WO2021146748A1

WO2021146748A1 - Database of retinal physiology derived from ophthalmic measurements performed by patients

Info

Publication number: WO2021146748A1
Application number: PCT/US2021/070023
Authority: WO
Inventors: Ryo Kubota; Philip M. Buscemi; Martin Junghans; Stefan Troller; Matthias Pfister
Original assignee: Acucela Inc.
Priority date: 2020-01-17
Filing date: 2021-01-12
Publication date: 2021-07-22

Abstract

A homebased retinal monitoring system comprises a retinal scanning module and a visual acuity assessment module. The modules are operated by a software system that is interfaced with a web portal. The web portal interfaces a web-based server and a database that is compliant with one or more of the Health Insurance Portability and Accountability Act or General Data Protection Regulation.

Description

DATABASE OF RETINAL PHYSIOLOGY DERIVED FROM OPHTHALMIC MEASUREMENTS PERFORMED BY PATIENTS

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/962,478, filed January 17, 2020, entitled, “Database of Retinal Physiology Derived from Ophthalmic Measurements Performed By Patients” the disclosure of which is incorporated, in its entirety, by this reference.

BACKGROUND

[0002] Prior approaches to handling patient data and identifying disease progression can be less than ideal in at least some respects. With at least some prior approaches, the identification of disease progression and corresponding treatment may not occur as quickly as would be ideal in at least some instances due to delays in acquiring and processing patient data and obtaining up to date measurements of a patient’s physiology and medical parameters. Also, the prior databases and systems used for such purposes can be less than ideally suited for handling confidential patient data and allowing the patient data to be analyzed with algorithms or otherwise processed to identify disease progression while protecting confidential patient information from being improperly accessed or misused. As an example, there are many types of retinal disease for which treatment could benefit from improved monitoring, such as age-related macular degeneration (“AMD”), neovascular age related macular degeneration (“nAMD”), diabetic retinopathy (“DR”), or macular edema (“ME”), and particularly patients who are on anti-VEGF therapy.

[0003] Prior approaches to customizing the data provided to users with different roles can be less than ideal in at least some instances. In some instances, privacy regulations such as the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (“GDPR”) may exclude access to patient data by people who develop algorithms and instruments to detect diseases, which can make it somewhat more difficult than would be ideal to develop algorithms to detect diseases at early stages and to improve the performance of instruments that detect diseases. Also, it would be helpful for different users with different roles to have appropriate access to different types of data while maintaining compliance with privacy regulations, and the prior approaches can be less than ideal in at least some respects. [0004] In light of the above, improved systems, methods, apparatus and databases for storing, accessing and using confidential patient and other medical data would be helpful.

SUMMARY

[0005] In some embodiments, the present disclosure is directed to a remote monitoring system suitable for use at home by patients with diseases such as retinal diseases. In some embodiments, the system is interfaced with a web-based server in order to upload the raw measurement data obtained by an in-home monitor to a server, analyze the data using algorithms and/or other data processing methods, populate a database or databases with raw measurement, processed measurement, and patient identification and medical history data, and generate alerts as appropriate, in order to provide feedback to patients and caregivers. In some embodiments, the presently disclosed methods and apparatus can provide a detailed diagnosis with associated alerts and suggestions for treatment when appropriate.

[0006] Embodiments of the system, apparatus, and methods described herein enable the acquisition, transfer, processing, and storage of data related to the condition of a patient’s eyes using an in-home retinal scanning apparatus. In some embodiments, the measurement data acquired by the handheld unit (HU) may be isolated from personally identifiable information (PII) or other patient information that might be considered private and/or subject to regulation, such as under HIPAA or GDPR regulations related to privacy. The isolation of the measurement data may include its separation from private patient data during acquisition of a patient’s eye measurements, data transfer, data analysis and data storage to prevent unauthorized access to private patient information. [0007] In some embodiments, the data involved may be separated into four categories: (1) raw measurement data obtained by a patient using an in-home handheld device; (2) processed raw measurement data, where the processing may involve application of a machine learning model, filtering, signal processing, etc.; (3) patient identification data, such as name and demographic data (age, nationality, location, etc.); and (4) patient medical history and diagnosis data. As will be described in greater detail, embodiments comprise the storage of one or more these types of data alone or in combination in one or more databases or database partitions as needed to enable a set of uses that comply with relevant privacy regulations. In some embodiments, the uses may include both diagnosis, treatment, and care of a specific patient based on their own measurement data, and the use of anonymized or partially anonymized sets of patient data for research, identifying candidates for drugs or treatments, etc. In some embodiments, the sources of data include OCT or other data obtained from an office visit or data derived from other devices, such as refraction, axial length, etc.

[0008] In some embodiments, isolation and protection of private patient data may be accomplished by the use of separate partitions in a database and/or separate databases, with access to the partitions or databases being limited to those having an appropriate password or token. In some embodiments, the data contained in a database or database partition may be encrypted or otherwise encoded to prevent its use without proper authorization. Embodiments of the system architecture described herein enable processing and evaluation of retinal measurement data while maintaining control over access to private patient information. In some embodiments, protection of personal information about individual patients may be provided by use of a unique identifier that is associated with the patient and with all of their data, where the mapping between the patient and the identifier is only made available to authorized persons.

INCORPORATION BY REFERENCE

[0009] All patents, applications, and publications referred to and identified herein are hereby incorporated by reference in their entirety and shall be considered fully incorporated by reference even though referred to elsewhere in the application.

BRIEF DESCRIPTION OF THE DRAWINGS [0010] A better understanding of the features, advantages and principles of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0011] FIG. 1 shows the overall architecture of the patient-based ophthalmic suite (“PBOS”), in accordance with some embodiments;

[0012] FIG. 2 shows an example data transfer path from the handheld unit (“HU”) to the tablet to the Cloud-based database and the web portal, in accordance with some embodiments;

[0013] FIG. 3 shows example system interfaces that may be used by various entities to access data and functionality of the patient based ophthalmic suite (“PBOS”), in accordance with some embodiments;

[0014] FIGS. 4A and 4B show an example design of the PBOS software architecture, in accordance with some embodiments; [0015] FIG. 5 shows an overview of example use cases of the PBOS Tablet and Server system, in accordance with some embodiments;

[0016] FIG. 6 shows an example architecture of the interface between the PBOS tablet and a server, such as a cloud-based server operated by Amazon Web Services (“AWS”), in accordance with some embodiments;

[0017] FIG. 7 is a flowchart or flow diagram illustrating a processor implemented method or process that may be used for configuring a handheld unit (HU) used as part of the patient-based ophthalmic suite (“PBOS”), in accordance with some embodiments; and [0018] FIG. 8 shows an example system architecture that may be used to implement the functionality of the PBOS system, in accordance with some embodiments.

DETAILED DESCRIPTION

[0019] The following detailed description and provides a better understanding of the features and advantages of the inventions described in the present disclosure in accordance with the embodiments disclosed herein. Although the detailed description includes many specific embodiments, these are provided by way of example only and should not be construed as limiting the scope of the inventions disclosed herein.

