Transparent and secure links for point-of-care devices

Abstract

Aspects and features relate to a system that transparently connects a point-of-care testing (POCT) device with an electronic health record associated with a remote laboratory information system (LIS) for reporting test results in real time or near real time. POCT results can be received from the POCT device at a mobile computing device. The mobile computing device and the POCT device are located outside the LIS environment, such as a doctor's office or a remote clinic. The mobile computing device can use its own data broker to configure low-level instrument protocol data from the POCT device for secure transmission over a wide area network infrastructure. The POCT results can then be received in the LIS environment and provided to the LIS, which can transparently populate an electronic medical record (EMR) with the POCT results. In some examples, the LIS or hospital information system can also update the point-of-care EMR.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 018334, filed April 30, 2020, which is incorporated herein by reference in its entirety for all purposes.

[0002] This disclosure relates generally to systems and methods for point-of-care services to medical patients. More specifically, but not by way of limitation, this disclosure relates to systems and methods for providing point-of-care testing (POCT) and medical record management using an infrastructure that includes high data security while linking remote point-of-care devices to healthcare records in real-time or near-real-time. [Background technology]

[0003] While testing of patient samples at a central laboratory is effective for most clinical needs, in certain situations, patients and physicians can benefit from test results being delivered during a consultation. For example, if an International Normalized Ratio / Prothrombin Time (INR / PT) test result for blood clotting time can be provided during a patient's visit to a healthcare provider while they are being monitored during anticoagulation medication, the patient can benefit from on-site clinical advice and further action. The delivery of such test results can be achieved through testing performed near the patient, known as "point-of-care testing" (POCT).

[0004] POCT programs provide accurate results while enabling timely clinical decisions and improving patient engagement. POCT continues to expand, driven by new technologies, transforming healthcare delivery models toward patient-centered, community-based healthcare. Results from POCT can be observed and evaluated "on the spot" by healthcare providers and then entered into the medical record by administrative staff for later reference. As POCT expands, more and more healthcare providers are learning how to effectively use POCT performed in their own clinics, as opposed to using results based on the same tests performed on specimens collected by the healthcare provider and then sent to a central testing laboratory. Summary of the Invention [Means for solving the problem]

[0005] In one example, a non-transitory computer-readable medium includes computer program code executable by a processor to cause a mobile computing device to receive lower-level instrument protocol data from a POCT device located outside a laboratory information system (LIS) environment and configure the lower-level instrument protocol data to generate secured POCT data using a data broker on the mobile computing device. The computer program code is further executable by the processor to cause the mobile computing device to transmit the secured POCT data to the LIS environment using a wide area network infrastructure.

[0006] In another example, a system includes a non-transitory computer-readable medium containing computer program code for providing a transparent and secure link for a POCT device, and a processor device communicatively coupled to the non-transitory computer-readable medium. The processor device is configured to execute the computer program code to access lower-level device protocol data from the POCT device using a mobile computing device. The mobile computing device and the POCT device may be located outside the LIS environment. The processor device is further configured to execute the computer program code to configure the lower-level device protocol data using a data broker on the mobile computing device to generate secured POCT data and to transmit the secured POCT data to the LIS environment using a wide area network infrastructure. The processing device is further configured to execute the computer program code in one or both of the wide area network infrastructure and the LIS environment to access the lower-level device protocol data from the secured POCT data and to populate an LIS electronic medical record (EMR) in the LIS environment using information from the lower-level device protocol data accessed from the secured POCT data.

[0007] In another example, a method includes accessing lower-level device protocol data from a POCT device using a mobile computing device, where the mobile computing device and the POCT device are located outside the LIS environment. The method also includes configuring the lower-level device protocol data to generate secured POCT data using a data broker on the mobile computing device and transmitting the secured POCT data to the LIS environment using a wide area network infrastructure. The method further includes accessing the lower-level device protocol data from the secured POCT data in at least one of the wide area network infrastructure or the LIS environment and populating an LIS EMR of the LIS environment using information from the lower-level device protocol data.

[0008] In another example, a system includes a non-transitory computer-readable medium containing computer program code and a processor device communicatively coupled to the non-transitory computer-readable medium. The processor device is configured to execute the computer program code to access lower-level EMR data within a laboratory information system (LIS) environment or a hospital information system (HIS) environment and configure the lower-level EMR data to generate secured EMR data using a remote broker. The processor device is further configured to transmit the secured EMR data to a point-of-care (POC) environment using a wide area network infrastructure. The lower-level EMR data is accessed from the secured EMR data in the POC environment, the POC environment being located outside the LIS or HIS environment. The POC EMR is updated using information from the lower-level EMR data accessed from the secured EMR data. [Brief explanation of the drawings]

