Patent Issued for Method For Automating Collection, Association, And Coordination Of Multiple Medical Data Sources (USPTO 10,687,705)

2020 JUL 06 (NewsRx) -- By a News Reporter-Staff News Editor at Hospital & Nursing Home Daily -- A patent by the inventors Dirghangi, Arjun (Charlottesville, VA); Williams, Dustin (Bothell, WA); Iris, Jeffrey (Sammamish, WA); Sagar, Ayush (Somerville, MA), filed on July 1, 2019, was published online on July 6, 2020, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents.

Patent number 10,687,705 is assigned to Scanoptix Inc. (Charlottesville, Virginia, United States).

The following quote was obtained by the news editors from the background information supplied by the inventors: “Field of the Invention

“The present invention is directed to a medical data network system and method of capturing, coordinating, linking, organizing, storing, and/or communicating between one or more connected health workers or devices using a system of electronic sensors, computational devices, and networked antennas embedded--in one embodiment into or onto clinical equipment and medical instruments--in an edge computing model to direct on-device computational processing power, special sensing capabilities, and networked off-device storage and remote processing. In embodiments, the system and method is, in part, to directly extend and augment the capabilities of connected health workers beyond the traditional paradigm of separate medical instruments, personal mobile computing devices, and independently located computer terminals into an interconnected, connected examination room, in which the capacity to record clinical data, refer to independent electronic data sets in separate databases, and algorithmically track and predict the activities and needs of clinicians is embedded directly into the tools used by connected health workers on a regular basis, minimizing the need for manual processes and user-unfriendly, inefficient keyboard-and-mouse user interfaces for routine computational tasks in clinical medicine. The system and method allow for the capabilities of special sensing, data linking, cross-referencing, and algorithmic analysis of patient-related data, which may be shared with clinicians and health workers. This type of coordination would ordinarily would be either impossible or extremely onerous to perform. By using an edge computing model directly embedding networked computational power into the medical devices used routinely in clinical settings, multiple use cases and clinical decision making tools can be enabled algorithmically which, by linking diverse data types in real- or close to real-time, are not currently possible or available to clinicians and health workers simultaneously within their daily clinical workflows. Use of this technology allows for the automation of medical device management, capture of clinical practice-related data, and generation of medical documentation and billing- and coding-related reports with, in aspects, one set of compatible electronic medical devices capable of automatically generating networks of medical devices that are capable of linking basic demographic and financial patient-related data with location-, physician- and allied health worker-related authentication and data audit trail-, type of device-, scheduling- and time-based, examination type-, and patient exam-related data.

“Description of Related Art

“Multiple clinical, administrative, business, maintenance and support, clinical research, and clinical engineering staff are required to do only a subset of the above described processes, which often require special, ad hoc, project undertaking to achieve complex tasks such as: tracking and optimizing bottlenecks in clinical workflows; monitoring and addressing clinical device maintenance and inventory tasks; tracking patient and staff location-based movements within clinical spaces and steps of clinical encounters; and determining medical risks for individual patients based upon linking medical examination-related findings cross-referencing physical findings with demographic, medication use, and other health record-based data. In addition to the inherent inefficiencies in current practices to achieve such goals (which in practice means most such information is usually unknown or known only in limited or distorted ways), existing limitations in linking diverse and difficult-to-link data types in clinical practice means that many of the most salient insights into clinical practice management and examination of each patient are de facto not possible. Additionally, these types of manual processes inherently miss data intrinsic to the current, in-progress clinical examination by the doctor and have to be manually associated with clinical documentation generated by the physician for the specific clinical encounter in question (or imported into a linked entry into the electronic medical record). Limitations in physicians and ancillary staff availability and time to accomplish more than the minimum activities key to clinical care, as well as increasing documentation burdens instituted by medicolegal concerns, insurance payer requirements, and profound inefficiencies inherent in conventional keyboard- and mouse-based user interfaces of conventional electronic health record software systems, render most such activities de facto currently impossible during routine clinical activities.

“Additionally, detailed insights regarding medical device usage and clinical process activities are currently difficult or impossible to obtain using conventional techniques. By linking patient medical histories with algorithmic deep learning approaches to image classification systems, researchers have found previously unknown biomarkers for diseases like Alzheimer’s dementia from fundus photographs (images of the retina and optic nerves of patients). However, these algorithmic processes are at present not linked to the daily workflows of clinicians and practice personnel, and as such, the entry and registration of patient-related history and physical data, the collection of examination-related data such as patient imaging, and the computational processing, analysis, and reporting of findings often require multiple personnel, different physical locations required for patient movement within the clinical encounter, and data capture and analysis occurring asynchronously from the place and time that the examining physician or allied health worker would actually be examining and treating the patient.

