Data Access Framework (DAF) Phase 3 Launch Data Access for Research 1 September 9, 2015 S&I Initiative Coordinator: Johnathan Coleman HHS/ONC Sponsor: Mera Choi

2 All participants on this call are muted. If you want to ask questions or make comments please use the “Chat” feature on the web meeting Select “All Panelists” to send your message in order to ensure the comments are addressed publically These slides will be posted after the call: +Meeting+Artifacts +Meeting+Artifacts From S&I Framework to Participants: Could you please explain how the terminologies are used in this instance? All Panelists CHAT  Click on the “chat” bubble at the top of the meeting window NOTE: This meeting is being recorded and will be archived on the DAF Wikipage, under “Materials”  “Past Meetings” Meeting Etiquette

3  Opening Remarks Steven Posnack, M.S., M.H.S., Director, Office of Standards and Technology Dr. Ed Hammond, PhD, FACMI, FAIMBE, FIMIA, FHL7, Director, Duke Center for Health Informatics, Duke Translational Medicine Institute and ONC SDC Initiative Coordinator Johnathan Coleman, CISSP, CISM, CBRM, CRISC, S&I Framework Initiative Coordinator and ONC DAF Initiative Coordinator  Introduction to DAF Phase 3  Other DAF Related Activities  Next Steps/Call for Participation  Questions & Answers  Additional DAF Resources Agenda

Opening Remarks Steven Posnack, M.S., M.H.S., Director, Office of Standards and Technology 4

5 Coordinates nationwide efforts to implement and use most advanced HIT and electronic exchange of health information Established by HITECH in 2009 Office of Standards and Technology (OST)

S&I Framework Overview  The Standards and Interoperability (S&I) Framework represents one investment and approach adopted by OST to fulfill its charge of prescribing health IT standards and specifications to support national health outcomes and healthcare priorities 6  The S&I Framework consists of a collaborative community of participants from the public and private sectors who are focused on providing the tools, services and guidance to facilitate the functional exchange of health information

 S&I Framework has produced, supported and enabled key standards and implementation guides used in Certification Criteria for Meaningful Use. Those include DIRECT Certificate and Provider Directory Services, Consolidated CDA used in Transitions of Care, Laboratory Results Reporting, and Quality Reporting Document  Active presence in Standards Development Organizations (SDOs) meetings to support and speed up process for S&I, including supporting the balloting of standards harmonized by S&I 7 Value of S&I Collaboration

8 Collaborative Approach Create Problem Statement & Functional Requirements Conduct Pilots Finalize/Select Technical Solution from Pilots sent to SDO(s) Create/Update /Publish Standards or IG using SDO Processes & Resources (based off finalized pilot solution) S&I Support Team + Pilot Community S&I Support Team + Pilot Community + SDO SDO Engage with SDOs

Opening Remarks Dr. Ed Hammond, PhD, FACMI, FAIMBE, FIMIA, FHL7, Director, Duke Center for Health Informatics, Duke Translational Medicine Institute and ONC SDC Initiative Coordinator 9

 The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit, nongovernmental organization located in Washington, DC, which was authorized by Congress in 2010 to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions  Phase 3 of DAF will enable researchers to use standardized technical capabilities to access data from multiple organizations and data sources within a Learning Health System (LHS) infrastructure. Ongoing LHS activities include researchers accessing data under the current PCORI and the National Patient- Centered Clinical Research Network (PCORnet) grant activities 10 PCORI

 Under the PCORI and PCORnet environment is an expansive set of health systems who are partnered to conduct research as a network, known as the Clinical Data Research Networks (CDRNs) and the Patient-Powered Research Networks (PPRNs). Both of these research networks collect data from multiple sources and makes them available for research along with a governing Institutional Review Board (IRB) that helps to address various policy issues surrounding consent, data use, data release, anonymization, security and privacy, etc. 11 PCORI CONTINUED

Opening Remarks Johnathan Coleman, CISSP, CISM, CBRM, CRISC, S&I Framework Initiative Coordinator and ONC DAF Initiative Coordinator 12

DAF Project Team  ONC Sponsor: Mera Choi  S&I & DAF Initiative Coordinator: Johnathan Coleman  Support Team: Project Management: o Jamie Parker o Gayathri Jayawardena Technical SME: o Nagesh (Dragon) Bashyam Standards SME: o Brett Marquard o Ed Larsen Privacy and Security SME: o Glen Marshall Standards Development Support: o Angelique Cortez 13