[0009] [Figure 1]FIG. 1 is a block diagram depicting a system for providing a transparent and secure link for point-of-care testing (POCT) devices, according to an aspect of the present disclosure. [Figure 2] FIG. 1 is a block diagram depicting a device for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 3] FIG. 1 is a block diagram depicting another system for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 4] 1 is a flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 5] 10 is an additional flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 6] 10 is an additional flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 7] 10 is an additional flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 8] 10 is an additional flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. [Figure 9A] 1 illustrates a message flow diagram for messaging that can be used to provide a transparent and secure link for POCT devices, according to an embodiment of the present disclosure. [Figure 9B] 1 illustrates a message flow diagram for messaging that can be used to provide a transparent and secure link for POCT devices, according to an embodiment of the present disclosure. [Figure 10] FIG. 1 is a block diagram depicting a system for providing a transparent and secure link for point-of-care medical records according to an aspect of the present disclosure. [Figure 11]1 is a flowchart illustrating a process for providing a transparent and secure link for point-of-care medical records according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] Aspects and features of the present disclosure provide a system that can transparently connect remote point-of-care testing (POCT) devices with electronic health records associated with a laboratory information system (LIS) and update the point-of-care medical record with information from the LIS or hospital information system (HIS). The system can report test results in real time. The test results appear virtually as if they were performed at a central laboratory associated with the LIS. Additionally, the test results are secured for transmission to the LIS without the processing overhead that would be required for end-to-end encryption-based solutions such as virtual private networks (VPNs).

[0011] Modern healthcare increasingly relies on the availability of a central electronic medical record (EMR) for each patient. The central EMR can be securely accessed by multiple providers, such as hospitals, clinics, and physician offices. A patient's EMR can be kept up to date, allowing each provider access to vital interim histories without having to collect them from the patient each time a medical service is provided. Test results are typically provided as part of the patient's EMR. When tests are performed on specimens collected by a healthcare provider and then sent to a central testing laboratory, the test results can be entered into a copy of the EMR stored in the laboratory's central LIS. The EMR is then automatically updated wherever it exists and can be accessed by the patient's healthcare providers (including those who collected the specimen and requested the test).

[0012] POCT devices have not been able to connect to central electronic medical systems in a manner that allows test results obtained using the POCT device to update a patient's electronic medical record (EMR) in real time or near real time. In some cases, test results obtained from the device itself are ultimately entered into the patient's EMR by the healthcare provider. In other cases, the POCT device can transfer test results to a proprietary system maintained by the POCT device manufacturer for access by the healthcare provider. The healthcare provider can ultimately enter the results into the patient's EMR. In either case, the availability of test results to other providers is delayed, and the test results may not be recorded at all or may not be accurately entered into the patient's record.

[0013] Aspects and features of the systems herein include network communication between a POCT device external to the LIS environment and an LIS to enable secure, automated, real-time transfer of POCT results to the LIS (and thus to the patient's EMR). Additionally, test results are automatically and transparently provided to the EMR, meaning that test results can be quickly and automatically formatted for display as part of the EMR in the same manner as similar test results obtained through traditional central laboratory testing, thus eliminating the need for manual transcription and / or interpretation. This allows healthcare professionals to complete laboratory tests at an external location and at a time convenient for the healthcare provider and patient while automatically populating the patient's EMR, thereby improving the timeliness and accessibility of laboratory test results from POCT devices. The LIS or HIS can also populate the point-of-care EMR with test results or other information. For purposes of this disclosure, the terms LIS and HIS are interchangeable, and both can include an EMR and receive and / or transmit test result data or EMR data as described herein.

[0014] In some examples, the system includes a wireless mobile computing device (e.g., a tablet or smartphone) having computer program code for establishing a connection with a POCT device located proximate to the mobile computing device. Both the POCT device and the computing device may be located outside the LIS environment. The computer program code causes the mobile computing device to receive POCT results in the form of low-level device protocol data, generate secured POCT data, and transmit the secured POCT data, including the test results, to the remote LIS. The system can utilize central middleware to transparently populate an EMR associated with the LIS with the POCT results.

[0015] In some examples, secured POCT result data is generated using a data broker on the mobile computing device and provided to a remote broker over a wide area network infrastructure, which may include the Internet, and then provided to an LIS. In some examples, the POCT results are provided to central middleware configured to format the POCT result data for an EMR. The test results can be made available in real time or near real time as part of the patient's EMR. For example, EMR updates including the test results can be sent back to the mobile computing device interfaced with the POCT device or to another computing device in the healthcare provider's office so that the test results can be quickly viewed as part of the patient's EMR.

[0016] In some examples, the system includes the ability to access lower-level EMR data within an LIS or HIS environment and configure the lower-level EMR data using a remote broker to generate secured EMR data. The lower-level EMR data can be transmitted to a point-of-care (POC) environment using a wide area network infrastructure. The lower-level EMR data is accessed from the secured EMR data in the POC environment. The POC environment is located outside the LIS or HIS environment. The lower-level EMR data can then be used to populate or update the POC EMR.

[0017] Detailed descriptions of specific examples are discussed below. These illustrative examples are provided to introduce the reader to the general subject matter discussed herein and are not intended to limit the scope of the disclosed concepts. The following sections describe various additional aspects and examples with reference to the drawings, in which like numbers refer to like elements and directional descriptions are used to describe the illustrative examples, but, as such, should not be used to limit the disclosure.

