EP2702549A2 - Systems and methods for creating and managing trusted health-user communities - Google Patents

Abstract

Systems and methods of creating trusted communities of users and managing communications by and between said trusted users are disclosed. In one embodiment, a system is depicting implementing a medical treatment plan for a set of patients wherein said communications between users, such as physicians and patients, are secure, HIPAA-compliant and sufficiently versatile to enable such communications via known networking infrastructure.

Description

SYSTEMS AND METHODS FOR CREATING AND MANAGING TRUSTED HEALTH-

USER COMMUNITIES

BACKGROUND

[0001] Today, the field of healthcare is governed by a set of stringent laws and regulations. One such law is the Health Insurance Portability and Accountability Act (HIPAA). HIPAA was enacted by the U.S. Congress in 1996. Title II of HIPAA requires a set of national standards for the maintenance of certain healthcare related electronic transactions. As a result, the Department of Health and Human Services (HHS) has promulgated a set of "Rules" to implement the requirements of Title II. These five Rules are: the Privacy Rule, the Transaction and Code Sets Rules, the Security Rules, the Unique Identifiers Rule and the Enforcement Rule.

[0002] The Privacy Rule provides for the use and maintenance of

Protected Health Information (PHI). PHI is generally any information that pertains to the health and care of individual patients that may be held by "covered entities". Such covered entities may include a variety of Health Care Providers ("HCPs") - e.g. hospitals, insurance companies, pharmacies, doctors, doctor groups and the like.

[0003] As the Privacy Rules provide for the security and privacy of such PHI, HCPs (such as hospitals) 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.

[0004] Therefore, HCPs have adequate incentive to provide

authenticated, secure, HIPAA-compliant means of communication that enforce stringent HCP policies regarding communications between patients and HCPs and the maintenance of a complete set of electronic health records ("EHRs") and/or electronic medical repositories ("EMRs") that might result from such communications.

SUMMARY [0005] 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.

[0006] In another embodiment, 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

associated with the care pod. If extracted information and patient information do not match, an error flag may be sent.

[0007] Other features and advantages of the present system are presented below in the Detailed Description when read in connection with the drawings presented within this application.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] 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.

[0009] Figure 2 depicts the concept of a social pod as made in accordance with several of the present embodiments.

[00010] Figure 3 shows a flow chart of one embodiment of creating and authenticating a social pod within the context of a medical application.

[00011] Figure 4 is a high level block diagram of a system architecture built according to the principles of the present application. [00012] 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.

[00013] Figure 6 is one embodiment of a present system as built and hosted using existing network infrastructure.

[00014] Figures 7A and 7B show one embodiment of a present system as built for the treatment of PTSD for returning military veterans.

[00015] 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.

[00016] Figure 9 depicts one embodiment of a screen shot showing the functionality of a treatment plan set up for a patient by a physician.

[00017] 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.

[00018] 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.

[00019] 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.

[00020] 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.

[00021] Figure 14 depicts conventional methods where patient medical and/or physiological data is send from a medical device to the patient's caregivers. [00022] 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.

[00023] 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.

[00024] 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.

[00025] 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.

[00026] Figure 19 is one embodiment of a system and/or method for creating a treatment plan for a patient having a condition.

[00027] Figure 20 is one embodiment of a system and/or method of setting reminders to patients and caregivers during the course of a treatment.

[00028] 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.

DETAILED DESCRIPTION

Introduction

[00029] As hospitals and other HCPs promulgated internal regulations in response to the requirements of laws and regulations of HIPAA, one

embodiment of the present invention 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. [00030] In one embodiment, 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

interactions are compliant to federal, state and their own non-governmental (e.g. university, corporate or the like) privacy and security requirements. The present system should also be flexible to allow users (i.e. HCPs, issue groups or the like) to create specific on-line communities to address particular

conditions, diseases or other health-related conditions or issues.

[00031] In another aspect of the flexibility, 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.

[00032] In one aspect, it is desirable to construct the present system in a versatile manner. For example, 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. As literally hundreds of millions of Facebook, Linkedln and Twitter users already know how to use social networking technology, the present system

incorporates a suite of easy-to-use social networking functions, including audio and video blogging, text messaging and video chats, within a HIPAA-compliant online platform. This, in turn, greatly expanding the ability to connect clinical services to patients (and research studies to research subjects) in novel ways, remotely, cost-effectively, synchronously and asynchronously.

[00033] In addition, it is desirable that 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.

[00034] In addition to the features listed above, it may also be desirable that the present system include other contemporary technologies to improve the user experience. For example, 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.

Trusted Communities and/or Social Pods

[00035] In one possible aspect, the present embodiment may require that the physician communicate with a patient who is authenticated at the time of communication to the patient. In addition, the system stores and/or otherwise archives the interaction between the physician and the patient to form a part of the latter's EHR.

[00036] In another possible aspect, 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.

[00037] 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.

[00038] Each of the users 102 represent entities that may have known communication and computing devices (not shown) in order to affect a networked environment. For example, 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. It will be appreciated that the present system encompasses the use of all known devices and means of networked communication that would facilitate the present system as described herein.

[00039] The present system may also allow for easy dynamic management of the social pod. For example, the present system may allow for the addition and/or deletion of members in a seamless manner. To appreciate the flexibility of communities that the present system could enable, trusted communities might comprise one, two, or any number of members depending on their specific purpose. For mere exemplary purposes, communities may consist of:

- a single member using a self-directed therapeutic intervention

- doctor + doctor

- doctor to pharmacy

- doctor to health insurance agent, e.g., for utilization review

- doctor + patient

- doctor + patient + family

- doctor + entire care team

- patient + entire care team

- doctor + multiple patients or multiple families

- research team

- research team + participants - wellness program enrollees medical-educational program enrollees

[00040] The identity of every participant in a community may be

authenticated using one or more conventional identity authentication methods each time the member signs on to the community or accesses a content file. 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.

[00041] Communities may be moderated, or self-directed. One or more moderators may oversee some types of programs, being able, for example, to add new members, remove objectionable content, and update content files. Other types of programs may be completely unsupervised and self-directed.

[00042] Because the present system may ensure HIPAA privacy and security compliance, communications and medical records that contain personal health information may be shared among members of the

community, synchronously and asynchronously, online and on tablets and mobile phones.

