1. Data Access Framework (DAF) The Use of DAF for Clinical Research 1 July 21, 2015 S&I Initiative Coordinator: John Feikema/Johnathan Coleman HHS/ONC Sponsor: Mera Choi

2. 1.Background and Overview 2.DAF Phase 1 & 2: Artifacts and PCORnet Applicability 3.DAF Phase 3: PCORnet Collaboration 4.Questions 5.Additional Resources 2 Agenda

3. Background and Overview 3

4. In 2011, the Office of the National Coordinator for Health Information Technology (ONC), an office in HHS, launched the “Query Health Initiative.” The Query Health (QH) Initiative enabled providers and researchers access to aggregated data from multiple data sources (known as distributed queries) – During QH, multiple pilots were conducted and multiple standards for queries and results were developed. The initiative later concluded in 2013 and was succeeded by the Data Access Framework (DAF) Lessons Learned from QH: – Barriers exist to extracting data from clinical data sources (EMRs, Warehouses, etc.) – Data Mapping challenges (specifically around vocabularies, semantic meanings, etc.) – The need to simplify standards for Query and Query Results – The need to create modular standards for Transport, Security, Query Structure, Query Results and Information Models so they could be replaced as better approaches evolve In July of 2013, the Data Access Framework (DAF) was launched to address these challenges and also help enable data access for multiple use cases, which include: – Enabling data access within a organization (Local DAF) – Phase 1 – Enabling data access from a single external organization (Targeted DAF) – Phase 2 – Enabling data access from multiple organizations (Federated DAF) – Phase 3 4 Data Access Framework: Background

5. 5 Data Access Framework Local Access via Intra-Organization Query (Phase 1) Targeted Access via Inter-Organization Query (Phase 2) Federated (Distributed) Access Across Multiple Organizations (Phase 3) Standards based approach to enable information access at all levels: Local, Targeted, and Federated (Distributed) Create and disseminate queries internal to organization Query Structure Layer APIs for Data Access Authentication/Authorization Layer Receive standardized responses Query Results Layer Create and disseminate queries internal to organization Query Structure Layer APIs for Data Access Authentication/Authorization Layer Receive standardized responses Query Results Layer Create and disseminate queries to single external Organization Query Structure Layer Transport Layer Authentication/Authorization Layer Receive standardized responses from external orgs Query Results Layer Create and disseminate queries to single external Organization Query Structure Layer Transport Layer Authentication/Authorization Layer Receive standardized responses from external orgs Query Results Layer Create and disseminate queries to multiple orgs governed by a network Receive aggregated or de-identified responses Focus on Information Model for the network and leverage standards from earlier phases. Create and disseminate queries to multiple orgs governed by a network Receive aggregated or de-identified responses Focus on Information Model for the network and leverage standards from earlier phases. Data Source (Org2) Data Source (Org3) Data Source (Org1) Query Request Query Response X Hospital System Y Hospital System Data Access Framework: Overview and Phases

6. DAF Phase 1 & 2: Artifacts and PCORnet Applicability 6

7. Da ta Access Framework: Phase 1 & 2 Overview 7 Basic Transport Protocols Application Transport Protocols Query Structure Query Vocabularies and Value Sets Authentication/Autho rization Result Structure Result Vocabularies and Value Sets Information Models Transport Layer Security Layer Query Structure Query Results Data Model to support queries Data Access Framework Building Blocks DAF Scope: Develop Implementation Guides (IG) using standards/profiles for specific use cases Local (Intra-Organization) access of clinical information from one or more systems Targeted (Inter-Organization) access of clinical information from a single known external organization Use cases deal with accessing both data elements (e.g. problems, medications, procedures) and documents (e.g. C-CDA, C32) DAF Out-of-Scope Trust establishment between organizations for Targeted Query Discovery of End Points for Targeted Query Patient Matching rules and algorithms that organizations may implement Policies that allow/dis-allow disclosure of patient data

8. Data Access Framework: Phase 1 & 2 Query Stacks 8 Basic Transport Protocols Application Transport Protocols Query Structure Query Vocabularies and Value Sets Authentication/Autho rization Result Structure Result Vocabularies and Value Sets Information Models Transport Layer Security Layer Query Structure Query Results Data Model to support queries Data Access Framework Building Blocks HTTP TLS OAuth2 profiles* FHIR FHIR + MU2 vocabularies FHIR Resources FHIR + MU2 vocabularies FHIR RESTful FHIR based Query Stack for Data Element based access HTTP TLS OAuth2 profiles* IHE MHD v2 FHIR based Profile FHIR + XDS Metadata FHIR Resources + CCDA FHIR + MU2 (CCDA vocabularies) FHIR + XDS Metadata RESTful FHIR based Query Stack for Document Metadata based access HTTP Mutual TLS IHE XUA (SAML) XCA XDS Metadata CCDA MU2 (CCDA vocabularies) ebRIM + XDS Metadata SOAP 1.2 SOAP Query Stack for Document Metadata based access DAF Data Element IG DAF Document IG * - OAuth2 profiles still evolving

9. Argonaut – Project led by industry in collaboration with HL7, with goals that include the following: Development of CCDA to FHIR Mappings Security Guidance for FHIR Accelerate FHIR Implementation and DSTU publication http://hl7.org/implement/standards/FHIR-Develop/argonauts.html Relationship: DAF Data Element IG is based on FHIR profiles and is being reused by Argonaut HEART – An MIT project supported by ONC as a Committed Member – The goal is to harmonize and develop set of privacy and security specifications/profiles to enable individuals to control access to RESTful health related resources using OAuth, OpenId, UMA – Develop open source reference implementations for the developed specifications/profiles http://openid.net/wg/heart/charter/ Relationship: DAF Security layer could potentially reuse profiles/specifications developed by HEART http://openid.net/wg/heart/charter/ 9 Data Access Framework: Other Related Projects