[0018] Referring now to the drawings, FIG. 1 depicts an example of a system 100 for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. The system 100 includes a POCT device 102 and a mobile wireless computing device 104. Both the POCT device and the mobile computing device are located outside the LIS environment, such as in a healthcare provider's office or a remote clinic. The computing device 104 may be, by way of example, a tablet computer or a mobile phone. Alternatively, the computing device 104 may be a laptop or notebook computer. As another alternative, a desktop workstation may be used as the mobile computing device. The POCT device interfaces with the mobile computing device 104 via a wireless connection (e.g., Bluetooth, Wi-Fi, NFC, etc.). In one example, the mobile computing device 104 can activate a Wi-Fi hotspot and access the POCT device 102 through the Wi-Fi hotspot using computer program code, such as an application or "app," on the mobile computing device 104. The wireless mobile computing device also includes a local data broker 106, which may be part of an application or a separate software module for explicitly transmitting POCT result data to a remote system over a wide area network infrastructure (which in this example includes the Internet 107 and a cloud services platform 108).

[0019] The local data broker 106 may be a message-oriented middleware software module for handling the flow of data between the POCT device 102 and a service bus 110 deployed on the cloud services platform 108. The local data broker 106 acts as an intermediary between applications handling POCT on the mobile computing device 104 and other applications with which the mobile computing device must interface over a wide area network infrastructure. The service bus 110 is used to decouple applications on the mobile computing device 104 from applications deployed on or behind the wide area network infrastructure. The service bus 110 also provides load balancing, routing, and control access and may include cloud service message queues, such as an incoming message queue and a POCT queue. The local data broker 106 translates and / or encapsulates lower-level device protocol data received from the POCT device 102 to provide secured POCT data for traversing the wide area network infrastructure without requiring an end-to-end encrypted channel, such as that which may be provided by a VPN connection.

[0020] Still referring to FIG. 1 , the remote broker 112 receives the secured POCT data from the local data broker 106 over the wide area network infrastructure. In this example, the remote broker 112 handles the flow of data between the local data broker 106 and the central middleware 116. The remote broker 112 accesses the lower-level device protocol data, or at least information from the lower-level device protocol data, from the secured POCT data to populate the EMR of the laboratory information system 118 with test results. In this example, the central middleware 116 provides a translation layer between the remote broker 112 and the LIS 118. The central middleware 116 contains stored information regarding data elements of the lower-level device protocol data and data elements maintained in the LIS for the patient EMR. The central middleware 116 formats the information from the lower-level device protocol data received from the remote broker 112 for storage in the LIS 118 as part of the EMR by appropriately mapping data elements from one side to the other.

[0021] The LIS 118 includes one or more servers, each having one or more processors and computer program code instructions for operating the one or more processors. The LIS 118 includes various data stores 120. These data stores may include, by way of example, a laboratory administration data store, a healthcare provider data store, a health plan provider data store, and a laboratory data store. They may also include a medical code database and a policy database. The laboratory information database may contain information distinguishing internal laboratories from external laboratories and POCT testing locations.

[0022] The data store 120 and the LIS 118 are part of the LIS environment. The LIS environment also includes any equipment and computer systems (not shown) within testing laboratories, hospitals, clinics, etc. that are connected to the LIS via a LAN, virtual LAN, VPN, or within the firewall or information security structure of the LIS. Devices that are not connected to or associated with the LIS in any of these ways are said to be located outside or external to the LIS environment. Laboratories, hospitals, clinics, and the like that are located within the LIS environment are typically affiliated with or partnered in some way with the same entity that maintains the LIS. The remote data broker 112 and central middleware 116 can be part of the LIS environment or part of a wide-area network infrastructure, and one or both components can reside in both the LIS environment and the wide-area network infrastructure.

[0023] FIG. 2 is a block diagram depicting a mobile computing device for providing a transparent and secure link for a POCT device, according to an embodiment of the present disclosure. Referring now to FIG. 2, an exemplary wireless mobile computing device 104 (e.g., a tablet computer) from FIG. 1 will be described in detail. The mobile computing device of FIG. 2 includes a high-power radio subsystem block 201, a baseband logic block 202, a main processor and control logic block (“main logic”) 203, and an audio interface block 204. A subscriber identity module (SIM) 208 is shown operatively connected to the main processor and control logic. The SIM is used to connect to a cellular network and is optional. If present, the SIM may be a separate device or electronic (eSIM). The SIM may contain subscriber information to enable the computing device 104 to connect to a wide-area network infrastructure using LTE or another cellular protocol. Additionally, because a particular device is always within Wi-Fi connectivity to the Internet, a SIM, even if present, need not be activated if not required by the device.