[0020] PBOS System Architecture

[0021] FIG. 1 illustrates sub-systems of the Patient Based Ophthalmology Suite (“PBOS”) system 100, which comprises a retinal health monitor 101 configured to communicate with a remote server, such as PBOS cloud software 105. The retinal health monitor 101 may comprise a handheld unit 102 and a mobile device configured with instructions to run an application 104. In some embodiments, the components of the subsystems may include:

[0022] Handheld Unit 102 (“HU”)

[0023] This unit is used by a patient to acquire retinal measurement data. Its characteristics and operational capabilities typically include one or more of:

[0024] Acquisition and digitalization of data related to retina thickness;

[0025] Handheld form-factor;

[0026] Optionally includes a mechanical stand; or

[0027] Optionally directly wired to a tablet in which is installed the PBOS application during use (or otherwise capable of transferring acquired measurement data to the tablet for processing and/or transfer to server). [0028] Tablet & Installed PBOS Application 104

[0029] In some embodiments, this combination of device and software provides one or more of the following capabilities:

[0030] Serves as the primary patient interface, e.g., the patient is guided through a retinal thickness (RT)-measurement process, and/or vision test such as a visual acuity test (“VA”) test by the application software (“app”);

[0031] Serves as the primary interface for the configuration provider (“CP”) to the Web Portal, e.g., for purposes of HU configuration and configuration guidance;

[0032] May perform retinal thickness (RT) computations, based on the data collected by the HU;

[0033] Enables connectivity to the cloud-based platform and server(s) via Wi-Fi and/or other networking technologies;

[0034] Capable of communication with the HU (via USB or other direct or indirect connection); and

[0035] May include the ability to execute a test to evaluate a patient’s visual acuity.

This can be performed to establish a patient’s overall vision at the time the retinal measurements are made.

[0036] In some embodiments, the communication capability with the HU, e.g. connectivity, includes the capability to transfer retinal measurement data acquired using the HU to a remote platform/server for storage and processing. In some embodiments, initial processing of the acquired measurement data may occur on the tablet device under the control of the PBOS application software, where this initial processing may comprise one or more of:

[0037] Filtering of data;

[0038] Thresholding of data;

[0039] Determining a retinal thickness measurement;

[0040] Performing a comparison to other data acquired from the same patient; or [0041] Anonymizing or otherwise “cleansing” the acquired data to remove metadata or associated information that could be used to identify the patient and replace it with an identifier/token representing the patient or the HU.

[0042] As an example, a PBOS system suitable for use in accordance with the present disclosure is described in PCT application PCT/US2017/067603 entitled “Miniaturized Mobile, Low Cost Optical Coherence Tomography System For Home Based Ophthalmic Applications”, filed December 20, 2017, and published as WO2018119077 on June 28, 2018, the entire disclosure of which is incorporated herein by reference.

[0043] In some embodiments, the tablet is dedicated to being used for PBOS only, for example. In some embodiments, the tablet may be replaced by a dedicated external unit that has a dedicated, customized processor in which signal processing algorithms are stored in the system firmware. The tablet can be configured with software instructions to present a stimulus on the display of the table in order to measure vision of the patient, such as the visual acuity of the patient.

[0044] PBOS Web Portal 106

[0045] The PBOS Web Portal 106 provides access to data processing functionalities and a cloud database or databases for one or more of authorized personnel of a responsible software service provider entity, an independent testing facility (“IDTF”), a health care provider (“HCP”), a configuration provider (“CP”), an office administrator, a nurse or a technician. The responsible software service provider entity may comprise a corporation or other entity that provides the database and software services to the patient and health care provider as described herein.

[0046] PBOS Cloud Services 108. These include one or more services (such as data processing applications, modeling and/or data storage) that are provided to a patient/HU user or other entity through data transmission from the tablet PBOS client application 104 to the cloud-based service platform/server(s). These services may include one or more of 1) databases 110, 2) hosting or providing access to algorithms, or 3) a service that provides an application program interface (“API”) 112.

[0047] In some embodiments, a database or databases 110 stores retinal thickness (RT) data (and if desired other medical data, such as visual acuity (VA) data), patient personal information and patient electronic medical records. One or more of these types of data may be encrypted or otherwise encoded in order to comply with data privacy regulations. For example, encrypting patient personal information would restrict access to the encrypted data to only those having proper authorization (as evidenced by possession of the encryption key). Further, different types of personal information (e.g., demographic data, name and contact information, medical records or medical history) may be encrypted using different keys to permit access to the information to be segmented and allow different types of personal information to be provided to different users. In some embodiments, stored retinal thickness data may be associated with a unique identifier, with a separate data file “mapping” that identifier to a set of patient personal data. In this embodiment, access to the separate data file may require use of a token that is only provided to authorized users.

[0048] As examples, in some embodiments, certain of the types of data may be stored in separate databases or sections/partitions of a database to enable compliance with data privacy or other data-related regulations or protocols. In some embodiments, certain of the data may be encrypted or otherwise encoded to prevent unauthorized access or usage. In some embodiments, RT and/or VA data may not be associated directly with a patient but instead associated with a patient identifier, tablet identifier or token in a database, with a separate database containing a mapping between a specific patient (name, age, etc.) and a corresponding identifier/token. In some embodiments, processed, evaluated or modeled RT and/or VA data may not be associated directly with a patient but instead associated with a patient identifier, tablet identifier or token in a database.

[0049] In some embodiments, the processed or modeled RT and/or VA data may be associated with anonymized or partially anonymized patient data to allow a medical professional or researcher to use the data for studying a cohort of patients (in such cases, perhaps only the age, gender, and/or nationality of a patient might be directly associated with the data, with all other personal information associated with an identifier/token). [0050] As suggested by the discussion of patient personal information and retinal measurement or other medical information, in some embodiments, these two primary categories of information may be divided into sub-categories, with access to each sub category being made available to only certain end-users. In such an arrangement, each sub-category may be associated with a unique identifier or be encrypted, and a set of identifiers, tokens, or encryption keys may be provided to an end-user in whatever combination is needed to allow them to access the data they are authorized to access while maintaining compliance with data privacy regulations or protocols.

[0051] While the categories of information can be divided into categories and sub categories in many ways, in some embodiments patient personal information may be segmented into sub-categories of: (a) name and contact information, (b) medical records and medical history, and (c) demographic data (age, race, location, etc.). Medical or measurement data may be segmented into sub-categories of: (a) measured retinal data, (b) processed retinal data that provides RT and/or other characteristics of a patient’s eyes, (c) data indicating a patient’s VA, and (d) data indicating other aspects of a patient’s condition (blood pressure, pulse, oxygen level, presence or absence of diabetes or another medical condition, etc.). [0052] In some embodiments, PBOS Cloud Services 108 is configured to host or provide access to algorithms, rules, machine learning and other models, data processing applications, etc. to enable (depending upon access rights) a search of one or more of the database(s), the access of data and the ability to derive relationships and correlations between medical treatment and RT (and if desired, VA) outcomes for specific cohorts of patients.

[0053] In some embodiments, the PBOS Cloud Services 108 comprises a service that provides an application program interface (“API”) 112 for accessing the various PBOS cloud services.

