Record Lifecycle Event-Oriented Standards. Presentation to S&I DPROV Community Gary L. Dickinson 11 December 2014
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1 Record Lifecycle Event-Oriented Standards Presentation to S&I DPROV Community Gary L. Dickinson 11 December 2014
2 Approved in 2004 Foundational Standard ISO Trusted End-to-End Information Flows Reviewed by DPROV on 20 November Link to presentation Year Type Conformance Criteria? 2004 Informative No 2014/15 Revision Normative Yes 11 December 2014 Record Lifecycle Event Oriented Standards 2
3 Basic Paradigm Actions and Record Entries Occurrence Act/Action Taken Thus Retention Persistent Record Entry Originated Then Interchange (Copy of) Persistent Record Entry Extracted Subset or 11 December 2014 Record Lifecycle Event Oriented Standards 3
4 Record Lifecycle Event-Oriented Progression of Standards 2004 ISO Trusted End-to-End Information Flows 2007 HL7 EHR Interoperability Model DSTU 2008 HL7 CDA R2 Implementation Guide for EHR Interoperability DSTU 2008 HL7 EHR Lifecycle Model DSTU 2009 HL7 Records Management/Evidentiary Support Functional Profile (of EHR-S FM R1.1), R ISO/HL EHR-S FM R ISO/HL PHR-S FM R Record Lifecycle Events using HL7 Fast Health Interoperable Resources (FHIR) 2014 ISO Re-usable Component Strategy for Use Case Development (based on S&I Simplification) Today s Presentation 11 December 2014 Record Lifecycle Event Oriented Standards 4
5 ISO/HL7 Standard Year Type ISO Trusted End-to-End Info Flows Lifecycle Events CCs? 2004 Inform 15 N Rev Norm 27 Y Scope/Appli cability Any System $ $165/ISO $200/ANSI HL7 EHR Interop Model 2007 DSTU N/A Y EHR System HL7 free HL7 CDAR2 IG for EHR Interop HL7 EHR Lifecycle Model HL7 Rec Management/Evidentiary Support FP ISO/HL EHR System FM R2 ISO/HL PHR System FM R1 HL7 Record Lifecycle Events on FHIR 2008 DSTU N/A Y 2008 DSTU 16 Y Rev Inform 27 Y 2009 Inform N/A Y Rev Norm 27 Y EHR or Intermediary EHR System EHR System 2014 Norm 24 Y EHR System 2014 Norm N/A Y Rev Norm 27 Y PHR System HL7 free HL7 free HL7 free HL7 free ISO TBD HL7 free ISO TBD New Norm 27 Y Any System HL7 free 11 December 2014 Record Lifecycle Event Oriented Standards 5
6 1st Question What is Interoperability? Not seeking new definition, rather wisdom of others Surveyed ~100 US and International Definitions of Interoperability Coming to Terms White Paper (2007) Lead: Pat Gibbons, Mayo Clinic Conclusion: key aspects of interoperability include Exchange (technical)* Use (semantic)* Process: as integral to patient, process (work) and information flow * IEEE, December 2014 Record Lifecycle Event Oriented Standards 6
7 Next Question What is EHR(S) Interoperability? What are the characteristics (properties) of EHR/EHRS interoperability? How might we measure and show achievement of EHR/EHRS interoperability? Hence: HL7 EHR Interoperability Model DSTU (2007) 11 December 2014 Record Lifecycle Event Oriented Standards 7
8 Key Record Lifecycle Event Pre-Cursor Standard HL7 EHR Interoperability Model Spreadsheet Sections (Rows 3-130) 1. Health(care) Delivery 2. Health(care) Acts 3. Act Record 4. Act Record Attributes 5. Health Record 6. Patient Encounter Record 7. Patient Summary Record 8. EHR Interoperability 11 December 2014 Record Lifecycle Event Oriented Standards 8
9 Key Record Lifecycle Event Pre-Cursor Standard HL7 EHR Interoperability Model Columns A. ID B. Assertion/Characteristic C. Elaboration D. Abstract Attribute E. Example F. Use Case Example G. Legal Record Requirement? H-L. Conformance Criteria M-O. Stakeholder Assurance P. Standards Reference Q. EHR-S FM Reference R. Conformance Clause S. Progression T-U. CDA R2 Reference Profile (DRAFT) 11 December 2014 Record Lifecycle Event Oriented Standards 9
10 Next Question How does CDA R2 Measure Up? Regarding one HL7 implementable Standard (CDA R2), how might we measure it with regard to applicable EHR/EHRS Interoperability characteristics? As posited by the HL7 EHR Interoperability Model? Both for use as: Transient (exchange) artifact; and Persistent (EHR record) entry? Hence: Implementation Guide for CDA Release 2: Reference Profile for EHR Interoperability DSTU (2008) 11 December 2014 Record Lifecycle Event Oriented Standards 10
11 Key Record Lifecycle Event Pre-Cursor Standard CDA R2 IG for EHR Interoperability Not considered: HL7 v2 or v3 messages, FHIR (As measured in 2008: 51 of 56 applicable EHR interoperability characteristics are met by HL7 Clinical Document Architecture Release 2.) 11 December 2014 Record Lifecycle Event Oriented Standards 11
