US Core Data for Interoperability (USCDI): Data Provenance IG January 2019 Presentation at HL7 Working Group Meeting

USCDI History 21st Century Cures Act – Dec 13, 2016 (10) INTEROPERABILITY.—The term ‘interoperability’, with respect to health information technology, means such health information technology that— ‘‘(A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; ‘‘(B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and ‘‘(C) does not constitute information blocking as defined in section 3022(a).’’. Draft U.S. Core Data for Interoperability (USCDI) and Proposed Expansion Process – Jan 5, 2018 … “provides ONC’s first draft of the data classes that would be in the USCDI and lays out the process and structure by which the USCDI will be updated and expanded” https://www.congress.gov/bill/114th-congress/house-bill/34/text#toc-HF4DFF8B9C70B4DC8984506C3257564BF

USCDI Data Classes “Similarly, understanding the provenance of the data being exchanged was also referenced by stakeholders as a fundamental need to improve the trustworthiness and reliability of the data being shared.” – Draft USCDI page 6

October 2018 WGM: Call to Action Thursday Q2 – Joint Patient Care + Structured Documents “Provenance” as a component of USCDI discussed with ONC reps Agreement that there isn’t explicit guidance on how to meet USCDI provenance requirement today Agreement that HL7 should provide guidance on how to populate data provenance information in C-CDA and FHIR Key Principles discussed: Success is being able to track two things: The last "handshake" who handed you the data The data "originator" who initially authored the data If anyone changes the data along the way, they become the new "author" for the changed data.

C-CDA Implementation January 2019 Concurred with prior discussion: Who ‘authored’ Who ‘handed to you’ Additional insight Data, and metadata for the purposes for trust, traceability and identification of ‘Who’ and ‘When’ Capture at least the last system that provided, if not the full chain of provenance. The full chain can be recreated by asking each system that is ‘one-hop’ prior. The system that provided you the data It’s not inherently bad to contain the full chain, but that may not be possible Information contained within a document may have its own "provenance" however, when this information is packaged into a document the document has a separate set of provenance metadata Consider Performer element in addition to Author as Provenance

Prior Data Provenance Efforts Data Segmentation for Privacy (DS4P) FHIR Provenance Resource FHIR Provenance Profile directly in FHIR core HL7 Version 3 Standard: Privacy and Security Architecture Framework - Volume 3 Provenance, Release 1 (recent ballot) EHR Functional Model (profile on the FHIR Provenance resource) IHE set of profiles - MHD profiles, QEDM, RECON profile ONC Challenge for tracking provenance ONC S&I Initiative on Data Provenance (led to CDA IG) HL7 CDA R2 Data Provenance (written by CBCP) EHR Lifecycle events – how an EHR manages a record over lifecycle events – focused on CRUD (27 lifecycle events) What other projects have considered Provenance?

Data Provenance IG: Vision Informative Implementation Guide Functional Guidance Which data classes should be communicated with provenance info Clear specification for the use cases for provenance (e.g., create, consume) Technical Guidance What constitutes supplying sufficient provenance info for a data class Reference Standards Scope: C-CDA 2.1 FHIR, using US Core profiles where applicable Content Scope: “Data Classes” listed in draft USCDI Goal is to support easy, wide implementation

Sponsorship Received Security WG (sponsor) Historical references and guidance on provenance attributes Patient Care WG (co-sponsor) Selection of data classes for which provenance is important Selection of provenance attributes that should be required Structured Documents WG (co-sponsor) C-CDA 2.1 technical guidance EHR FM (co-sponsor) FHIR technical guidance CBCP (co-sponsor) Prior CDA Data Provenance IG owner