[0054] In some embodiments, the application 104 running on the mobile computing device such as the tablet is configured to securely transfer data to and from the PBOS Cloud API 104.

[0055] FIG. 2 shows an example data transfer path from the handheld unit (“HU”) to the tablet to the Cloud-based database and the web portal, in accordance with some embodiments. As shown in the figure, in some embodiments, the handheld unit (HU) 202 used to acquire measurement data may be connected (via USB 203 or other wired or unwired data transfer means) to tablet 204. Tablet 204 includes an installed PBOS application or other form of software instructions. Tablet 204 communicates with cloud- based services 206 using Wi-Fi 205 or another suitable data transfer mechanism (such as Wi-Fi to a local router to a modem to the Internet or other network). Cloud services 206 may include one or more databases, a database server, one or more data processing applications, and/or other functionality used to process, store, and analyze measurement data for patients using a HU, and to make raw measurement data, processed measurement data, and/or patient data available to authorized entities. An entity having the proper authorization and wanting to access the stored data and/or other services may use a browser installed on a computing device 208 to communicate with Cloud services 206 using an https request 207 or similar protocol.

[0056] FIG. 3 shows example system interfaces that may be used by various entities to access data and functionality of the patient based ophthalmic suite (PBOS) system 100, in accordance with some embodiments. As examples, PBOS suite 102 may include interfaces for a patient 302 and/or a configuration provider of the suite and related staff 304 to access the handheld unit 102 and the tablet and associated application 104, and for one or more of the configuration provider of the suite and related staff 306, the system administrator of the PBOS suite 308, an independent diagnostic testing facility 310, and a healthcare provider and staff 312 to access the stored and/or processed data and the patient identification and medical history data using the web portal 106. Thus, FIG. 3 shows example system interfaces for users who may be patients, care providers, database managers and administrators, and consumers of healthcare information, such as pharmaceutical companies, insurance companies or agencies administering healthcare policy and reimbursement services.

[0057] Database Configuration(s)

[0058] There are multiple possible arrangements for how the different types of data used and/or generated by the PBOS system may be stored and how the types of data may be allocated or partitioned between storage elements when implementing an embodiment of the system and methods described. These possible allocations or partitioning of retinal measurement and other data between one or more databases (or database partitions) allow embodiments to be configured in multiple ways while maintaining the ability to protect patient privacy and ensure compliance with relevant regulations.

[0059] One example of an embodiment of the design of the PBOS software architecture and associated databases is shown in FIGs. 4A and 4B. FIG. 4A shows the handheld unit (HU) 402 and HU software 403, the PBOS software 404 (including both client 405 and server/platform side 406 software applications) and PBOS cloud datacenter 408 and PBOS cloud services 407, and the interface with other systems 410, such as additional data systems and databases for storing and analyzing or otherwise evaluating patient retinal data. The additional data systems operatively coupled to the PBOS software can be configured to provide access to data and/or the results of processing data to authorized persons or entities. In some embodiments, the additional system comprises a database of retinal scan data. Alternatively, or in combination, the additional system comprises an external AI system 409 for performing modeling and evaluation of retinal scan data. An artificial intelligence capability or function may also run in other modules, such as on the tablet as well as on the cloud services. In some embodiments, the AI-based signal processing runs on the tablet.

[0060] As shown in FIG. 4B, the PBOS software suite includes software executing in the handheld unit (HU) 403, software executing in the tablet application 405 (which may include an application or routine to execute a visual text (VF module) and an application or routine to derive a retinal thickness from measurements obtained from the HU), a web portal 406, the PBOS cloud-based services 407, and the optional external AI/Expert system 409. PBOS cloud-based services 407 may comprise one or more of a database or databases 420, Big Data Storage S3 database 422, identity provider 424 for controlling access to stored data and/or mapping between identifiers, identity “keys” or tokens and patient information, and a PBOS Cloud API for accessing cloud-based services 407 using a browser. The tablet application 405 provides the main software user interface for the patient. It is therefore optimized for ease of use. For example, in some embodiments, the level of provided information is appropriate for elderly patients. The tablet software guides the patient through the entire measurement workflow. The web portal 406 provides the main user interface for the healthcare professional, the configuration provider, the IDTF staff, the nurse/technician and administrators. Permissions (such as access rights and functionalities) may be role dependent. For example, logging in with an HCP user account allows to see different type(s) of information than logging in with a nurse/technician user account. In that sense, the web portal filters access to information stored in the cloud data center depending on role-dependent permissions. Databases 420 may have different characteristics, e.g., cost per storage and access time.

[0061] In some embodiments, the system architecture includes one or more cloud-based databases, that can be reconfigured by suitable algorithms, rules, or heuristics, with expert system, machine learning, or other artificial intelligence (“AI”) data processing and data storage configuration capabilities. In some embodiments, this reconfiguring comprises the allocation and storage of specific types of data (e.g., patient personal data, patient identifiers/tokens, retinal scan data, processed retinal scan data, patient medical history data, etc.) in specific databases or partitions of databases, based at least in part on the desired use of that data and whether the requester is authorized to access certain data. [0062] In some embodiments, the cloud-based database or databases includes patients’ electronic medical records, preferably including history of diagnoses of eye disease, treatments (surgical and pharmaceutical) administered to the patient, and more preferably, optical coherence tomographic (OCT) scans of the patient’s retina, past measurements of visual acuity, intraocular pressure measurements and the like.

[0063] The cloud database(s) can be configured in many ways, with two or more encrypted cloud databases, for example in one embodiment. In some embodiments, a first encrypted database comprises patient data and a second encrypted database comprises information related to measurements acquired by the PBOS system, e.g., data acquired from a patient using the HU. In this example embodiment, the first database may comprise one or more of the following: processed data on retinal thickness (RT); central retinal thickness (CRT); processed visual acuity (VA) data (scalar per exam); or personal information on patients (including in some examples, personally identifiable information). In some embodiments, the personal information may instead be stored in a separate (third) database or partition, with the information stored in the first database being associated with a patient’s personal information by a token or other anonymizing identifier, label or data.

[0064] In this example embodiment, the second database may comprise one or more of the following: raw data of retinal scans obtained from a patient using the HU; pre- processed images of retinal scans, where the pre-processing may have been performed by the HU and/or tablet; or VA data obtained from a patient using the HU and/or tablet. [0065] The encrypted cloud databases can be configured in many ways and can be stored on one or more commercially available cloud storage services such as Amazon AWS, e.g., the Amazon S3 cloud storage service.

[0066] In some embodiments, access to the various types of data may be provided through a multi-tenant platform or other form of Software-as-a-Service (SaaS). In these embodiments, each entity seeking access to the data (whether patient demographic data, patient medical history data, raw measurement data, or processed measurement data) may be provided with access through an “account” on the platform. The data storage associated with the account may be provided with access to a dynamically configured set of databases or database partitions that contain the data the entity is permitted to access, with the data being encrypted, encoded, or otherwise protected if helpful, to comply with privacy regulations. In this way, embodiments can provide access to different combinations of data at different levels of privacy protection as are needed for specific use cases and users.