[0024] The mobile computing device 104 also includes flash storage 209, a battery 210, and random access memory (RAM) 211. The RAM 211 may include various memory devices, possibly including memory dedicated to specific purposes such as graphics. A portion of the RAM 211 may be used to store data currently being viewed on the mobile computing device's display. The display (not shown) is part of a tactile and visual input / output (I / O) block 212. Within the high-power radio subsystem block 201, transmitted and received information is converted to and from radio frequency (RF) of various carrier types and filtered using baseband or intermediate frequency circuitry. Radio subsystems for local communications, such as Wi-Fi and Bluetooth, are included in this block. The device's main antenna system 213 is connected to the radio subsystem block 201. The device also includes a combined Wi-Fi / Bluetooth antenna 214. The mobile computing device 104 also includes a bidirectional short-range / near-field communications (NFC) interface 240.

[0025] Still referring to FIG. 2 , the audio interface block 204 handles audio and analog-to-digital (A / D) and D / A processing. The audio interface block 204 also generates output through a speaker 216, which may include an audible signal to notify the clinician, such as when a connection with the POCT device 102 has been established or when POCT results have been received from the POCT device 102. The baseband logic block 202 performs basic signal processing, such as synchronization, channel coding, decoding, and burst formatting. The main logic 203 coordinates the aforementioned blocks and is also responsible for controlling interface components such as the screen and touch interface or keyboard. The functions of the aforementioned blocks are directed and controlled by a processor or processor device included in the main logic, such as a general-purpose microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), or various types of signal conditioning circuits (including analog-to-digital converters, digital-to-analog converters, input / output buffers, etc.).

[0026] The flash storage 209 shown in FIG. 2 includes one or more memory devices, such as at least one array of non-volatile memory cells. The RAM 211 includes one or more memory devices, such as at least one array of dynamic random access memory (DRAM) cells. The contents of the flash memory can be pre-programmed and then write-protected, while the contents of at least a portion of the RAM can be selectively modified and / or erased. Thus, the flash memory device is a non-transitory computer-readable medium used to store operating system software and application programs (apps) (including app 250), which contain instructions executable by the computing device 104 to transparently, real-time, and securely link the POCT device 102 with the network (and thus with the LIS 118). In this example, app 250 includes the local data broker 106. The RAM can be used to temporarily store the POCT results 252 and secured POCT data 256. In some examples, the POCT results take the form of lower-level device protocol data. For purposes of this example, POCT results may include data conforming to a lower-level instrument protocol (such as the Minimum Lower Layer Protocol (MLLP) or a protocol conforming to the standards of the American Society for Testing and Materials (ASTM)). Secured POCT data is test result data that is encapsulated or converted by the data broker 106 for transmission over a wide area network infrastructure. For example, the test result data may be formatted as a Transport Control Protocol (TCP) message, and the message may be encapsulated as a JavaScript Object Notation (JSON) message.

[0027] FIG. 3 is a block diagram depicting another system for providing a transparent and secure link for POCT devices according to an embodiment of the present disclosure. The system 300 includes a processor device 303 and a memory device 306 communicatively coupled to the processor device 303. Such a system may, for example, be implemented as a network server within or connected to the wide area network infrastructure of FIG. 1 or connected to an LIS environment. The processor device 303 may execute computer program code (also referred to as instructions or program code instructions 305) for performing the operations of the remote broker 112 of FIG. 1. The processor device 303 may use the wide area network infrastructure to read secured POCT data 310 from the service bus 110, temporarily store the secured POCT data 310 in the memory device 306, access the encapsulated POCT result data by decapsulating the data, for example, from a JSON message, and forward the original POCT result data 312 to the central middleware 116. The POCT result data 312 may be temporarily stored in the memory device 306. The POCT result data may be original lower-level device protocol data from the POCT device or information derived from or describing the lower-level device protocol data.

[0028] Non-limiting examples of the processor device 303 include a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a microprocessor, etc. The processor device 303 may perform one or more operations to run program code instructions 305 stored in the memory device 306. The computer program code instructions 305 may include executable instructions to receive secured POCT data from the cloud services platform 108, store secured POCT data 310, access POCT result data 312, store POCT result data 312, and forward the POCT result data to the central middleware 116.

[0029] The memory device 306 may include one or more memory devices. The memory device 306 may be non-volatile and may include any type of memory device that retains stored information when powered off. In some examples, at least some of the memory devices may include non-transitory computer-readable media from which the processor device can read the instructions 305. The computer-readable media may include electronic, optical, magnetic, or other storage devices that can provide computer-readable instructions 305 or other program code to the processor device. Non-limiting examples of the memory device 306 include electrically erasable programmable read-only memory (EEPROM), flash memory, or any other type of non-volatile memory. Non-limiting examples of computer-readable media include magnetic disks, memory chips, ROM, random access memory (RAM), ASICs, configured processors, optical storage devices, or any other medium from which a computer processor can read instructions. The memory device 306 also includes one or more input / output (I / O) modules 314, as well as buses or interconnects (not shown) for enabling inter- and intra-device communication. The I / O module 314 may include a network interface (not shown), which communicates with the cloud services platform 108 .

