EP2702549A2 - Systeme und verfahren zur erzeugung und verwaltung sicherer patientencommunities - Google Patents

Systeme und verfahren zur erzeugung und verwaltung sicherer patientencommunities

Info

Publication number
EP2702549A2
EP2702549A2 EP12776957.8A EP12776957A EP2702549A2 EP 2702549 A2 EP2702549 A2 EP 2702549A2 EP 12776957 A EP12776957 A EP 12776957A EP 2702549 A2 EP2702549 A2 EP 2702549A2
Authority
EP
European Patent Office
Prior art keywords
module
patient
data
carepod
recited
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12776957.8A
Other languages
English (en)
French (fr)
Other versions
EP2702549A4 (de
Inventor
Joydip HOMCHOWDHURY
Kimberlie CERRONE
Ratan BHARDWAJ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TIATROS Inc
Original Assignee
TIATROS Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/096,887 external-priority patent/US20120278101A1/en
Priority claimed from US13/449,808 external-priority patent/US20120278103A1/en
Priority claimed from US13/450,138 external-priority patent/US20120278095A1/en
Priority claimed from US13/449,972 external-priority patent/US20120277543A1/en
Application filed by TIATROS Inc filed Critical TIATROS Inc
Publication of EP2702549A2 publication Critical patent/EP2702549A2/de
Publication of EP2702549A4 publication Critical patent/EP2702549A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60Protecting data
    • G06F21/62Protecting access to data via a platform, e.g. using keys or access control rules
    • G06F21/6218Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
    • G06F21/6245Protecting personal data, e.g. for financial or medical purposes
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/01Social networking
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H80/00ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Definitions

  • HIPAA Health Insurance Portability and Accountability Act
  • PHI Protected Health Information
  • covered entities may include a variety of Health Care Providers ("HCPs") - e.g. hospitals, insurance companies, pharmacies, doctors, doctor groups and the like.
  • HCPs Health Care Providers
  • HCPs such as hospitals
  • HCPs have adopted and/or promulgated very stringent rules for their doctors, staff and administrators that govern the manner in which such providers interact with patients or anyone who might have a legally vested interest in such patients.
  • Several embodiments of the present invention comprise systems and methods of uploading image files of sensitive documents are disclosed to at least one trusted community of users.
  • the trusted community may be an automated care pod used by medical providers to treat a patient.
  • the image files may comprise the individual's patient records.
  • a request for uploading may be made to the care pod and the care pod may generate a unique identifying symbol which is sent back to the sender.
  • the care pod or managing system may receive the image file with the unique identifying symbol embedded or associated with the image file.
  • an automated extractor/verifier may process the uploaded image data and extract user information. Said extracted user information may then be compared against patient information
  • an error flag may be sent.
  • Figure 1 shows a high level block diagram of a possible set of trusted users and possible modules for a system built in accordance with the principles of the present invention, and more particularly for medical applications built upon the system.
  • Figure 2 depicts the concept of a social pod as made in accordance with several of the present embodiments.
  • Figure 3 shows a flow chart of one embodiment of creating and authenticating a social pod within the context of a medical application.
  • Figure 4 is a high level block diagram of a system architecture built according to the principles of the present application.
  • Figure 5 shows a flow chart of one embodiment of a multimedia content engine as made in accordance with several of the present system embodiments.
  • Figure 6 is one embodiment of a present system as built and hosted using existing network infrastructure.
  • Figures 7A and 7B show one embodiment of a present system as built for the treatment of PTSD for returning military veterans.
  • Figures 8A and 8B show one embodiment of a de-identifier module to de-link information within communications of the social pod that contains certain data that might identify patients receiving treatment.
  • Figure 9 depicts one embodiment of a screen shot showing the functionality of a treatment plan set up for a patient by a physician.
  • Figure 10 shows one embodiment of a program funding module that enables administrators of a social pod to raise funds for programs via the present system.
  • Figure 11 depicts a typical transaction that might occur between two physicians whereby one physician refers a patient to a second physician and faxes the patient's medical records to the second physician.
  • Figure 12 is one embodiment of a system and/or method of automatically and securely upload medical records or other sensitive documents to a CarePod.
  • Figure 13 is one embodiment of a system and/or method of automatically extracting and/or verifying patient data from image files and securely associate such data and/or metadata with the patient's CarePod and associated records.
  • Figure 14 depicts conventional methods where patient medical and/or physiological data is send from a medical device to the patient's caregivers.
  • Figure 15 is one embodiment of a system and/or method of enabling secure and authenticated communications of patient medical data from a device to the patient's CarePod.
  • Figure 16 is one embodiment of a system and/or method to prevent the accidental misdirection of patient medical data from a device to the patient's CarePod.
  • Figure 17 is one embodiment of a system and/or method of providing secure and authenticated therapeutic treatment to a patient under guidance from doctors and other caregivers from the patient's CarePod.
  • Figure 18 depicts one embodiment of a module for the creation of a template to capture data from a medical instrument that may be used in the monitoring of treatment.
  • Figure 19 is one embodiment of a system and/or method for creating a treatment plan for a patient having a condition.
  • Figure 20 is one embodiment of a system and/or method of setting reminders to patients and caregivers during the course of a treatment.
  • Figure 21 is one embodiment of a system and/or module for the capturing of data of a medical instrument monitoring the efficacy of a treatment of a condition.
  • the present system helps HCPs comply with their internal regulations by providing for a networked system and method of managing the communications among a number of "trusted" users - e.g. by and between a physician and a patient.
  • the present system comprises a versatile cloud computing software platform where doctors and researchers may use contemporary social networking tools to communicate with patients and the extended care team online, on tablets and via mobile phones, sharing personal health information and medical records within a HIPAA privacy and security compliant environment.
  • the present system may be constructed as a rule- based computing system that insures that all trusted users and their
  • one embodiment of the present system should be to have the system available to users online, on tablets, and on mobile phones. This may be desirable in order to 'cross the digital divide' that separates low-income user/patients who do not have highspeed Internet access from health care and support services from which they may otherwise be excluded.
  • the present system may be used to construct and support many different types of specific-purpose online communities.
  • the present system may incorporate one or many different types of social networking tools, including audio and video blogging and video chats, and other known types of synchronous and asynchronous communications.
  • social networking tools including audio and video blogging and video chats, and other known types of synchronous and asynchronous communications.
  • the present system incorporate content files into such communications - e.g. audio, video, medical application and any other commonly used documents or applications.
  • the present system handles content files of any size, and content files that are created in virtually any underlying application, including the commonly used document, audio, video and specialized medical applications. It may be desirable for the present system to accurately preserve the fidelity of such files and records.
  • the ability to use and share information and medical records within specific purpose communities creates the opportunity to develop new and efficient ways of using it.
  • the present system include other contemporary technologies to improve the user experience.
  • the use of avatars and other gaming technologies may increase the appeal of programs for some users, while other technologies may improve the user experience for veterans who are blind or hearing impaired.
  • the present embodiment may require that the physician communicate with a patient who is authenticated at the time of communication to the patient.
  • the system stores and/or otherwise archives the interaction between the physician and the patient to form a part of the latter's EHR.
  • the present system may define a set of "trusted" users of the network. Such trusted users may need to be
  • authenticated to establish their level of engagement and interaction with the system.