[0067] In some embodiments, the second database containing data acquired using the HU does not contain personal information on patients but instead has unique patient- identifiers associated with each dataset. Although reference is made to S3 storage, it should be clear that any suitable encrypted data storage can be used.

[0068] The first and second databases can be configured in many ways and in some embodiments, the PBOS system and architecture as described herein allows user-role- restricted access to patient information and provides corresponding raw- and image-data from the S3 storage to authorized users. Here, user-role may refer to a caregiver, a physician, a provider of the system for acquiring the retinal scan data, a researcher, etc. [0069] In some embodiments, the database comprises two databases, one being accessible only to the personnel of the responsible software service provider entity (i.e., the provider of the PBOS system), and the other being accessible to caregivers and other users, (typically, as authorized by the personnel of the responsible software service provider entity).

[0070] In this example embodiment, a first database comprises one or more of raw data of retinal scans, VA data, and processed data such as clean data on retinal thickness (RT), central retinal thickness (CRT), scans of various retinal layers derived from the raw scan data, other scan data uploaded by the caregiver as part of the electronic medical record of the patient, or personal information on patients. Access to algorithms used to generate the clean data and the resulting data may be provided and controlled through a separate authorization process, consistent with compliance with HIPAA regulations and GDPR regulations.

[0071] In some embodiments, a second database comprises processed RT data such as clean data on retinal thickness, central retinal thickness and VA data on patients, their personal information (or a portion of it to protect a specific level of privacy) as well as an electronic medical record of each patient (which may be associated with an identifier or token to maintain a level of privacy). This database can be searched to find patient cohorts meeting a particular treatment profile or history and history of disease progression, or patient subgroups of a particular demographic profile, or a combination thereof. Algorithms to search the second database or derive correlations between VA and RT or CRT, either each singly or both with treatment history (preferably treatment history involving administration of any particular anti-VEGF medication) may be provided to authorized users on a subscription or other basis.

[0072] In some embodiments, the second database may also be used to generate alerts that may be transmitted to the patient, the caregiver or both, in a manner that is customized for each patient by the caregiver. Such alerts may be transmitted in the form of emails, text messages, or automated calls. The alerts may remind the patient to go through the regular self-measurement process using the HU if data have not been uploaded to the database by a certain time of day or to seek an appointment with the eyecare practitioner within a specified period, or even to visit an urgent care facility immediately.

[0073] Alerts may also or instead be based on VA data or RT and CRT data generated by a patient, since either VA or RT/CRT data may be a more definitive biomarker for the occurrence or progression of retinal disease, depending on the patient and his/her retinal pathophysiology. In some embodiments, a record of all alerts issued is stored in a third database, so that this record is immediately accessible to database administrators and caregivers without the need to search through the second database. In this embodiment, input to the second database comes from the first database and caregivers who upload the electronic medical record of each patient who is provided with a HU and a tablet.

[0074] In general terms, the type of data that may be acquired, processed, and/or stored by embodiments of the system and methods described include the following: (1) Raw measured retinal scan data obtained by using the HU; (2) Patient ID personal data (such as data that may be used to identify an individual patient and as a result, may be the subject of a privacy regulation); (3) Patient medical history data (which may or may not contain data that may be used to identify an individual patient, and hence in some situations may be the subject of a privacy regulation); or (4) Processed raw scan data (such as RT measurements, data processed to increase a signal-to-noise ratio, data processed to enhance the identification of certain features or trends, data processed by a trained model, etc.).

[0075] The raw measured retinal scan data obtained by using the HU may be associated with a unique anonymous identifier/token associated with the HU and/or the tablet connected to HU to indicate how the data was acquired and permit associating the data with other information (such as the patient to whom the HU was assigned).

[0076] The Patient ID personal data may comprise one or more of name, age, gender, location, date of data acquisition, other demographic data, etc. This data may be associated with/mapped to the unique identifier/token.

[0077] Patient medical history may comprise one or more of tests, diagnosis, reports or evaluations by medical professionals, or medical records. This data may be associated with or mapped to the unique identifier/token.

[0078] The processed raw scan data, may comprise, filtered, threshholded, data evaluated by a trained machine learning (ML) model, for example. In some embodiments, the processed raw scan data is accessed by a physician or other medical professional for interpretation. This data may be associated with or mapped to the unique identifier/token.

[0079] Given the above types of data, the data may be stored in a database or databases in different ways, with the storage approach used being selected or determined by consideration of both the type of data (raw, processed, patient medical history, patient identifying data, etc.) and the purpose of the end-user in seeking access, while taking into account any relevant data privacy or related regulations. In addition, or instead, certain types or categories of data may be encrypted, with the associated encryption key being provided to only those end-users authorized to access that data. This allows access to certain types of private patient or measurement data to be restricted to authorized users and also for different combinations of data to be made available to different end-users depending on their need and authorization.

[0080] For example, each of Tables 1 to 4 below represent a possible allocation of the different types of data to a database or database partition. As shown by Examples A to D in Tables 1 to 4, respectively, a unique and anonymous token or patient identifier may be associated with each type of data and inserted with the data into the database or partition, with the mapping or way of associating the token or identifier to an actual patient being stored separately (and possibly being encrypted or subject to other protections).

[0081] Table 1, Example A.

[0082] Table 2, Example B.

[0083] Table 3, Example C.

[0084] Table 4, Example D.

[0085] As described, the allocation of specific types of data (raw, processed, patient medical history, patient identifying data, etc.) to a database or database partition may be performed automatically by database configuration or reconfiguration processes. These database configuration or reconfiguration processes may be executed under the control of a provider of the retinal data acquisition and processing services in response to a request for access from a particular end-user, where depending on the needs or goal of the end- user, different levels of data access and/or patient privacy may apply. For example, in the case of a researcher, certain patient information may be needed but not all (such as name, location, etc.) in order to conduct a study of a broad demographic and its eye diseases or progression of diseases.

[0086] In some embodiments, the databases are populated by the data provided from the tablet app, and no direct access to the database is provided to the HU, except via the tablet app. In some embodiments, the tablet app is directly accessible to the patient. In addition, the tablet application provides authorization for configuration providers (“CPs”) to access the web services on the tablet. The CPs can assess similar services via a web portal also, such as a web portal running in a browser on a personal computer (“PC”). [0087] The databases and systems can be configured in many additional and alternative ways. In some embodiments, a caregiver may elect to create a separate database or partition for each individual patient, the design and contents of which may be customized by the caregiver through a Wi-Fi link or via the cellular network. The caregiver is allocated memory to store and search such customized databases for individual patients and may be charged a subscription fee for this service. Creation of such customized databases for each individual patient makes it easier for the caregiver to monitor administration and reprogramming of alerts, when helpful. In some embodiments, a customized database is generated for the IDTF. Alternatively, or in combination, a customized database can be generated for developing artificial intelligence algorithms. [0088] For example, caregivers or third parties may be charged for cloud storage by each individual examination performed and uploaded, by thresholds based on examination volume, by a flat monthly fee, by individual caregiver, or by groups of caregivers. Caregivers or third parties may be charged for data analytics by each individual examination performed and uploaded, by thresholds based on examination volume, by a flat monthly fee, by individual caregiver, or by groups of caregivers. Caregivers or third parties may be charged for mechanisms to alert the caregiver and/or patient to potential disease states, progression, or regression of disease states, by each individual notification performed and uploaded, by thresholds based on notification volume, by a flat monthly fee, by individual caregiver, or by groups of caregivers. Caregivers or third parties may be charged for creation of personalized treatment nomograms by each individual examination performed and uploaded, by thresholds based on examination volume, by a flat monthly fee, by individual caregiver, or by groups of caregivers, each being provided individual or group based treatment nomograms.

