Optically-readable encoded health data

Abstract

The disclosed systems and method create an optically-readable code, such as a QR code, based on diagnostic test results and output for display or storing in memory the optically-readable code along with input patient data. The patient data can include patient biographic data, patient history, and medical records, for example. The optically-readable code can include the present diagnostic test results along with any past test results for the patient. The patient results include both input data about the patient and generated data about the diagnostic test results. This information is encoded in an optically-readable code, which can be displayed and stored in environments that do not have developed infrastructure to communicate with remote servers and devices, such as in remote location or under-served communities that do not have reliable Wi-Fi.

Description

PATENT Attorney Ref. No. 1001.1038.WOPCT OPTICALLY-READABLE ENCODED HEALTH DATA CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority and benefit from the U.S. Provisional Patent Application 63 / 668,611, filed July 8, 2024, and titled, “OPTICALLY-READABLE ENCODED HEALTH DATA,” which is incorporated herein by reference in its entirety for all purposes. BACKGROUND

[0002] Resourced communities often have developed infrastructure to support communications, especially when creating health care records for patients across multiple care providers and providing access to such records to the patients and care providers. Most resourced communities have widespread communications capabilities, such as computing networks that transmit and receive the medical data over the Internet. Even in these resourced locations, reliance on communications networks is vast and, without them, such as during outages or system failures, medical data is not timely transmitted to a patient health record or communicated to care providers that might need to know the data. For example, resourced communities that experience a system failure, power outage, or Internet or Wi-Fi outage must then rely on manual transfer of medical data to a patient record or communication to a care provider that may need the patient data, such as an emergency or critical care department provider or other critical care provider.

[0003] Further, in under-resourced or remote communities, infrastructure, such as Internet or Wi- Fi capabilities, may be unreliable or non-existent. Documenting patient data is performed manually in these locations, often by hand or entered manually in a computing device. For example, diagnostic data is generated by a diagnostic device, then manually or input by hand on a hard copy of a patient health record or manually entered into a local computing device that is not connected or is unreliably connected to remote servers. Often in such under-resourced and remote communities, patients and care providers access patient health records by searching in a physical ledger, such as a book, or reviewing records retrieved from memory on a local computer. If the ledger were lost or the local computer were to fail, the data would be lost, leaving those patients with gaps in their medical care history and poor communication of critical data to providers in emergency, long and other critical health situations.PATENT Attorney Ref. No. 1001.1038.WOPCT

[0004] In addition, many regions of the world do not maintain medical records relying on the patient to keep records. A paper record is easy to lose or damage.

[0005] Patients and caregivers in under-resourced and remote communities deserve to have access to patient health data to maintain a high-fidelity system and to be informed of all critical patient data during emergency care situations. Resourced communities deserve to have back-up systems that protect health data and allow patients and caregivers to enhance their access to and communication about the patient health data. The industry will benefit globally from improved systems and methods that store and transmit patient data. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Non-limiting and non-exhaustive embodiments of the invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures, unless otherwise specified, wherein:

[0007] FIG. 1 is a block diagram of an example set of patient results according to aspects of the invention.

[0008] FIG. 2 is an example diagram of a system that prepares diagnostic results for a patient.

[0009] FIGS. 3A and 3B are example patient results according to examples of the disclosure.

[0010] FIG. 4 is a flowchart showing a method of preparing diagnostic results for a patient. DETAILED DESCRIPTION

