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Unique Device Identifier (UDI) Implementation Guidance Requirements

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Basics

Unique Device Identifier (UDI) Implementation Guidance Requirements

1238
Ballot - Informative


Domain Analysis Model (DAM)

Supplement to a Current Standard

Details

With the introduction of the Unique Device Identifier (UDI) it is important to enable health IT to exchange the UDI with or without individual components to provide access to implantable device lists, support post market surveillance, perform recalls, provide clinical decision support, and analysis/research. Exchange across the device ecosystem needs to be enabled for manufacturing, utilization, implanting, monitoring, reporting and other administrative and clinical uses (e.g., inventory, invoicing, pricing, and/or other financial transactions). HL7 embarked on an effort to ensure the UDI string, at a minimum, is represented in V2, V3, and FHIR such that implementation guide and profile developers can provide the necessary guidance for the specific use cases of how to apply the standards. This resulted in a white paper, dated November 13, 2014, published by HL7 as 'Harmonization Pattern for Unique Device Identifiers'. HL7 needs to develop further guidance as well, in coordination with other parties, to ensure there is clarity when to communicate UDI information, and if so, how given that use case. See the PSS Word doc for additional scope.


As the FDA and other national authorities mandate the labeling of devices to include UDI and are actively promoting the use of UDI in the information chain to enable recalls, CDS, postmarket surveillance and research in general, there is an increased need to communicate UDI to enable downstream stakeholders to access that information for their purposes. A subset of that information exchange needs to be consistently defined at a national if not global level to ease exchange.



Establish project team under OO to meet regularly to develop requirements - Target: January 2016 Submission of initial DAM to OO for review - Target: 2016 January In 2020 the decision was made to separate the IG content from the DAM UDI DAM Publication - 2021 May UDI DAM - aiming for Sept 2021 Publication UDI IG - Submit for Informative Ballot - Target: 2024 September Ballot UDI IG Published 2024 April


https://wiki.hl7.org/UDI

IHE, FDA, GS1, X12, NCPDP, JIC, IEEE. HSI will help facilitate/coordinate with these organizations.

None

Regulatory Agency, Standards Development Organizations (SDOs),Clinical and Public Health Laboratories; Emergency Services; Local and State Departments of Health; Medical Imaging Service; Healthcare Institutions (hospitals, long term care, home care, mental health),Equipment; Health Care IT


Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project.

UDI

N/A

Don't Know

N/A

No

2021 Sept: TSC approved Informative publication request for HL7 Domain Analysis Model: Unique Device Identification (UDI) , Release 1. 2022 October: OO planning to ballot the IG in the Jan 2023 cycle.
Organization & Realm

Universal

People

Marti Velezis, Bob Dieterle, MaryKay McDaniel, Hans Buitendijk,



Orders and Observations Work Group


Status & Dates

Active

Normative - ANSI Approved

02/05/2016

01/01/2030

2030 Jan WGM/Ballot

01/01/2028

2028 Jan WGM/Ballot

2023 Jan Ballot Cycle Info: INFORMATIVE Ballot Results: Postponed Document Name: HL7 Cross Paradigm Implementation Guide: Unique Device Identifier (UDI), Release 1 2021 May Ballot Cycle Info: INFORMATIVE Ballot Results: Postponed Document Name: HL7 Cross Paradigm Implementation Guide: Unique Device Identifier (UDI), Release 1 2021 Jan Ballot Cycle Info: INFORMATIVE Ballot Results: Postponed Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1- US Realm 2020 Sept Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 1 Negatives to reconcile Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2020 May Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 12 Negatives to reconcile Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2019 May Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 10 Negatives to reconcile Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2018 May Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2018 Jan Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 6 Negatives to reconcile Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2017 Sept Ballot Cycle Info: STU Ballot results: Did not meet basic vote requirements Document Name: HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes; Unique Device Identifier (UDI) Templates, Release 1 - US Realm 2017 Sept Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 26 Negatives to reconcile Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2017 May Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 2017 Jan Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance, Release 1 Submitter: Hans Buitendijk MSc 2016 May Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Domain Analysis Model: Unique Device Identifier (UDI) Implementation Guidance Requirements, Release 1 Requesting alternate ballot title HL7 Domain Analysis Model: Device Data Exchange, Release 1
Approvals

03/10/2016


Not Needed


Not Needed




System Info



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