[0089] FIG. 5 shows an overview of example use cases of the PBOS Tablet and Server system 500, in accordance with some embodiments. The system 500 may comprise one or more features and configurations of databases and partitions to allow system access, data transmission and encryption and configurations as described herein, for example with reference to FIGS. 1 to 4B. The figure shows examples of users and use situations for the features and capabilities in accordance some embodiments.

[0090] As shown in the figure, and moving clockwise from the top, the system administrator 510 has administrative rights and administers the database and database access. This may include registering persons or organizations authorized to access the data and/or functionality of the system, such as one or more of the healthcare professional 520, staff 530 of the independent testing facility (“IDTF”), the office administrator 540, the nurse or technician 550, the configuration provider 560, the tablet application 570, or the patient 580. In some embodiments, the administrator 510 regulates the IDTF staff and associated credentials and access. In some embodiments, the healthcare professional 520 can view data from his/her set of patients, but not the data of patients of other professionals.

[0091] In some embodiments, the IDTF staff 530 can view the measurement data, but generally are not authorized to view the complete medical records of patients. In some embodiments, an IDTF may request access to data for purposes of processing the data for a study or to identify candidates for a particular treatment or medication, for example.

This can often be done with partially anonymized data, so that complete patient records are not needed. IDTF staff 530 may define search parameters for use in discovering candidates or filtering patient data.

[0092] In some embodiments, the office administrator 540 has access and a role but is typically limited to registering the configuration provider(s) (CP) and heath care provider(s) (HCP). The nurse or technician 550 may register a patient by entering personal patient data.

[0093] In some embodiments, the configuration provider 560 configures the patient device (HU), and may perform other tasks as shown, such as patient training on the use of the HU. The configuration provider 560 is able to switch between training and home-use mode(s). The mode of operation is selected in the web portal. The training mode provides certain tools to support proper personalization of the HU, e.g., images from the alignment sensor that allow fine-tuning of the eyecup settings. The configuration provider 560 can customize the device for the patient, for example by setting one or more parameters of the HU, such as the type of eyecup, length of eyecup, alignment sensor parameters depending on the pupil size, OCT beam convergence or divergence depending on the refraction of the eye, the distance between eyecups depending on the inter pupillary distance (IPD), distance of the comeal apex to the first optic of the HU, optical path distance of the reference arm of the HU (in some cases derived from the axial length of the eye, in other cases derived from the interferogram generated from the interaction of the reference and measurement optical paths of the device), or another aspect of the HU. A further description of the configuration process is described with reference to FIG. 7. In some cases, the configuration provider may decide that the HU cannot be configured to a patient. For example, depending on the IPD and the cornea position vertex, it may be impossible to configure for some extreme head shapes. The PBOS tablet application may be accessed by the patient and possibly others to assist the patient to obtain measurement data and transfer that data to the system platform.

[0094] As evident from the preceding description, the system described herein has multiple component elements and functions. Each of these functions may be accessible by one or more people or systems with different people or systems having different levels of access to (or in some cases no access to) certain data. The differing levels of access permit the system to protect personal patient data from unauthorized or unnecessary access, and also to comply with relevant regulations concerning data privacy. As suggested by FIG. 5, each person or entity may have a specific role and set of functions with regards to the overall system, and as a result may only require and be authorized to access certain data, databases, or database partitions when performing those functions. [0095] With regards to specific data privacy regulations or protocols, HIPAA and GDPR Compliance Requirements are readily included in the design of the PBOS software system described herein. In some embodiments, these include one or more of the following:

[0096] Traffic from and to the cloud is encrypted, such as over Transport Layer Security (TLS). Hence, information that is being transported is encrypted;

[0097] Protected health information (“PHI”) is backed up and is recoverable;

[0098] The information is only accessible by authorized personnel; or [0099] The information is not tampered with or altered.

[0100] FIG. 6 shows the architecture 600 of the interface between the web portal 602 accessible via a browser or from the tablet, the tablet App 604 and the cloud-based server 606. The cloud-based server may provide or enable the provision of HIPAA and GDPR compliant services, allowing the processing of protected health information (PHI).

[0101] Referring to FIG. 6, below is a description of the purpose and functionality of the primary elements or components illustrated:

[0102] Web Portal

[0103] The web portal 602 is a custom HTML based web application used by HCPs to assess patients and to configure their daily or weekly routines. The information is transferred via API Gateway 608 to the RDS (Cloud) Database 610 where it is stored.

[0104] Tablet App

[0105] The tablet app 604 is used by the patients and informs them about their daily or weekly routines. It also guides the patients through the RT measurements. The routine results are transferred via API Gateway 608 to the RDS (Cloud) Database 610 where they are stored. In addition, the raw measurement data is transferred by the Transfer Utility 612 (which implements a multipart upload functionality 618) into the S3 (Cloud) Data Store 614 where they are stored.

[0106] API Gateway

[0107] The API Gateway 608 acts as a secure and scalable entry point for the API (application programming interface), forwarding the requests to the appropriate back-end service and manages authorization, access control, monitoring, and API version management. Access to the APIs are protected by Amazon Cognito 616.

[0108] Amazon Cognito

[0109] The Amazon Cognito Service 616 is used for the identification of HCPs and patients in PBOS by creating unique identities for the users and to authenticate them for secure access to AWS resources such as Amazon S3 614 (holding the raw measurement data).

[0110] Multipart Upload

[0111] Multipart upload 618 is a functionality that operates to separate large files (such as the ones holding raw data) into multiple parts and to upload them one at a time or in parallel.

[0112] Transfer Utility

[0113] The transfer utility 612 checks the size of a file being uploaded and automatically switches over to using multi part uploading 618 if the file size exceeds 5 MB.

[0114] Data Store

[0115] The Amazon Simple Storage Service (S3) 614 is used to store the raw data in a HIPAA compliant data center. PHI is not used in bucket names, object names or metadata.

[0116] CloudFront (CDN)

[0117] The Amazon CloudFront CDN (content delivery network) service 620 is used to implement a fast and secure delivery of data (such as the patient’s raw data from the Web Portal).

[0118] NAT Gateway

[0119] The Amazon NAT (network address translation) gateway 622 is used to enable instances in a private subnet while preventing the Internet from initiating a connection with those instances.

[0120] AWS ECS

[0121] The HIPAA-compliani Amazon EC2 Container Service (AWS ECS) 624 is used to process encrypted Protected Health Information (PHI) of the patients.