[0011] The disclosed systems and methods help prepare diagnostic results for patients in remote, under-resourced locations, or in areas in which infrastructure fails but medical care needs to continue. The disclosed system and methods receive input about a patient, which can include patient biographic data, patient history, patient electronic health record data, and the like; and results from a diagnostic test for the patient and combine both the patient input and the diagnostic test results output to create patient results that can be easily transferred from the medical device to another computing device, a printer, or stored in on board or external memory for later use. The patient results can include an optically-readable code, such as a QR code, and an image of the diagnostic results, which can include one or more images of diagnostic assays or cartridges orPATENT Attorney Ref. No. 1001.1038.WOPCT diagnostic tests results that require an image or can convey valuable patient information about the diagnostic test(s) to a provider or patient. The optically-readable code can also be a printed code, a bar code, a holographic image, or an audio signal in other examples. The patient input and some of the diagnostic test results data that is not required or beneficial to be in an image are encoded in the optically-readable code. The optically-readable code can be transmitted between the diagnostic medical device performing the diagnostic test, such as reader of a diagnostic assay like electrophoresis, without relying on the Internet, Wi-Fi, or other communications infrastructure.

[0012] Optical readers like cameras are ubiquitous in personal devices, such as mobile phones, personal computers and the like including in remote and under-resources locations. Such optical readers are able to decode the optically-readable code, which can be displayed on a display of the medical device, like a monitor of a diagnostic assay reader, or can be printed directly from the medical device, such as in a patient results report that is transmitted to the printer via a local or wireless connection. None of these options requires an operable computer network, access to the Internet at the time of transmission or data transfer, or a communications module in the medical device. The transfer of the patient’s input patient data and the diagnostic test results output occurs between the medical device and a personal computing device (e.g., a provider’s mobile phone or laptop), an external memory (e.g., thumb drive), or a local printer without relying on the Internet, another network connection, or any sophisticated infrastructure.

[0013] In the examples in which the input patient data and the diagnostic test results output are transferred from the medical device to a personal computing device like a provider’s mobile phone or laptop, the provider may later, asynchronous to the act of performing the diagnostic test on the medical device for the patient, transfer the input patient input data and the diagnostic test results output to a different device or server through the optically-readable code and image. This can occur after the provider performs tests on multiple patients at a remote location, then travels to a different location with reliable infrastructure a period of time later. If the transfer of the patients’ input data and the diagnostic test output data for each patient is transferred to servers for long-term storage of this data over communications networks, such as the Internet or another network , it is transferred asynchronously from the time and remote from the location where the diagnostic test occurred. The patient input data and the diagnostic test results output are transferred to the remote servers at a period of time after the patient data is input and the diagnostic test is completePATENT Attorney Ref. No. 1001.1038.WOPCT whenever the communications infrastructure is not available or do not exist to support communication between the medical device and a remote server.

[0014] In the examples in which the input patient data and the diagnostic test results output are transferred from the medical device to a printer via a local wired or wireless connection, the patient results are printed from the medical device in the form of a patient report that includes the optically-readable code. The hard copy printed patient report includes the optically-readable code, which is then physically transported to another location to be decoded by an optical reader like a camera into another system, server, memory, or the like. The hard copy printed patient report can also be imaged by a local optical imager, such as a provider’s mobile phone camera for later decoding at a different location to avoid the risk of losing the physical printout.

[0015] The disclosed systems and methods overcome the significant barriers faced by people living in remote and under-resourced locations that do not have infrastructure to provide reliable communications systems, like the Internet, to connect to sophisticated remote servers that store data, such as patient electronic health records (EHRs). The disclosed systems and methods give care givers and patients alike easy access to the patient data without requiring substantial infrastructure that communicates over networks. Conventionally, care providers manually write down diagnostic test results for patients in remote and under-resourced locations because they lack a computer, local or remote servers, and / or access to a computing network that can transmit then store data on a remote server, such as in the cloud. Manual entry of data from diagnostic tests to a physical ledger, such a hard copy of a patient’s EHR or test result, or manual entry of the diagnostic test result into a computer, suffer as high as a 20-40% error rate. Further, many medical devices in remote and under-resourced locations are incapable of communicating over a network because they do not have a communications module, which again forces manual entry of their data output to either a hard copy ledger or a computer. In these remote and under-resourced locations, many patients access their EHRs from a local computing device or a hard copy ledger so the disclosed systems and methods provide the ability for patients to easily view and store their EHRs.

