NVLAP Lab Bulletin LB-165-2026

Department of Commerce
National Institute of Standards and Technology
National Voluntary Laboratory Accreditation Program

Issue date: April 24, 2026
Number: LB-165-2026
LAP: Healthcare IT LAP
Subject: Addition of the Health Data, Technology, and Interoperability Final Rules to the HIT LAP

Purpose: The purpose of this bulletin is to notify laboratories in the Healthcare IT (HIT) laboratory accreditation program (LAP) of an update to the language reflected on their scope of accreditation. This bulletin also clarifies the process for verifying competence for future final rule publications by providing instructions for submitting a self-declaration of implementation and documentation to support compliance, starting with the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) 2024 final rules for the HIT LAP.

Background: A HIT laboratory’s scope is updated to reflect a scope expansion when new final rules are published in the Federal Register. Previously, each final rule was added to the scope of accreditation when new ONC Health IT Certification Program (Program) requirements were adopted through rulemaking. NVLAP and ASTP/ONC, as program stakeholders, have determined that it would be more efficient for laboratory scopes to reference the Title, Part, and Subparts within the Code of Federal Regulations that outline all Program requirements. The scope of accreditation will also reference which final rule was last verified while including prior final rules.

Laboratories in the HIT LAP are required to meet all requirements for scope expansions, as specified in this bulletin.

Notice: The Health Data, Technology, and Interoperability (HTI) Final Rules were published in the Federal Register on the following dates:

January 9, 2024: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)

• This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program); makes several updates to certification criteria and standards recognized by the Program; and provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions improves algorithm transparency, supports the advancement of interoperability, enhances health IT certification, and reduces burden and costs for health IT developers and users of health IT.
• ASTP/ONC focused on two strategic objectives: (1) advancing the development and use of health IT capabilities; and (2) establishing expectations for data sharing. This final rule fulfills statutory requirements and aligns with administrative priorities; advances equity, innovation, and interoperability; and supports the access, exchange, and use of electronic health information (EHI). It also promotes responsible development and use of artificial intelligence through transparency and improves patient care through policies that advance standards-based interoperability and EHI exchange

December 17, 2024: Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2)

• This final rule fulfills statutory requirements; advances equity, innovation, and interoperability; and supports the access to, and exchange and use of, EHI. Additionally, it amends information blocking regulations by including definitions related to the Trusted Exchange Framework and Common Agreement (TEFCA) Manner Exception; implements provisions related to the TEFCA, which will support the reliability, privacy, security, and trust within TEFCA; and includes corrections and updates to current regulatory provisions of the ONC Health IT Certification Program.

December 17, 2024: Health Data, Technology, and Interoperability: Protecting Care Access (HTI-3)

• This final rule amends the information blocking regulations to revise two existing information blocking exceptions and establish an additional reasonable and necessary activity that does not constitute information blocking referred to as the Protecting Care Access Exception. It finalizes enhancements to support information sharing under the information blocking regulations and promotes innovation and competition, while ensuring patients' privacy and access to care remain protected. The revisions to the information blocking regulations, including the addition of the new exception finalized in this final rule, will continue to promote innovation and support the lawful access, exchange, and use of EHI, while strengthening support for individuals' privacy and EHI sharing preferences.

August 4, 2025: Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4)

• This final rule adopts new and revised standards and certification criteria to include: 1) minimum standards code sets updates, 2) revised electronic prescribing certification criterion, 3) new real-time prescription benefit criterion, 4) new certification criteria for modular API capabilities, and 5) new certification criteria for electronic prior authorization. ASTP/ONC finalized these criteria to make available Health IT Modules that can enable health care providers to conduct prior authorization transactions using payer APIs established by CMS in the Interoperability and Prior Authorization rule.

The ONC Health IT Certification Program Test Method includes test procedures, test tools and test data and is published on the ONC website.

Based on these rules and the approved test method, NVLAP has updated its HIT LAP to indicate laboratory accreditation scopes as follows:

• This laboratory is accredited to perform the testing activities based on requirements in HTI-4 (2025) and prior final rules as detailed in the subparts below to support 45 CFR Part 170 - Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Program for Health Information Technology; Subpart E - ONC Health IT Certification Program:

Health Data, Technology, and Interoperability (HTI) Final Rules

• 45 CFR Part 170; Subpart B - Standards and Implementation Specifications for Health Information Technology
• 45 CFR Part 170; Subpart C - Criteria for Health Information Technology

For laboratories currently accredited in the NVLAP HIT program, self-declaration to compliance with testing requirements outlined in the HTI-1, HTI-2, HTI-3 and HTI-4 final rules must be submitted in writing (an e-mail request is sufficient) to request the update to the scope of accreditation. With the written request, each applicant must also provide:

• The NVLAP HIT LAP Self-Declaration of Implementation form (April 2026 version), for HTI updates, signed by the laboratory’s authorized representative, with applicable supporting documentation; and
• A current list of key staff, including all testers authorized to perform HIT testing in the laboratory.

Once this information is received, NVLAP will proceed with a documentary review. If this information is determined to be incomplete, follow-up information will be requested. The testing will be assessed during the laboratory’s next onsite assessment.

Questions should be directed to Program Manager Janneth Marcelo at janneth.marcelo [at] nist.gov (janneth[dot]marcelo[at]nist[dot]gov)