  • Such authentication may be accomplished by any known method, manner or system for such authentication. Examples include password protection, challenge-response interactions, biometrics or the like.
  • Figure 1 describes a set of entities that might comprise a prototypical environment of trusted users. Users (collectively labeled 102) are shown interconnectedly with the present system 100 and, possibly, connected amongst themselves apart from system 100.
  • a set of users might comprise the following types of individuals: physicians 102a, practice staff and nurses 102b, researchers 102c, consulting physicians 102d, payor and donors 102e, patient's friends and family members 102f, patients 102g and students 102h.
  • Each of the users 102 represent entities that may have known communication and computing devices (not shown) in order to affect a networked environment.
  • users 102 may variously have smart phones, cell phones, computers, tablets and the like that may be configured to run a secure, encrypted software environment, as might be presented in a browser or in any other known interfaces.
  • the present system encompasses the use of all known devices and means of networked communication that would facilitate the present system as described herein.
  • the present system may also allow for easy dynamic management of the social pod.
  • the present system may allow for the addition and/or deletion of members in a seamless manner.
  • trusted communities might comprise one, two, or any number of members depending on their specific purpose.
  • communities may consist of:
  • the present system may incorporate a variety of conventional authentication methods; the specific method(s) used to authenticate the members of a given community may vary as appropriate to its specific purpose.
  • the present system may use a number of technical strategies to pre-set and enforce access rights to ensure the privacy of communications, and
  • System 100 may comprise a set of networked computers and/or processors - in communications possibly with computers, processors or mobile devices that are in the possession or under the control of the users 102. There are many desirable and optional features that system 100 provides to users 102 and to the various HCP that are connected to the users.
  • system 100 may provide the following: (1) establish networked infrastructure for programs for health, education, prevention, wellness, treatment and/or research (104);
  • One embodiment of analysis and optimization of the present system provides that the interactions of involving users and the present system provides a feedback mechanism to sharpen and improve the effectiveness of the system for treating or servicing its users.
  • one embodiment of the present system might be a Clinical Care and Education program that allows providers several means to capture the data about the effectiveness of their programs.
  • the "social" interactions inherent in the solution may be captured by the system, for example as unstructured data.
  • the built Query - Response service allows the system to get explicit feedback in a secure fashion.
  • the Therapeutics module might allow the system to capture responses from their patients and participants e.g. level of pain, mood, etc., along with compliance data such as "Did you take all three dosages of the medicine, on time” etc. This data set allows the system and its designers (which could be the clinicians and researchers of the program itself) to look for correlation among a particular protocol and its effectiveness and make changes to their programs, be it therapeutics or course material, style of presentation, etc.
  • System 100 may be employed to create a networked
  • FIG. 2 depicts a social pod 200.
  • Social pod 200 is enabled or otherwise hosted by system 100 as a set of interconnected computers, processors, mobile devices or the like. Desirable features of social pod 200 may include: a set of trusted connections brokered through the system; a polycommunication service (e.g. email, SMS, voicemail or the like); short question and response service; and a viewport and/or an application (called an "anicaport” for purposes of this application, as described below).
  • This anicaport may act, at a high level, as a viewport for downloading, uploading, and/or streaming of content. Such content may be placed into appropriate formatting and made available to all or a subset of trusted users, possibly in some universal format.
  • a polycommunication service e.g. email, SMS, voicemail or the like
  • short question and response service e.g. email, SMS, voicemail or the like
  • an application e.g. email, SMS, voicemail or the like
  • This anicaport may act, at a high level
  • a social pod may provide a restricted and secure way for a micro community of people organized around a specific outcome (e.g. clinical research, treatment of a medical condition, education for wellness etc.) to interact, collaborate, capture structured data, etc.
  • a specific outcome e.g. clinical research, treatment of a medical condition, education for wellness etc.
  • Figure 3 depicts one embodiment of a method of creating a social pod.
  • the system may allow for a multi-part authentication procedure and mechanism. It will be appreciated, however, other mechanisms - with varying levels of authentication - may be set up and managed. It will be appreciated that the following description is merely by way of example and that other mechanisms and methods may be employed to created trusted communities and/or social pods.
  • Social pod 308 may be created by a provider, a physician or researcher 304 via the present system.
  • Provider 304 alerts the system that a new "Care" pod is to be created and provider 304 may populate the pod by listing individuals (e.g. patient 306) and have the system invite patient 306 via some identified means of communication (e.g. by providing the patient's email address to the system) at 310.
  • the system may manage social pod 308 as a set of data structures and/or routines to affect its creation and dynamic
  • the system via social pod 308 or the like) creates the new "Care” pod and adds patient 306 as a pod member, pending
  • Pod 308 may then request the system to create patient as a User - in this example, via a request to the system's authentication module 302.
  • Authentication module 302 may perform such actions as shown at 314. To wit, module 302 may generate a security token and associate the token with the user's email address or any other identifier. Module 302 may return an invitation to the identified email address of the putative new user /patient 306. Patient 306 may then (at 316) access her email and confirm the address, setup a user password and enter other means of communication for the system (such as mobile phone number or the like). This other means of communication may be used to receive a second part authentication for the user. Once initial confirmation is received from patient 306, module 302 may confirm the token against the previously generated token (at 314) and send a text message to the mobile phone (or call the phone directly) with a second part token. Patient 306 may enter the second part token and return to module 302 for further authentication. If module 302 confirms the second part token, module 302 may signal to pod 308 that there is a trusted individual/user at 318.
  • Additional authentication means may optionally be set up, as desired.
  • patient 306 may set up a voice recognition match for further authentication at 320, back to module 302.
  • patient 308 is then considered a trusted user and may access the pod with suitable credentials at 322.
  • the present system may provide flexibility in setting up trusted relationships. For this, it may be desirable to establish that the forms of identifications provided by the user are indeed accessible by the user. For this, the present system may establish such multi-part authentication mechanism as desired. In addition, the administrators or providers of the system can choose the levels of authentication required for trusted users, with a basic minimum possibly designed.
  • FIG. 4 depicts one embodiment of an architecture of a system that may perform in accordance with the teachings of the present invention.
  • System 400 may advantageously comprise multiple modules for the creation and dynamic operation of the present system. Such modules may comprise the following: communication engine 402, multimedia content engine 404, external ecosystem integration module 406, therapeutic and research management engine 408, social networking engine 410 and analytic engine 412. Each module/engine will be discussed in turn below.
  • Communication engine 402 is the part of system 400 that comprises sufficient hardware and logic to setup and dynamically manage the flow of communications between trusted users of the present system.
  • Communication engine 402 may manage communications from disparate means and modes of communications - e.g. text messages, chat, email, voice, video chat and the like.
  • Multimedia content engine 404 is that part of the system 400 that comprises sufficient hardware and logic to create, store, disseminate and dynamically manage the flow of data in and out of system 400 by and to trusted users of the system.
  • Submodules of engine 404 might advantageously comprise: injest submodule, transcoding submodule, presentation submodule, storage, and delivery submodules.
  • External ecosystem integration engine 406 may present a set of RESTful API, that allows it to exchange its data with third party systems and using (when applicable) industry standards such as HL7 etc. These API's will allow external systems to send information to the present system, e.g. a medical device or EHR system.