[0122] RDS

[0123] The Amazon Relational Database Service (RDS) 610 is used to operate and scale a relational (PostgreSQL) database in the cloud. [0124] FIG. 7 is a flowchart or flow diagram illustrating a processor implemented method or process that may be used for configuring a handheld unit (HU) used as part of the patient-based ophthalmic suite (“PBOS”), in accordance with some embodiments. As shown in the figure, the configuration process may involve a series of steps or stages that include Preparation 710, Configuration of the Refraction Error (RE) 720, Configuration of the Interpupillary Distance (IPD) 730, Configuration of the Eye-Cups 740, and Configuration of the OPD 750, with each configuration stage or process including the additional steps to be described.

[0125] Preparation 710 may include step 711 at which the configuration provider (CP) instructs the patient about the configuration procedure, a step 712 at which the CP logs into the tablet app with his/her credentials, a step 713 at which the CP measures with the PD stick the patient’s IPD and enters the IPD value into the Web Portal, a step 714 at which the CP measures (with the pupil measurement tool) the patient pupil diameters and enters the values into the Web Portal, a step 715 at which the CP adjusts CMF IPD according to the patient IPD previously measured with the PD stick, a step 716 at which the CP measures with the CMF the cornea vertex position of the patient eyes and enters the values into the Web Portal, and a step 717 at which the CP enters any missing information (e.g., RE, axial length, monocular / binocular), etc.

[0126] Configuration of the Refraction Error (RE) 720 may include a step 722 at which Refraction Error (RE) information is transferred from the tablet to the HU and a step 724 at which the HU sets the RE correction according to the HU orientation.

[0127] Configuration of the Interpupillary Distance (IPD) 730 may include a step 732 at which the CP adjusts the patient’s IPD on the HU.

[0128] Configuration of the Eye-Cups 740 may include a step 742 at which the Web Service computes eye-cup SKU and eye-cup setting position and transfers the information to the Tablet, a step 744 at which the CP mounts the selected eye-cup SKU and adjusts (on the HU) the same eye cup gradation for both oculars, and a step 746 at which the CP locks the eye-cup position.

[0129] Configuration of the OPD 750 may include a step 751 at which if available, the axial lengths are transferred from the tablet to the HU, a step 752 at which if available, the HU compensates OPD according to new axial lengths and HU orientation, a step 753 at which the CP instructs the patient about the alignment procedure, a step 754 at which the Tablet App waits for the first RT signal with sufficient quality, a step 755 at which the Patient executes RT measurements during training, a step 756 at which the RT algorithm on the tablet computes the new OPD compensation based on the RT signal, a step 757 at which the Tablet stores the new OPD compensation value in the cloud and transfers it to the HU, and a step 758 at which the HU compensates OPD according to the computed OPD and HU orientation. Note that steps 754-758 are performed for each eye of the patient.

[0130] In some embodiments, patient specific parameters that are stored in the cloud & tablet, and transmitted to the HU each time it is connected may include OPD correction value (right/left), refraction error (right/left), binocular / monocular, and axial length. Patient specific HU parameters that are stored in the cloud and not transmitted to the HU may include IPD value, pupil diameters, eye-cup SKU, and eye-cup setting position. [0131] FIG. 8 shows an example system architecture 800 that may be used to implement the functionality of the PBOS system, in accordance with some embodiments. As shown in the figure, a handheld unit 802 is used by a patient to conduct a visual acuity test and/or perform measurements of the patient’s retina. HU 802 is connected (either directly or indirectly) to Tablet 804. Tablet 804 is associated with a unique identifier or token that is mapped to the patient, with the mapping stored separately. Tablet 804 may contain an application for assisting the patient to perform the visual acuity test and/or perform the measurements. Tablet 804 may also contain an application that performs processing on the raw data obtained from HU 802. This processing may be to determine a retinal thickness or other metric used to evaluate the patient’s eye health.

[0132] Tablet 804 communicates and transfers data over Network 806 (which represents one or more networks that enable Tablet to communicate and exchange data with server 808). Server 808 may be part of a cloud-based system or platform. Server 808 controls the storage and access to the types of data that may be acquired and/or used by the PBOS system. In some embodiments, server 808 may cause certain types of data to be stored in certain data storage databases or partitions of databases.

[0133] As one example, Database 1 (812) may be used to store raw measurement data for patients, with each set of raw data associated with an identifier or token. Database 2 (814) may store processed measurement data, such as retinal measurement data that has been filtered, modeled, or otherwise evaluated, along with the appropriate identifier or token. Database 3 (816) may store a table or other data structure that “maps” each unique identifier/token to a specific patient name and/or other identifying information. Note that without access to the table(s) in Database 3, someone having access to the raw and/or processed data cannot directly associate that data to a specific patient. Database 4 (818) may store each patient’s personal demographic and/or medical record data, along with the appropriate identifier or token.

[0134] In addition, or instead of using a token or identifier, certain types of data may be encrypted, with the encryption key only provided to an authorized end-user. For example, the data in Database 4 may be encrypted with the encryption key made available to only those end-users needing that data for a study of a cohort of patients. Similarly, the data in Database 3 may be encrypted, with the encryption key made available to only those end- users needing to contact a specific patient for purposes of an authorized examination, trial of a new medication, or medical procedure.

[0135] Raw data may be processed by an application, machine learning model, or other form of image or signal processing 820, with its access to raw measurement data, processed measurement data, and/or patient personal data controlled by server 808. Note that data processing services 820 may be provided by the provider of the PBOS system and/or by another entity such as a research facility, hospital, etc.

[0136] As described herein, the computing devices and systems described and/or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0137] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and/or computer-readable instructions. In one example, a memory device may store, load, and/or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0138] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and/or executing computer-readable instructions. In one example, a physical processor may access and/or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field- Programmable Gate Arrays (FPGAs) that implement softcore processors, Application- Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor. The processor may comprise a distributed processor system, e.g. running parallel processors, or a remote processor such as a server, and combinations thereof.

[0139] Although illustrated as separate elements, the method steps described and/or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0140] In addition, one or more of the devices described herein may transform data, physical devices, and/or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and/or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and/or otherwise interacting with the computing device.

[0141] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical- storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0142] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0143] The various exemplary methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein. [0144] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively, or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein. [0145] Unless otherwise noted, the terms “connected to” and “coupled to” (and their derivatives), as used in the specification and claims, are to be construed as permitting both direct and indirect (i.e., via other elements or components) connection. In addition, the terms “a” or “an,” as used in the specification and claims, are to be construed as meaning “at least one of.” Finally, for ease of use, the terms “including” and “having” (and their derivatives), as used in the specification and claims, are interchangeable with and shall have the same meaning as the word “comprising.

[0146] The processor as disclosed herein can be configured with instructions to perform any one or more steps of any method as disclosed herein.

[0147] It will be understood that although the terms “first,” “second,” “third”, etc. may be used herein to describe various layers, elements, components, regions or sections without referring to any particular order or sequence of events. These terms are merely used to distinguish one layer, element, component, region or section from another layer, element, component, region or section. A first layer, element, component, region or section as described herein could be referred to as a second layer, element, component, region or section without departing from the teachings of the present disclosure.

