1. Standards and Harmonization Data Provenance S&I Framework December 4 th, 2014 1

2. Agenda TopicTime Allotted Announcements5 minutes HL7 Implementation Guide for CDA® Release 2: Digital Signatures and Delegation of Rights, Release 1 presentation by Bob Dieterle 15 minutes CDA R2, CCDA, CDA IG, HL7 V2 presentation by Bob Yencha30 minutes Comments and Questions10 minutes

3. 3 Today Standards Evaluation Solution Planning IG Development DPROV Harm Launch Standards SME presentations Solution Planning Create IG Template Introduction Implementation Approach Suggested Enhancements End-to-End Review 1/29 – 3/5 10/23 – 1/8 12/15 - 1/5 1/22 - 2/5 3/5 – 4/5 4/5 – 4/12 4/12 – 5/5 DPROV Harmonization Timeline Standards Analysis & Assessment 1/8-2/5

4. Data Provenance Standards Presentations Schedule DateStandard to PresentSME NameConfirmed 11/20/2014 ISO 21089 Health Informatics: Trusted End-to-End Information FlowsGary Dickinson Y SOAPGlen Marshall Y THANKSGIVING HOLIDAY 12/4/2014 1. C-CDA 2. CDA R2 3. HL7 Implementation Guide for CDA® Release 2: Data Provenance, Release 1 – US Realm 4. HL7 V2 Bob Yencha + Kathleen Connor Y HL7 Implementation Guide for CDA® Release 2: Digital Signatures and Delegation of Rights, Release 1 Bob Dieterle Y 12/11/2014 1.HL7 EHR Interoperability Model DSTU (2007) 2. HL7 Implementation Guide for CDA Release 2: Reference Profile for EHR Interoperability DSTU (2008) 3. HL7 EHR Lifecycle Model DSTU (2008) 4. ISO/HL7 10781 EHR System Functional Model, Release 2 (2014) 5. HL7 Record Lifecycle Events on FHIR (project underway 2014 for FHIR DSTU Release 2) Gary Dickinson Y 12/18/2014 HL7 Implementation Guide for CDA®, Release 2: Consent Directives, Release 1Serafina Versaggi Y HL7 EHR Records Management and Evidentiary Support (RM-ES) Functional Model, Release 1 Reed Gelzer Diana Warner Y 1/8/2015 As a grouping of Implementation Guides: 1. HL7 Health Care Privacy and Security Classification System, Release 1 2. HL7 Version 3 Standard: Privacy, Access and Security Services (PASS) 3. HL7 Version 3 Standard: Privacy, Access and Security Services; Security Labeling Service, Release 1 (SLS) *Associated vocabulary HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 Kathleen Connor Y

5. Updated Candidate Standards #TransactionContent and Structure Terminology and Code Values - DP TransportSecurity 1 a) Start Point sends clinical data with provenance information to End Point *C-CDA *CDA R2 *W3C PROV: PROV-AQ, PROV- CONSTRAINTS, PROV-XML *Personal Health Record System Functional Model *HL7 EHR Records Management and Evidentiary Support (RM-ES) Functional Model, Release 1 *ISO/HL7 EHR System Functional Model Release 2 *HL7 EHR Lifecycle Model (2008) *HL7 Record Lifecycle Event Metadata using FHIR (project underway 2014) *HL7 V.2.x *ISO 21089 Health Informatics: Trusted End-to-End Information Flows *HL7 FHIR DSTU Release 1.1 Provenance Resource *HL7 Implementation Guide for CDA® Release 2: Data Provenance, Release 1 – US Realm *HL7 Implementation Guide for CDA®, Release 2: Consent Directives, Release 1 *HL7 EHR Interoperability Model DSTU (2007) *HL7 Implementation Guide for CDA Release 2: Reference Profile for EHR Interoperability DSTU (2008) *HL7 V.2/ V.3 Vocabulary & Terminology Standards *Representation State Transfer (RESTful) *Cross Enterprise Document-Sharing XDS *SOAP *HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 * HL7 Health Care Privacy and Security Classification System, Release 1 (HCS) *HL7 Version 3 Standard: Privacy, Access and Security Services (PASS) *HL7 Version 3 Standard: Privacy, Access and Security Services; Security Labeling Service, Release 1 (SLS) *HL7 Implementation Guide for CDA® Release 2: Digital Signatures and Delegation of Rights, Release 1 2 a) Start Point sends clinical data to transmitter with provenance information 2 b) Transmitter send clinical data to end point with provenance information 3 a) Start Point sends clinical data to assembler/composer with provenance information 3 b) Assembler/composer compiles clinical data which is sent to end point with provenance information

