Researchers Submit Patent Application, “Remote Diagnostic Testing Systems And Methods”, for Approval (USPTO 20230121265): Patent Application
2023 MAY 08 (NewsRx) -- By a
No assignee for this patent application has been made.
News editors obtained the following quote from the background information supplied by the inventors: “
“Field
“The present application is directed to systems, methods, and devices that are configured to enable or facilitate remote healthcare, such as for remote medical testing and diagnostics. Some embodiments provide for remote health care using a personal user device, such as a smartphone or tablet.
“The present application also is directed to systems, methods, and devices that are configured to enable or facilitate image verification and/or processing, such as image verification and/or processing used during remote medical testing and diagnostics. Some embodiments provide for remote health care using a personal user device, such as a smartphone or tablet.
“The present application also is directed to remote testing sessions, such as those including remote health testing or diagnostics. Some embodiments are directed at improving efficiency for remote testing sessions.
“Description
“Use of telehealth to deliver healthcare services has grown consistently over the last several decades and has experienced very rapid growth in the last several years. Telehealth can include the distribution of health-related services and information via electronic information and telecommunication technologies. Telehealth can allow for long-distance patient and health provider contact, care, advice, reminders, education, intervention, monitoring, and remote admissions. Often, telehealth can involve the use of a user or patient’s personal user device, such as a smartphone, tablet, laptop, personal computer, or other device. For example, a user or patient can interact with a remotely located medical care provider using live video, audio, or text-based chat through the personal user device. Generally, such communication occurs over a network, such as a cellular or internet network.
“Remote or at-home healthcare testing and diagnostics can solve or alleviate some problems associated with in-person testing. For example, health insurance may not be required, travel to a testing site is avoided, and tests can be completed at a testing user’s convenience. However, remote or at-home testing introduces various additional logistical and technical issues, such as guaranteeing timely test delivery to a testing user, providing test delivery from a testing user to an appropriate lab, ensuring proper sample collection, ensuring test verification and integrity, providing test result reporting to appropriate authorities and medical providers, and connecting testing users with medical providers who are needed to provide guidance and/or oversight of the testing procedures remotely.”
As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “Remote or at-home healthcare often involves the use of a user or patient’s personal user device, such as the user’s smartphone, tablet, laptop, personal computer, or other device. While this greatly increases the availability and ease of access to healthcare, use of or reliance on the user’s personal user device may pose challenges. For instance, in many countries or regions, governmental regulatory bodies may provide strict requirements related to which devices can be used for medical testing or diagnostics. For example, in
“Some of the systems, methods, and devices described in this application can facilitate and enable the use of personal user devices, such as smartphones, tablets, laptops, personal computers, or other devices, for remote or at-home healthcare through the use of medical sensor subsystems, which can be included in the personal user devices. The medical sensor subsystems can be configured such that they comply with the necessary regulatory requirements (e.g., qualifying themselves as medical devices) and such that they can be readily integrated into various personal user devices (where, in some instances, the various personal user devices themselves or as a whole need not comply with the regulatory requirements). The medical sensor subsystems can further be configured for use in remote or at-home healthcare, for example, as part of a remote health testing or diagnostic process. The medical sensor subsystem can also be configured such that the computation associated with a medical test that is carried out on the personal user device itself (e.g., on a processor of the personal user device) is minimized or even eliminated. Instead, the computing can be mainly or entirely performed on a remote server or device, such as a device in the cloud. The remote server or device can also be configured to comply with the necessary regulatory requirements. In this way, remote health testing or diagnostics, which would normally be required to be performed on a regulatorily compliant device, can be performed on a personal user device that itself is not regulatorily certified, but which includes regulatorily certified medical sensor subsystems that can be in electronic communication with regulatorily certified remote servers or devices over a network, such as the internet.
“Examples of such medical sensor subsystems can include, for example, camera or imaging sensor subsystems, microphone or other audio recording subsystems, inertial measurement subsystems, pressure sensor subsystems, or others.
“In some embodiments, a camera or imaging sensor subsystem can include one or more of the following components, among others: a camera module (including one or more of a lens array, a filter, an image sensor, or an autofocus mechanism) and supporting hardware (such as, for example, an image signal processor (ISP), an autofocus driver, and/or other supporting circuit components or control associated with the camera).
“In some embodiments, a microphone or other audio recording subsystem can include one or more of the following components, among others: microphone hardware, preprocessing integrated circuits (if necessary), a printed circuit board (PCB) layout for noise and/or function, and or a case opening or porting.
“In some embodiments, an inertial measurement subsystem can include one or more of the following components, among others: IMU hardware (e.g. accelerometers, magnetometers, and/or gyrometers or gyroscopes), preprocessing integrated circuits (if necessary), a printed circuit board (PCB) layout for noise and/or function, and or orientation and mounting structures.
“In some embodiments, a pressure sensor subsystem can include one or more of the following components, among others: a pressure sensor, preprocessing integrated circuits (if necessary), a printed circuit board (PCB) layout for noise and/or function, and or a case opening or porting.