[0148] As used herein, the term “or” is used inclusively to refer items in the alternative and in combination.

[0149] As used herein, characters such as numerals refer to like elements.

[0150] The present disclosure includes the following numbered clauses.

[0151] Clause 1. A retinal monitoring system for a patient, comprising: an application installed on a computing device separate from a retinal scanner and configured to receive retinal data from the retinal scanner and securely transfer the retinal data to a remote server; and the remote server, wherein the remote server is configured to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

[0152] Clause 2. The system of clause 1, wherein a first portion of the received data is stored in a first database or database partition and a second portion of the received data is stored in a second database or second database partition. [0153] Clause 3. The system of clause 2, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

[0154] Clause 4. The system of clause 3, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

[0155] Clause 5. The system of clause 1, wherein the retinal data comprises measurement data of the patient’s retina.

[0156] Clause 6. The system of clause 3, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

[0157] Clause 7. The system of clause 6, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

[0158] Clause 8. The system of clause 1, further comprising the retinal scanner, wherein the retinal scanner comprises a handheld device that acquires the retinal data. [0159] Clause 9. The system of clause 1, wherein the application is further configured to process retinal measurement data received from the retinal scanner and generate retinal thickness data from the retinal measurement data.

[0160] Clause 10. The system of clause 1, wherein the plurality of databases or database partitions further comprises: a first database or database partition configured to store retinal data received from the retinal scanner and an identifier or token associated with the retinal scanner or with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

[0161] Clause 11. The system of clause 10, further comprising a third database or database partition configured to store a mapping between the identifier or token and the associated retinal scanner or computing device.

[0162] Clause 12. The system of clause 10, wherein the patient medical history information comprises one or more of medical test data, medical diagnosis information, or a report or evaluation of the patient by a medical professional.

[0163] Clause 13. The system of clause 10, wherein the retinal data comprises one or more of filtered retinal measurement data, retinal data evaluated by a trained model, or an interpretation by a physician of the filtered or evaluated data. [0164] Clause 14. The system of clause 1, wherein the server is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

[0165] Clause 15. The system of clause 1, wherein the application installed on the computing device receives retinal data from the retinal scanner using a wireless connection.

[0166] Clause 16. The system of clause 8, wherein the retinal scanner further comprises a retinal scanning module configured to obtain measurements of the patient’s retina by illuminating the patient’s retina and detecting light reflected from the retina.

[0167] Clause 17. The system of clause 16, further comprising a visual acuity assessment module configured to obtain a measurement of the visual acuity of the patient. [0168] Clause 18. The system of clause 1, wherein the server is further configured to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

[0169] Clause 19. The system of clause 1, wherein the server is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

[0170] Clause 20. The system of clause 19, wherein the one or more algorithms or applications further comprise a machine learning model.

[0171] Clause 21. An apparatus comprising: an electronic processor coupled to an electronic storage element; the electronic storage element, wherein the storage element contains a set of computer-executable instructions, and wherein when the processor is programmed with the set of instructions and executes the instructions, the apparatus is configured to receive, with a secure transfer protocol, retinal data from an application installed on a computing device; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

[0172] Clause 22. The apparatus of clause 21, wherein a first portion of the received data is stored in a first database or database partition and a second portion of the received data is stored in a second database or second database partition.

[0173] Clause 23. The apparatus of clause 22, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data. [0174] Clause 24. The apparatus of clause 23, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

[0175] Clause 25. The apparatus of clause 21, wherein the retinal data comprises measurement data of the patient’s retina.

[0176] Clause 26. The apparatus of clause 23, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

[0177] Clause 27. The apparatus of clause 26, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

[0178] Clause 28. The apparatus of clause 21, wherein the plurality of databases or database partitions further comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

[0179] Clause 29. The apparatus of clause 28, further comprising a third database or database partition configured to store a mapping between the identifier or token and the associated retinal scanner or computing device.

[0180] Clause 30. The apparatus of clause 21, wherein the apparatus is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

[0181] Clause 31. The apparatus of clause 25, wherein the apparatus is further configured to create alerts for one or more of a caregiver or the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

[0182] Clause 32. The apparatus of clause 21, wherein the apparatus is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

[0183] Clause 33. The apparatus of clause 32, wherein the one or more algorithms or applications further comprise a machine learning model.

[0184] Clause 34. A method of monitoring a patient, comprising: receiving retinal data for the patient at a computing device, wherein the computing device comprises an application configured to securely transfer the retinal data to a remote server; and wherein the remote server is configured to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data. [0185] Clause 35. The method of clause 34, wherein the remote server is further configured to store a first portion of the received data in a first database or database partition and store a second portion of the received data in a second database or second database partition.

[0186] Clause 36. The method of clause 35, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

[0187] Clause 37. The method of clause 36, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

[0188] Clause 38. The method of clause 34, wherein the retinal data comprises measurement data of the patient’s retina.

[0189] Clause 39. The method of clause 36, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

[0190] Clause 40. The method of clause 39, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

[0191] Clause 41. The method of clause 34, wherein the plurality of databases or database partitions comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

[0192] Clause 42. The method of clause 41, wherein the plurality of databases or database partitions further comprises a third database or database partition configured to store a mapping between the identifier or token and the associated computing device. [0193] Clause 43. The method of clause 34, wherein the server is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

[0194] Clause 44. The method of clause 34, wherein the server is further configured to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment. [0195] Clause 45. The method of clause 34, wherein the server is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

[0196] Clause 46. The method of clause 45, wherein the one or more algorithms or applications further comprise a machine learning model.

[0197] Clause 47. A set of one or more non-transitory computer-readable media comprising a set of computer-executable instructions that when executed by one or more programmed electronic processors, cause the processors to cause an application installed on a computing device to receive retinal data for a patient and securely transfer the retinal data to a remote server; and cause the remote server to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partition, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

[0198] Clause 48. The set of non-transitory computer-readable media of clause 47, wherein the set of computer-executable instructions further comprise instructions that cause the remote server to store a first portion of the received data in a first database or database partition and store a second portion of the received data in a second database or second database partition.

[0199] Clause 49. The set of non-transitory computer-readable media of clause 48, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

[0200] Clause 50. The set of non-transitory computer-readable media of clause 47, wherein the plurality of databases or database partitions comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

[0201] Clause 51. The set of non-transitory computer-readable media of clause 50, wherein the plurality of databases or database partitions further comprises a third database or database partition configured to store a mapping between the identifier or token and the associated computing device. [0202] Clause 52. The set of non-transitory computer-readable media of clause 47, wherein the server is further caused to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

[0203] Clause 53. The set of non-transitory computer-readable media of clause 47, wherein the server is further caused to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

[0204] Clause 54. The set of non-transitory computer-readable media of clause 47, wherein the server is further caused to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

[0205] Clause 55. The set of non-transitory computer-readable media of clause 54, wherein the one or more algorithms or applications further comprise a machine learning model.

