35. Has the Work Group posted its consideration of all comments received in its reconciliation document on the ballot desktop?
36. Substantive Changes Since Last Ballot?
37. Product Brief Reviewed By
EHR WG Co-Chairs
38. Date Product Brief Reviewed
Apr 10, 2020
39. Has the Product Brief changed?
43. Please Describe the Topic
44. Product Type
45. Parent standard
46. Parent Standard Status
47. Update/replace standard
HL7 Electronic Health Record System Functional Model, Release 2.01
48. Common name/search keyword
EHR-S, EHR-S FM, EHR, FM
Incremental update to the EHR System Functional Model (EHR-S FM), encompassing all the EHR functions and conformance criteria found in its predecessor Release 2, and incorporating:
1) Changes to the Record Infrastructure Section to accommodate three additional record lifecycle events (verify, encrypt, decrypt) and ensure compatibility with FHIR Core R4 Record Lifecycle Event Implementation Guide (2019) and recent updates to ISO 21089:2018, Trusted End-to-End Information Flows;
2) Changes to the Glossary Section to support the full set of record lifecycle events (now 27 in total) and corresponding descriptions;
3) Previously identified updates included in the EHR-S FM R2.01 errata version;
4) Changes to the Conformance Chapter to align with characteristics and requirements of recent EHR-S FM R2 based Functional Profiles, including FPs developed for the US Meaningful Use (EHR Incentive) Program, 2011/2014 and 2015 Editions;
5) Domain analysis (models and artifacts) companion to EHR system development and implementation.
6) Adding a header in the TI section on clinical model services (DCMs, CIMI models, FHIR, HL7 template) comparable to TI.4 Standard Terminology and Terminology Services.
These are categories of potential users, implementers, or other interested parties such as those that are indicated on the Project Scope Statement under “Stakeholders/Vendors/Providers”. Select those that are applicable, or suggest others:
Regulatory Agency, Standards Development Organizations (SDOs), Payors
EHR, PHR, Health Care IT, Clinical Decision Support Systems, HIS
Healthcare Institutions (hospitals, long term care, home care, mental health)
1) Establishes an extensive set of functions and related conformance criteria (requirements) for use in EHR system design, development, implementation, support and procurement.
2) Supports EHR System conformance and certification programs.
3) Includes US and international requirements for EHR system functionality.
4) Supports interoperability functions of EHR systems to exchange health information.
5) Includes a formal specification for management of health records, at rest and in motion, for the full lifespan of record entries, including lifecycle events occurring within the lifespan.
6) Is closely aligned with ISO/HL7 16527 Personal Health Record System Functional Model (Release 1 in 2016 and now Release 2 in 2020), also ISO 21089 Trusted End-to-End Information Flows (2018).
7) Passed HL7 ballot: as a Draft Standard for Trial Use (2004), as a full normative Standard (Release 1, 2007). Passed HL7, ISO and CEN ballot as a full normative and international Standard (Release 1.1, 2009), then designated ISO/HL7 10781. Passed HL7 and ISO ballot again (Release 2, 2014/15).
54. Implementations/Case Studies
ISO/HL7 10781 EHR-S FM - particularly previous Releases 1.1 and 2, have been utilized/referenced in a number of national/regional EHR adoption programs, including: Argentina, Australia, Brazil, Chile, Columbia, Finland, Italy, Ireland, Japan, Korea, Mexico, The Netherlands, Peru, Sweden and the US. These releases of the Standard have also been translated, in whole or part, into Spanish, Portuguese and Japanese.