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Publication Request

Publication Request

1. Published Name of the Standard for which request is being made

2. Standards Material/Document

Normative

3. Date of Request

Apr 10, 2020

4. Use Period

5. Reason for extension, timeline, and actions

6. Original Publication Date

7. End date of the current STU period

8. Length of the requested extension

9. Review Process

10. HL7 Work Group making this request and date

EHR Work Group

10a. Requesting WG Date

Apr 07, 2020

11. URL of approval minutes

https://confluence.hl7.org/download/attachments/34439638/EHR%20WG%20Minutes%2020200407.docx?version=1&modificationDate=1586526789025&api=v2

12. HL7 Product Management Group

12a. Management Group Date of Approval

13. URL of approval minutes

14. Is the artifact ready for final publication?

Yes

15. If not ready, please describe remaining steps.

N/A

16. Tool name used to produce the machine processable artifacts in the IG

N/A

17. The name of the “IG artifact” within the context of the above mentioned tool.

N/A

18. Balloted Name of the standard for which request is being made

HL7 Electronic Health Records - System Functional Model, Release 2.1

19. Requested name for published standard

HL7 Electronic Health Record System Functional Model, Release 2.1

20. If CMET, list IDs balloted

N/A

21. Project Insight Number

1381

22. Document Realm

EHR/PHR System Functional Models and Profiles

23. Ballot cycle in which the document was successfully balloted

2019-JAN

24. Results of that ballot (following reconciliation activities):

24. Results of that ballot (following reconciliation activities):

(not needed for errata, STU extension, or unballoted STU update)

25. Affirmative

44

26. Negative

0

27. Abstentions

77

28. Not Returned

15

29. Total in ballot pool

136

30. Date on which final document/standards material was supplied to HQ

Apr 10, 2020

31. URL of publication material/ SVN repository

Emailed to Lynn Laakso on 2020-03-10

32. Publishing Facilitator

Michael Van Der Zel

33. Special Publication Instructions

Not that computable artifacts should have limited access - to HL7 members only.

34. URL of ballot reconciliation document

http://www.hl7.org/documentcenter/public/ballots/2019JAN/reconciliation/recon_ehrs_fm_r2.1_n1_2019jan.xls

35. Has the Work Group posted its consideration of all comments received in its reconciliation document on the ballot desktop?

Yes

36. Substantive Changes Since Last Ballot?

No

37. Product Brief Reviewed By

EHR WG Co-Chairs

38. Date Product Brief Reviewed

Apr 10, 2020

39. Has the Product Brief changed?

Product Brief

Product Brief

40. Family

EHR

41. Section

EHR Profiles

42. Topic

Attachments

43. Please Describe the Topic

Functional Model

44. Product Type

Functional Model

45. Parent standard

N/A

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

49. Description

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.

Targets

Targets

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:

50. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Payors

51. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems, HIS

52. Providers

Healthcare Institutions (hospitals, long term care, home care, mental health)

53. Benefits

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.

55. Development Background