[00043] In addition to setting up and populating trusted communities, the present system may use a number of technical strategies to pre-set and enforce access rights to ensure the privacy of communications, and

appropriately limit access to certain files. Easy-to-use and redundant methods assure that the moderator(s) exercise complete and dynamic control over which communications and medical records, or parts thereof, are available to everyone, and which are available only to a certain subset of the community.

[00044] 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.

[00045] For example, system 100 may provide the following: (1) establish networked infrastructure for programs for health, education, prevention, wellness, treatment and/or research (104);

(2) enable automated and/or distributed funding of programs from donors, granting organizations, payors and private payors (106);

(3) establish micro social networks of trusted relationships around the program;

(4) run programs through engagement and interactions over networks (e.g. intranets, the internet or the like) and mobile devices; and

(5) analyze de-identified data that flows through system 100 and optimize programs that are made in accordance with the present system (112) .

[00046] 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. For example, 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. In addition, 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.

[00047] System 100 may be employed to create a networked

"microcommunity" of users -- a construct called a "social pod". Figure 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. In one

embodiment, 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.

[00048] Figure 3 depicts one embodiment of a method of creating a social pod. In this embodiment, 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.

[00049] 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

management. At 312, the system (via social pod 308 or the like) creates the new "Care" pod and adds patient 306 as a pod member, pending

authentication. 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.

[00050] 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.

[00051] Additional authentication means may optionally be set up, as desired. For example patient 306 may set up a voice recognition match for further authentication at 320, back to module 302. As time goes forward, patient 308 is then considered a trusted user and may access the pod with suitable credentials at 322.

[00052] In one embodiment, 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.

System Architecture

[00053] Having described one aspect of the present system - i.e. the notion of trusted users and the social pod, one or more suitable architecture embodiments for the construction of the present system will now be described. In addition, it will be shown how one embodiment of the present system may leverage existing internet and other infrastructures for efficient build-out of the present system. [00054] Figure 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.

[00055] 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.

[00056] 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.

[00057] 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.

[00058] 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.

[00059] 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.

[00060] 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.

[00061] 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. With 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. In addition, content files may be streamed and transmitted over secure, encrypted protocols and designed to be accessible from anywhere on the globe.

[00062] Figure 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.

[00063] This file or data may be queued for further processing at 522 and/or 524, if needed. If the file or data is a form of a document (e.g. office, pdf, etc.), then 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.

[00064] At 526, transcoding engine 508 may then send the processed data/file to storage (perhaps over SSL) at 528. In addition, 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.

[00065] Over time, 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.

[00066] One embodiment of code that implements an anicaport is shown immediately below. It will be appreciated that many different

implementations are possible and are contemplated within the scope of the present invention.

anicaport / app / controllers

accounts controller.rb application_controller.rb

documents_controller.rb anicaport / app / models

account, rb

document.rb

user.rb

Source Code

app/models/account.rb

include ApplicationHelper

class Account < ActiveRecord::Base

has_many :documents, dependent => :destroy validates :account_name, :presence => true after_create :create_aws_objects def create_aws_objects

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id,

:secret_access_key => aws_secret_access_key

)

AWS::S3::Bucket.create("#{self.account_name}")

AWS::S3::S30bject.store("crossdomain.xml",

open("#{Rails.root.join("lib/crossdomain.xml")}"), self.accountjname, :access => :public_read)

AmazeSNS.akey = aws_access_key_id

AmazeSNS.skey = aws_secret_access_key

AmazeSNS["#{self.account_name}"].create

AmazeSNS["#{self.account_name}"].subscribe({:endpoint=>"#{anicaport _protocol}://#{anicaport_host_name}/accounts/processfiles", :protocol => "#{anicaport_protocol}"})

end end

app/models/document.rb

include ApplicationHelper

class Document < ActiveRecord::Base

belongs_to :account

validates :account, :presence => true

validates :document_name, :presence => true after_create :processandsend def reprocess

self.processed = false

self.save doc_dir = self.document_dir

file_basename = self.document_name.split('.').first

file_extension = self.document_name.split('.').last

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id,

:secret_access_key => aws_secret_access_key

)

if AWS::S3::S30bject.exists?

"#{doc_dir}/#{file_basename}/original/#{file_basename}.#{file_extensio n}", "#{self.account.account_name}"

AWS::S3::S30bject.copy

"#{doc_dir}/#{file_basename}/original/#{file_basename}.#{file_extensio n}", "#{self.document_name}'\ "#{self.account.account_name}" end

processandsend

end def processandsend

#connect to s3

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id, :secret_access_key => aws_secret_access_key

)

if AWS::S3::S30bject.exists? "#{self.document_name}'\

"#{self.account.account_name}"

begin

#start proessing file

doc_dir = self.document_dir

file_basename = self.document_name.split('.').first

file_extension = self.document_name.split('.').last

account_dir =

Rails. root.join("public/system/#{self.account.account_name}/").to_s processing_dir = "#{account_dir}#{file_basename}/"

original_file_path =

"#{processing_dir}original/#{self.document_name}" command "mkdir #{account_dir}" if File.exists?(account_dir) == false

command "mkdir #{processing_dir}" if File.exists?(processing_dir) == false

command "mkdir #{processing_dir}original/" if

File.exists?("#{processing_dir}original/") == false

command "mkdir #{processing_dir}processed/" if

File.exists?("#{processing_dir}processed/") == false

command "mkdir #{processing_dir}thumbnail/" if

File.exists?("#{processing_dir}thumbnail/") == false

command "mkdir #{processing_dir}tmp/" if

File.exists?("#{processing_dir}tmp/") == false

#download file

open(original_file_path, "w") do | file |

AWS::S3::S30bject.stream("#{self.document_name}'\

"#{self.account.account_name}") do | chunk |

file.write chunk

end

end #if video

if is_video?(file_extension)

command "ffmpeg -i #{original_file_path} -acodec libfaac -ab 96k - vcodec Iibx264 -vpre slow -erf 22 -threads 0

#{processing_dir}processed/#{file_basename}.flv"

command "ffmpeg -i #{original_file_path} -vcodec png -vframes 1 -an -f rawvideo -s 320x240 #{processing_dir}tmp/#{file_basename}.png" make_thumbnail "#{processing_dir}tmp/#{file_basename}.png", "#{processing_dir}thumbnail/#{file_basename}.png", 1