[0030] FIG. 4 is a flowchart illustrating a process for providing a transparent and secure link for a POCT device according to an embodiment of the present disclosure. The process 400 of FIG. 4 is described below with reference to the components discussed above. In block 402, a processing device in the main logic 203 establishes a connection between the POCT device and a local data broker in a mobile computing device. The POCT device and the mobile computing device are located outside the LIS environment. The connection includes a TCP connection between the POCT device and the mobile computing device. In block 404, in response to the POCT device connecting, a real-time connection between the local data broker and a remote broker is automatically established. The real-time connection between the broker in the application on the mobile computing device and the downstream remote broker provides a real-time connection between the POCT device and the LIS 118. In block 405, the processing device in the main logic 203 receives the POCT result 252 from the point-of-care testing device 102. The POCT result is, by way of example, received as lower-level device protocol data. At block 406, a processing device in the control logic 203 configures the lower-level instrument protocol data using a local data broker to generate secured POCT data 256 for transport to the LIS 118. In one example, the processor device configures the POCT test result data by encapsulating lower-level (TCP) messages containing the test result data within JSON messages. At block 408, the secured POCT data is transmitted to a remote broker over a wide area network infrastructure including the cloud services platform 108.

[0031] In block 410, the processor device 303 causes the remote broker to access the POCT result data from the secured POCT data 310, for example, by deencapsulating the lower-level device protocol data from the JSON message. In block 412, the processor device 303 can provide the POCT results 312 to the LIS 118 for inclusion in the EMR. The POCT results can be provided to the central middleware 116 for additional formatting and data alignment to transparently inject the test results into the EMR. Once the test results have been in the EMR, the EMR or a portion of the EMR containing the POCT results can be accessed from the LIS by the provider computing device upon request. Upon request, in block 414, the EMR can be transmitted to the provider computing device. In some examples, the provider computing device is any computing device used by a clinician, physician, or similar healthcare provider to access patient records. Additionally, a point-of-care EMR, such as an EMR maintained by a clinic, can be updated from the LIS to include test results or other information, as described below with reference to FIGS. 10 and 11 .

[0032] 5-7 are flowcharts illustrating processes used in providing a transparent and secure link for a POCT device according to aspects of the present disclosure. These figures illustrate how a mobile computing device application interacts with a cloud service platform. FIG. 5 illustrates a connection process 500. At block 502, a POCT device is connected to the mobile computing device, and at block 504, the mobile computing device determines whether it is already connected to an appropriate cloud service. If it is already connected to an appropriate cloud service, the process ends at block 506. If it is not already connected to an appropriate cloud service, at block 508, the mobile computing device application sends a connection message to the cloud service. The mobile computing device can connect to one cloud service or multiple cloud services. By way of example, the cloud service may include encoding / decoding services, additional middleware, additional brokers, and / or message queues. In this example, for a POCT TCP connection, the connection messaging of FIGS. 5 and 6 establishes a WebSocket connection with service bus 110 to listen for messages and establishes a WebSocket connection with service bus 110 to send messages.

[0033] FIG. 6 illustrates an example of data transmission. When data is sent from the POCT device in block 602 of process 600, the system connection status is determined in block 604. If the system is not connected because the connection process has not yet occurred or the connection has been lost, a new connection message is generated and sent in block 606. If the system is connected, data encapsulation occurs in block 608, and the data is sent to the appropriate cloud service in block 610. In this example, the message sent from the POCT device to the mobile computing device is a lower-level device communication protocol over TCP. When the POCT device sends data to the mobile computing device, a data broker on the mobile computing device can encapsulate the data and send it to the service bus 110. The mobile computing device application can be designed so that the data broker must send the message and the data is pushed from the POCT device buffer to the application using the TCP:psh,ack command. At the application layer, this command can be interpreted as a message event from the TCP stack.

[0034] 7 illustrates a disconnection process 700. At block 702, the POCT device disconnects from the mobile computing device. At block 704, the mobile computing device determines whether an active connection with the system is maintained. If an active connection with the system is not maintained, the process ends at block 706. If an active connection with the system is maintained, a disconnection message is sent to the cloud services platform 108 at block 708.

[0035] 8 illustrates an example process for the cloud services platform 108 to communicate back to the mobile computing device. In block 802 of process 800, a message is received from an upstream server (e.g., running the remote broker 112 and / or central middleware 116). In block 804, a data connection message is sent to determine if a connection with the application still exists. If a connection with the application still exists, a determination is made in block 806 regarding the message type. If the message is data, in block 808, the message is sent over TCP. If the message is not data, in block 810, a disconnect message is sent to the mobile computing device. If the connection does not exist, in block 812, a message is sent to reestablish the connection between the POCT device and the upstream platform. If successful, the data is sent in block 808. If not successful, a disconnect message is sent in block 816.