12 Next Question EHR Lifespan/Lifecycle? What are the characteristics (properties) of EHR records in terms of lifecycle events (within lifespan): At their source: point of origination? At their update: point of amendment? At their attestation: point of completion, validation, signature? At other key points in their lifespan? How might we ensure EHR records have these characteristics? Hence: HL7 EHR Lifecycle Model DSTU (2008) 11 December 2014 Record Lifecycle Event Oriented Standards 12
13 Key Record Lifecycle Event-Oriented Standard HL7 EHR Lifecycle Model Sections 1. Background 2. Purpose 3. Objectives 4. Health(care) Delivery 5. The Health(care) Act 6. The Act Record 7. The Act/Act Record Paradigm 8. The Act Record Interchange Paradigm 9. Events in the Act Record Lifecycle 10. EHR Lifecycle Event Initiators 11. Description of EHR Lifecycle Events 12. System Roles in the EHR Lifecycle 13. Audit and Traceability 14. Conformance Criteria 11 December 2014 Record Lifecycle Event Oriented Standards 13
14 Next Question EHR System Functionality? How might we ensure trusted management of EHR records (by EHR systems) throughout their lifespan, including at each record lifecycle event? Hence: HL7 EHR System Functional Model Release 2 (2014), Record Infrastructure Section 11 December 2014 Record Lifecycle Event Oriented Standards 14
15 Key Record Lifecycle Event-Oriented Standard HL7 EHR System Functional Model Sections OV Overarching CP Care Provision CPS Care Provision Support POP Population Health AS Administrative Support RI Record Infrastructure RI.1 Record Lifecycle and Lifespan TI Trust Infrastructure 11 December 2014 Record Lifecycle Event Oriented Standards 15
16 EHR Record Lifecycle/Lifespan Dimensions of End-to-End Flow Record Lifespan 1. Within Single System Starting at point of origination, in Source System, OR Starting at point of receipt, in Receiving System Ending at point of deletion 2. Across Multiple Systems Starting at point of origination, in Source System Traversing one or more Points of Exchange Ending at point of deletion, in each System 11 December 2014 Record Lifecycle Event Oriented Standards 16
17 Record Lifespan End-to-End Within Single System Record Lifespan Start Intervening Record Lifecycle Events (0 to many) End Source System (1) Originate/Retain Record Entry Receiving System (9) Receive/Retain Record Entry (2) Amend (3) Translate (25,4) Verify, Attest (5) View/Access (6) Output/Report (7) Disclose (8) Transmit (10) De-Identify (11) Pseudo-nymize (12) Re-Identify (13) Extract (14,15) Archive, Restore (17,18) Deprecate/Retract, Re-Activate (19,20) Merge, Unmerge (21,22) Link, Unlink (23,24) Place, Remove Legal Hold (26,27) Encrypt, Decrypt (16) Destroy (16) Destroy 11 December 2014 Record Lifecycle Event Oriented Standards 17
18 Record Lifecycle Event-Oriented Requirements Implementation 2004 ISO Trusted End-to-End Information Flows 2007 HL7 EHR Interoperability Model DSTU 2008 HL7 CDA R2 Implementation Guide for EHR Interoperability DSTU 2008 HL7 EHR Lifecycle Model DSTU 2009 HL7 Records Management/Evidentiary Support Functional Profile (of EHR-S FM R1.1), R ISO/HL EHR-S FM R ISO/HL PHR-S FM R Record Lifecycle Events using HL7 Fast Health Interoperability Resources (FHIR) 2014 ISO Re-usable Component Strategy for Use Case Development (based on S&I Simplification) 11 December 2014 Record Lifecycle Event Oriented Standards 18
19 Basics Record Entry and FHIR Resources An EHR System manages a persistent EHR comprising Record Entries for One or more provider organizations, One or more individual practitioners, and Many patients An EHR comprises Many Record Entry instances A Record Entry instance may comprise One or more FHIR Resource instance(s) With signature bindings 11 December 2014 Record Lifecycle Event Oriented Standards 19
20 Next Question FHIR Implementation? How can EHR Record Lifecycle Events be captured by systems implementing HL7 Fast Health Interoperable Resources (FHIR)? For transient (exchange) artifacts? For persistent (EHR record) entries? Hence: HL7 Record Lifecycle Events using FHIR (2014) FHIR Resource Worksheet Vocabulary (code/value set) Worksheet 11 December 2014 Record Lifecycle Event Oriented Standards 20
21 Volunteers Needed Ready to Contribute? 11 December 2014 Record Lifecycle Event Oriented Standards 21
22 ISO Trusted End-to-End Information Flows Contact/Links Gary L. Dickinson Director, Healthcare Standards, CentriHealth Co-Chair, HL7 EHR Work Group Co-Facilitator, HL7 EHR Interoperability Work Group Lead, US Standards and Interoperability (S&I) Framework Simplification Work Group (+1) HL7 EHR Interop Wiki: 11 December 2014 Record Lifecycle Event Oriented Standards 22
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