File.open("#{processing_dir}processed/pagecount.txt", "w") do m

f.write("l")

end

toamazon("#{doc_dir}/#{file_basename}/processed/pagecount.txt", "#{processing_dir}processed/pagecount.txt") toamazon("#{doc_dir}/#{file_basename}/processed/#{file_basename}.flv ", "#{processing_dir}processed/#{file_basename}.flv") toamazon("#{doc_dir}/#{file_basename}/thumbnail/#{file_basename}.p ng'\ "#{processing_dir}thumbnail/#{file_basename}.png")

#if image

elsif is_image?(file_extension)

command "convert #{original_file_path}

#{processing_dir}processed/#{file_basename}.png"

make_thumbnail

"#{processing_dir}processed/#{file_basename}.png",

"#{processing_dir}thumbnail/#{file_basename}.png", 1

File.open("#{processing_dir}processed/pagecount.txt", "w") do m

f.write("l") end

toamazon("#{doc_dir}/#{file_basename}/processed/pagecount.txt", "#{processing_dir}processed/pagecount.txt") toamazon(''#{doc_dir}/#{file asename}/processed/#{file_basename}.p ng'\ "#{processing_dir}processed/#{file_basename}.png") toamazon(''#{doc_dir}/#{file asename}/thumbnail/#{file asename}.p ng'\ "#{processing_dir}thumbnail/#{file_basename}.png")

#if office

elsif is_office?(file_extension)

ConvertOffice::ConvertOfficeFormat.new.convert(original_file_path,

"#{processing_dir}tmp/#{f ile_basenamej.pdf")

command "pdf2svg #{processing_dir}tmp/#{file_basename}.pdf

#{processing_dir}processed/%d.svg all"

@files = Dir.glob("#{processing_dir}processed/*.svg")

File.open("#{processing_dir}processed/pagecount.txt", "w") do m

f.write("#{@files.count}")

end

@files.count.times do | i |

command "convert -density 300x300 -resize 1130x989 -quality 90 #{processing_dir}tmp/#{f ile_basenamej.pdf [#{i}]

#{processing_dir}processed/page-#{i}.png"

end

make_thumbnail

"#{processing_dir}tmp/#{file_basename}.pdf[0]",

"#{processing_dir}thumbnail/#{file_basename}.png", @files.count toamazon(^l'#{doc_dir}/#{file_basename}/processed/pagecount.txt¹', "#{processing_dir}processed/pagecount.txt")

for file in Dir.glob("#{processing_dir}processed/*.svg") toamazongzip(^l'#{doc_dir}/#{file asename}/processed/#{file.split('7^l').l ast}", "#{file}")

end

for file in Dir.glob("#{processing_dir}processed/*.png") toamazon("#{doc_dir}/#{file_basename}/processed/#{file.split("/").last}"

, "#{file}")

end toamazon(^l'#{doc_dir}/#{file_basename}/thumbnail/#{file_basename}.p ng'\ "#{processing_dir}thumbnail/#{file_basename}.png")

#if pdf

elsif file_extension == 'pdf

command "pdf2svg #{original_file_path}

#{processing_dir}processed/%d.svg all"

@files = Dir.glob("#{processing_dir}processed/*.svg")

File.open("#{processing_dir}processed/pagecount.txt", "w") do

| f |

f.write("#{@files.count}")

end

@files.count.times do | i |

command "convert -density 300x300 -resize 1130x989 -quality 90 #{original_file_path}[#{i}] #{processing_dir}processed/page-#{i}.png" end

make_thumbnail "#{original_file_path}[0]'\

"#{processing_dir}thumbnail/#{file_basename}.png", @files.count ΐθ3 ηΊ3ζοη(^,'#{άοε_ά ί Γ}/#{ίΝθ_ 35θη3 Γηθ}/ρΓοεθ55θά/ρ3 θεουηΐ.ΐχΐ^,', "#{processing_dir}processed/pagecount.txt")

for file in Dir.glob("#{processing_dir}processed/*.svg") toamazongzip(''#{doc_dir}/#{file_basename}/processed/#{file.split('7^,').l ast}", "#{file}")

end

for file in Dir.glob("#{processing_dir}processed/*.png") toamazon(^,'#{doc_dir}/#{file_basename}/processed/#{file.split(^,7^,').last}^,'

, "#{file}")

end toamazon("#{doc_dir}/#{file_basename}/thumbnail/#{file_basename}.p ng'\ "#{processing_dir}thumbnail/#{file_basename}.png") end

AWS::S3::S30bject. rename "#{self.document_name}",

"#{doc_dir}/#{file_basename}/original/#{file_basename}.#{file_extensio n}", "#{self.account.account_name}"

AmazeSNS.akey = aws_access_key_id

AmazeSNS.skey = aws_secret_access_key

@topic = AmazeSNS["#{self.account.account_name}"]

@topic. create

@topic.publish("#{self.document_name}'\ "File Processed at #{self.account.account_name}/#{doc_dir}.") self.processed = true

self.save

rescue Exception => e

AmazeSNS.akey = aws_access_key_id

AmazeSNS.skey = aws_secret_access_key @topic = AmazeSNS["#{self.account.account_name}"]

@topic. create

@topic.publish("#{e. message} => #{self.document_name}'\ "File Processing Failed at #{self.account.account_name}/#{doc_dir}.") self.processed = false

self.save

end command "rm -rf #{processing_dir}" if self.processed

end end

handle_asynchronously :processandsend def deletefile(uuid, count)

begin

bucket_name = self.account.account_name

doc_dir = self.document_dir

#delete thumbnail

delete_from_s3 "#{doc_dir}/#{uuid}thumbnail/#{uuid}.png", bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}thumbnail'\ bucket_name

#delete processed

count.to_i.times do | i |

page_no = i + 1

delete_from_s3 "#{doc_dir}/#{uuid}/processed/page- #{page_no}.png", bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}/processed/#{page_no}.svg", bucket_name

end

delete_from_s3 "#{doc_dir}/#{uuid}/processed/#{uuid}.svg", bucket_name delete_from_s3 "#{doc_dir}/#{uuid}/processed/#{uuid}.png", bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}/processed/#{uuid}.flv", bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}/processed/pagecount.txt", bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}/processed'\ bucket_name