[0036] 9A and 9B illustrate a message flow 900 that can be used to provide a transparent and secure link for a POCT device, according to an embodiment of the present disclosure. In this example, the mobile computing device is a tablet computer 904 being used by healthcare delivery personnel 905. The POCT device 102 is connected to the tablet computer 904. The tablet computer 902 includes an application 908, which, as previously discussed, includes a local data broker. A POCT messaging queue 910 is used to exchange data with the POCT device. A messaging queue 912 is used to exchange data with the remote broker 112. In this example, the remote broker 112 automatically establishes a queue connection and remains connected while the POCT is in progress. The connection with the middleware 116 can also persist while the POCT is in progress. Thus, from the user's perspective, the POCT device maintains a connection with the remote LIS. Alternatively, the POCT device can connect and disconnect as needed while maintaining this user perspective. Thus, messaging queue 912 exchanges messages with POCT messaging queue 910 and remote broker 112. Middleware 116 may be, by way of example, the central middleware shown in FIG.

[0037] During an initialization phase 916 as shown in FIG. 9A , the tablet computer 904 receives input from healthcare personnel to begin an examination. For example, the tablet can receive user input through (I / O) block 212 based on a displayed “Start” or “Initiate” virtual button. When the application 908 receives this indication, a local TCP port is opened to listen for connection messages in block 918. Connection messaging, shown in the initialization phase 916 of the message flow 900, can then occur. During a connection phase 920 of the message flow 900, connection messages are sent, enqueued, and dequeued to send JSON messages through the system. In block 922, the JSON message is decapsulated and a connection request is sent to the middleware 116 using TCP to access the connection request. Responses from the LIS received through the middleware 116 are encapsulated in JSON messages in block 914 and the remaining messaging in the connection phase 920.

[0038] During the transmission loop step 924 of Figure 9B, the POCT device acts accordingly based on the connection response and queues the POCT test results. At block 926, the POCT result data is encapsulated into a JSON message to provide the secured POCT data, and at block 928, the secured POCT data is enqueued, dequeued, and accessed to retrieve the original POCT test results. The response in the transmission loop step 924 proceeds in the reverse direction, with the binary response encapsulated into a JSON message at block 930. Once the test is complete, the connection disconnection step 940 is entered.

[0039] The JSON message shown in the example in Figure 9 has the following format: { type:<msg type enum> , body:<base64 encoded binary data> }, The message type is one of "data", "connect", and "disconnect". The body contains the raw TCP buffer information base64 encoded and is only populated if the message type is "data". As an example, a JSON data transfer message might appear as follows: { type:data, body:<aGVsbG93b3JsZA==> }. An exemplary connect message may appear as follows: { type:connect }.

[0040] FIG. 10 is a block diagram depicting a system for providing a transparent and secure link for point-of-care medical records according to an aspect of the present disclosure. The system 1000 includes a point-of-care (POC) environment 101, such as a doctor's office. The POC environment 101 includes a computing device (not shown), which may be a mobile computing device as previously discussed. The POC environment 1001 may also include one or more POCT devices as previously discussed. The computing device and local systems within the POC environment can maintain a patient EMR (e.g., EMR 1003). A local data broker 1006 can receive information from an LIS environment 1011 over a wide area network infrastructure and populate or update the EMR 1003 with information, as previously described.

[0041] The local data broker 1006 may be a message-oriented middleware software module for handling the flow of data between the POC EMR 1003 and a service bus 1010 deployed on the cloud services platform 1008. The local data broker 1006 acts as an intermediary between applications handling the EMR 1003 and other applications with which the mobile computing device must interface over a wide area network infrastructure. The service bus 1010 is used to decouple applications in the POC environment 1001 from applications deployed on or behind the wide area network infrastructure.

[0042] 10 , the remote broker 1012 translates and / or encapsulates lower-level EMR data received from the LIS 1018 of the LIS environment 1011 to provide secured EMR data for traversing a wide area network infrastructure, including the Internet 1007, without requiring an end-to-end encrypted channel such as that which may be provided by a VPN connection. The local data broker 1006 receives the secured EMR data from the remote broker 1012 over the wide area network infrastructure. In this example, the remote broker 1012 handles the flow of data between the central middleware 1016 and the local data broker 1006. The remote broker 1012 receives the lower-level EMR protocol data, or at least information from the lower-level EMR protocol data, from the middleware 1016, encapsulates the lower-level EMR data, or information from the lower-level EMR data, and transmits the data to the POC environment 1001 so that the healthcare information in the POC EMR 1003 can be updated. In this example, the central middleware 116 provides a translation layer between the LIS 1018 and the remote broker 1012 .

[0043] The LIS environment 1011 includes computer systems (not shown) within testing laboratories, hospitals, clinics, etc., that are connected to the LIS via a LAN, virtual LAN, VPN, or within the firewall or information security structure of the LIS. Devices that are not connected to or associated with the LIS in any of these ways are said to be located outside or external to the LIS environment. Laboratories, hospitals, clinics, and the like that are located within the LIS environment are typically affiliated with or partnered in some way with the same entity that maintains the LIS. The remote data broker 1012 and central middleware 1016 may be part of the LIS environment or part of the wide area network infrastructure, and one or both components may reside in both the LIS environment and the wide area network infrastructure.