[0016] In contrast, the disclosed systems and methods have an optically-readable code with the encoded patient input data and diagnostic test results output data and an image of the diagnostic test. In some examples, the image(s) of the diagnostic test are captured by the medical device performing the test. The image(s) can alternatively be captured by an optical imager that is external to the medical device. A single image can be captured in some examples although inPATENT Attorney Ref. No. 1001.1038.WOPCT alternatives multiple images can be captured. For example, a patient compound tested by an electrophoresis reader could produce different bands of compounds throughout an assay run, some of which appear and disappear throughout the assay run. Here, multiple images may be desirable to capture a known or estimated time mid-way through the assay run when a band is expected to appear, then disappear later if the associated compound or biomarker is either present or absent in the patient sample.

[0017] Specifically, in example diagnostic tests that include cartridges, printouts (e.g., electrocardiograms (ECGs) from a defibrillator), images of the cartridges at the end of an assay run help a provider understand the test results with more robust and detailed information than having the providers only analyze the output data about the results and / or interpretive data. The combination of the test results being encoded into the optically-readable code and the image of the cartridge at the end of the assay helps care providers understand the complete set of data about the patient’s diagnostic test results to provide the best care possible.

[0018] In other examples, the patient’s results or output from the medical device is only the optically-readable code that includes the patient data and the results of the diagnostic test without an image of the diagnostic test. Some of the diagnostic tests do not easily lend themselves to imaging, such as a pulse oximeter reading for example. Any medical device can be part of the disclosed systems and methods, which can include diagnostics and other medical devices that have outputs that are valuable to image and others that either cannot be imaged or an image of the results does not provide value to a care provider.

[0019] FIG. 1 shows a medical device 100 that has an output 101 that includes an image of a diagnostic test results 102, graphs of diagnostic test results 104, and interpretive data of diagnostic test results 106. The medical device 100 output 101 also includes an optically-readable code 108. As discussed above, the medical device 100 can be any medical device that generates patient data, which can include monitoring devices, therapeutic devices, and diagnostic devices. Patient monitors used in a hospital or pre-hospital emergency setting could monitor patient vital signs, for example. Such monitoring devices could produce reports that have an image of a patient’s ECG , interpretive data of the ECG showing a certain arrythmia is present, and an optically-readable code that includes patient biographic and EMR data and monitoring data as it is monitored periodically and the interpretive data. In another example, a defibrillator monitors a patient’s heart rhythm, outputs an ECG graph, and gives interpretive data regarding whether the patient is suffering aPATENT Attorney Ref. No. 1001.1038.WOPCT shockable rhythm, then administers the shock to the patient and adds the administered shock therapy to the patient to the patient EMR. In this defibrillator example, the patient biographic and some EMR data are input, then patient data and the defibrillator’s diagnostic and therapeutic history is encoded in the optically-readable code. An image of the ECG graph can be included in the output with the optically-readable code.

[0020] In diagnostic medical devices, such as readers that run immunoassays on cartridges with patient samples, such as electrophoresis, an image of the cartridge helps provide a care provider with critical information about the patient’s diagnostic test results. The data related to the specific findings in the diagnostic test are encoded in the optically-readable code along with any diagnostic interpretive data, graphs, and previous tests for the same patient. An image of the bands that appear on a strip in an electrophoresis cartridge helps a care provider understand the band separation, band thickness, presence of certain bands, and the like. Multiple images of an electrophoresis cartridge over the time duration of the assay run can also be helpful as some bands appear during a certain time period of the assay run but disappear by the end of the assay run. In this example, multiple images of the electrophoresis cartridge can be included in the output of the medical device. With the electrophoresis example, presence, absence, and / or percentages of various compounds or biomarkers can be included along with optional interpretive data and recommendations or graphs relating to the presence, absence, or percentage of the compounds and / or biomarkers.