#delete orifinal

delete_from_s3

''ttido^dirVttiuuidJoriginal/ttiself.documen^name}¹', bucket_name

delete_from_s3 "#{doc_dir}/#{uuid}original'\ bucket_name delete_from_s3 "#{doc_dir}/#{uuid}'\ bucket_name self.destroy

rescue Exception => e

AmazeSNS.akey = aws_access_key_id

AmazeSNS.skey = aws_secret_access_key

@topic = AmazeSNS["#{self.account.account_name}"]

@topic. create

@topic.publish("#{e. message} => #{self.document_name}'\ "File Deleting Failed at #{self.account.account_name}/#{doc_dir}.")

end

end

handle_asynchronously rdeletefile private

def make_thumbnail(source, destination, number_of_page)

if number_of_page>l

command "convert #{source} -thumbnail 80x80 -bordercolor white - border 3 -bordercolor grey60 -border 1 -bordercolor none -background none \\( -clone 0 -rotate ^"convert null: -format '%[fx:rand()*30-15]' info:^" \\) \\( -clone 0 -rotate ^"convert null: -format '%[fx:rand()*30-15]' info:^" \\) \\( -clone 0 -rotate ^"convert null: -format '%[fx:rand()*30-15]' info:^" \\) \\( -clone 0 -rotate Convert null: -format '%[fx:rand()*30-15]' infof \\) -delete 0 -border 100x80 -gravity center -crop 200x160+0+0 +repage -flatten -trim +repage -background black \\( +clone -shadow 60x4+4+4 \\) +swap -background none -flatten #{destination}"

else

command "convert #{source} -thumbnail 80x80 -bordercolor white - border 3 -bordercolor grey60 -border 1 -bordercolor none -background none -rotate -0 \\( +clone -shadow 60x4+4+4 \\) +swap -flatten

#{destination}"

end

end

def toamazon(to,from)

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id,

:secret_access_key => aws_secret_access_key

)

AWS::S3::S30bject.store(to, open(from), self.account.accountjname, :access => :private)

end

def toamazongzip(to,from)

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id,

:secret_access_key => aws_secret_access_key

)

strio = Stringl0.open('\ 'w')

gz = Zlib::GzipWriter.new(strio)

gz.write(open(from).read)

gz. close

AWS::S3::S30bject.store(to, strio.string, self.account.accountjname, :access => :private, "Content-Encoding" => 'gzip' )

end

def delete_from_s3(file, bucket)

AWS::S3::Base.establish_connection !(

:access_key_id => aws_access_key_id,

:secret_access_key => aws_secret_access_key )

AWS::S3::S30bject.delete file, bucket if AWS::S3::S30bject.exists? file, bucket

end

def is_image?(file_extension)

extensions = %w{jpg jpeg gif png tiff bmp}

extensions. include?(file_extension.downcase)

end

def is_office?(file_extension)

extensions = %w{odt sxw rtf doc txt html wiki docx ods sxc xls csv tsv html xlsx swf odp sxi ppt html pptx}

extensions. include?(file_extension.downcase)

end

def is_video?(file_extension)

extensions = %w{flv m4v mov wmv mp4}

extensions. include?(file_extension.downcase)

end

def command (str)

logger.info str

system str

end

end

System Infrastructure

[00067] While the architecture of the present system presents one embodiment for the various modules that may be desirable in such a system, 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.

[00068] 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.

[00069] 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.

[00070] In one embodiment, 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.

[00071] In operation, 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. In addition, 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.

Example of Use and Operation [00072] Having described possible architectures and build-out of the present system, it will now be described the uses and operation of an exemplary system, built in accordance with the principles of the present invention.

[00073] 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.

[00074] In this embodiment, various users may be in communication with other users via and through the present system itself. For example, 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.

[00075] In this example, 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.

[00076] In following-up, 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.

[00077] In Figure 7B, 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. In addition, 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.

streamable content. [00078] 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. Lastly, physician 702 may review charts and trends of patient 704 at 752.

De-Identification

[00079] One possible useful feature of a system made in accordance with the principles of the present invention might be the unlinking of patient data from the positive identification of the patient herself. As HIPAA requires that PHI be disseminated in a controlled fashion, Figures 8A and 8B depict one embodiment of such a de-identification module.

[00080] As noted above, various users of the social pod may be

communicating with other users or the system via its interfaces. In this example, physician 802 may be communicating with social pod/system 804. 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.

[00081] At 810, physician may post a message or a response to the social pod. Such a message, as noted above, 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. At 812, such information passed to the social pod 804 may be captured by de-identifier 806. In the case of text at 814, 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.

[00082] In the case of voice at 818, 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.

[00083] 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.

[00084] In one embodiment, 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. In these cases, 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.

Therapeutics

[00085] The present system may also provide a more comprehensive and high engagement support system for better compliance with a therapeutics module. For example, 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.

[00086] Figure 9 shows an exemplary screen shot 900 of such a

therapeutics interface/module, as may be presented on a web browser or the like. 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).

[00087] In addition, accessible content may be made available through this interface at 908. In this example, 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.

Donations and Payments

[00088] Another aspect of a present system might be a donation and/or payment module that improves the flow of donations and/or payments for programs implemented to address needs of a given social pod. For example, Figure 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.

[00089] 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

Facebook or any other social media or outlet at 1012 - or market directly to donors. Donors 1004 may receive such marketing at 1014 and pledge some amount at 1016 - via the present system. In addition, 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. To keep the donors informed and engaged, 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.

Overview of Uploading Documents to a Pod [00090] The various embodiments of "Pods" (e.g., "CarePods", "SocialPod" and the like - the terms may be used interchangeably) described herein (and as further depicted in Figures 1-10) create a unique place (e.g., in the "cloud") that unifies communication and tools needed to coordinate, manage and provide care to a patient. 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. Several embodiments of the present application herein provide users of CarePods with systems and methods of sharing paper documents by and between these users.

Embodiments of Paper Records Upload and Sharing to CarePods

[00091] In reference to the discussion below regarding Pods and CarePods (and as further discussed in reference to Figures 1-10), it will now be described various embodiments of the uploading and sharing of paper documents into CarePods.