Introduction to DAF Phase 3 14

15 DAF Initiative Overview  Goal: The Data Access Framework (DAF) Initiative aims to increase access to patient data, using standards for data queries, APIs, or services, in order to expand the ability of users to create value out of their data without having to rely on existing access paths based on clinical workflow events  Benefit: Standards based access can enable a provider to further analyze the collected data to understand a patient’s overall health, the health of a provider’s collective patient population, and use the data with innovative new applications and tools to improve care for patients and populations This will improve patient care across the continuum and provide the capability to analyze and use patient data collected in the care process to improve population health

16 DAF Initiative Overview CONTINUED  DAF has approached standardized data access in three phases: Phase 1: Local Data Access within an organization (Intra-Organizational Query) Phase 2: Targeted Data Access with a known organization (Inter-Organizational Query) Phase 3: Distributed Data Access across multiple organizations (Distributed/Federated Query)

17 DAF Phase 3 Objective  Enable researchers to access data from multiple organizations and data sources within a Learning Health System (LHS) infrastructure

18 PCORI/PCORnet Abstract Model Step A: Creation of Data Marts within CDRN’s and PPRN’s ETL’s are written to extract data from one or more data sources and loaded into a data mart to be queried by researchers Step 1, 2,3, 4: Researcher submitting a query and examining the query results 1.Researcher composes a query to be submitted to various data marts (permissions and access controls determine who can query what data, at what time, and for what purpose) 2.Queries are distributed to various sites depending on access controls, frequency, date, time, orchestration pattern, etc. 3.Queries are executed and results computed on the data marts, optionally reviewed manually 4.Query results are released by the networks to the researcher along with data disclosure policies Out of Band Activities: Network creation along with governing bodies such as IRB’s, on-boarding processes; data use agreements Registering data marts and publishing metadata; approve queries for execution Authorization policies allowing researchers (who, when, what purpose, what data) access to data Researcher Interface CDRN 1 PPRN CDRN 2 Data Mart Data Source 1 Data Data Source 2 Data Data Source 3 Data Data Source 4 Data Patient Generated Data A

 DAF will develop the following technical capabilities to enable PCORI/PCORnet researchers to access data Each capability will be driven by an overarching Charter/Challenge Statement/ Problem Statement/Functional Requirements Document Each capability will be piloted by the DAF community prior to finalizing deliverables 19 Proposed Technical Capabilities CapabilityBenefits Abstract Model Reference Pilot Deliverable C1: Standardize data extraction mechanism from clinical data sources Reduces the onboarding time for data sources within each network Step A DAF Extract Transform Load (ETL) Technical Specification written by DAF support team based on pilot feedback Reuses all the work completed in DAF Phases 1 & 2 C2: Standardize metadata about data marts, data sources and networks Provides researchers ability to determine which networks have the right data for their activities Happens out of band currently Proposal and content submitted to HL7 for new FHIR resources capturing the data mart metadata C3: Standardize Query Distribution mechanism LHS Data infrastructure not tied to a particular vendor or product Also helps bridge multiple networks Step 2 Proposal and content submitted to HL7 for new FHIR resources to submit queries

20 CapabilityBenefitsAbstract Model Reference Deliverables C4: Standardize Query Results for aggregate data LHS Data infrastructure not tied to a particular vendor or product Can be used for other use cases such as surveillance, quality reporting Step 4 Proposal and content submitted to HL7 for new FHIR resources capturing the query results data Proposal covers C4 C5: Standardize Query Results for de- identified and patient level data LHS Data infrastructure not tied to a particular vendor or product Can be used for other use cases such as surveillance, quality reporting Step 4 Proposal and content submitted to HL7 for new FHIR resources capturing the query results data Proposal covers C5 C6: Standardize Query Structure LHS Data infrastructure not tied to a particular vendor or product Step 1 DAF Support team Draft a “DAF Query Composition Technical Specification” based on pilot feedback Reuses existing FHIR Search capability Technical Specification Covers C6 Proposed Technical Capabilities CONTINUED

 Inter-Organizational Trust: Data use agreements, compliance with privacy laws, authorization policies related to data disclosure, governance, de-identification, etc. Suitability of different technical mechanisms for authentication and authorization to enable data access from an external organization  Identity Matching: Policies, patient matching rules and matching algorithms to identify patients and their related clinical data over time and from multiple sources  Research Community Specific Considerations: IRB requirements, constraints, and potential limitations for distributed queries  Patient-centered Considerations: Patient consent and data donation Patient privacy and data disclosure We will add and address additional policy considerations as Phase 3 evolves. 21 Policy Considerations