“As such, collecting and analyzing such additional data types require additional staff, with analytical reports generated and available at another time (usually after) than the treating physician is actually seeing the patient, and often after the patient has left the medical office or hospital setting. Usually, such reports can only be generated ad hoc as part of either dedicated clinical research or quality improvement projects, and usually require dedicated data science personnel and software to collect and analyze such data, with often manual retrieval and association of various data types required in order to generate the analysis. Additionally, indirect or ad hoc approaches must be taken to infer and indirectly measure metrics relevant to clinical activities due to the inability to routinely directly capture the said clinical activities in real time given the sorts of technological and staffing limitations in the current clinical standard of care previously discussed. In practice, this leads to profound inefficiencies and a clinical workflow of data collection and analysis which is de-linked from the actual process of the medical encounter. The examining physician, in this example, does not have additional information needed from such novel algorithms or medical devices during their patient encounter, when the data could be most useful, and will need to resort to other strategies such as calling the patient back for a discussion of findings once the analysis of additional data is made available to them. Finally, the actual practice of collecting, linking, and organizing such data and then making medical decisions based upon what the analysis may entail often creates a host of additional clerical and user interface-related processes that creates an added burden for the treating physician which further serves to distance, distract, and slow down their clinical workflow and presents additional demands on their time either within or after the medical encounter. It also represents additional ‘screen time’ not addressing the patient during the medical encounter, when it is preferable to both physician and patient to instead maximize ‘face time’ during the medical encounter.”

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors’ summary information for this patent: “The system and method taught herein constitutes an electronic connection, in aspects, between medical devices, physicians, and/or patients or patient data with a paired ‘hub’ system to manage devices (the ‘spokes’ in a hub-and-spoke analogy), examinations, and people (e.g., physicians and patients) involved in the examination process. The hub comprises, in aspects, a processor (e.g., a CPU) or coordinating service application and associated computing processes, wirelessly connected to a device(s) or an examiner(s) in or around an examining facility, such as a doctor’s office or hospital setting, to monitor activity and permit multiple device control and coordination. In one aspect, for example, the hub will receive images and data/information from a device taught herein (e.g., an ophthalmoscope) or other devices (including, but not limited to, mobile and networked embedded systems in which medical devices and instruments have compatible networked microprocessor/microcontroller, device software, and operating system embedded into their physical makeup or by the use of hardware adapters to achieve the same goals), and the hub will be used, along with uniquely identifiable markers such as, but not limited to, hardware tokens, bar- or QR-codes, identification cards, encoded magnetic or solid-state electronic memory cards and/or compatible wireless antennas and solid state computing chips to detect and manage the hierarchy of trusted users engaged in use of a connected network of devices to perform tasks from administrative organization tasks to improvement of medical examination. The system, in aspects, authenticates and correlates users seeking to use the system and associated devices with patients and their associated examination sessions to link users with devices, patients, and examination sessions and to maintain an associated audit trail of user access and usage of protected health information. The system also reviews and analyzes the data obtained from an examination, manages the data for storage, syncs images and data from an examination (e.g., fundus photos with diagnoses), processes images or information, and/or manages remote data synchronization and/or local or remote data and imagery (including, but no limited to, still- or video images) redisplay. It may manage storing such information locally or remotely, such as in the cloud. (See, e.g., FIG. 1.)”

The claims supplied by the inventors are:

“The invention claimed is:

“1. A method of managing coordination of information related to a medical examination, comprising: Analyzing user credentials and authenticating access to a premises or a device or device group based on the user credentials; Validating use of the device or device group based on the user credentials and the type of device or device group; Associating a medical examination with a patient or patients or a medical examination schedule; Associating medical examination data and/or metadata from one or more device or device group with a related medical examination session; Routing medical examination data and/or metadata to a local and/or external computer database or databases; Pairing the medical examination session and/or medical examination data and/or metadata with a manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination; and Allowing the user to authenticate or sign the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination, wherein the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination is displayed to the user, wherein the user indicates a review and/or an approval or rejection of the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination, and/or wherein the user indicates signing or delaying signature of the medical examination, the medical examination data and/or metadata, and/or the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination.

“2. A method of managing coordination of information related to a medical examination according to claim 1, wherein the medical examination schedule is correlated with time of use of the device or device group, physical location or physical locations of the user or the device or device group, physical location or physical locations of a compatible device or a compatible device group, electronic medical record or electronic scheduling software, and/or manual or automated schedules.

“3. A method of managing coordination of information related to a medical examination according to claim 1, wherein the location or locations and/or identity of the user or users of the device or device group is determined by geolocation, physical tokens, virtual tokens, software-based tokens, passcode, QR codes, bar codes, identification cards, encoded magnetic or solid-state electronic memory cards and/or compatible wireless antennas and solid state computing chips, Near Field Communication cards, Wi-Fi pairing, Bluetooth or ZigBee pairing, radio beacons, paired and authenticated mobile devices, Radio Frequency Identification tags or sensors, manual entry of the location or locations, detection of wired or wireless beacon, biometric identification techniques, Internet Protocol and/or Media Access Control address of the device or device group, scanning of the user or the device or device group, passcodes, and/or software applications.