[0044] Continuing with FIG. 10 , by way of example, messages within one or both of the LIS environment 1011 and the POC environment 1001 may be transmitted in accordance with the Health Level 7 (HL7) standard, under which messages are exchanged using the ASCII-based Minimal Lower Layer Protocol (MLLP) as a lower-level protocol for EMR data. Thus, in the context of system 1000, the lower-level EMR data may consist, at least in part, of MLLP messages. In the example of FIG. 10 , such messages may be sent from middleware 1016 and received by TCP listening stack 1019 for remote broker 1012. Similarly, MLLP messages may also be sent from remote broker 1012 to TCP listening stack 1020 for middleware 1016. Remote broker 1012 encapsulates the received lower-level EMR data and transmits it securely over the wide area network infrastructure to POC environment 1001.

[0045] The data broker 1006 receives the secured EMR data, accesses lower level EMR data (MLLP) from the secured EMR data, and can use the EMR data to populate or update the POC EMR 1003, which may include new test results originally recorded by a POCT device within the POC environment 1001 or at another remote provider or clinic. If information from the POC EMR needs to be sent back to the LIS, the data broker 1006 includes a TCP listening stack 1009 to receive MLLP messages containing data from the POC EMR 1003.

[0046] FIG. 11 is a flowchart illustrating a process for providing a transparent and secure link for point-of-care medical record management according to an embodiment of the present disclosure. In block 1102, processing devices in the POC environment and the LIS environment establish a connection between a local data broker 1006 and a remote broker 1012. The data broker 1006 and the computing device running the data broker are located outside the LIS environment. The real-time connection between the brokers then provides a connection between the POC EMR 1003 and the LIS 1018. In block 1106, a computing device (e.g., a server running the remote broker 1012 in the LIS environment) configures the lower-level EMR data to generate secured EMR data for transport to the POC environment 1001. By way of example, the secured EMR data may include a JSON message encapsulating an MLLP message further including the EMR data. In block 1108, the secured POCT data is transmitted to the POC local data broker 1006 over a wide area network infrastructure, including the cloud services platform 1008. The cloud services platform 1008 may include a service bus 1010, which provides load balancing, routing, and other functions using message queues. In block 1110, a computing device in the POC environment 1001 running a local data broker 1006 accesses the lower-level EMR data from the secured EMR data, for example, by deencapsulating the MLLP message from the JSON message. In block 1112, the POC EMR 1003 is updated with or populated with the lower-level EMR data from the LIS.

[0047] Unless specifically stated otherwise, throughout this specification, "processing," "computing," or similar terms refer to the acts or processes of a computing or processing device, such as one or more computers or one or more similar electronic computing devices, that manipulate or transform data represented as physical electronic or magnetic quantities in the memory, registers, or other information storage, transmission, or display devices of a computing platform. The term "patient" can refer not only to human patients, but also to animals on which POCT may be performed in veterinary practice.

[0048] The system or systems discussed herein are not limited to any particular hardware architecture or configuration. A computing device may include any suitable arrangement of components that provide tailored results based on one or more inputs. Suitable computing devices include general-purpose microprocessor-based computing systems that access stored software that programs or configures the computing system from a general-purpose computing device to a special-purpose computing device that performs one or more aspects of the present subject matter. Any suitable programming language, scripting language, or other type of language, or combination of languages, can be used to implement the teachings contained herein in software used in programming or configuring a computing device.

[0049] Aspects of the methods disclosed herein may be performed in operation of such a computing device. The order of some of the blocks presented in the above examples may be changed, e.g., the blocks may be rearranged, combined, or divided into sub-blocks. Certain blocks or processes may be performed in parallel.

[0050] The use of the term "configured to" herein is intended to be open-ended and inclusive language and does not exclude devices configured to perform additional tasks or steps. Additionally, the use of the term "based on" is intended to be open-ended and inclusive in that it refers to the acts or processes of a computing or processing device, and that in practice, a process, step, calculation, or other act that is "based on" one or more recited conditions or values ​​may be based on additional conditions or values ​​beyond those recited. Headings, lists, and numbering contained herein are for ease of description only and are not intended to be limiting. A "connection" between structures, systems, modules, networks, or the like may refer to a direct connection or a connection through an intervening structure, system, module, network, etc.

[0051] The foregoing description of examples of the subject matter (including illustrative examples) has been presented for purposes of illustration and description only, and is not intended to be exhaustive or to limit the subject matter to the precise form disclosed. Many modifications, adaptations, and uses of this subject matter will be apparent to those skilled in the art without departing from the scope of the subject matter. The illustrative examples set forth above are provided to introduce the reader to the general subject matter discussed herein and are not intended to limit the scope of the disclosed concepts.

Claims

1. a non-transitory computer readable medium containing computer program code for providing a transparent and secure link for a point-of-care testing (POCT) device; a processor device communicatively coupled to the non-transitory computer-readable medium; Including, the processor device: Using a mobile computing device to access lower level instrument protocol data from a POCT device, wherein the mobile computing device and the POCT device are located outside a laboratory information system (LIS) environment; configuring the lower level instrument protocol data to generate secured POCT data using a data broker on the mobile computing device; transmitting the secured POCT data to the LIS environment using a wide area network infrastructure; accessing the lower level device protocol data from the secured POCT data in at least one of the wide area network infrastructure or the LIS environment; populating an LIS Electronic Medical Record (EMR) of the LIS environment using information from the lower level device protocol data accessed from the secured POCT data; populating the EMR of the LIS by providing the information to a central middleware configured to format the information for the EMR; configured to execute the computer program code to perform system.

