1. S&I Public Health Education Series: Data Provenance July 9th, 2014 Johnathan Coleman Initiative Coordinator – Data Provenance ONC/OCPO/OST (CTR)

2. Agenda 2 Background Initiative Purpose and Goals Initiative Activities Standards and Interoperability (S&I) Framework Progress Draft Use Cases Tiger Team Conclusion

3. Background Data Provenance Definition: Information on the place and time of origin or derivation or a resource or a record or proof of authenticity or of past ownership. [ISO 19153:2014(en), 4.39]* 3 *One of several definitions of Data Provenance

4. Growing Demand for Provenance As the exchange of health data increases, so does the demand to track the provenance of this data over time and with each exchange instance. Confidence in the authenticity, trustworthiness and reliability of the data may be improved by means of a standardized way to capture and express the provenance of the data, and by the expectation that systems have the ability to recognize and validate the provenance information. This in turn can lead to uses such as “chain of trust” and “chain of custody” and other business requirements/applications (for example records management, evidentiary support and clinical decision support). 4 Background

5. Challenge While there are several existing efforts to address data provenance, no authoritative specification, standard, or model for provenance has been universally adopted to-date within the context of HIT. The variability in how HIEs, EHRs, and PHRs currently capture, retain, and display provenance is problematic for the interoperable exchange, integration, and interpretation of health data. 5 Background

6. Initiative Purpose and Goals To establish a standardized way for capturing, retaining, and exchanging the provenance of health information (including inbound, system generated, and outbound provenance). The initiative will: – Establish guidance for handling data provenance in content standards, including the level to which provenance should be applied – Establish the minimum set of provenance data elements and vocabulary – Standardize the provenance capabilities to enable interoperability 6 Background

7. Initiative Activities: S&I Framework PhasePlanned Activities Pre-Discovery  Development of Initiative Synopsis  Development of Initiative Charter  Definition of Goals & Initiative Outcomes Discovery  Creation/Validation of Use Cases, User Stories & Functional Requirements  Identification of interoperability gaps, barriers, obstacles and costs  Review of Candidate Standards Implementation  Creation of aligned specification  Documentation of relevant specifications and reference implementations such as guides, design documents, etc.  Development of testing tools and reference implementation tools Pilot  Validation of aligned specifications, testing tools, and reference implementation tools  Revision of documentation and tools Evaluation  Measurement of initiative success against goals and outcomes  Identification of best practices and lessons learned from pilots for wider scale deployment  Identification of hard and soft policy tools that could be considered for wider scale deployments We are Here 7

8. 8 End Point (EHR) End Point (EHR) Data Source (EHR, Lab, Other) Data Source (EHR, Lab, Other) Transmitter ONLY (HIE, other systems) Transmitter ONLY (HIE, other systems) Scenario 1 Scenario 2 Scenario 3 Data Source (EHR, Lab, Other) Data Source (EHR, Lab, Other) Pre-step : Creation of the data and associated provenance information Assembler (EHR, HIE, other systems) Assembler (EHR, HIE, other systems) Initiative Activities: Use Case Scenarios (DRAFT)

9. Initiative Activities Data Provenance Tiger Team Established as a subgroup of the S&I Initiative. Tasked with working with SDOs to accelerate the S&I Framework harmonization phase by: – Evaluating current provenance requirements in CDA and various HL7 specifications. – Supporting development of a harmonized Implementation Guide (IG) for Provenance in a CDA. Meets weekly as part of a joint S&I/HL7 working meeting. Reports on progress to HL7 Community Based Collaborative Care (CBCC) WG meetings and the S&I Data Provenance Initiative meetings. 9

10. Data Provenance Tiger Team Accomplishments: Proposed the Data Provenance project in HL7 and received approval from: – US Realm Task Force – Community Based Collaborative Care (CBCC) (sponsoring WG) – Structured Documents Work Group (SDWG) (co-sponsor) – Domain Experts Steering Division (DESD) – Technical Steering Committee (TSC) Supporting development of HL7 Provenance Specification: – HL7 Implementation Guide for CDA® Release 2: Data Provenance, Release 1 – Targeted for September 2014 ballot as DSTU – Working with other HL7 workgroups on vocabulary harmonization 10 Initiative Activities

11. Conclusion Expected Outcomes: Technical specifications which enable provenance information to be conveyed in a standardized way, from creation to exchange and integration across multiple health information systems. Ultimately these standards will improve the confidence in the integrity of health information, facilitating greater trust in healthcare data and its use in clinical care, interventions, analysis, decision making and clinical research, and others. Community Participation: S&I Data Provenance Initiative: Thursdays 2:30-3:30 pm ET – http://wiki.siframework.org/Data+Provenance+Initiative http://wiki.siframework.org/Data+Provenance+Initiative HL7/S&I D-PROV Working Sessions: Mondays 3:00-4:00pm ET – https://www3.gotomeeting.com/register/868770014 https://www3.gotomeeting.com/register/868770014 11

12. Conclusion Thank you! Questions? 12 Johnathan Coleman, CISSP, CISM Initiative Coordinator OCPO/ONC/HHS (CTR) Tel: (843) 647-1556 Cell:(843) 442-9104 jc@securityrs.com Julie Anne Chua, PMP, CAP, CISSP IT Specialist InfoSec Office of the Chief Privacy Officer (OCPO) Department of Health and Human Services julie.chua@hhs.gov