  • Therapeutics and Research Management Engine 408 is that part of the system 400 that comprises sufficient hardware and logic to create, store, disseminate, and dynamically manage treatment plans and pathways for trusted users on the system. It may be desirable for each trusted user of the system that is actively being treated via system 400 to be tracked by engine 408 and their progress logged and processed.
  • Submodules of engine 408 may advantageously comprise: querio dynamic data capture submodule, therapeutic library, patient education library, and reminders and compliance tracking submodule.
  • Social networking engine 410 is that part of system 400 that comprises sufficient hardware and logic to dynamically manage the various communications and relationships between trusted users of system 400. It should be appreciated that any known combination of processors, data structures, storage and communication media - including transport of data across networks, intranets, the internet - may be utilized to affect the implementation of the present system, as is known to one skilled in the art.
  • One aspect of the present system is the ability to transcode, store, deliver and present content of a variety of media types. This would be desirable in any number of applications and context - and one such application is in the field of healthcare where patients may thrive better in a treatment program where use of multiple means of communications and messaging (both synchronous and/or asynchronous) may be applied. For example, a patient may not feel like talking directly to a doctor, or writing a lengthy email about conditions and results; but the patient might be amenable to uploading an audio or video file describing such. So, users and applications can use a multimedia content server/network -- such as "anicaport" to affect solutions.
  • anicaport it may also be desirable to create an anicaport in such a way as to build solutions that may have shared content; but it is not desired to transmit the files multiple times.
  • Anicaport content files of practically any size can be shared.
  • the content files that are authored in native formats may be uploaded and shared, anicaport may transcodes them to ensure that files will display in Web browser or Mobile device without the need for additional software.
  • content files may be streamed and transmitted over secure, encrypted protocols and designed to be accessible from anywhere on the globe.
  • FIG. 5 show one flow chart of the multimedia content engine ("anicaport") in dynamic operation.
  • Anicaport 502 in this embodiment, comprises injest API 506, transcoding engine 508, presentation API 510, storage 512, and content delivery network 514.
  • Some application (under user control or otherwise) 504 may make an injest request at 516 - e.g. a live recording or upload or the like.
  • Injest API 506 may, at 518, store any metadata (if any) in storage or database and send the file associated with the request to storage 520.
  • This file or data may be queued for further processing at 522 and/or 524, if needed.
  • transcoding engine 508 may process and generate one or more versions, perhaps in different formats, such as image format (e.g. SVG & PNG). Any metadata associated with the transcoding, if any, may be updated in a database or storage. If the file or the data is either an audio or video file, then transcoding engine 508 may process it to a different format - e.g. H.264. Any metadata generated there may also be stored as noted.
  • transcoding engine 508 may then send the processed data/file to storage (perhaps over SSL) at 528.
  • the data/file may be distributed to content delivery network at 530. If there is any update that is needed to earlier saved metadata, it may be accomplished at 532.
  • the same or different application 504 may make a request for a presentation of stored content (to which the user or owner of the application has rights to) at 534.
  • Such request may be made to a presentation API 510, which then may select a presentation player at 536 and initiated streaming content at 538 from content delivery network at 538.
  • Presentation API may then oversee such streaming data to application at 534. All of this may be accomplished with the anicaport or other parts of the system checking and enforcing authorizations and permissions - matching users/applications to content.
  • AmazeSNS.skey aws_secret_access_key
  • file_basename self.document_name.split('.').first
  • file_basename self.document_name.split('.').first
  • AmazeSNS.skey aws_secret_access_key
  • bucket_name self.account.account_name
  • AmazeSNS.skey aws_secret_access_key
  • AWS::S3::S30bject.store(to, open(from), self.account.accountjname, :access > :private)
  • AWS::S3::S30bject.delete file bucket if AWS::S3::S30bject.exists? file, bucket
  • the present system itself may be hosted in a myriad of ways, to include leveraging existing infrastructures and the different companies that may provide services and hardware for such hosting and infrastructure.
  • Figure 6 depicts one embodiment of the present system (600) as it may be hosted over existing infrastructure. Users of the present system may connect by a myriad of communication pathways. For example, users may connect via phone (602), mobile or otherwise, and by a browser 604 through standard interfaces 606. Once connected to the present system 600, the various modules of the present system may be a set of separately hosted modules that are in communication with one another.
  • the embodiment depicted in Figure 6 has modules -- instrumentation and notification module 608, integrated text and/or voice messaging 610, email service 612, application server and webserver 614, database 616, media server 618, simple queuing service 620, content transcoding engine 622, content storage 624 and content delivery network 626 - interconnected in a manner in which each module may be separately hosted, or a set of such modules may be resident on a single site and/or processor.
  • the present system may be built on top of best of breed infrastructure available from existing companies—e.g. database hosting services and cloud computing services. It may be desirable that the communication framework of the present system integrates with media servers, SMS gateways and voice capabilities.
  • content transcoding engine 622 may convert content files that are uploaded to content storage 624 in any format, e.g., Microsoft Office documents, pdf files, and various image and video formats, preparing them for direct preview and streaming delivery to computing devices, tablet or smartphones (without any downloads).
  • the present system may also advantageously support the sharing of very large image and video content files such as ultrasounds and MRIs.
  • the present system may also support parallel and separate communication threads among various subsets of a community, ensuring selective and appropriate access to communications, personal health information, and medical reports.
  • the present system may automatically deposit every communication and medical record into a EHR and EMR repository.
  • Notification engine 608 may support therapeutic reminders, workflows and communications.
  • Figures 7A and 7B depict the flow of operation of one such embodiment of the present system - i.e. a social pod built and maintained for the management of post-traumatic stress disorder in returning military veterans. It will be appreciated that this embodiment is offered merely for exposition of the present system and does not necessarily limit the scope of invention as claimed below.
  • various users may be in communication with other users via and through the present system itself.
  • physicians 702, patient 704, consulting physician 706, other trusted users 708 may be in communication with each other, or various modules of the present system, such as polycommunication service 710, short question and response service 712 and anicaport 714.
  • patient 704 may post a private message (at 720, via any known means, e.g. video, web, audio/SMS or the like) meant to be viewed by physician 702.
  • the message may be received by communications service 710 (at 722) and relayed to physician 702 (at 724).
  • Physician 702 may view the post and respond, which is relayed via communication service.
  • physician 702 may post a consultation request at 726 to communication service 710, from which a notification may be sent to consulting physician 706 and a message sent to anicaport 714 at 732.
  • consulting physician 706 may view the message and content at 730 and then post results of the review back to physician 702 at 734.
  • Anicaport 714 logs all such communications via encrypted content at 732.
  • physician 702 may invite a new patient 704 and a new consulting physician 706 (at 742 and 746) to join the social pod (as described above) and accept invitations at 744.
  • physician 702 may decide at 748 to upload certain educational or training materials relating to PTSD to anicaport 750, which then may be viewed by patient 704 as, e.g.
  • Physician 702 may decide to set up a therapeutic regiment for patient 704 at 750.
  • Short question and response service 712 may be employed at 752 to provide reminders and capture any other relevant data (e.g. mood, clinical results, etc.) from the patient at 754. If any alert is triggered by the crossing of a threshold (either clinically or via answers or non-compliance noted by the present system), then an alert may be generated and sent to physician at 752, 756 and 750.