[00092] 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 (Sender 1202) 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.

[00094] At 1208, 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.

[00095] 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. Such

communication module would be configured to receive such requests for uploading an image file.

[00096] Once such a request for uploading is received by the CarePod, systems and/or methods are affected to securing upload such image files, correctly associated with the individual associated with the CarePod. In one embodiment, 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.

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.

[00098] At 1216, CarePod may queue the incoming facsimile or other electronic transmission - and a sequence of other, optional, steps may then take place. For example, 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.

[00099] Once the QR code (or any other suitable identifier and/or watermark) is extracted, 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.

[000100] Once the image file has been properly stored in the CarePod's database for a particular patient and/or individual, other member's of the patient's and/or individual's CarePod may view the image file from whatever browser and/or device that is allowable on the CarePod at 1222. Of course, there may be a finer granularity of which particular CarePod members may have access to any particular image file - the rules of authorization and authentication possibly being controlled by the CarePod.

Automatic Extraction and/or Verification

[000101] Once 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.

[000102] Figure 13 depicts a flowchart for such an automated extraction and optional verification. 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.

[000103] At 1314, 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.

[000104] If the metadata falls within the parameter of expected data (e.g. by matching a threshold of expected data, and possibly based on statistical data, heuristics or other rule-based tests), then 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.

[000105] If the patient information matches at 1318, then 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. [000106] Alternatively, if the patient information does not match at this point - or if any other anomaly occurs - extractor/verifier 1304 may set a flag that a problem may have occurred at 1324. As an optional protective measure, 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.

Embodiments of Real-Time Data Upload to and Sharing Within CarePods

[000107] 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.

[000108] 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). In the top path, 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. In the bottom path, 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) may be entered thereafter to the patient's record.

[000109] 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.

[000110] In one embodiment, 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.

[000111] In one embodiment, 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.

[000112] As mentioned, 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,

communications port or the like) or a hand-held device (e.g., a phone, smart device or the like).

[000113] In one embodiment, 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. Through such paired communication modules 1508 and 1510, 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

standardized format and possibly in an encrypted format. 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.

[000114] From the communication module 1514, 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).

[000115] 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.

[000116] In other embodiments, it may be possible to utilize data that is de- identified (that is, scrubbed of any identifying indicia of linking the medical data to an individual patient). Such 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.

[000117] As mentioned, once the data is uploaded to a patient's CarePod (and possibly in substantially real-time), doctors 1522 and/or care givers 1524 may analyze the data and make treatment decisions in response (e.g. in substantially real-time). In such a case, 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.

Embodiment to Prevent Accidental Misdirection of Data

[000118] In one embodiment of the present application, 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.

[000119] In one scenario, 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.

[000120] In the present embodiment, 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.

[000121] 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. Such 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.

[000122] At 1616, communication module 1604 may update device 1602 with the GUID. In addition, 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

communications with the CarePod.

[000123] At 1618, medical data sensed by device 1602 may be

communicated to communication module 1604. 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.

Embodiments Comprising Therapeutic Treatment

[000125] In many medical situations, patients are admitted to hospital services under substantially emergency conditions. In such cases, key medical data about the patient may often not be accessible during these emergent admissions (e.g., trauma and ICU). In many embodiments of the present application, 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.

[000126] In this scenario, 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. In one embodiment, doctors may be able to utilize this data (possibly de-identified if desired) for research studies. In another embodiment, 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.

[000127] In other embodiments, 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. [000128] 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).

[000129] Deep brain stimulation (DBS) 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

modulates local and general brain function. Primarily, motor function may be improved in Parkinson's patients, but new studies seem to indicate that severe depression may show benefits as well as possible cognition improvements in Alzheimer's. Patients have been noted to show improvements from deep coma as well.

[000130] In one application, DBS in children may suffer from motor dyskinesias (abnormal jerky motor movements) as a result of perinatal strokes (eg. Cerebral palsy). Once children are properly selected for surgery (e.g., they have severe motor abnormalities and/or speech disabilities that greatly impact their activities of daily living), they may undergo a procedure for DBS electrode placement. After surgery, 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).

[000131] In one embodiment, it may be possible to transmit the data of charge settings back and forth through a radio device 1710 to a mobile phone or other smart device and/or communications module 1706 as discussed above, then this data may be transmitted to a safe, HIPAA compliant cloud- based server in a manner such as disclosed herein.

[000132] Apart from the valuable data collection, it may be possible for a neurologist to make changes to the DBS setting remotely, and these changes may be sent via the cloud, to the patient's mobile device, which would then change the device settings on the child's device. This may be time saving and desirable as the care provider of the child may keep a substantially real-time diary and note improvements or worsening of motor function.

[000133] In addition, 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.

[000134] During this remote and automatic monitoring, it may be possible to include therapeutic steps that would be able to - with constantly

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.

[000135] 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.

[000136] It will be appreciated that other therapeutic treatments may be envisioned - e.g. other implantable devices could benefit from a closed loop approach. Devices monitoring arrthymias (e.g., Holter monitors) and cardiac pacemakers could also transmit data to the cloud via the above approach. In addition, it is possible to place DBS for epilepsy and create a closed loop system - whereby the wrist or ankle motion detectors may immediately sense abnormal motor discharge (as in a seizure) and then the DBS current may apply a different setting to attempt to dissipate or lessen the abnormal neural discharge, which would cause a generalized seizure to occur.

[000137]

Evidence-Based Analysis of Therapeutic Treatment

[000138] 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. Several embodiments of systems and methods are disclosed herein that affect the administering, monitoring, gathering evidence of healthcare interventions and making continuous improvement on intervention based on the evidence, possibly across large populations of patients

[000139] As described herein, it may be desirable to provide a system that allows healthcare providers the ability to test administer and do continuous improvements based on evidences for therapeutic intervention protocols. Such therapeutic treatments may have any number of clinical and non-clinical steps, and administered to one or many patients. It may also be desirable to streamline these activities, and to provide interactions and coordination required to administer them. Many embodiments herein affect the tracking of the efficacy of various interventions - whether in evidence-based medicine or translational medicine. In many embodiments, the concepts of the CarePod may provide the coordination, handoffs and the myriad of tools that may increase accuracy and decrease the cost to perform such analysis.