[0206] Embodiments of the present disclosure have been shown and described as set forth herein and are provided by way of example only. One of ordinary skill in the art will recognize numerous adaptations, changes, variations and substitutions without departing from the scope of the present disclosure. Several alternatives and combinations of the embodiments disclosed herein may be utilized without departing from the scope of the present disclosure and the inventions disclosed herein. Therefore, the scope of the presently disclosed inventions shall be defined solely by the scope of the appended claims and the equivalents thereof.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A retinal monitoring system for a patient, comprising: an application installed on a computing device separate from a retinal scanner and configured to receive retinal data from the retinal scanner and securely transfer the retinal data to a remote server; and the remote server, wherein the remote server is configured to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

2. The system of claim 1, wherein a first portion of the received data is stored in a first database or database partition and a second portion of the received data is stored in a second database or second database partition.

3. The system of claim 2, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

4. The system of claim 3, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

5. The system of claim 1, wherein the retinal data comprises measurement data of the patient’s retina.

6. The system of claim 3, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

7. The system of claim 6, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

8. The system of claim 1, further comprising the retinal scanner, wherein the retinal scanner comprises a handheld device that acquires the retinal data.

9. The system of claim 1, wherein the application is further configured to process retinal measurement data received from the retinal scanner and generate retinal thickness data from the retinal measurement data.

10. The system of claim 1, wherein the plurality of databases or database partitions further comprises: a first database or database partition configured to store retinal data received from the retinal scanner and an identifier or token associated with the retinal scanner or with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

11. The system of claim 10, further comprising a third database or database partition configured to store a mapping between the identifier or token and the associated retinal scanner or computing device.

12. The system of claim 10, wherein the patient medical history information comprises one or more of medical test data, medical diagnosis information, or a report or evaluation of the patient by a medical professional.

13. The system of claim 10, wherein the retinal data comprises one or more of filtered retinal measurement data, retinal data evaluated by a trained model, or an interpretation by a physician of the filtered or evaluated data.

14. The system of claim 1, wherein the server is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

15. The system of claim 1, wherein the application installed on the computing device receives retinal data from the retinal scanner using a wireless connection.

16. The system of claim 8, wherein the retinal scanner further comprises a retinal scanning module configured to obtain measurements of the patient’s retina by illuminating the patient’s retina and detecting light reflected from the retina.

17. The system of claim 16, further comprising a visual acuity assessment module configured to obtain a measurement of the visual acuity of the patient.

18. The system of claim 1, wherein the server is further configured to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

19. The system of claim 1, wherein the server is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

20. The system of claim 19, wherein the one or more algorithms or applications further comprise a machine learning model.

21. An apparatus comprising: an electronic processor coupled to an electronic storage element; the electronic storage element, wherein the storage element contains a set of computer-executable instructions, and wherein when the processor is programmed with the set of instructions and executes the instructions, the apparatus is configured to receive, with a secure transfer protocol, retinal data from an application installed on a computing device; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

22. The apparatus of claim 21, wherein a first portion of the received data is stored in a first database or database partition and a second portion of the received data is stored in a second database or second database partition.

23. The apparatus of claim 22, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

24. The apparatus of claim 23, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

25. The apparatus of claim 21, wherein the retinal data comprises measurement data of the patient’s retina.

26. The apparatus of claim 23, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

27. The apparatus of claim 26, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

28. The apparatus of claim 21, wherein the plurality of databases or database partitions further comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

29. The apparatus of claim 28, further comprising a third database or database partition configured to store a mapping between the identifier or token and the associated retinal scanner or computing device.

30. The apparatus of claim 21, wherein the apparatus is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

31. The apparatus of claim 25, wherein the apparatus is further configured to create alerts for one or more of a caregiver or the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

32. The apparatus of claim 21, wherein the apparatus is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

33. The apparatus of claim 32, wherein the one or more algorithms or applications further comprise a machine learning model.

34. A method of monitoring a patient, comprising: receiving retinal data for the patient at a computing device, wherein the computing device comprises an application configured to securely transfer the retinal data to a remote server; and wherein the remote server is configured to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partitions, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

35. The method of claim 34, wherein the remote server is further configured to store a first portion of the received data in a first database or database partition and store a second portion of the received data in a second database or second database partition.

36. The method of claim 35, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

37. The method of claim 36, wherein the personal patient data comprises one or more of patient name and contact information, patient demographic data, or patient medical records.

38. The method of claim 34, wherein the retinal data comprises measurement data of the patient’s retina.

39. The method of claim 36, wherein the personal patient data is encrypted in accordance with the requirements of a data privacy regulation.

40. The method of claim 39, wherein the data privacy regulation comprises one or more of the Health Insurance Portability and Accountability Act (HIPAA) or the General Data Protection Regulation (GDPR).

41. The method of claim 34, wherein the plurality of databases or database partitions comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

42. The method of claim 41, wherein the plurality of databases or database partitions further comprises a third database or database partition configured to store a mapping between the identifier or token and the associated computing device.

43. The method of claim 34, wherein the server is further configured to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

44. The method of claim 34, wherein the server is further configured to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

45. The method of claim 34, wherein the server is further configured to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

46. The method of claim 45, wherein the one or more algorithms or applications further comprise a machine learning model.

47. A set of one or more non-transitory computer-readable media comprising a set of computer-executable instructions that when executed by one or more programmed electronic processors, cause the processors to cause an application installed on a computing device to receive retinal data for a patient and securely transfer the retinal data to a remote server; and cause the remote server to receive the transferred retinal data; and store a portion of the received data in each of a plurality of databases or database partition, wherein one or more of the plurality of databases or database partitions comprises encrypted data.

48. The set of non-transitory computer-readable media of claim 47, wherein the set of computer-executable instructions further comprise instructions that cause the remote server to store a first portion of the received data in a first database or database partition and store a second portion of the received data in a second database or second database partition.

49. The set of non-transitory computer-readable media of claim 48, wherein the first portion of the received data comprises encrypted retinal data and the second portion of the received data comprises encrypted personal patient data.

50. The set of non-transitory computer-readable media of claim 47, wherein the plurality of databases or database partitions comprises: a first database or database partition configured to store the retinal data and an identifier or token associated with the computing device; and a second database or database partition configured to store the identifier or token and one or more of patient personal data and patient medical history information.

51. The set of non-transitory computer-readable media of claim 50, wherein the plurality of databases or database partitions further comprises a third database or database partition configured to store a mapping between the identifier or token and the associated computing device.

52. The set of non-transitory computer-readable media of claim 47, wherein the server is further caused to generate a user interface for an authorized user to permit access to one or more of the plurality of databases or database partitions.

53. The set of non-transitory computer-readable media of claim 47, wherein the server is further caused to create alerts for one or more of a caregiver and the patient, wherein the alerts are intended to recall patients to the caregiver for further diagnosis and/or treatment.

54. The set of non-transitory computer-readable media of claim 47, wherein the server is further caused to execute one or more algorithms or applications to analyze the retinal data for a plurality of patients to develop knowledge of a response of a patient cohort to certain treatment modalities.

55. The set of non-transitory computer-readable media of claim 54, wherein the one or more algorithms or applications further comprise a machine learning model.