[0021] FIG. 2 shows an example system 200 that includes a medical device 202 that communicates with a computing device that has an optical imager 224. The computing device with the optical imager 224 can be a personal computing device like a mobile phone or laptop with a camera. The medical device 202 has an input 204 that receives all patient input data, such as patient biographic data, EHRs, previous test results, patient history, and the like. The medical device 202 can also include a controller 206 that has instructions that help prepare the output for the patient, such as the diagnostic test results for the patient. The medical device 202 has an output that transmits or displays the patient test results or a patient report from the medical device 202 to another device like the computing device with an optical imager 224 or a printer 223. The medical device 202 includes a display 210 that displays the output with the patient test results or patient report to a patient and / or a care provider. The medical device 202 includes memory 212 in some examples that can store patient data, patient test results, and / or patient reports in on-board memory in the medical device 202. In some examples, the medical device 202 includes a communicationsPATENT Attorney Ref. No. 1001.1038.WOPCT module 214 that is able to electronically connect the medical device 202 to a network, such as the Internet.

[0022] The medical device 202 can transfer data with the patient report that includes the patient test results that have the optically-readable code and the image of the diagnostic test results to the printer 223 to print a hard copy that can be shared with the patient and / or a care provider. The optically-readable code on the printed hard copy allows a patient and / or care provider to later access the encoded patient data. If Wi-Fi or a hard wired Internet connection is available 216, the medical device 202 can transmit the patient data to a remote server or computing device 218. In some examples, the patient test results and / or patient report can be stored on the medical device 202 in on board memory 212 as a temporary storage solution and later transmitted to the remote server or computing device 218 for long-term storage over Wi-Fi or the Internet at a later time when the medical device 202 is able to connect to the Wi-Fi or Internet. This could mean that the Wi-Fi or Internet was not available at the time the diagnostic test was performed for the patient, such as from an Internet outage, or it could be that a care provider transports the medical device 202 to a new location that has Wi-Fi or Internet service.

[0023] When Wi-Fi or Internet service are unavailable 220, a synchronous communication 222 can occur that transfers the patient data and optionally the image of the diagnostic test result from the medical device 202 to the computing device with the optical imager 224. Alternatively, an asynchronous communication can occur to transfer the patient data and optionally the image of the diagnostic test result from the medical device 202 to the computing device with the optical imager 224. The optical imager of the computing device 224 decodes the optically-readable code to receive the input of the patient data to the computing device 224 for either on device storage on a temporary or long-term basis. Temporary storage could include storing the data on the computing device 224 until it can be uploaded over a communications network like the Internet at a later time when the computing device 224 can access the Internet. This could occur, for example, in the form of an application on a personal mobile device or laptop that ingests the patient test results and image through the device’s camera for temporary storage, then automatically or manually uploads that data at a later time to a server for long-term storage, such as patient EHRs or public health server. The computing device with the optical imager 224 has an asynchronous communication with the remote server 218 in this example. Long-term storage on the computing device 224 can include a personal laptop that uses its camera to ingest the patient test results withPATENT Attorney Ref. No. 1001.1038.WOPCT the optically-readable code and the image of the diagnostic test results for long-term storage in device 224 memory or external device memory.

[0024] The controller 206 of the medical device 202 can also evaluate a patient’s health record data and identify a portion of the patient health record data that impacts the diagnostic results for the patient. The patient health record data evaluated by the controller 206 can be stored as the input patient data on a local memory. For example, the diagnostic test results for a patient with sickle cell disease are impacted by whether the patient recently had a blood transfusion. For sickle cell patients having their hemoglobin evaluated in the diagnostic test, this data is input as the patient data and encoded into the optically-readable code or stored locally in a patient data file. When this happens, the controller 206 can output the identified portion of the patient health record that impacts the diagnostic results for the patient. In the sickle cell disease example, the output would include data that the patient recently received a blood transfusion. This patient data is collected before the patient undergoes the diagnostic test, in some examples, and input into the medical device and / or the patient data file. Any relevant test result, patient information or other input data about the patient can be included that might impact the patient’s diagnostic test results.