  • physician 702 may review charts and trends of patient 704 at 752.
  • FIG. 8A and 8B depict one embodiment of such a de-identification module.
  • De-identification module 806 may be implemented within the system on top of, or in communication with, query module or communication module or the like. In response, de-identification module 806 may strip out information or data which may be linked to, and help identify, any given patient.
  • physician may post a message or a response to the social pod.
  • a message may be posted in various forms (e.g. text, voice or video), and it may be desirable that de-identifier module 806 strip out any such identifying data.
  • de-identifier module 806 strip out any such identifying data.
  • such information passed to the social pod 804 may be captured by de-identifier 806.
  • module 806 may parse and remove references to physician and/or patients and create an object without such references, and subsequently be stored at 816.
  • module 806 may perform speech recognition to capture information within the message. In addition, module 806 might use voice altering to de-identify the tonal qualities of the individual leaving the message. In the case of video at 822, module 806 may alter pixel data within an image to obscure facial recognition. In addition, module 806 might alter sound and voice data as noted above.
  • Figure 8B depicts data and information as may be viewed by either a physician who is authorized to know the identity of the data to whom it is referring - and to others who are not so similarly authorized.
  • the data which is stripped from the data by the present system is depicted in the third column of Figure 8B.
  • the present system may be constructed to capture de-identified data in real-time for research purposes. For example, actual conversations between Physicians/Researchers and Patients (as well as other structured captured data) are typically stored in an encrypted fashion to protect privacy. This however tends to render the data unusable for search and analysis.
  • a social pod may be tagged to be "For research", in which case, the system logs its data in a de-identified form, with the pertinent information but the identifiable elements removed.
  • the present system may also provide a more comprehensive and high engagement support system for better compliance with a therapeutics module.
  • physicians may easily setup a therapeutic action plan and, for each of the components, associate a basket of supporting materials from their online library or record instructions directly through the webcam.
  • the system will, if setup, send reminders through one or multiple means such as email, voice call or text messages and may require the patient to confirm.
  • Figure 9 shows an exemplary screen shot 900 of such a
  • Tabs 902 may be constructed in a user-friendly fashion and, as described above, a To Do tab 904 could be one possible interface to affect a more comprehensive treatment plan for a patient.
  • Possible interfaces might include therapeutic item box 906, where text may be entered by users regarding aspects of the treatment and a set of reminders for treatment may be set in accordance with the treatment plan (e.g. take medications every day, or describe symptoms once a week, take and record vital signs once a month or the like).
  • accessible content may be made available through this interface at 908.
  • the patient has access to a document that describes the medication that she is taking, or the patient may have access to video/audio file 912 that she uploaded to inquire about treatment aspect.
  • Her physician may have responded with a video/audio file 914 in response.
  • Such robust treatment of multimedia content may be delivered as described above.
  • FIG. 10 shows one embodiment of a donation interaction that, in this case, allows providers to raise funds for, e.g., a health outreach program. Donors, in turn, might pledge funds, review outcomes and pay the providers.
  • Provider 1002 might set up program and outline program cost and funds needed to setup and maintain the program at 1010.
  • Provider 1002 might market such program through any number of channels, e.g. via
  • Donors 1004 may receive such marketing at 1014 and pledge some amount at 1016 - via the present system.
  • donors may be made a trusted user and a part of the trusted community, with certain rights and access to materials on the present system.
  • Donor 1004 may make payments at 1018 to payment module 1008 at 1020.
  • program metrics 1006 may send such metrics -e.g. program satisfaction scores - to donors at 1024, in order for donors to see their donation money at useful work.
  • This capability may allow the parties involved to have a single and common place to go to find the information they need about a patient, even if they are physically distant as well organizationally separated - i.e., they could be part of two different Healthcare providers in two different parts of the world.
  • CarePod accommodates the storage of records that exists in an electronic form. This provides the opportunity for healthcare providers to upload files that are in electronic form into the CarePod.
  • Several embodiments of the present application herein provide users of CarePods with systems and methods of sharing paper documents by and between these users.
  • Figure 11 depicts a typical transaction 1100 by which paper files are shared via facsimile between doctors' offices. Often, a doctor in office 1102 will refer a patient to another physician in a second office 1104. At that time, the patient's record (in paper format) 1106 is faxed 1108 (or otherwise scanned and sent electronically) across by telephone, computer networks - e.g., Internet, or other known means for sending electronic information and received at 1112. Often times, instead of maintaining the patient records in electronic format, another second paper copy 1114 of the patient's records is made at office 1104. [00093] In one embodiment, systems and methods are provided that leverage the trusted and secure nature of the Carepod paradigm and structure to import patient records (usually from paper format) into the Carepod.
  • Figure 12 shows one embodiment of a flowchart of one such possible system and method.
  • a sender of patient records may be a physician, nurse or someone on staff of an office, practice or hospital.
  • Sender 1202 may be a registered user and/or caregiver known to the CarePod (e.g. a trusted user), possibly in relation to a particular patient. If the sender is not yet a registered user, such sender may go through appropriate procedures to be included in the set of registered users.
  • sender 1202 may login to the CarePod. Thereafter, sender may either create a new Carepod - or may create a "referral" for the particular patient at hand.
  • a "referral” may be construed broadly - e.g., to encompass a general practitioner making a referral to a specialist, or a hospital administer making a referral to an insurance company for payment for services rendered. It should be appreciated that such "referrals" encompass the usual and typical transactions that may be made with paper - or unsecured and/or authenticated electronic transactions.
  • sender By creating a new CarePod or a new referral, sender sends the Carepod - and/or the computing/communications environment that affects the CarePod - a message at 1210 indicating the intent (e.g. create a referral).
  • This message may be received by the CarePod by a communications module that allows the CarePod to interface with a plurality of devices.
  • communication module would be configured to receive such requests for uploading an image file.
  • CarePod 1204 may generate a Global Unique Identifier (GUID) for the message request. If the request was to create a new CarePod, then a new CarePod may optionally be made at 1210. Assuming that the request was to make a referral - and such referral was transfer records in paper format, then CarePod 1204 may generate a cover sheet (e.g. for facsimile or other electronic format transfer) that comprises a unique QR code. [00097] At 1212, sender may download, print or otherwise secure the cover letter (in print or electronic format). At 1214, the cover letter may then be included with the patient record in either paper or electronic format.
  • GUID Global Unique Identifier
  • Sender may then take whatever appropriate technological steps and measures to transmit the patient record (or other suitable record to be secured) to the CarePod.
  • CarePod may queue the incoming facsimile or other electronic transmission - and a sequence of other, optional, steps may then take place.
  • CarePod may encrypt and store the fax image (or other electronic image format).
  • CarePod may process and/or extract the QR code from the image file.
  • CarePod may search and match the database for the CarePod associated with the patient and/or individual at 1218. Once the CarePod (or the system that manages multiple CarePods, if more than one CarePod is available to the system) has made the association between the image file and the particular patient or individual in question, CarePod may save and/or otherwise store the image file, together with the unique identifier in the database. In addition, the CarePod may save and/or store the CarePod ID together with the fax and/or image file ID at 1220.
