by any LIS or LIMS and/or any EHR or EMR).

Thus, the device according to the invention is a completely generalized appliance for connecting any in vitro diagnostic (IVD) testing appliance (and/or any electronic hospital appliance) to any laboratory (LIS/LIMS) or hospital (EHR or EMR) information system. Hence, the device is a device dedicated to that connection. The device can be installed in plug and play mode.

The device therefore allows reducing the time needed to establish connectivity between such an appliance and an information management system. This is particularly advantageous when one or more appliances are substituted.

Further, the device makes the connectivity particularly reliable and easy to manage because the device is not affected by typical software problems such as operating system updates, anti-virus software updates, incorrect installation and so on.

The device is also advantageous in terms of laboratory or hospital hygiene because for routine operation it does not require the use of external peripherals (such as keyboard, mouse or monitor) and thus reduces the risk of biological contamination. Indeed, connection to an external peripheral is required only during an initial step of setting up the device. In light of this, it should be noted that the card of the device (the firmware) is preferably implemented with instructions configured to perform the following steps (in other words, the memory contains instructions configured to perform the following actions when they are run by the processor):

a) preparing a first list, representing a plurality of communications protocols for the information system and a second list representing a plurality of appliance types to allow a person (a technician in charge of setting up the device) to select an item from the first list and an item from the second list using the peripheral unit;

b) setting a driver as a function of the item selected from the first list in step (a), and a communications protocol as a function of the item selected from the second list in step (a);

c) preparing a list representing a plurality of output parameters of the appliance selected in step (a), to allow the person to enter with the peripheral unit at least one code for each item in the list of parameters; d) storing the codes entered in the preceding step, in order to define a transcoding table configured to associate with each item in the list of parameters a first code to be used for communication with the information system and a second code to be used for communication with the appliance.

Further, the device of the invention is a multi-channel device designed for connection to a plurality of appliances (in that case, the device comprises a plurality of second communications ports, and the card is configured for simultaneous connection to a plurality of appliances).

In light of this, during set-up, steps a-d must be repeated for each appliance connected to the device.

As regards step (c), the person (that is, the user who sets up the device) preferably enters two codes (for example, alphanumeric strings) for each parameter: the first code is the name used to designate that parameter in the information management system; the second code is the name used to designate that parameter in the appliance.

In light of this, according to the invention, the appliance allows setting a desired name in the appliance itself to designate one or more parameters

(in other words, in some appliances, the names used for the parameters are not predetermined but can be changed during setup). In that case, in the device of the invention, the person need only enter the first code, relating to the management system. In that case, the processor is programmed to automatically set, in the transcoding table, the item relating to the second code, forcing the second code to be equal to the first code (in this case, the person will change the code in the appliance itself).

Thus, the card of the device is programmed to set the communications engine as a function of the driver and communications protocol set (during set-up).

Preferably, therefore, following set-up, the processor of the device generates the transcoding table, which is stored in the memory of the device itself.

Furthermore, in principle, the transcoding table is generated and stored in the device beforehand, that it is to say, before the device is connected to the information management system and to the appliance or appliances to be interfaced with the information system.

According to another aspect of the invention, the memory preferably defines a database of identification codes which can be associated unambiguously with corresponding appliances of a plurality of the appliances, the database being accessible to the interface.

In light of this, when an appliance is connected to the device for the first time, the device updates the database (preferably automatically) by filling in a line in the database corresponding to that appliance.

This function serves to allow the device to automatically recognize an appliance connected thereto after the device has been set up for connection to that appliance (according to steps a-d described above, with the added further step of updating the database of the identification codes of the appliances).

This invention thus also provides a method for interconnecting a information management system of a testing laboratory or a hospital with at least one electrical appliance set up to provide as output a plurality of health care parameters.

The method comprises the following steps:

- preparing a communications device programmed with an integrated software (embedded device), defining a communications engine for translating and interpreting messages travelling from the information system to the appliance and vice versa;

- connecting the device to the information system through a first communications port of the device and to the appliance through a second communications port of the device;

- setting the communications engine as a function of the information system and of the appliance connected to the device and as a function of pre-set information contained in the memory of the device; this information relates to a plurality of health-care appliances and to a plurality of communications protocols for the information system.

In light of this, it should be noted that before the step of setting the communications engine, there is a step of setting up the device through an interface of the device itself.

Setting up comprises the following steps:

- preparing a first list, representing a plurality of communications protocols for the information system and a second list representing a plurality of appliance types to allow a person to select an item from the first list and an item from the second list using the peripheral unit;

- setting a driver as a function of the item selected from the first list in the preceding step and a communications protocol as a function of the item selected from the second list in the preceding step;

- preparing a list representing a plurality of output parameters of the selected appliance, to allow the person to enter at least one code for each item in the list of parameters;

- storing the codes entered in the preceding step, in order to define a transcoding table configured to associate with each item in the list of parameters a first code to be used for communication with the information system and a second code to be used for communication with the appliance.