2. the processor device is configured to execute the computer program code to transmit at least a portion of the EMR containing the information from the LIS to the mobile computing device. The system of claim 1 .

3. the data broker on the mobile computing device is configured to encapsulate the lower-level device protocol data in a JSON message; 3. The system according to claim 1 or 2.

4. the processor device is configured to execute the computer program code to decapsulate the lower level device protocol data using a remote broker in at least one of the wide area network infrastructure or the LIS environment. A system according to any one of claims 1 to 3.

5. the processor device: establishing a connection between the POCT device and the data broker on the mobile computing device; automatically establishing a real-time connection between the data broker on the mobile computing device and the LIS based on establishing the connection between the POCT device and the data broker on the mobile computing device; configured to execute the computer program code to perform Optionally, the connection between the POCT device and the data broker on the mobile computing device comprises TCP messages from the POCT device to the mobile computing device; 5. A system according to any one of claims 1 to 4.

6. A computer-implemented method comprising: Using a mobile computing device to access lower level instrument protocol data from a point-of-care testing (POCT) device, wherein the mobile computing device and the POCT device are located outside a laboratory information system (LIS) environment; configuring the lower level instrument protocol data to generate secured POCT data using a data broker on the mobile computing device; transmitting the secured POCT data to the LIS environment using a wide area network infrastructure; accessing the lower level device protocol data from the secured POCT data in at least one of the wide area network infrastructure or the LIS environment; populating an LIS Electronic Medical Record (EMR) of the LIS environment using information from the lower level device protocol data accessed from the secured POCT data; populating the EMR of the LIS by providing the information to a central middleware configured to format the information for the EMR; Including, method.

7. and / or further comprising transmitting at least a portion of the EMR containing the information from the LIS to the mobile computing device. and / or wherein configuring the lower level device protocol data further comprises encapsulating the lower level device protocol data in a JSON message. and decapsulating the lower-level device protocol data using a remote broker in at least one of the wide area network infrastructure or the LIS environment. The method of claim 6.

8. establishing a connection between the POCT device and the data broker on the mobile computing device; automatically establishing a real-time connection between the data broker on the mobile computing device and the LIS based on establishing the connection between the POCT device and the data broker on the mobile computing device; further comprising Optionally, the connection between the POCT device and the data broker on the mobile computing device comprises TCP messages from the POCT device to the mobile computing device; The method of claim 6.

9. A non-transitory computer readable medium containing computer program code, comprising: the computer program code comprising: receiving low-level device protocol data from a point-of-care testing (POCT) device located outside a laboratory information system (LIS) environment; configuring the lower level device protocol data to generate secured POCT data using a data broker on the mobile computing device; transmitting the secured POCT data to the LIS environment using a central middleware and wide area network infrastructure; executable by a processor to cause the mobile computing device to Non-transitory computer-readable medium.

10. the computer program code being executable by the processor to cause the mobile computing device to receive at least a portion of an electronic medical record including information from the LIS; and / or the data broker on the mobile computing device is configured to encapsulate the lower-level device protocol data in a JSON message; The non-transitory computer-readable medium of claim 9.

11. the computer program code comprising: establishing a connection between the POCT device and the data broker on the mobile computing device; automatically establishing a real-time connection between the data broker on the mobile computing device and the LIS based on establishing the connection between the POCT device and the data broker on the mobile computing device; executable by the processor to cause the mobile computing device to Optionally, the connection between the POCT device and the data broker on the mobile computing device comprises TCP messages from the POCT device to the mobile computing device; Optionally, the connection between the POCT device and the data broker comprises a TCP message from the POCT device to the mobile computing device, and the computer program code is executable by the processor to cause the mobile computing device to receive a user input and, in response to the user input, open a TCP port to listen for a connection message from the POCT device.

11. The non-transitory computer-readable medium of claim 9 or 10.

12. a non-transitory computer readable medium containing computer program code for providing a secure link for a point-of-care (POC) electronic medical record (EMR); a computing device communicatively coupled to the non-transitory computer-readable medium; Including, the computing device: Accessing low-level EMR data within a Laboratory Information System (LIS) or Hospital Information System (HIS) environment; configuring the lower-level EMR data to generate secured EMR data using a remote broker; transmitting the secured EMR data to a POC environment using a wide area network infrastructure; accessing the lower-level EMR data from the secured EMR data in the POC environment, the POC environment being located outside the LIS or HIS environment; populating or updating the POC EMR using information from the lower level EMR data; Populating the POC EMR by providing the information to a central middleware configured to format the information for the POC EMR; configured to execute the computer program code to perform system.

13. the remote broker is configured to encapsulate the lower-level EMR data in a JSON message; The system of claim 12.

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