6. HL7 CDA and V2 Bob Yencha RTY LLC December 4, 2014

7. Basics Clinical Document Architecture ANSI/HL7 CDA R1.0-2000 ANSI/HL7 CDA R2.0-2005, Re-affirmed 2010 Created & maintained by HL7 Structured Documents Work Group (SDWG) An XML specification for document exchange HL7 Reference Information Model (RIM) Vocabulary (HL7, SNOMED, LOINC, ICD, local,…) Transport agnostic

8. CDA Characteristics (§2.1) “A clinical document... has the following characteristics :  Persistence  Stewardship  Potential for authentication  Context  Wholeness  Human readability” (§4.2.1) “A clinical document is a documentation of clinical observations and services…” A snapshot in time, immutable set of facts

9. Core Concepts of CDA Provides a framework for defining models (templates) for: Documents Sections Entries Documents provide a context Referral, Surgical Note, Continuity of Care … Sections and entries are re-used across document types Vital Signs Section: Blood Pressure, Weight, et al Medications Section: active and inactive medications

10. RIM Concepts Every happening (event) is an Act Procedure, observation, substance administration, etc. Participation defines involvement in an Act Author, performer, subject, location, etc. The participants have Roles Patient, agent, responsible party. Roles are played and scoped by Entities Persons, organizations, material, places, devices, etc Acts are related through ActRelationship

11. CDA and Provenance CDA documents have characteristics that support traceability and verification Provenance meta-data is “built-in” to CDA but not specifically enforced or uniformly applied for today’s requirements Solution is to provide constraining templates that orchestrate the available components to present a consistent capture of core data provenance facts (who/what/when/where/how/why) at all levels: Documents Sections Entries

12. Implementation Guides Consolidated CDA, R2 A catalog of document, section and entry level templates Has namespace extensions to support evolving requirements, e.g., digital signatures The architecture allows for additional external constraints to be applied without conflict, e.g., the HL7 DPROV for CDA IG Defines additional constraints to orchestrate the capture of information regarding Entities that are Participants in an Act, the Roles they are playing, and they’re relationship to the other Participants

13. DPROV STANDARDS HARMONIZATION HL7 DPROV CDA IG Optimizing CDA inherent provenance leveraging HL7 ControlAct Provenance Metadata Patterns

14. DPROV CDA IG as Provenance Enabling Overlay Like HL7 DS4P CDA IG, DPROV CDA IG offers a set of Provenance Enabling Overlays that can be flexibly applied to meet use case requirements to any CDA IG Any set of DPROV CDA IG Document/Section/Entry templates may be used as applicable Provenance Metadata maximizes CDA provenance support

15. Use of Multiple DPROV Template Overlays A DPROV conformant IG permits the use of any of the DPROV Document templates where there are multiple Authors, i.e., where a Provider is an Author of a Document that includes Assembler generated content. Any DPROV conformant document may include one or more Assembler generated entries where the Assembler is the sole author or is a co-author of the entry.