 DAF will facilitate a process to help address policy issues as they arise and will be working with the Office of the Chief Privacy Officer (OCPO) and the DAF pilot community. Proposed activities may include: Capture policy decisions and identify technical standards currently used in PCORI/PCORnet environment for: o Patient consent and data donation o Patient privacy and data disclosure o Patient matching o Shared/centralized IRB methods Establish a workgroup to address DAF policy issues, which includes OCPO representation: o Work closely with ONC OCPO led PCOR Privacy and Security Projects o Seek OCPO assistance on any additional clarifications required beyond existing regulations, policies and guidance on above topics 22 Proposed Policy Activities

23 30 Sep Dec Mar June Sep 2016 WORKGROUP 1: C1 Capability Finalize scope and pilot kick-off Execute Pilots Draft IG and Submit to SDO for balloting Finalize scope and pilots for C2 thru C4 Execute Pilots for C2 thru C4 Draft Proposals, IG’s and Submit to SDO for balloting C2 thru C4 Finalize scope and pilots for C5, C6 Execute Pilots for C5, C6 Draft Proposals, IG’s and Submit to SDO for balloting C5, C6 31 Dec 2016 Proposed Timeline WORKGROUP 2: C2-C6 Capabilities

Other DAF Related Activities 24

HL7: DAF FHIR IG  DAF FHIR DSTU IG ballot reconciliations have concluded and received sufficient affirmative votes to pass ballot and will move to publication. You can review the ballot here:  Implementation of reconciled comments disposition actions have been completed and publication is anticipated late September 2015, in accordance with the FHIR DSTU2 release  The sponsoring work group for the DAF FHIR DSTU IG, Infrastructure and Messaging (InM), meeting artifacts can be found here: Other DAF Related Activities Ongoing SDO Activities

IHE: DAF Document Metadata IG  IHE USA and IHE Patient Care Coordination (PCC) domain have approved the Data Access Framework Document Metadata Based Access Implementation Guide to move to trial implementation text publicationData Access Framework Document Metadata Based Access Implementation Guide The target for final publication is the second week of September 2015  The DAF Document Metadata IG will be available for testing at the IHE NA Connectathon 2016 at the HIMSS Innovation Center in Cleveland OH, January , Other DAF Related Activities Ongoing SDO Activities CONTINUED

 Purpose: Harmonize and develop a set of privacy and security specifications that enable an individual to control the authorization of access to RESTful health- related data sharing APIs, and to facilitate the development of interoperable implementations of these specifications by others The HEART WG is run under the auspices of OpenID, not ONC. Requires intellectual property release (IPR) to participate References OpenID, OAuth 2.0, and UMA 1.0 specifications  Has completed use-case for PHR-EHR communication, using Oauth 2.0. This work is to be aligned with HL7 FHIR, SMART, and Argonaut  Artifacts: 27 Other DAF Related Activities HEART Workgroup

 Purpose: Develop a first-generation FHIR-based API and Core Data Services specification to: enable expanded information sharing for electronic health records and other health information technology based on Internet standards and architectural patterns and styles  The project will accelerate current FHIR development efforts to provide practical and focused FHIR profiles and implementation guides to the industry.  Artifacts: 28 Other DAF Related Activities Argonaut Workgroup

Next Steps/Call for Participation 29

 NEXT MEETING: Join us on Wednesday, September 23, 2015 at 12:00 PM (ET) for our next meeting. Agenda: We will review the proposed project charter for Phase 3 Webinar details:  SUBSCRIBE TO DAF: Please visit the “Join the Initiative” section of the DAF wikipage to subscribe to our listserv:  BECOME A PILOT: If you are interested in becoming a pilot site for DAF Phase 3, please complete the sign-up form located here: MvjI/viewform MvjI/viewform  DAF WIKI HOMEPAGE: The ONC DAF Initiative is open for anyone to join! Please visit the DAF wikipage to access all our meeting calendars, past meeting materials, initiative charter, Phase 1 and 2 artifacts as well as our current work activities: Next Steps/Call for Participation

 A recording of today’s webinar and slide presentation will be available shortly after this call  To access these meeting artifacts, please visit: rtifacts rtifacts 31 Next Steps

Questions 32

Additional DAF Resources 33

Useful Links DAF Homepage – DAF Initiative Signup – DAF Charter – DAF Standards, Harmonization and Implementation Activities – tion tion DAF HL7 FHIR IG – DAF IHE White Paper – ev1.1_ pdf ev1.1_ pdf 34

DAF Project Team  ONC Sponsor: Mera Choi  S&I & DAF Initiative Coordinator: Johnathan Coleman  Support Team: Project Management: o Jamie Parker o Gayathri Jayawardena Technical SME: o Nagesh (Dragon) Bashyam Standards SME: o Brett Marquard o Ed Larsen Privacy and Security SME: o Glen Marshall Standards Development Support: o Angelique Cortez 35