[000140] In addition, the framework of the CarePod may support and provide for a Therapeutic Intervention Management (TIM) system. 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) and these instruments 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.

[000141] In many embodiment, 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. In one embodiment, 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.

[000142] Often in current practice, clinical research & trials and the actual treatment of patients are not tightly integrated. In one embodiment, 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.

[000143] 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. Unlike existing enterprise applications such as EMR tools or clinical research databases, that tend to be silos of information and may be architecturally limited in its ability to scale, 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

[000144] There is increasingly demand for alternatives to hospital based, skilled nursing home-based, and doctors' office-based care services. Growth in the prevalence of alternative care services and facilities, e.g., home-based care services, visiting nurse and visiting aids services, home-based end-of-life care services, home-based maternity and neo-natal care, home-based stroke rehabilitation services, assisted living facilities, outpatient care programs, hospice centers, "step down" care facilities, transitional care facilities, and other home-based and alternative facilities-based services is being driven by many factors, including the aging baby boomer population's preferences for such services, and the critical need to reduce the overall cost of care services.

[000145] The expansion of these alternative care services is impeded by the inability of doctors and other care providers to monitor patients' medical conditions while the patients are outside of traditional care settings. Further, the adoption of such services is impeded by the inability of doctors and other care providers to collect, analyze and use data about patients' evolving medical conditions as the basis of better informed, faster, more personalized decisions about their patients' on-going treatment outside of traditional care settings.

[000146] Further, doctors and other care providers increasingly need to track the efficacy of therapeutic interventions for cost justification and other purposes. It is especially difficult to fulfill these outcome study requirements when patients are receiving their care outside of traditional care settings.

[000147] 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.

[000149] 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:

(i) Data emitted by medical devices and biosensors that are collected within the patient's CarePod;

(ii) Data queries that are delivered to, and responded to by the patient, his family members or other caretakers within the patient's CarePod;

(iii) Data that are contained in self-initiated reports submitted by the patient, his family members, or other caretakers within the patient's CarePod;

(iv) Data that are collected by mobile device applications and gathered within the patient's CarePod;

(v) Data that are gathered with the patient's CarePod about the patient's genomic, proteinomic, and metabonomic profiles from various sources.

[000150] The present embodiment may also enable the rapid analysis of data about a patient's medical condition. In addition, 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.

[000151] 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. For example, 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;

(ii) Order stronger pain medications for an end-of-life cancer patient based on his family member's report that the patient is experiencing increasing levels of pain; and

(iii) Prescribe a dietary prohibition based on metabolic profile data that relate to the patient's changing ability to metabolize particular foods.

[000152] 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. For example, 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.

[000153] 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. For example, 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.

[000154] Further, 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

[000155] In addition, since 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

intervention. For example, 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.

[000156] Further, 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.

[000157] As discussed herein, 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. Increasingly the health care community has felt the need for tracking the efficacy of their interventions whether in evidence based medicine or translational medicine. However the coordination, handoffs and the myriad of tools needed to do that effectively makes it cost prohibitive and is fraught with inaccuracies.

[000158] 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.

One Exemplary Embodiment

[000159] It will now be discussed one possible exemplary embodiment made in accordance with the principles of the present application. It should be appreciated that the present example is provided merely for its expository nature - and is not meant to limit the scope of the claimed invention herein.

[000160] In this example, it will be considered a simple intervention and the how that intervention is administered and managed using current processes and tools. Assume a hospital develops a "Post-Operative Discharge" intervention protocol that has the following steps spread over 6 weeks:

(1) Provide the patient and their family with a checklist of the steps to be followed.

(2) Provide the patient and their family with education material about the post-operative care.

(3) Medication management for the first 2 weeks. (4) Track of progress that requires them to capture in a form - e.g., their mood or blood pressure and/or blood glucose.

(5) Have a check-in appointment after 2 weeks.

(6) Continue medication management for another 2 weeks along with

tracking data.

(7) Have another check-in appointment after 4 weeks.

(8) Have a final appointment at 6 weeks.

[000161] In current and typical practice, patients are hand-delivered paper checklists which have the risk of getting lost. In addition, DVDs may be burned for videos if applicable and handed to patients. Medication management and compliance may be placed in the hands of the patient which risks a lack of compliance -- one of the key reasons for re-admissions. Side effects may not be tracked in real time. Timely escalation to physicians for adverse effects may or may not happen.

[000162] In addition, typical tracking of progress requires patients to capture in a form which may incomplete. Data capture may not be consistent because it is burdensome and patients may forget. This captured data is typically available to the physician only during the scheduled follow-up office visits. Check-in visits usually require a physical trip to the Hospital or a visit from the hospital, which tends to be time consuming and expensive. Paper reports have to collected, collated, filed and possibly manually entered into a database by the hospital staff

[000163] By contrast, 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.

[000165] 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.

Embodiment of Therapeutic Intervention Management (TIM) System

[000166] In one embodiment, 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.

Create Instrument Module

[000167] 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.

[000168] 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).

[000169] In addition to these fields, designers may desire to Add Smart Attribute 1818. Such a Smart Attribute 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. Thus, if one of the CarePod designers uses the Pertinent History smart attribute while customizing a Patient CarePod, or Creating a Patient Intake form, or a Clinical Trial Case Report form, or a Research project, then values, that may be entered, will conform to the standardized language used worldwide.

Create Treatment Plan Module [000170] 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.

[000171] 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, as depicted, may employ one or more modules to create such a Plan. For example, 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

disseminate the information.

[000172] As mentioned, other modules may be employed to aid in the Plan's construction. For example, the creator may access Instrument Database module 1904 and its associated database 1916 to access metadata forms (e.g. as may have been created using Create Instrument module, discussed above. In one embodiment, 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.

[000173] To implement a Plan, 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. In one embodiment, 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. In addition, 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.

[000174] If the Plan is complete, then the creator and/or caregiver may Create Treatment Plan and release it to CarePod Treatment Plan module 1908 and its associated database 1920. In addition, 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. Lastly, 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.

Send Reminders Module

[000175] 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.

[000176] In this embodiment, CarePod Treatment Plan module 2002 and/or its associated database 2012 may send a Treatment Plan Item to Notifier Module 2004 at 2018. Such Treatment Plan Item may comprise data and/or metadata regarding the patient's treatment plan. Such 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.