  • CarePod has stored the image file appropriately for the associated patient and/or individual, it may be desirable to extract the information from the image file on in an automated fashion - and one in which separate (and possibly automated) verification is affected.
  • Extractor/verifier 1304 may be called by CarePod, users or other executables of the CarePod, once an image file (e.g. fax image) is stored in appropriate storage 1302. At 1308, extractor 1304 may read the image from storage. Once such images are available, extractor/verifier 1304 may perform Optical Character Recognition (OCR) and/or any other known means for extracting information from image files at 1310. Once the image data is now in another format (e.g. ASCII or other computer readable formats), extractor/verifier 1304 may start to extract metadata from the computer readable format at 1312.
  • OCR Optical Character Recognition
  • extractor/verifier 1304 may inquire whether the metadata it is extracting has the "look and feel" of data that such a record may be expected to comprise - e.g. does the metadata contain or otherwise comprise a patient name, an age, a Date of Birth (DOB), gender, etc. ? If not, then the extractor/verifier may either terminate its process - or alternatively, alert the CarePod that the image file does not seem to be what it was expecting to extract.
  • DOB Date of birth
  • the extractor/verifier 1304 may read patient data from CarePod 1306 at 1316 - as an additional verification that the image file at issue accurately corresponds to the particular patient and/or individual. It should be appreciated that the automated
  • extractor/verifier may be maintained separately from CarePod (e.g. not share information with the CarePod or its storage at this point). Such separation tends to increase the accuracy of the overall system and tends to minimize the possibility that someone else's sensitive information may be inadvertently shared to members of the CarePod.
  • extractor/verifier 1304 may then associate and store the metadata (e.g. the computer-readable format, and not image format) in the CarePod at 1320.
  • extractor/verifier 1304 may set a flag that a problem may have occurred at 1324.
  • the information extracted may be stored separate and away from CarePod access. This would also minimize the possibility that patient confidential information is not compromised.
  • Medical data - either patient-gathered, medical device-gathered or biosensor-gathered - should properly be reviewed by physicians or other health care providers in order to provide proper treatment to the patient. It may be desirable to review this medical data in a near real-time basis, in order to provide timely medical care to the patient.
  • Figure 14 depicts a plurality of conventional paths by which physicians and other care givers may receive health data (e.g., in substantially real-time) from either patients (tracking their own health data) or from medical devices and/or biosensors (either implantable or external) and possibly gathered from a mobile devices (e.g. iPhone, iPad or the like).
  • device 1402 may either create data and the data is manually input into a computer 1404, or may provide the data automatically (via wired, wireless, telemetry or the like). The data is typically then sent to the doctor 1406 and/or care giver 1408, via a physical printout or may be provided electronically to a monitor or the like.
  • device 1410 may be internal or external to the patient and its data may be shared with the doctor 1406 and/or care giver 1408 substantially in real-time.
  • a record e.g., on paper or electronically
  • Figure 15 depicts one embodiment of systems and/or methods for the sharing of real-time data - as might be generated by a medical device, biosensor or mobile application - with other trusted users of a CarePod.
  • Device 1502 may be either internal or external to the patient - and device 1502 may represent a whole host of possible devices, measuring any number of medical and/or physiological conditions (e.g., blood pressure, glucose level, EKG, ECG, implantable sensors or devices or the like). Device 1502 may have one or more sensors 1508. Sensors 1508 may be in command and/or communication connection with communication and/or control module 1504. In one embodiment, module 1504 may be made in accordance with the secure and/or HIPAA compliant systems and methods of the present application.
  • sensors 1508 may also comprise active therapy modules as well, such as defibrillator, stimulation or the like, that may be actuated by control signals from module 1504 - possibly automatically (e.g., defibrillation) or possibly sent after sensor data 1520 has been reviewed by doctor 1522, care giver 1524, patient family member 1526 and/or other entities within the patient's CarePod 1518.
  • active therapy modules such as defibrillator, stimulation or the like, that may be actuated by control signals from module 1504 - possibly automatically (e.g., defibrillation) or possibly sent after sensor data 1520 has been reviewed by doctor 1522, care giver 1524, patient family member 1526 and/or other entities within the patient's CarePod 1518.
  • module 1504 may comprise, or otherwise be in communication with, a communication module 1506.
  • Communication module 1506 may be wired or wireless communications. As depicted in Figure 15, communication module 1506 may be compliant to any known or potential wireless standard - e.g., NFC, Bluetooth or the like.
  • device 1502 may be either internal or external to the patient and device 1502 may be collecting medical data derived from the patient. Such patient information may possibly represent data that should be controlled in a HIPAA compliant manner. In one embodiment, this patient medical data may be communicated ultimately to the patient's CarePod via a communication module 1514.
  • the platform that implements module 1514 may be either a stand-alone communication station (e.g., a desktop,
  • a communications port or the like or the like
  • a hand-held device e.g., a phone, smart device or the like.
  • module 1514 may also comprises a pairing communication module 1510 (e.g., a wired port, Bluetooth, NFC or the like) - in order to affect communications with device 1502.
  • a pairing communication module 1510 e.g., a wired port, Bluetooth, NFC or the like
  • data may be transmitted from device 1502 to communication module 1514 - e.g., by establishing communication and/or command connections and read medical data, possibly in a
  • This medical data may also be placed in a format that may be employed by patient's CarePod by module 1504. In another embodiment, such data may be formatted for CarePod further downstream in the communications pathway - via, e.g., another module 1512.
  • medical data may be sent to CarePod 1518 via any suitable communication pathway (e.g., depicted as an encrypted wireless connection in Figure 15; but may be any other suitable communications pathway that may be capable of transmitting encrypted data, such as wired networks, wireless networks, the Internet or the like).
  • any suitable communication pathway e.g., depicted as an encrypted wireless connection in Figure 15; but may be any other suitable communications pathway that may be capable of transmitting encrypted data, such as wired networks, wireless networks, the Internet or the like).
  • This data may be communicated to a cloud-based structure 1516, as is known in the art.
  • Cloud structure may comprise various storage and applications to store and possibly modify the medical data.
  • Cloud structure 1516 may also store a plurality of CarePods - which may be constructed for individual patients and/or individuals. The data arriving from device 1502, however, is likely meant to be stored with the CarePod 1518 that is unique to that individual patient.
  • de-identified data may be used by other CarePods or other entities for other purposes - e.g., to supply data for the efficacy of various treatments or therapies or the like.
  • doctors 1522 and/or care givers 1524 may analyze the data and make treatment decisions in response (e.g. in substantially real-time).
  • suitable commands if meant for device 1502 may be channeled along the same communication pathway as before.
  • Such commands may themselves represent HIPAA compliant data - in which case, the secure and authenticated protocols for communication to and/or from the CarePod would also apply.
  • care may be desirable in order not to misdirect any sensitive and/or HIPAA compliant patient data to another CarePod that is not associated with individual patient.
  • Figure 16 depicts one embodiment of a system and/or method to prevent such misdirection.
  • data may be flowing to and/or from device 1602, via communications module 1604 and ultimately to a cloud structure that comprises the CarePod of the individual patient associated with the data.
  • the cloud structure may also comprise other CarePods for other patients (that are not associated with data).
  • Such cloud structure may be implemented across a number of entities - e.g. practice clinics, hospitals, care centers or the like.