10. Can address the challenge of building specific APIs (ETLs) required at each data source – DAF HL7 FHIR profiles being reused by Argonaut project 10 Vendor 1 DB Vendor 2 DB Vendor 3 DB PCOR Data Mart (Problems, Meds, Procedures…) DAF API Vendor 1 DB Vendor 2 DB Vendor 3 DB PCOR Data Mart (Problems, Meds, Procedures…) Specific API’s for each data source API - 1 API - 2 API - 3 Data Access Framework: Phase 1 & 2 Artifacts & PCORnet Applicability

11. Can address the challenge of accessing data from a known external data source over the internet 11 Requestor (Systems or Researchers, etc.) Responder NOTE: Each Requestor/Responder interaction is unique Data Access Framework: Phase 1 & 2 Artifacts & PCORnet Applicability CONTINUED

12. PCORnet could leverage the data structures and logical models developed by DAF Models very well aligned with PCORnet CDM Vocabularies and Value Sets aligned with national standards for interoperability from ONC Open Source Reference Implementations available for HL7 FHIR APIs All DAF Phase 1 & 2 artifacts and technical support available for PCORnet pilot opportunities 12 Data Access Framework: Phase 1 & 2 Artifacts & PCORnet Applicability CONTINUED

13. DAF Phase 3 and PCORnet Collaboration 13

14. By leveraging work performed in DAF Phase 1 & 2, DAF Phase 3 aims to address PCORnet challenges Examples include: Enabling access to data for researchers using Distributed Queries Enhancing existing data models (standards) to include claims and other data sources for queries Enhancing existing standards for aggregate, de-identified data collection Developing a policy framework that enables Distributed Queries Enabling patient controlled data release using internet standards such as OAuth2, OpenID Connect, and UMA Data quality improvement (e.g. Patient Matching) 14 Data Access Framework: Phase 3 Overview

15. DAF Phase 3 would request collaboration with PCORnet members to: ⁻Identify challenges that could be addressed by ONC DAF Phase 3 ⁻Pilot solutions to challenges that are identified ⁻DAF support team will provide technical support where appropriate ⁻ONC will use the solutions to inform/guide the standards created ⁻Help ONC address any policy issues that require additional guidance ⁻Provide expertise and guidance for the development of DAF Phase 3 artifacts 15 Data Access Framework: Phase 3 PCORnet Collaboration

16. Please sign-up for the DAF initiative to ensure you stay up-to-date with the latest information Complete the “Join” form on the DAF Wiki Page: http://wiki.siframework.org/Dat a+Access+Framework+Join+the +Initiative http://wiki.siframework.org/Dat a+Access+Framework+Join+the +Initiative Join us as we begin the process of identifying the problem statement and identifying the technical/policy issues that need to be addressed by Phase 3 pilots Consider piloting DAF Phase 1, 2 or 3 artifacts 16 Data Access Framework: How You Can Join DAF

17. Questions 17

18. Additional Resources 18

19. Useful Links DAF Homepage – http://wiki.siframework.org/Data+Access+Framework+Homepage http://wiki.siframework.org/Data+Access+Framework+Homepage DAF Initiative Signup – http://wiki.siframework.org/Data+Access+Framework+Join+the+Initiative http://wiki.siframework.org/Data+Access+Framework+Join+the+Initiative DAF Charter – http://wiki.siframework.org/Data+Access+Framework+Charter+and+Members http://wiki.siframework.org/Data+Access+Framework+Charter+and+Members DAF Standards, Harmonization and Implementation Activities – http://wiki.siframework.org/DAF+Standards+Harmonization+and+Implementa tion http://wiki.siframework.org/DAF+Standards+Harmonization+and+Implementa tion DAF HL7 FHIR IG – http://hl7.org/fhir/2015May/daf.html http://hl7.org/fhir/2015May/daf.html DAF IHE White Paper – http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_White_Paper_DAF_R ev1.1_2014-10-24.pdf http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_White_Paper_DAF_R ev1.1_2014-10-24.pdf 19

20. Initiative Support Leads For questions, please feel free to contact your support leads: – Initiative Coordinator: John Feikema john.feikema@siframework.org /Johnathan Coleman jc@securityrs.comjohn.feikema@siframework.orgjc@securityrs.com – ONC Sponsors: Mera Choi mera.choi@hhs.govmera.choi@hhs.gov – Support Team: Project Management: – Jamie Parker jamie.parker@esacinc.comjamie.parker@esacinc.com – Gayathri Jayawardena gayathri.jayawardena@esacinc.comgayathri.jayawardena@esacinc.com Technical Support: – Dragon (Nagesh) Bashyam nagesh.bashyam@drajer.comnagesh.bashyam@drajer.com Standards SME: – Brett Marquard brett@riverrockassociates.combrett@riverrockassociates.com – Ed Larsen ed_larsen@comcast.neted_larsen@comcast.net Privacy and Security SME: Glen Marshall gfm@securityrs.comgfm@securityrs.com Standards Support: – Angelique Cortez angelique.j.cortez@accenture.comangelique.j.cortez@accenture.com 20