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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

Feb 27, 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

Orders & Observations

10a. Requesting WG Date

Feb 27, 2020

11. URL of approval minutes

https://confluence.hl7.org/display/OO/OO+Conf+Call+Minutes+-+Main+Call%3A+February+27%2C+2020

12. HL7 Product Management Group

FMG: 2020-03-04
CDA Management Group: 2020-03-11
v2 Mgmt Group: 2020-03-13

12a. Management Group Date of Approval

Mar 13, 2020

13. URL of approval minutes

https://confluence.hl7.org/display/V2MG/2020-03-13+v2MG+call

14. Is the artifact ready for final publication?

Yes

15. If not ready, please describe remaining steps.

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

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

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

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2

19. Requested name for published standard

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2

20. If CMET, list IDs balloted

21. Project Insight Number

1512

22. Document Realm

Universal

23. Ballot cycle in which the document was successfully balloted

2020-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

56

26. Negative

1

27. Abstentions

53

28. Not Returned

11

29. Total in ballot pool

121

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

31. URL of publication material/ SVN repository

http://www.hl7.org/documentcenter/public/wg/orders/UDI_Pattern_20191031%20-%20Final.docx

32. Publishing Facilitator

Hans Buitendijk

33. Special Publication Instructions

34. URL of ballot reconciliation document

http://www.hl7.org/documentcenter/public/ballots/2019MAY/reconciliation/recon_hl7_ig_udi_r2_n1_2019may.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

Orders & Observations

38. Date Product Brief Reviewed

39. Has the Product Brief changed?

Product Brief

Product Brief

40. Family

Cross-Paradigm

41. Section

Clinical and Administrative Domains, Implementation Guides

42. Topic

Attachments

43. Please Describe the Topic

Device Identification

44. Product Type

45. Parent standard

HL7 v2, HL7 CDA C-CDA, HL7 FHIR

46. Parent Standard Status

47. Update/replace standard

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 1

48. Common name/search keyword

UDI Pattern R2
"HL7 XParadigm IG: UDI Pattern, R1",
Unique Device Identifier,
UDI, Pattern,
HL7 Version 3 Cross Paradigm Implementation Guide: Medical Devices and Unique Device Identification (UDI) Pattern, Release 1

49. Description

The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients. This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR. The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).

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

Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

51. Vendors

EHR, PHR, Equipment, Health Care IT, HIS

52. Providers

Emergency Services Local and State Departments of Health Medical Imaging Service Healthcare Institutions (hospitals, long term care, home care, mental health)

53. Benefits

- Creates clarity on where and how to document UDI related information in the base standards
- Enables implementation guides that require access and/or exchange of UDI related information to consistently define how to communicate it

54. Implementations/Case Studies

EHRs Certified to ONC’s 2015 Certification Edition
US FDA GUDID
IHE Patient Care Device Technical Framework

55. Development Background

The UDI Pattern was initially defined as a harmonization document. As the definitions solidified in the respective standard, the guidance was put in normative, cross-paradigm specification to ensure a higher degree of conformance.
With Release 2, updates resulting from HL7 v2.9 and HL7 FHIR R4 were included.