  • communication module 1604 may send (at 1608) a code capable to pairing the communication module 1604 to device 1602. Upon receipt of such a code, device 1602 may confirm receipt of the code. Such code may be used to further secure and authenticate data and communications.
  • Communications module 1604 may further communicate at 1610 with the cloud structure in order to enter the patient information and authenticate further communications with the CarePod at 1612.
  • CarePod and/or cloud structure may create a Unique Identifier (GUID) that is read by communication module 1604.
  • GUID may uniquely identify the patient, the CarePod and/or both - and may be employed to further authenticate communications further that may comprise sensitive patient data.
  • communication module 1604 may update device 1602 with the GUID.
  • device 1602 may send - and/or communication module 1604 may receive - metadata about the device and data content and/or format from any processing module embedded within device 1602 meant to affect proper formatting for secure and authenticated
  • medical data sensed by device 1602 may be any medical data sensed by device 1602.
  • the data may have the GUID embedded in any known manner within the data - which may be validated against the GUID that is known to the communication module 1604. If the validation is proper at the communication module 1604, then the data may then be sent to the CarePod that is associated with the individual patient. [000124] It will be appreciated that this GUID check may also occur at other points along the communications pathway from the device to the CarePod - including within the cloud structure itself. An opportunity to perform this check may be made at any point of relaying such information.
  • systems and/or methods may provide a solution linking many modalities seamlessly together to aid in medical provision under one institution, e.g., a Children's Hospital (CH) or the like. Images, lab reports, etc. from different hospitals may all be made available real time under one umbrella.
  • CH Children's Hospital
  • the patient may be fitted with various devices and sensors and this data (e.g., blood pressure, pulse oximetry, respiration rate) may be uploaded via wired, wireless, telemetry or the like to a HIPAA compliant cloud based server, such as described herein.
  • doctors may be able to utilize this data (possibly de-identified if desired) for research studies.
  • set trigger points may be set (either by doctors, care givers or the CarePod on an autonomous or semi- autonomous basis) to elicit a call to 911, the neurosurgeon on call, the nurse, or intensivist on call when a certain threshold value has been reached.
  • medical data may be sent from the sensor to a mobile device up to the cloud based server. If for example a sensor was measuring an infant's respiratory rate or EKG, then emergency response services (via 911) as well as the parent's cell phones may be simultaneously triggered to notify the ambulance and parents that concerning readings were being sensed, and that immediate notification and intervention would then be initiated.
  • Figure 17 depicts merely one possible treatment condition that helps to illustrate the therapeutic nature of various embodiments of the present application. In this case, the treatment condition depicted is therapeutic Closed Loop Deep Brain Stimulation (DBS).
  • DBS Closed Loop Deep Brain Stimulation
  • Deep brain stimulation is a system where electrodes 1704 are placed within the human brain (under an operative procedure) within very specific brain regions. Each electrode has 4 leads, and electrical current is able to pass through a combination of these leads. The actual shape and intensity of the current field is based upon a variety of factors, namely which electrodes are selected to be activated, the amount of the current, the voltage of the current, and the impedance within the circuit. This electrical activity
  • DBS in children may suffer from motor dyskinesias (abnormal jerky motor movements) as a result of perinatal strokes (eg. Cerebral palsy).
  • motor dyskinesias abnormal jerky motor movements
  • perinatal strokes eg. Cerebral palsy
  • they may undergo a procedure for DBS electrode placement.
  • they typically would see a neurologist many times to fine tune the DBS system's parameters. Small changes may be made, and the clinician would look for improvements or declines. This is time consuming, and effects are not always apparent after making changes to voltage, current, and other characteristics (e.g., unipolar or bipolar current configuration).
  • bracelets 1702 may be placed on the patient's arms and/or legs, with a motion sensing device within the bracelet. This would monitor the patient's motor output, and could then be sent to the patient's mobile device and then to a cloud based, HIPAA compliant computer server. It could be employed to correlate motor activity with actual DBS settings. It may thus be possible to monitor change and also see how the patient is doing at all hours, as night monitoring would be automatic and may not be depend on anyone to observe.
  • monitoring -- change DBS settings (e.g., within carefully set parameters to ensure safety). Such embodiment may allow for closed-loop automatic fine tuning and 24-hour real time adjustments to be made, possibly within pre-set parameters. It is also possible to note that settings may differ while sleeping, after meals, at school; and that DBS changes could be altered accordingly. Circadian rhythms may also be measured. If these diurnal variations are important, than this closed loop monitoring system may be able to pick up these subtleties - and also make the appropriate changes.
  • This system may enable optimization of the current DBS paradigm at an individual patient perspective. From a global standpoint, it may be possible to study data real time from every child with a DBS, and make appropriate changes and optimizations to hardware, programming paradigms, anatomic localization, etc. all based on studying all data from all patients - leveraged by cloud based, HIPAA compliant platforms.
  • the CarePod has the ability to provide controlled access to various people involved in the care of a patient within and between Doctor's offices to the various parts of a CarePod, such as the communication tools, the charts and records etc. This capability may allow the parties involved to have a single and common place to go to find the information they need about a patient, even if they are physically distant as well organizationally separated -- i.e they could be part of two different Healthcare providers in two different parts of the world.
  • the charts and records portion of the CarePod accommodates the storage of records that exists in an electronic form. This provides the opportunity for healthcare providers to upload files that are in electronic form into the CarePod.
  • the framework of the CarePod may support and provide for a Therapeutic Intervention Management (TIM) system.
  • TIM Therapeutic Intervention Management
  • Many present embodiments tend to simplify the process of setting up a therapeutic plan by integrating medical instruments to aid in capturing data, formatting such data and sharing it to relevant groups of doctors, caregivers and researchers.
  • Medical instruments and/or devices are either external (e.g. blood pressure monitor, glucose monitor and the like) or internal (e.g.
  • defibrillators, other electrodes and the like are typically monitoring the medical status of individual patients while they are engaged in some therapeutic treatment and/or protocol. It is desirable that the data captured by such instruments and/or devices be placed into a manageable set of forms and made available to other CarePods - so that data from large patient populations may be aggregated to perform meaningful (and possibly, very timely) clinical analysis.
  • systems and methods are provided for the framing the instruments to capture data, administering the instruments, sending reminders, capturing data from the patients or devices connected to the patient and presenting the data.
  • the information flow from instruments to doctors/researchers may be designed as "touch-less" - i.e., there does not have to be physical handoffs involved between clinical staff, patents, caregivers and the data is available substantially in real-time.
  • a tighter integration may be provided by the framework of the CarePod by providing access ubiquity and a unified platform wherein the research and practice occurs in a single continuum - with each providing a flow of information one to the other, resulting in continuous improvement and innovation.
  • Many embodiments of the present system may be implemented as a cloud-based platform and may provide a networked model where combinations of trusted people, patients, their devices and data around the world may be linked together.
  • many present embodiments may allow data from potentially millions of patients to be aggregated using common instruments and common medical terminology within the system.