“Some systems, methods, and devices described in this application can facilitate and enable the use of personal user devices, such as smartphones, tablets, laptops, personal computers, or other devices, for remote or at-home healthcare through the use of remote image quality verification. As described herein, with remote image quality verification, images captured during a health test or diagnostic with a camera of a personal user devices (e.g., the user’s own smartphone, tablet, laptop, personal computer, or other similar device) can be verified on a system or device that is remote (e.g., separate from) the user’s personal device. In some embodiments, the system of device that performs the remote image quality verification is located on a cloud-based network.
“In some embodiments, the system or device that performs the remote image quality verification can be configured such that it complies with and/or receives approval from one or more of the regulatory bodies that regulate medical devices. By having such a system or device perform the image quality verification, in some instances, the personal user device itself need not receive regulatory approval. For instance, during a medical diagnostic test, a user can capture an image using a camera on his or her smartphone. The camera and/or the smartphone may not qualify as a medical device under the regulatory schemes. However, the image can be transmitted, for example, over a computer network such as the internet, to a remote system or device that, as described herein, can be configured to perform image quality verification. This system or device can be configured to qualify as a medical device under one or more regulatory schemes. By having such a device perform image quality verification, it can be possible to use the image captured by the user’s smartphone (which may not be a regulatorily approved device), but which image has been verified by a remote system or device (which can be a regulatorily approved device) for medical treatment, diagnosis, etc. This can greatly expand access to digital healthcare and provide improved patient outcomes, reliability, and accuracy.
“Further, personal user devices, such as smartphones and tablets, are available in a wide variety of models from a number of different manufacturers. Many manufacturers provide new or updated models of their personal user devices on a yearly (or even more frequent) basis. Due to the wide variation in personal user devices, it can be difficult to ensure that images captured by such devices will be of sufficient quality for use in medical diagnosis or procedures. However, the remote image quality verification processes and techniques described here can provide a solution, verifying such images before they can be relied on for medical purposes.
“As one example of remote health testing or diagnostics using a personal device and remote image quality verification, a user may be prompted to take an image, for example, of a reference card, using a camera of his or her personal user device. The image of the reference card can be uploaded by the personal user device to a server on the cloud. The server can be configured to evaluate the image to determine whether the image is already of sufficient quality (for being used in medical diagnostics under FDA or other regulatory requirements) or the image can be processed using designated processing techniques and parameters to produce a processed image of sufficient quality. Finally, the server can respond to the user device with an indication of the determination result.
“In some remote testing implementations, users can be monitored during a testing procedure by a live proctor. Monitoring by a live proctor can help to ensure that test procedures are followed, verify identity, interpret test results, and so forth. However, users may encounter difficulties and delays if they have to take tests under the observation of a live proctor. High testing volumes can require many proctors and user experiences may suffer if they have to wait for a proctor to become available.
“Some of the systems, methods, and devices described herein are directed to self-guided testing. These systems, methods, and devices may decrease the need for live proctors and/or may reduce the amount of time proctors must spend on each test, thereby reducing costs and improving efficiency. In some instances, users may be able to complete a test without real-time observation by a proctor. This can lead to improved user experiences as users do not have to wait for a proctor. In some embodiments, a proctor may be present for limited portions of a testing session. In some embodiments, a proctor may review a testing session, test result, etc., asynchronously.”
There is additional summary information. Please visit full patent to read further.”
The claims supplied by the inventors are:
“1. A method for image analysis of a medical diagnostic test, the method comprising: receiving, by an image verification server, specifications of a camera of a user device; comparing, by the image verification server, the specifications to a database of specifications to determine if the specifications are sufficient for use in the medical diagnostic test; if the image verification server determines the specifications are sufficient for use in the medical diagnostic test, prompting, by a telehealth platform in communication with the image verification server, a user to capture an image of a reference using the camera of the user device; receiving, by the image verification server, the image of the reference; automatically processing, by the image verification server, the image of the reference using a calibration model to produce a processed image, wherein the calibration model is based on the specifications; determining, by the image verification server, whether a quality of the processed image is above a predetermined threshold; if the processed image does not have a quality above the predetermined threshold, automatically updating, by the image verification server, the calibration model, processing, by the image verification server, the processed image using the calibration model, and determining, by the image verification server, whether the quality of the processed image is above the predetermined threshold; if the processed image has a quality above the predetermined threshold, prompting, by the telehealth platform, the user to capture an image of a diagnostic test result; receiving, by the image verification server, the image of the diagnostic test result; processing, by the image verification server, the image of the diagnostic test result using the calibration model to produce a processed test image; transmitting, by the image verification server, the processed test image to the telehealth platform; and analyzing, by the telehealth platform, the processed test image to determine if the diagnostic test result is positive or negative.
“2. The method of claim 1, wherein the reference is a reference card comprising a unique code, graduated color strips, a plurality of color reference blocks, and a plurality of fiducials.
“3. The method of claim 2, wherein the quality of the processed image is based on one or more of a resolution, a sharpness, a brightness, a noise, a dynamic range, a contrast, a saturation, and/or a white balance.