[000177] Notifier Module 2004 may read a Reminder Schedule - which may be received from Reminders module 2006 and its associated database 2014. In addition, 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. Further, 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.

[000178] From this set of metadata, 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.

Capture Data Module

[000179] Another possible module in an embodiment of the present application might be Capture Data Module, as depicted in Figure 21. In this module, 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).

[000180] In one embodiment, CarePod Treatment Plan module may send a monitor request to such Instrument module. In response, 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. In addition, 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.

[000181] Once this data and/or metadata has been received, 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.

Big Data Analytics

[000183] As discussed above, therapeutic interventions designed and administered through the systems and methods of the present application described herein may be aggregated and scaled to hundreds of thousands patients from the healthcare providers towards capturing and collating information. This creates a significantly large database of data also referred to as "Big Data". The tagging of data items using standard medical terminology in the Instrument Designer module makes it conducive to Big Data Analytics, which is currently a challenge of fragmented data capture and data

interpretation methods. Data collected in this fashion may make it possible to significantly accelerate the ability to gather information about the efficacy of an intervention, leading to quicker correction and refinement of intervention protocols.

[000184] A detailed description of one or more embodiments of the invention, read along with accompanying figures, that illustrate the principles of the invention has now been given. It is to be appreciated that the invention is described in connection with such embodiments, but the invention is not limited to any embodiment. The scope of the invention is limited only by the claims and the invention encompasses numerous alternatives, modifications and equivalents. Numerous specific details have been set forth in this description in order to provide a thorough understanding of the invention. These details are provided for the purpose of example and the invention may be practiced according to the claims without some or all of these specific details. For the purpose of clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the invention is not unnecessarily obscured.

Claims

CLAIMS:

1. A system for managing networked communications within a set of trusted users, the system comprising:

a communications module for enabling electronic

communications within said set of trusted users;

a directory of trusted users, said directory being capable of dynamically adjusting said set of trusted users of said system; and

a multimedia content module for the uploading of a plurality of multimedia content from said trusted users and the delivery of said multimedia content to said trusted users.

2. The system as recited in Claim 1 wherein said system further comprises a treatment program for a disease condition and further wherein said set of trusted users comprises physicians and patients involved in the treatment of said disease condition.

3. The system as recited in Claim 2 where said patients may upload multimedia content regarding said patient's treatment program; and

wherein further said multimedia content may be viewed by said patient's physician.

4. The system as recited in Claim 3 wherein said system further comprises:

a reminder and compliance module where said reminder and compliance module reminds said patient regarding scheduled treatments and records said patient compliance.

5. The system as recited in Claim 4 wherein said communication module further comprises an interface to accept secure and authenticated communications from said set of trusted users from a set of

communications messages, said communications messages comprising one of a group, said group comprising: text messages, voice messages, email messages, text chat messages and video messages.

6. The system as recited in Claim 5 wherein said system further comprises:

a transcoding module for processing said communication messages into an associated content format; and

a presentation module for presenting said associated content format in response to a request for content presentation from at least one of said trusted users.

7. The system as recited in Claim 2 wherein said system further comprises a payment module, said payment module is capable of receiving a pledged amount from a donor and further wherein said donor is capable of receiving program metrics regarding the effectiveness of said treatment.

8. A method for managing a secure communication set of trusted users in a computer network, said trusted users comprising a set of associated physicians and patients in a treatment program, the steps of said method comprising:

setting up a therapeutic program for at least one patient by an associated physician;

sending automatic reminder messages to said at least one patient regarding said patient's therapeutic program; and

receiving compliance and status messages from said at least one patient regarding said therapeutic program; and

alerting said associated physician automatically if said compliance and status messages from said at least one patient are over a given threshold condition.

9. The method as recited in Claim 8 where said method further comprises:

de-identifying personal information regarding at least one of said patients from messages received regarding said at least one of said patients.

10. The method as recited in Claim 9 wherein said step of de- identifying personal information further comprises: altering tonal parameters of voice if said patient leaves a voicemail message.

11. The method as recited in Claim 9 wherein said step of de- identifying personal information further comprises: altering facial parameters of an image if said patient leaves a video clip.

12. The method as recited in Claim 9 wherein said step of de- identifying personal information further comprises:

removing personal references in a text message to said patient if said text message contains personal references to said patient.

13. A computer readable medium, said computer readable medium being capable of being executed by a processor, said computer readable medium comprising a method further comprising computer executable instructions, the steps of said method comprising:

setting up a therapeutic program for at least one patient by an associated physician;

sending automatic reminder messages to said at least one patient regarding said patient's therapeutic program; and

receiving compliance and status messages from said at least one patient regarding said therapeutic program; and

alerting said associated physician automatically if said compliance and status messages from said at least one patient are over a given threshold condition.

14. The computer readable medium as recited in Claim 13 wherein said method further comprises the step of de-identifying personal information regarding at least one of said patients from messages received regarding said at least one of said patients.

15. A system for uploading image files to a CarePod, said image files associated with an individual for whom said CarePod is further associated, the system comprising:

a request communications module for receiving a request for uploading an image file from a sender, said request comprising data associated with said individual;

a unique identifier generator module for generating a unique identification symbol, said unique identification symbol being associated said individual and said unique identification symbol being sent to said sender; and

an image file receiving module for the receiving at least one image file, said image file further comprising said unique identification symbol.

16. The system as recited in Claim 15 wherein said sender is a trusted user of said system.

17. The system as recited in Claim 15 wherein said image file comprises one of a group, said group comprising: a facsimile of a paper file and an electronic image file.

18. The system as recited in Claim 15 wherein said unique identifier generator module generates a QR code, said QR code capable of being associated with said image file to be uploaded.

19. The system as recited in Claim 18 wherein said image file to be uploaded comprises a facsimile of a paper file and further wherein said QR code is embedded in a cover letter to be appended to said paper file upon facsimile transmission.

20. The system as recited in Claim 15 wherein said image file receiving module is capable of receiving said image file and said unique identifier from said sender.

21. The system as recited in Claim 20 wherein said system is capable of storing said image file and an associated CarePod ID.