  • One embodiment of the present application may enable doctors and other care providers who work within traditional care settings to share information and collaborate with their patients and other care providers who work outside the traditional care settings, including the patients' family members, caseworkers, home-based care providers, etc. Such persons may be physically located anywhere in the world. Any number of people connecting to the Internet through any number of computer networks may collaborate with each other and share information about a patient's care within the patient's CarePod. [000148] The present embodiment may also enable doctors and other care providers to distribute medical expertise, medical advice and care to patients and their other caretakers while the patient is at home or at an alternative care facility using various previously disclosed means.
  • the present embodiment further tends to support the real-time collection of data about a patient's medical condition gathered from various sources by various means within a patient's CarePod. For example:
  • the present embodiment may also enable the rapid analysis of data about a patient's medical condition.
  • the present application tends to support the appropriately limited dissemination and display of patient information to a patient's various care providers in a HIPAA-compliant manner using previously disclosed means. For example, it may be necessary for a given patient's psychiatrist and OB/GYN doctor to receive clinical information related to the patient's sexual practices, while it is undesirable for the patient's cardiologist or home-care nurse to receive such clinical information.
  • the present embodiment tends to enable doctors and other care providers to access and use data collected within the patient's CarePod about his medical condition to formulate, change, and personalize the patient's treatment plan.
  • a doctor may: (i) Change a patient's medication based on the patient's report of deleterious side effects from a pharmacologic agent or a drug combination;
  • the present embodiment may also enable doctors to correlate (i) data that are collected within a patient's CarePod relating to one or more certain aspects of a therapeutic intervention with (ii) data that are also collected with the patient's CarePod relating to the patient's concurrent and/or resultant medical condition.
  • doctors may correlate (i) varied stimulation levels of electrodes that have been surgically implanted in a patient's brain to affect Deep Brain Stimulation ("DBS") therapy with (ii) data relating to the patient's involuntary movements collected using ankle- or wrist- based motion detectors, and/or data related to the patient's speech disability leveled collected through application of the Guy's Neurological Disability Scale.
  • DBS Deep Brain Stimulation
  • the present embodiment may also enable doctors to correlate (i) data collected within a patient's CarePod relating to the function of a medical device with (ii) data that are also collected within the patient's CarePod relating to his concurrent and/or resultant medical condition.
  • doctors may correlate (i) data relating to the magnetic settings of a dynamic compression medical device system for correction of Pectus Carinatum deformity with (ii) data relating to a patient's medical condition collected by performing intermittent manual measurements of the patient's chest circumference, and/or continuously recording the pressure resistance between the patient's chest wall and the compression medical device system, and/or collecting intermittent reports from the patient regarding his relative satisfaction with his physical appearance.
  • doctors may base clinical decisions on such data correlations, including, for example, adjusting BDS patients' electrode stimulation levels therapeutic intervention based on such data correlations, or changing the magnetic settings of a dynamic compression system for correction of Pectus Carinatum deformity
  • the present embodiment may enable doctors to monitor a patient's medical conditions with whatever degree of frequency and accuracy desired within his CarePod. It enables doctors to monitor the effects of various factors that may affect the efficacy of a given therapeutic
  • the present embodiment may enable doctors to monitor various factors that may affect a patient's response to DBS treatment, e.g., the sleep vs. wake cycle, posture, etc., in order to devise a better, more personalized therapeutic protocol for the patient.
  • DBS treatment e.g., the sleep vs. wake cycle, posture, etc.
  • the present embodiment may enable the conduct of new clinical research trials that are designed to develop a wide variety of new, evidence-based therapeutic interventions, e.g., new, improved DBS-based therapeutic interventions for Parkinson's Disease and other tremor disorders, and faster, more efficient medical device-mediated interventions for chest deformities.
  • new, evidence-based therapeutic interventions e.g., new, improved DBS-based therapeutic interventions for Parkinson's Disease and other tremor disorders, and faster, more efficient medical device-mediated interventions for chest deformities.
  • the present embodiment provides a system that enables healthcare providers to test administer and do continuous improvements based on evidences for Therapeutic intervention protocols having any number of clinical and non-clinical steps, to one or many patients and streamline the activities, interactions and coordination required to administer them.
  • Therapeutic intervention protocols having any number of clinical and non-clinical steps, to one or many patients and streamline the activities, interactions and coordination required to administer them.
  • the health care community has felt the need for tracking the efficacy of their interventions whether in evidence based medicine or translational medicine.
  • the present Therapeutic Intervention Management system provides a solution to this problem in a single platform. It tends to simplify the whole process of setting up a Therapeutic plan, framing the instruments to capture data, administering the instruments, sending reminders, capturing data from the patients or devices connected to the patient and presenting the data. The whole process may be completely touch-less, meaning there are no physical handoffs involved between clinical staff, patents, caregivers and all the data is available in real-time. Current tools and processes separate Clinical research & trials and actual practice. The present embodiment tends to remove this barrier and transform the current approaches through its access ubiquity and unified platform wherein the research and practice occurs in a single continuum, each feeding the other, resulting in continuous improvement and innovation.
  • the present embodiment may be cloud based and the implementation of the CarePod construct allows it to be a networked model where any combination of people, patients, their devices and data around the world can be linked together.
  • Current existing enterprise applications such as EMR tools or clinical research databases tend to be silos of information and architecturally limited in its ability to scale.
  • the present embodiment however allows data from millions of patients to be aggregated using common instruments and common medical terminology within the system.
  • the above protocol may be streamlined in one embodiment of the present application. If this streamlined protocol is made available to new and existing CarePods, then a CarePod -- created for a patient -may begin to automatically seed the Treatment Protocol. Patient educational material may also be pre-seeded into the Treatment plan. These materials may be made available to the patient from anywhere location where the patient can access his/her CarePod. [000164] For medication management, the patient and their caregivers may receive automated reminders and compliance may be captured from the patient directly using their computers or mobile devices or medical devices (over a wireless or wired link) that use the messaging framework of CarePod. Data may be automatically stored in the database and data is charted in the dashboard in real time. Automatic alerts may be sent to physicians if defined thresholds are crossed.
  • Check-in appointments may be performed by using an audiovisual application that is implemented in the CarePod - unless a physical checkup is required by the physician.
  • the patient's charts may be made directly available to the physician requiring no handoff.
  • the present system allows for the integration of data from medical instruments and/or devices into the TIM system and may be used by CarePods for both the individual treatment of the patient - as well as for the aggregation of such data across numerous patients.
  • the TIM system may comprise a number of different modules - designed to create tools for the designer to manage the TIM system.
  • Such modules will now be discussed herein and may comprise: (1) Create Instrument Module - for the creation of data structures and forms for the capture of data from various medical instruments and/or devices; (2) Create Treatment Plan Module - for the creation of therapeutic treatment protocols; (3) Send Reminder Module - for the creation of a reminder system for patients who are involved in a treatment protocol; and (4) Capture Data Module - for the effective capture of medical data from the patient and any medical device involved in the treatment protocol.
  • Figure 18 depicts a module for the creation and/or integration of the data from such instruments, possibly by the creation of electronic forms and/or templates that capture the metadata of such instruments and/or devices.
  • Instrument designer module 1802 e.g., via a Ul 1808 allows the healthcare professionals to create templates for instruments - and their associated medical data that they generate - to be populated electronically and stored in online library in the patient's CarePod.
  • the instrument designer allows the author to select from a rich set of data capture attributes that can be included in the instruments, possibly with built-in data validations.