“4. The method of claim 1, wherein the image verification server generates an image quality score of the quality of the processed image.
“5. The method of claim 1, wherein the user device comprises a medical sensor subsystem, the medical sensor subsystem comprising: the camera; an image signal processor; an autofocus driver; and a circuit.
“6. The method of claim 5, wherein the medical sensor subsystem meets guidelines or regulations of a regulatory body.
“7. The method of claim 5, wherein the camera is separated from the image signal processor, the autofocus driver, and the circuit via a shield.
“8. The method of claim 5, wherein the image verification server is configured to: Receive a plurality of images from a plurality of user devices comprising the medical sensor subsystem; and update the calibration model based on the quality of the plurality of images.
“9. The method of claim 1, wherein the image verification server is a remote image verification server separate from the user device.
“10. The method of claim 1, wherein the image verification server transmits an indication of the determination whether the quality of the processed image is above the predetermined threshold to the user device and/or a partner device, wherein the partner device is a device of a proctor.
“11. A method for self-guided testing, the method comprising: receiving, by a telehealth platform, a first video of a user performing one or more self-guided steps of a first phase of a medical diagnostic testing procedure, wherein the first video comprises a first frame rate; receiving, by the telehealth platform, a second video of the user performing one or more self-guided steps of a second phase of a of the medical diagnostic testing procedure, wherein the second video comprises a second frame rate, and wherein the second frame rate is higher than the first frame rate; transmitting, by the telehealth platform, the first video and the second video to a proctor device; displaying, by the telehealth platform, the first video and the second video to a proctor via the proctor device; receiving, by the telehealth platform, an input from the proctor, the input indicating whether the user performed the first phase and the second phase in compliance with the medical diagnostic testing procedure; based on the input from the proctor, selecting, by the telehealth platform, a third phase of the medical diagnostic testing procedure, wherein the third phase comprises one or more steps; and prompting, by the telehealth platform, the user to perform the one or more steps of the third phase.
“12. The method of claim 11, wherein the first phase comprises the user setting up testing materials or collecting a sample.
“13. The method of claim 11, wherein the second phase comprises the user waiting for a predetermined amount of time.
“14. The method of claim 11, wherein the input indicates the user performed the first phase and the second phase in compliance with the medical diagnostic testing procedure, and the one or more steps of the third phase comprise a test result interpretation procedure.
“15. The method of claim 14, wherein the test result interpretation procedure comprises: receiving, by the telehealth platform, an image of a test result and an interpretation of the test result input by the user; displaying, by the telehealth platform, the image of the test result to the proctor via the proctor device; receiving, by the telehealth platform, a second interpretation of the test result input by the proctor; and analyzing, by the telehealth platform, the interpretation and the second interpretation to determine the test result of the medical diagnostic testing procedure, wherein said analyzing comprises comparing the interpretation and the second interpretation to determine if the interpretation and the second interpretation indicate a same test result.
“16. The method of claim 11, wherein the input indicates the user performed the first phase and/or the second phase not in compliance with the medical diagnostic testing procedure, and the one or more steps of the third phase comprise the telehealth platform connecting the user with the proctor for assistance with the medical diagnostic procedure.
“17. A method of interpreting test results of a medical diagnostic test, the method comprising: receiving, by a telehealth platform, an image of a test result and an interpretation of the test result input by a user; displaying, by the telehealth platform, the image of the test result to a proctor via a proctor device; receiving, by the telehealth platform, a second interpretation of the test result input by the proctor; and analyzing, by the telehealth platform, the interpretation and the second interpretation to determine a test outcome of the medical diagnostic test, wherein said analyzing comprises comparing the interpretation and the second interpretation to determine if the interpretation and the second interpretation indicate a same test result.
“18. The method of claim 17, wherein if the interpretation and the second interpretation indicate the same test result, the test outcome is the same test result.
“19. The method of claim 17, wherein if the interpretation and the second interpretation do not indicate the same test result, the telehealth platform is configured to: analyze the image of the test result, via a results interpretation algorithm, to determine a third interpretation of the test result; display the image of the test result to a second proctor via a second proctor device; receive a fourth interpretation of the test result input by the second proctor; analyze the third interpretation and the fourth interpretation to determine the test outcome of the medical diagnostic testing procedure, by comparing the third interpretation and the fourth interpretation to determine if the third interpretation and the fourth interpretation indicate a same test result, if the third interpretation and the fourth interpretation indicate a same test result, the test outcome is the same result, and if the third interpretation and the fourth interpretation do not indicate a same test result, the test outcome is invalid, and the telehealth platform is configured to prompt the user to retake the medical diagnostic test.
“20. The method of claim 17, wherein if the interpretation and the second interpretation do not indicate the same test result, the telehealth platform is configured to: connect the user to a representative, wherein the representative reviews the test result with the user to guide the user to modify the interpretation to the same test result as the second interpretation, and if the user modifies the interpretation to the same test result as the second interpretation, the test outcome is the same test result, if the user does not modify the interpretation to the same test result as the second interpretations, the representative indicates the test outcome is invalid.”
For additional information on this patent application, see: Carlson,
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