[0025] One or more prior tests can also be included in the patient data including the same diagnostic test currently being performed or other related and / or unrelated tests. The current diagnostic test can be compared to prior tests and insights regarding changes to the patient’s health over time can be gleaned by an algorithm that evaluates the collective patient data and / or a care provider that can access it via the medical device memory or local computing device.

[0026] FIGS.3A and 3B show examples of patient test results 300A, 300B output by the disclosed medical devices. In both examples, the medical device is a diagnostic reader that performs electrophoresis immunoassay on cartridges that have a patient sample. FIG. 3A shows an output on a display of a diagnostic reader 300A, which includes an image of the electrophoresis cartridge 302 captured at the end of the assay run. The output also includes graphs of the phenotypes of the compounds 306 present and / or absent in the patient sample that were found in the assay run. In FIG. 3A, the compounds include hemoglobin phenotypes. The output also includes interpretive data about the diagnostic test results, which includes a likely presence of a certain disease state or biomarker, which is sickle cell trait in this example. The output 300A includes a QR code 304, which is the optically-readable code that encodes the patient data and diagnostic test results. The QR code can be encrypted or an open format. Here, the patient data includes patient biographicPATENT Attorney Ref. No. 1001.1038.WOPCT data, patient history, the percentage of phenotypes of hemoglobin in the patient sample from the assay run, the location and time the assay run occurred, diagnostic reader device data and software data, and diagnostic reader calibration data.

[0027] FIG.3B shows a patient report 300B that is generated based on the patient test results and output shown in FIG.3A. The patient report 300B can be stored as a data file in on board memory of the medical device, on an external memory device connected to the diagnostic reader, on an external local computing device such as a personal laptop, or it can be sent to a printer to print a hard copy. The patient report 300B shown in FIG. 3B shows patient data 310, which, in this example, includes patient biographic data and patient history. The patient report 300B also includes an image of the cartridge after the assay run 314 and a QR code that includes all patient data and diagnostic test results (including any previous diagnostic tests on the same patient). The patient report noted that a problem occurred with the test 312 that alerts the care provider to rerun the assay with a new patient sample to ensure high fidelity diagnostic results.

[0028] FIG. 4 illustrates a flowchart of an example method of preparing diagnostic results for a patient 400. In an example, these steps are performed as instructions for a controller or processor in the medical devices disclosed herein. The patient data input about a patient is received 402 and an image of the diagnostic electrophoresis cartridge with diagnostic results for the patient 404 is also received. The controller or a processor generates patient results that include both an optically- readable code that relates to the patient and an image of the diagnostic electrophoresis cartridge 406. The on board controller or processor outputs the patients results or stores the patients results in a patient report data file 408. The data can synchronously be transferred to a local computing device like a care provider’s mobile phone or laptop through a camera on the device that decodes the patient data encoded in the optically-readable code on the mobile device or laptop for local temporary or long-term storage. At a later time, asynchronous from the diagnostic test occurring, the patient data can be transmitted or transferred from the care giver’s mobile phone or laptop (or any other computing device) to another device either directly via a hard wired or direct connection or via a network connection like the Internet to store the data on a remote server. The transfer of the data from the medical device to the local computing device occurs even when no network connection to the remote server is available and ensures all patient data generated by the medical device is accurately transferred from the medical device to the local computing device with high fidelity data transfer accuracy (cf. manual entry or transcription with high error rates).PATENT Attorney Ref. No. 1001.1038.WOPCT

[0029] The subject matter of embodiments disclosed herein is described here with specificity to meet statutory requirements, but this description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be interpreted as implying any particular order or arrangement among or between various steps or elements except when the order of individual steps or arrangement of elements is explicitly described.

[0030] Embodiments will be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof, and which show, by way of illustration, exemplary embodiments by which the systems and methods described herein may be practiced. The systems and methods may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy the statutory requirements and convey the scope of the subject matter to those skilled in the art.