Preferably, the step of setting the driver is performed by selecting a driver from a plurality of drivers contained in the memory of the device, each driver of the plurality being a specific communications driver for an appliance of a plurality of the appliances. Alternatively, the required driver (or drivers) might be downloaded to the device from a remote server or from another external memory accessible through the Internet or other communications means.

If the device is a multi-channel device, it is connected to a plurality of appliances through a corresponding plurality of first communications ports. If the device is used to connect electrical (or electronic) appliances of a hospital to the EHR or EMR information system (for the management of electronic hospital files), there is a step (preferably concurrent with setting up) of storing an identification code and assigning that code unambiguously to the appliance.

It should also be noted that the invention also provides a system comprising:

- at least one information management system of a testing laboratory (LIS or LISM) or a hospital (EHR or EMR);

- a plurality of electrical or electronic appliances set up to provide as output a plurality of health care parameters (more specifically, one or more IVD testing appliances and/or one or more electrical or electronic hospital appliances);

- at least one device (preferably a plurality of devices) of the type described above.

Brief description of the drawings

These and other features of the invention will become more apparent from the following detailed description of a preferred, non-limiting example embodiment of it, with reference to the accompanying drawings, in which:

- Figure 1 schematically illustrates a device according to this invention;

- Figure 2 shows a functional diagram of the device of Figure 1 ;

- Figure 3 shows a flow diagram representing the method according to the invention, with reference in particular to the connecting step; - Figure 4 shows a flow diagram representing the method according to the invention, with reference in particular to the setting step.

Detailed description of preferred embodiments of the invention

The numeral 1 in the drawings denotes an information management system.

The information management system 1 is an LIS or LISM, an information system for the management of a testing laboratory or an information system of a hospital for the management of electronic clinical files (EHR or EMR).

The numeral 2 denotes electrical or electronic appliances to be interfaced with the information management system . The appliances 2 are testing laboratory (IVD) appliances or hospital appliances.

The numeral 3 denotes a device according to the invention.

The device 3 is a communications device dedicated to interconnecting the information management system 1 with the appliances 2. Preferably, the device 1 is a plug and play device equipped with hardware which runs dedicated embedded software.

The device 3 has at least one processor 31 and a memory (for example, a solid-state memory). Preferably, the processor 31 and the memory are integrated in a dedicated electronic card (the card is not illustrated in the drawings).

It should be noted that the memory contains instructions which, when performed by the processor 31 , define a communications engine 32.

The communications engine 32 is programmed to translate and interpret messages travelling from the information system 1 to the appliance 2 (or appliances) and vice versa.

More specifically, the memory of the device contains a software (that is, a sequence of instructions) which, when run by the processor, constitutes the communications engine.

The device 3 (that is, the card) also comprises a RAM memory 33 connected to the processor 31.

The numeral 4 denotes a first communications port (of the device 3) for transferring input and output data between the device 3 and the information system 1. The device comprises one or more first ports 4. The numeral 5 denotes a second communications port (of the device 3) for transferring input and output data between the device 1 and the appliance 2. The device comprises one or more second ports 5.

The numeral 6 denotes an interface connected to the card and designed to place the card in communication with a peripheral (input and output) unit 7 (at least one) in order to allow a person to program the card of the device 3. In the example illustrated, the peripheral unit comprises a display unit 8 and a keyboard 9.

For example, the memory of the device 3 is an SD card storage medium.

As regards the first and second ports 4 and 5, the device 3 comprises, for example, a TCP/IP Ethernet port and a plurality (preferably from 4 to 8)

RS23 serial ports, that is, TCP/IP socket ports or serial ports.

The device 3 is configured to be powered directly by the electricity grid.

The memory of the device 3 preferably contains information relating to a plurality of communications protocols for the information system 1. For example, the memory contains the protocols known as HL7 (for example, versions 2 and 3) and ASTM.

The memory of the device 3 preferably also contains information relating to a plurality of appliances 2. For example, the memory contains a list of the types of testing appliances and/or hospital medical appliances. For each of these types of appliances 2, the memory preferably also contains a corresponding driver (configured to activate and control communications of the appliance 2 itself).

The interface 6 is, for example, an Internet connection and/or a USB port. For example, the firmware is based on the Linux operating system which supports a Java Virtual Machine and several open-source libraries for creating a Web server. This provides remote Web access, through a browser, to the person (the user in charge of setting up) who, based on authorizations, will thus be able to access the set-up section of the device 3 or simply monitor the state of the connections and view the data.

Preferably, the device 3 has on-board (resident in the open-source 5 database) the configuration necessary for operation in order to simplify installation and setting up as much as possible.