22. A system for automatically extracting and verifying user information from an image file and securely associating said user information with the user's CarePod, said system comprising:

an image file receiving module for receiving image files;

an optical character recognition module, said optical character recognition module reading said image file and transforming said images into computer readable data;

a patient identification feature extracting module for extracting user information from said computer readable data, said user information giving some indication as to the identity of said user; and

a comparison module for initially comparing said extracted user information with an individual CarePod and for storing said extracted user information if said extracted user information matches with information about said individual.

23. The system as recited in Claim 22 wherein said image file is a facsimile of a patient's record.

24. The system as recited in Claim 23 wherein said extracted user information is one of a group, said group comprising: patient name, age, date of birth and gender.

25. The system as recited in Claim 24 wherein said comparison module comprises a threshold wherein said comparison module is capable of comparing said extracted user information with said information about a possible individual associated with a CarePod; and

further wherein if the number of extracted features do not match individual information exceeds said threshold, said comparison module is capable of setting an error flag.

26. A method for uploading image files to a CarePod, said image files associated with an individual for whom said CarePod is further associated, the steps of said method comprising:

receiving a request for uploading an image file to a CarePod from a sender, said request comprising data associated with said individual and said individual further associated with said CarePod;

generating a unique identification symbol, said unique identification symbol being associated with said CarePod and said unique identification symbol being sent to said sender; and

receiving at least one image file, said image file further comprising said unique identification symbol.

27. The method as recited in Claim 26 wherein said sender is a trusted member of said CarePod.

28. The method as recited in Claim 26 wherein said image file comprises one of a group, said group comprising: a facsimile of a paper file and an electronic image file.

29. The method as recited in Claim 26 where the steps of said method further comprise:

transforming said image file into computer readable data;

extracting user information from said computer readable data; and comparing said extracted user information with information about the individual for which the CarePod is associated.

30. A system for creating treatment plans for patients, wherein said patients and their caregivers are members of a trusted community of a CarePod, the system comprising:

a treatment plan module, said treatment plan module capable of creating a plan for treating a patient for a particular condition;

an instrument database module, said instrument database capable of receiving request by said treatment plan module and returning a template for collating data from one of a group, said group comprising: a medical instrument, a medical device and a biosensor; a CarePod members module, said CarePod members module capable of receiving request from said treatment plan module and returning a list of CarePod members who are trusted community entities for said patient; and

a reminders module, said reminders module capable of creating and storing reminders, said reminders capable of being sent

automatically to said patients and said caregivers regarding relevant treatment events in said treatment plan.

31. The system as recited in Claim 30 wherein said treatment plan module further comprises at one of a group, said group comprising: an Add Guidance Item module, an Add Medication module, an Add Monitor module and an Add Todo module.

32. The system as recited in Claim 31 wherein said treatment plan module further comprises a CarePod Treatment Plan module, said CarePod Treatment Plan module capable of storing a completed treatment plan for said patient in a database, said database capable of being accessed by entities in a Members Access List.

33. A system for sending reminders of treatment events in a treatment plan to patients and other members in a Member Access List, said patient and other members being members of a trusted community in a patient's CarePod, the system comprising:

a notifier module, said notifier module capable of inputting data regarding a patient's treatment plan and sending reminders of treatment events within said patient's treatment plan;

a CarePod Treatment Plan module, said CarePod Treatment Plan module capable of sending treatment plan data to said notifier module, said treatment plan data comprising data regarding said patient's treatment;

a reminders module, said reminders module capable of sending treatment reminders schedule of said treatment events to said notifier module; a Member Access module, said Member Access module capable of sending a list of members of patient's CarePod who are to be reminded of treatment events to said notifier module; and

a Member Profile module, said Member Profile module capable of sending notification preferences of said list of members who are to be reminded of treatment events; and

wherein said notifier module, capable of sending reminders to said list of members reminders of treatment events, said reminders sent according to the notification preference of each such member in said list of members.

34. A system for capturing data from treatment plans for patients, said patients having an associated CarePod and said treatment plan being associated with said CarePod, the system comprising:

an instrument module, said instrument module capable of inputting data regarding a treatment plan for patients, data regarding medical instrument templates, data from medical instruments, said medical instrument templates being associated with said medical instruments;

a CarePod Treatment Plan module, said CarePod treatment Plan module capable of sending data regarding medical instruments associated with said treatment plan to said instrument module;

an instrument database module, said instrument database module capable of sending templates regarding data capture from an instrument; and

a response database, said response database capable of storing data received by said instrument module from an instrument.

35. The system as recited in Claim 34 wherein said medical instrument is one of a group, said group comprising: a medical instrument, a medical device and a biosensor.

36. The system as recited in Claim 35 wherein said instrument module is capable of receiving data from a medical instrument, said medical instrument capturing data from said patient involved in said treatment plan.

37. The system as recited in Claim 36 wherein said response database is capable of storing patient data from a plurality of patients involved in said treatment plan.

38. A method for creating a treatment plan for a patient, said patient having an associated CarePod and associated trusted caregivers for said CarePod, the steps of said method comprising:

creating a treatment plan template for a patient having a condition;

assigning access to said treatment plan to a set of said CarePod members of said patient's CarePod;

creating a set of reminders for said treatment plan, said reminders associated with a set of treatment event.

39. The method as recited in Claim 38 wherein the step of creating a treatment plan template further comprises:

adding a guidance data item.

40. The method as recited in Claim 38 wherein the step of creating a treatment plan template further comprises:

adding a medication data item.

41. The method as recited in Claim 38 wherein the step of creating a treatment plan template further comprises:

adding a monitor data item.

42. The method as recited in Claim 38 wherein the step of creating a treatment plan template further comprises:

adding todo data item.

43. A method for capturing the data created during a treatment plan, said treatment plan treating a patient for a condition and wherein said patient has an associated CarePod, the step of said method comprising:

receiving treatment plan information;

receiving template information regarding instrument associated with said treatment plan;

verifying member access list for patient's treatment, said members being associated with patient's CarePod;

receiving data from said instruments, said instruments capturing data from said patients; and

storing treatment data from said instruments in a response database.

44. The method as recited in Claim 43 wherein said treatment data comprises data aggregated from a plurality of patients being treated for said condition.

45. The method as recited in Claim 44 wherein said aggregated data from a plurality of patients is input into an analytic process to assess the efficacy of said treatment plan.