“4. A method of managing coordination of information related to a medical examination according to claim 1, further comprising associating telemetry data from the medical device or device group with the medical examination session.

“5. A method of managing coordination of information related to a medical examination according to claim 1, wherein the medical examination data and/or metadata comprises information collected by the device or device group by the user during the medical examination session.

“6. A method of managing coordination of information related to a medical examination according to claim 1, wherein associating the medical examination data and/or metadata from one or more medical device or device group with a related medical examination session comprises: Retrieving information related to the medical examination schedule, the patient or patients, the device or device group, the user, and/or a location of the device or device group and associating that information with the medical examination session; and Associating the medical examination data and/or metadata with the medical examination schedule, a corresponding patient appointment time, and/or the medical examination session.

“7. A method of managing coordination of information related to a medical examination according to claim 1, further comprising retrieving medical data of the patient or patients from one or more medical record or one or more medical database and/or sending medical data of the patient or patients recorded during the medical examination session.

“8. A method of managing coordination of information related to a medical examination according to claim 7, wherein the user has full or partial access to medical data of the patient or patients depending on the user’s credentials.

“9. A method of managing coordination of information related to a medical examination according to claim 1, wherein routing medical examination data and/or metadata to a local and/or external computer database or databases is conducted via a coordinating service application.

“10. A method of managing coordination of information related to a medical examination according to claim 9, wherein the coordinating service application is hosted on a host of servers or a distributed cloud service which is remotely located.

“11. A method of managing coordination of information related to a medical examination according to claim 9, wherein the coordinating service application is hosted on a centralized server located locally to the device or device group.

“12. A method of managing coordination of information related to a medical examination according to claim 1, further comprising recording and/or tracking an audit trail record of one or more user, use of a device or device group, and/or who or what is accessing data and/or metadata related to the medical examination session or the patient record.

“13. A method of managing coordination of information related to a medical examination according to claim 1, further comprising generating documentation based on some or all of the medical examination data and/or metadata, and/or some or all of the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination.

“14. A method of managing coordination of information related to a medical examination according to claim 1, further comprising generating categories or formats of documentation for different or varying purposes including billing, medical charting, research, quality improvement, and/or backup based on data and/or metadata generated by the device or device group and/or the manual or automated medical interpretation, results, diagnosis or diagnoses, and/or recorded information from the medical examination.

“15. A method of managing coordination of information related to a medical examination according to claim 1, further comprising processing the medical examination data and/or metadata by cross-referencing with other medical information to aid in diagnosis.

“16. A method of managing coordination of information related to a medical examination according to claim 1, further comprising processing of data and/or metadata from the user, the patient or patients, and/or the device or device group to analyze and report clinical association or associations and/or finding or findings to aid in diagnosis, treatment, and/or management of the patient or patients.

“17. A method of managing coordination of information related to a medical examination according to claim 1, wherein the data and/or metadata from the user, the patient or patients, and/or the device or device group is sent to an external computing device or database for automated diagnoses, treatment, and/or management information for the patient or patients.

“18. A method of managing coordination of information related to a medical examination according to claim 1, further comprising displaying information related to the medical examination session to the user, the patient or patients, medical professional or medical professionals, and/or local or remote electronic device.

“19. A method of managing coordination of information related to a medical examination according to claim 1, further comprising allowing electronic signature, authentication, validation, rejection, delaying, and/or review of generated documents and reports using a physical device, virtual device, an electronic device, a computing device, and/or a mobile device.

“20. A method of managing coordination of information related to a medical examination according to claim 1, further comprising uploading telemetry and/or metadata from the device or device group to store, authenticate, and/or validate telemetry and/or metadata associated with the device or device group.

“21. A method of managing coordination of information related to a medical examination according to claim 1, further comprising linking telemetry and/or metadata from the device or device group with the medical examination session.

“22. A method of managing coordination of information related to a medical examination according to claim 1, further comprising allowing automation of certain functions of the device or device group, including setting predefined parameters, synchronizing, importing or exporting information, and/or using an external electronic device to send or retrieve information.

“23. A method of managing coordination of information related to a medical examination according to claim 1, further comprising providing the user an indication whether manual data entry tasks are required for validation, authentication, uploading, downloading, managing clinical inventory, sending, receiving, and/or recording.

“24. A method of managing coordination of information related to a medical examination according to claim 1, further comprising using device or device group or system telemetry and/or metadata to automatically and/or interactively generate clinical practice metrics and reports.”

URL and more information on this patent, see: Dirghangi, Arjun; Williams, Dustin; Iris, Jeffrey; Sagar, Ayush. Method For Automating Collection, Association, And Coordination Of Multiple Medical Data Sources. U.S. Patent Number 10,687,705, filed July 1, 2019, and published online on July 6, 2020. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10,687,705.PN.&OS=PN/10,687,705RS=PN/10,687,705

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