pcornet patient-powered research networks (pprns) – … · 2018-10-24 · pcornet patient-powered...
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PCORnet Patient-Powered Research Networks (PPRNs) – Empowering Consumers to Help Accelerate Biomedical Knowledge Discovery July 2016 Dixie B. Baker, Ph.D. Consultant to PCORnet Coordinating Center
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Discussion Outline
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Introduce PCORnet and the Patient-Powered Research Networks
Motivation for EHR Extraction
Vision
Proof-of-Concept Approach and Technology Base
Your thoughts and suggestions
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PCORnet
National Patient Centered Outcomes Research Network (PCORnet) seeks to facilitate and accelerate clinical research by harnessing the power of large amounts of health data and patient partnerships
Comprises Clinical Data Research Networks (CDRNs)[1] and Patient-Powered Research Networks (PPRNs)[2]
PCORnet Common Data Model (CDM)[3] based on FDA Mini-Sentinel CDM
The work reported here is being conducted by the PPRNs, led by the Coordinating Center at Genetic Alliance
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EHR Extraction Study (September 2015) PPRNs want to integrate electronic clinical data generated in a
healthcare setting, but few PPRNs actually hold provider-generated EHR data
PPRNs are obtaining clinical data through means that require the participant to enter, copy, upload, or mail physical or electronic records to the PPRN
A number of providers have implemented Blue Button to enable download of a PDF or C-CDA document, but few enable patients to send a C-CDA to a third party
No standard for portal presentation of EHR data or of Blue Button interface – making it difficult for an app to find EHR data, even when available
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Legal and Regulatory Foundation
The legal and regulatory foundation for enabling PPRNs to “extract EHR data” exists today: All certified EHR technology has capability to generate a
C-CDA document containing Common Clinical Data Set OAuth 2.0-based APIs for authorizing access to data has
been widely implemented outside health care HIPAA Privacy Rule requires that providers enable patients
to obtain electronic copies of their own data in the format the patient requests[4]
CMS 2018 objective for patients to be able to retrieve EHR data using the app of their choice
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The PPRNs Want to Help Change the Adoption Dynamic
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HL7 FHIR
App Access
Portal CCDA VDT
Basic Portal VDT
No access 2016 2017 2018 2019 2020
Federal incentives
Current capability
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The Vision
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Send Sally’s health record to her PPRN
My Health Record
OK?
BakerD
esob38ksl
Sally’s EHR data
Yes
Patient Portal
PPRN
Select sharing permissions
Allow
Search for: BRCA + nonsynonymous_variant + rare_variant + familial breast cancer
Participant App
Researcher
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Proof-of-Concept Technology: Data Registry Component
Genetic Alliance Platform for Engaging Everyone Responsibly (PEER)[5]
Enables individuals to make their own health information available to researchers as defined in participant-selected permissions managed by Private Access[6]
• Currently holds participant-reported data Private Access provides OAuth 2.0[7] and OpenID
Connect[8] services needed for single sign-on and user authorization
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Proof-of-Concept Technology: Mobile Application Component
Yale Hugo app[9,10]
Developed in partnership with Yale New Haven Health System
Mobile app designed to collect health data from EHRs and wide range of consumer health technology
Auto-updated with EHR data daily Conduit for interactive communication among patient,
providers, and researchers In use now at Yale, using “proxy” access to existing portals
– plan to migrate to FHIR resource retrieval when available from EHRs
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Proof-of-Concept Technology: Receiver and ETL
Implement RESTful API to enable PPRN to receive data
Technology to perform bi-direction transforms between CDM data elements and FHIR (for queries) and FHIR to CDM data elements (to extract and load into registry)
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Sequence Diagram for Interim, Password-Based Hugo Access to EHR Data
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Acting as user-proxy, Hugo logs into EHR
On participant’s behalf, Hugo uses BlueButton protocol to download C-CDA document Hugo persists C-CDA in User’s PHR and asks whether User wants to forward it to PEER If so, Hugo forwards C-CDA from PHR to PEER Participant assigns permissions
PEER extracts data elements, transforms to CDM elements, and persists data in registry
User launches Hugo app, logs in using PrivateAccess OpenID, and requests EHR data
Researchers discover and retrieve data as permitted
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Sequence Diagram for Hugo-based RESTful Extraction of FHIR Resources
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User launches Hugo app, logs in using PrivateAccess OpenID, and requests that EHR data be downloaded to PHR and sent to PEER
If User grants permission, EHR issues access token that enables Hugo to extract FHIR resources Hugo uses the token twice: once to extract resources and redirect them to the User’s PHR, and again to extract resources and redirect them to PEER Hugo notifies the User that EHR data have been sent to PHR and PEER Hugo asks User whether she wants to assign PEER permissions; if so, HUGO redirects to PEER (PrivateAccess) for this purpose
PEER extracts data elements, transforms to CDM elements, and persists in registry
Acting on participant’s behalf, Hugo requests FHIR resources from EHR EHR authenticates User and asks for permission to grant Hugo the requested access
Researchers discover and retrieve data as permitted
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Notional Screens for PPRN Pilot Scenario (based on actual Hugo UI)
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Create a Private Access Account
…or LOGIN to your Private Access Account
Would you like to put your health information to work in
medical research?
You can do so privately, under sharing rules that you define
for yourself, through a service we provide through Private
Access.
Read the Privacy Policy
Tell Me More
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Create a Private Access Account
…or LOGIN to your Private Access Account
The Hugo app enables you to make your medical information
available to PEER.
Private Access enables you to decide who can use your information and for what
purposes.
Read the Privacy Policy
Import my clinical records
Participant logs in using Private Access OpenID
Connect
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Send my records to PEER
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Current Status
Genetic Alliance and Yale Center for Outcomes Research and Evaluation (CORE) have agreed to work together on proof-of-concept
Concept presented at PPRN Design Day July 11 – other PPRNs invited to participate in Proof-of-Concept
Mapping between CDM and FHIR elements
Task is in queue for funding
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Sources
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[1] Clinical Data Research Networks (CDRNs) - http://www.pcornet.org/clinical-data-research-networks/) [2] Patient-Powered Research Networks (PPRNs) - http://www.pcornet.org/patient-powered-research-networks/ [3] PCORnet Common Data Model (CDM) - http://www.pcornet.org/pcornet-common-data-model/ [4] Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524 - http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/ [5] Platform for Engaging Everyone Responsibly (PEER) - http://www.geneticalliance.org/programs/biotrust/peer [6] Private Access Inc. - https://www.privateaccess.info [7] The OAuth 2.0 Authorization Framework - https://tools.ietf.org/html/rfc6749 [8] OpenID Connect - http://openid.net/connect/ [9] Yale Research Across the Spectrum - http://medicine.yale.edu/ycci/researchspectrum/informatics/hugo.asp [10] Hugo - http://hugophr.com