Claims

PATENT Attorney Ref. No. 1001.1038.WOPCT What is claimed is:

1. A method of preparing diagnostic results for a patient, comprising: receiving patient data input about the patient; receiving an image of a diagnostic cartridge with diagnostic results for the patient; generating patient results that include both an optically-readable code with encoded patient data and the image of the diagnostic cartridge; and outputting the patient results to a display, printing, or storing in a memory the patient results in a patient report.

2. The method of claim 1, wherein the generating the patient results occurs in a computing environment with a Wi-Fi or wired connection.

3. The method of claim 1, wherein the patient data is input asynchronously from receiving the image of the diagnostic electrophoresis cartridge with the diagnostic results for the patient.

4. The method of claim 1, further comprising asynchronously transmitting the patient results over a Wi-Fi or other communication connection from the output patient results to the display or by accessing the patient results in the patient report stored in the memory.

5. The method of claim 4, wherein asynchronously transmitting the patient results over the Wi-Fi or other communication connection from the output patient results to the display includes having an optical reader decode the optically-readable code with the encoded patient data and transmit it to another computing device over the Wi-Fi connection at a period of time after the patient results are output or stored in the memory.

6. The method of claim 5, wherein the optical reader is a camera on a personal computing device that includes a mobile phone or personal computer.

7. The method of claim 1, wherein the optically-readable code is a QR code.PATENT Attorney Ref. No. 1001.1038.WOPCT 8. The method of claim 7, wherein the QR code is encrypted.

9. The method of claim 7, wherein the QR code is an open format QR code.

10. The method of claim 1, wherein the encoded patient data includes at least one previous diagnostic test related to the patient.

11. The method of claim 1, wherein the optically-readable code is a printed code, bar code, holographic image, or an audio signal.

12. The method of claim 1, wherein the patient data includes patient biographic data, patient medical history data, or patient health record data.

13. The method of claim 1, wherein the patient data and the image of the diagnostic electrophoresis cartridge are received at a controller of a diagnostic reader that ran the diagnostic test on the diagnostic electrophoresis cartridge.

14. The method of claim 13, wherein the patient data is transmitted to the controller from an computing system that stores an electronic health record of the patient.

15. The method of claim 13, wherein the image of the diagnostic electrophoresis cartridge is generated by the diagnostic reader.

16. The method of claim 13, further comprising receiving interpretive data about the diagnostic results and generating the patient results to include the interpretive data.

17. The method of claim 16, wherein the interpretive data generated is generated by the controller based on the patient data input to the reader and the image of the diagnostic electrophoresis cartridge.PATENT Attorney Ref. No. 1001.1038.WOPCT 18. The method of claim 1, further comprising receiving test data, measurement data, or calibration data about the diagnostic electrophoresis cartridge or a reader that ran a diagnostic test to generate the diagnostic results on the diagnostic electrophoresis cartridge, and generating the patient results to include the received test data, measurement data, or calibration data.

19. The method of claim 1, wherein the diagnostic results include one or more identified hemoglobin phenotypes.

20. The method of claim 19, wherein the optically-readable code is readable by a camera or other optical imager.

21. The method of claim 1, further comprising transmitting the patient report to a printer.

22. The method of claim 1, wherein the diagnostic cartridge is a diagnostic electrophoresis cartridge.

23. A system to prepare diagnostic results for a patient, comprising: an input configured to: receive patient data input about the patient; receive an image of a diagnostic cartridge with diagnostic results for the patient; a controller configured to: generate a optically-readable code with encoded patient data; and create patient results that include the generated optically-readable code and the image of the diagnostic cartridge; and an output configured to output the patient results or to store in memory the patient results.

24. The system of claim 23, wherein the controller is further configured to evaluate the patient health record data and identify a portion of the patient health record data that impacts the diagnostic results for the patient.PATENT Attorney Ref. No. 1001.1038.WOPCT 25. The system of claim 24, wherein the output is further configured to output the identified portion of the patient health record data that impacts the diagnostic results for the patient with the patient results.

26. The system of claim 23, wherein the diagnostic cartridge is a diagnostic electrophoresis cartridge.

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