  • Process 1814 may be used by the designer to create such forms and/or templates - by adding one or more fields and/or data structures, as desired. It will be appreciated that process 1814, as shown, is merely given as one example of such a process - and that other fields and/or data structures may be appended to the process, as appropriate and/or as desired to adequately capture the medical data. Examples of such field additions may include: Add Entry Item 1816 (e.g. text, numeric data, date or the like), Add Rating Scale with weights 1820 (e.g., for the capture of possibly subjective data from the patient); Add Multiple Choice fields 1822 and 1824 (e.g. for whatever purpose desired by the designer to capture relevant clinical data); Add Matrix of Choice 1826 (e.g. for another manner of capturing relevant data).
  • Add Entry Item 1816 e.g. text, numeric data, date or the like
  • Add Rating Scale with weights 1820 e.g., for the capture of possibly subjective data from the patient
  • Smart Attribute 1818 may be available from Smart Attribute Module 1804 and an associated database 1810.
  • Smart Attributes allow the designer to construct Instruments, Forms, Tags, etc. for use within CarePods that may standardize data attributes and limit them to a potentially finite and common list.
  • These Smart Attributes may affect the ability to conduct Big Data analysis (as described below). For example, it may be possible to have a Smart Attribute called Pertinent History, and that attribute will have a list of value of the Category: Disease and Conditions. This may be synchronized with the Unified Medical Language System from NIH.
  • Figure 19 depicts one embodiment of a Create Treatment Plan Module that might allow a caregiver the ability to create a treatment plan (therapeutic or otherwise) for either a single patient in a CarePod, or a Plan template to be used by other caregivers for other patients in other CarePods.
  • Treatment plans tend to address a particular condition of a patient that may respond to therapy. It will be appreciated that the notion of treatment plan and condition for treatment may be considered broadly.
  • the condition may be a disease condition, a congenital condition, a mental condition or any other possible condition of a patient for which treatment plans may have efficacy.
  • Caregiver may use Treatment Plan module 1902 (e.g. via a Ul 1914) - and may access any number of possible other modules and/or databases to aid the creation of such a Plan.
  • Process 1924 may employ one or more modules to create such a Plan.
  • the creator may Add Guidance data item 1926, Add Medication data item 1928, Add Monitor data item 1930 (e.g., data and/or metadata about blood pressure monitor or glucose monitor, or other Instrument), Add Todo data item 1932 (for providing a checklist or other guidance).
  • These data items may be optionally added to the Plan (i.e. treatment plan template for the patient being treated for a condition).
  • a guidance data item may be an informational data item for the patient regarding the condition and treatment thereof.
  • the guidance data item may be any form of media possible or desired to
  • Treatment Plan module may request forms and/or templates that aid to capture, collect and/or collate data from any instrument, device or biosensor that may have relevant data to collect regarding the treatment (and the efficacy thereof) of the patient.
  • the creator and/or caregiver may consult a CarePod Members module 1906 and its associated database 1918 - to provide a list of CarePod Members for which are authorized to interface with the CarePod for a particular patient and his/her Plan.
  • the system may reduce the list of CarePod Members to only those who are both CarePod Members and are relevant to the treatment plan itself.
  • the creator and/or caregiver may employ Add Reminder module 1936 - to provide a scheduled reminder to the patient and/or caregiver for follow-up on treatment and status.
  • the creator and/or caregiver may Create Treatment Plan and release it to CarePod Treatment Plan module 1908 and its associated database 1920.
  • the creator and/or caregiver may Create Reminders and release to Reminders module 1910 and its associated database 1922 a set of reminders to patients, caregivers and/or relevant CarePod Members of treatment events that are incorporated into the treatment plan.
  • the creator and/or caregiver may Create Member Access List - to the Member Access module 1912 - to ensure secure and authenticated Plan communications are accurately disseminated to the correct entities.
  • Figure 20 depicts one embodiment of a Send Reminders Module.
  • This module takes the items that have a reminder and send notifications based on the methods specified -- e.g through email, push notifications in the mobile devices or SMS. It also presents the data capture instruments to users and stores the information in the database.
  • CarePod Treatment Plan module 2002 and/or its associated database 2012 may send a Treatment Plan Item to Notifier Module 2004 at 2018.
  • Treatment Plan Item may comprise data and/or metadata regarding the patient's treatment plan.
  • data and/or metadata may be the entire treatment plan itself or may be a subset of treatment plan data and/or metadata that is relevant to treatment events.
  • Notifier Module 2004 may read a Reminder Schedule - which may be received from Reminders module 2006 and its associated database 2014.
  • Notifier Module may read the Access List (at 2020) from Member Access module 2008 and its associated database 2016.
  • the Access List may comprise members who are in the patient's CarePod and are to be reminded of treatment events within the patient's treatment plan.
  • Notifier Module 2004 may read Notification Preferences from Member Profile module 2010 - which may list the preferred manner in which a member may desire to receive one or means of reminder communications. It will be appreciated that in other embodiments Member profiles may be included in the Member Access List.
  • Notifier Module 2004 may then Sent Reminders (e.g., at 2024) to Members regarding certain treatment events with a patient's treatment plan. As depicted, members may receive scheduled reminders of treatment via email, push notification, SMS or any other suitable means of communication.
  • FIG. 21 Another possible module in an embodiment of the present application might be Capture Data Module, as depicted in Figure 21.
  • CarePod Treatment Plan 2102 and its associated database 2114 may monitor medical data from an instrument and/or device associated with the treatment plan.
  • the forms and or data structures for the storage and management of data and/or metadata from such an instrument may have been created by Instrument module 2104 (via a Ul 2116).
  • CarePod Treatment Plan module may send a monitor request to such Instrument module.
  • the Instrument module may read the Treatment type and acquire an Access List of Members from Member Access module 2106 and its associated database 2118.
  • the Instrument module may acquire the forms and/or templates to capture relevant medical and/or clinical data from Instrument Database module 2108 and its associated database 2120.
  • Instrument module 2104 may acquire actual medical and/or clinical data from User/Device 2110. Instrument module may then store the response to the Treatment Plan into a Response Database 2112. [000182] This data may be used in a two-fold manner subsequently. First, it is possible to tell how well an individual patient is responding to his/her treatment plan. From that information, caregivers may be able to alter the Treatment Plan during its course. Secondly, this data may be aggregated together over a large patient population and be used to discern the overall efficacy of the Treatment Plan - and possibly use it for predictive measures for success of a treatment plan for a given patient.

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US13/096,887 US20120278101A1 (en) 2011-04-28 2011-04-28 System and method for creating trusted user communities and managing authenticated secure communications within same
US13/449,808 US20120278103A1 (en) 2011-04-28 2012-04-18 System and method for uploading and securing health care records to trusted health-user communities
US13/450,138 US20120278095A1 (en) 2011-04-28 2012-04-18 System and method for creating and managing therapeutic treatment protocols within trusted health-user communities
US13/449,972 US20120277543A1 (en) 2011-04-28 2012-04-18 System and method for uploading and securing health care data from patients and medical devices to trusted health-user communities
PCT/US2012/034498 WO2012148817A2 (en) 2011-04-28 2012-04-20 Systems and methods for creating and managing trusted health-user communities

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