16. DPROV Provenance Metadata Supports representation of provenance for: Any Clinical Statement Entry Type in one of 3 ways: – An Entry referencing another predecessor Entry in the Document Observation A is an except of internal Observation B – An Entry referencing a predecessor Entry external to the Document Observation B replaces an external Observation C Association of an Entry at: – State N with predecessor at State N-1 Legally authenticated Observation A – State N-1 with predecessor at State N-2 Authenticated Observation A – State N-2 with predecessor at State N-3 Newly created Observation A

17. How to Use Provenance Metadata Template There is both a Provenance Metadata Entry Relationship and a Provenance Metadata template. The entryRelationship may be on any Clinical Statement in any Section, and is intended to link predecessor versions of the Entry via state transitions following the same pattern used in v2 and v3 via ControlActEvents. ProvenanceMetadata Entry captures the CurrentState of a target Entry as a transition from a referenced internal or external Entry where the transition is not one supported by current entryRelationship or externalReference ActRelationshipType codes.

18. How to Use Provenance Metadata Template (cont.) E.g., if an Observation is an Excerpt from another Observation in the document, then provenance is conveyed by XCRPT type code from x_ActRelationshipEntryRelationship. If an Observation replaces an externally referenced Observation, then provenance is conveyed by RPLC type code from x_ActRelationshipExternalReference. However, if the transition from an internal or external referenced Observation is to the state that cannot be conveyed with the current CDA R2 x_ActRelationshipExternalReference and x_ActRelationshipEntryRelationship codes, then ProvenanceMetadata is used. For example, if a successor Observation is referenced by ProvenanceMetadata with a ProvenanceEventCurrentState code “legally authenticated” and the ProvenanceMetadata references an internal or external Observation, which is the predecessor of that Observation, then the ProvenanceMetadata indicates a state transition from a previous state, e.g., “authenticated.” The authenticated predecessor Observation may also have a component ProvenanceMetadata Entry, which would capture its state transition from a previous state, e.g., from a “new” Observation. This pattern supports conveyance of an Entry’s (in this case, Observation) Lifecycle.

19. Provenance Metadata LifeCycle Building Blocks

20. HL7 V2.x Messages Some parallels to documents but with very different goals leading to fundamental differences in what is available, how it is structured and how it is intended to be used. Message types supply context akin to a doctype: A lab order (OML) and a lab result (ORU) Patient registration and demographics (ADT) Unlike documents, not intended to persist Consume and incorporate/act on content.

21. Similar but… CDA defines Documents Documents have sections Sections have entries that are based on clinical statement patterns V2 defines Messages Messages have segments Segments have fields (concepts) with structure and content further defined by a data type

22. V2 and Data Provenance Given the difference in purpose, some of what is explicit in documents is not carried in messages,.e.g., who created a segment of a message. Authorship is not a concept available for every segment Some “source” concepts supported in specific segments, e.g. “Responsible Observer”: Definition: When required, this field contains the identifier of the individual directly responsible for the observation (i.e., the person who either performed or verified it). In a nursing service, the observer is usually the professional who performed the observation (e.g., took the blood pressure). In a laboratory, the observer is the technician who performed or verified the analysis.

23. Support Team and Questions Please feel free to reach out to any member of the Data Provenance Support Team: Initiative Coordinator: Johnathan Coleman: jc@securityrs.comjc@securityrs.com OCPO Sponsor: Julie Chua: julie.chua@hhs.govjulie.chua@hhs.gov OST Sponsor: Mera Choi: mera.choi@hhs.govmera.choi@hhs.gov Subject Matter Experts: Kathleen Conner: klc@securityrs.com and Bob Yencha: bobyencha@maine.rr.comklc@securityrs.combobyencha@maine.rr.com Support Team: –Project Management: Jamie Parker: jamie.parker@esacinc.comjamie.parker@esacinc.com –Use Case Development: Atanu Sen: atanu.sen@accenture.comatanu.sen@accenture.com –Harmonization and Standards Development Support: »Alex Lowitt: alexander.s.lowitt@accenturefederal.comalexander.s.lowitt@accenturefederal.com »Atanu Sen: atanu.sen@accenture.comatanu.sen@accenture.com »Perri Smith: perri.smith@accenturefederal.comperri.smith@accenturefederal.com –Support: Lynette Elliott: lynette.elliott@esacinc.com and Apurva Dharia: apurva.dharia@esacinc.comlynette.elliott@esacinc.com apurva.dharia@esacinc.com