The device 3 is therefore capable of connecting any appliance 2 (of the types mentioned above) to an information system 1 (of the types mentioned above) in two-way mode and in real time, while guaranteeing i o the security of the transmitted data.

Installation of the device 3 is simple and immediate (plug & play).

Thus, the device 3, once set up (it should be noted that the memory and the processor of the device 3 are accessible to and programmable by a person authorized for the purpose) is immediately ready and able to place

15 the information system 1 in communication with the appliances 2.

It should be noted that the interface 6 allows monitoring the device 3 for the entire duration of its use. In light of this, the device 3 of the invention is preferably provided with a Web-service interface which allows it to be monitored through a browser.

20 As regards setup (that is, initial setting) of the device 3, the following should be noted.

Setting up the device 3 preferably comprises the following steps.

Step a)

- selecting from a list (first list) the protocol used by the information system

25 1 which the device 3 is, or must be, connected to;

- selecting from a list (second list) the type of appliance 2 which the device 3 is, or must be, connected to;

Step b), the processor 31 of the device 3 selects a driver 34 corresponding to the information system selected previously and sets it; the processor 31

3 0 of the device 3 also selects a driver 35 corresponding to the type of appliance selected previously and sets it; Step c), the processor displays on (deliveres) the peripheral a list of the parameters of the selected appliance 2 and, for each parameter, allows entering a first code (which the device 3 will use in communications with the information system 1 ) and, if necessary, a second code (which the device 3 will use in communications with the appliance 2);

Step d), setting a transcoding table between the first and second codes associated with the selfsame parameters of the appliance 2, as a function of the previously selected appliance 2 and information system 1 ;

Step e), setting options, communications parameters, of the device 3. If the device 3 is to be connected to other appliances 2 (besides the first one already set up), setting up gives the possibility of repeating steps a-d for a plurality of appliances 2 (the device 3, in this case, is a multi-channel device).

The driver 34 selected and set, is therefore configured for communications directed from the device 3 to the information system 1. The driver 35 (or the drivers 35) selected and set, is configured for communications directed from the device 3 to the appliance (or appliances) 2.

The interface 6, that is, communication between the device 3 and the peripheral 7 during setting up, comprises, for example, an Internet connection through a Web server.

More specifically, after connecting up to the Internet, the person logs in and is authenticated (by the Web server). The purpose of this is to protect the device by preventing unauthorized persons from changing the settings. In Figure 3,

- the numeral 11 denotes the step of logging in and authentication;

- the numeral 12 denotes the step of selecting the types of information system 1 and appliance 2 connected to the device 3;

- the numeral 13 denotes the step of selecting the corresponding drivers 34 and 35 from the memory and setting them;

- the numeral 4 denotes the step of setting up the parameters;

- the numeral 15 denotes the step of storing the parameter set-up in the transcoding table.

If the device 3 is used to interconnect hospital medical appliances 2 with an EHR or E R (or like) information management system 1 , there is a step of associating each appliance 2 with a patient, allowing the user in charge of setting up (in this case, for example, a paramedic) to easily modify the setting.

For example, the device 3 might be set up to be automatically interfaced with a bar code reader.

It should also be noted that the appliances 2 might be equipped with a cable which is programmable with an EPROM, to allow the appliance 2 to be recognized automatically (according to essentially known technology).

Preferably, the device 3 defines a database of identification codes which can be associated unambiguously with corresponding appliances 2 of a plurality of the appliances. The database is accessible to the interface 6. In light of this, the device 3 is configured to identify the appliance 2 connected to it, thanks to the cable or to the setting of an unambiguous identification code in the device 3.

Thus, the device 3 is programmed to query the database and then to automatically set a driver suitable for the appliance 2 (provided the appliance 2 has already been set up).

In light of this, operatively, the connection (that is, the installation) of the device 3 comprises the following steps (with reference to Figure 4):

- connecting 16 the cable to the device 3 (the cable being unambiguously associated with the appliance 2);

- recognizing 17 the appliance 2 (automatically) by the device 3;

- setting 18 a communication between the device 3 and the appliance 2 (automatically); this setting step 18 substantially comprises automatic performance by the device 3 of steps 11 to 15, or some of them, regarding the appliance 2.

Preferably, the device 3 is equipped with a signalling device (acoustic or visual) capable of communicating to the outside whether or not the appliance which is connected to a port 5 is recognized because it has already been set up before. If it is not recognized, the user proceeds to setting up the appliance 2.

It should be noted that the assembly made up of the appliances 2, the information system 1 and the device 3, integrated with each other, defines an integrated system 10. Preferably, the system 10 comprises a plurality of devices 3. Each of the devices 3 may be connected to one or more of the appliances 2.