HIMSS Calls for Complete Testing Before Finalizing New Requirements in HTI-2 Certification Proposed Rule Response

Citing concerns about requiring the use of Bulk FHIR v2.0 in 2028 before it has been fully tested against all the required use cases, HIMSS called for modest delays in finalizing several proposed certification requirements as part of a public comment response to the Assistant Secretary for Technology Policy’s (ASTP/ONC) Health Information Technology Certification Program.

As part of public comments submitted by HIMSS on Friday Oct. 4 responding to the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability proposed rule (otherwise known as HTI-2), the response from HIMSS focused on Bulk FHIR v2.0 and many of the certification criteria it would support, still being in trial phase.

HIMSS recommended not including new requirements and supporting standards and specifications into final rules until the trial phase had been completed and the new requirements were validated to work properly to support the exchange of health and public health data.

HIMSS also called for a delay in the deadline for implementing new requirements for implementing predictive decision support interventions in certified health IT modules, citing previously raised concerns that the original deadline only allowed 13 months for developers to roll out updates to all their customers. HIMSS didn’t want providers to be negatively impacted if developers didn’t have the resources to update their systems before the Jan. 1, 2025, deadline for the updates.

HTI-2, released by ASTP/ONC on Aug. 5, proposed a variety of new certification criteria for EHRs and health IT modules that would require the use of United States Core Data for Interoperability Version 4 and Bulk FHIR v2.0 starting Jan. 1, 2028.

HIMSS stated its support of the proposed new and revised certification criteria, adoption standards and launch Insights program. These changes will facilitate nation-wide interoperability. However, HIMSS encouraged ASTP/ONC to consider the cost and resources for developers and end users to adopt the proposed changes when finalizing rulemaking.

In addition, HIMSS offered the following insights on other ASTP/ONC proposals:

• HIMSS supported the proposal to create a Protecting Care Access exception to the information blocking rule for providers. The exception would allow providers to information block if sharing the information presented risk of legal retribution to patients or the provider for receiving, providing or aiding a patient in seeking legal reproductive healthcare. HIMSS called for ASTP/ONC to simplify the six required conditions for the exception to be met to ensure that providers acting in good faith to protect their patients are not punished.
• HIMSS supported the concept of a voluntary certification for health IT modules used in public health settings. However, HIMSS called on ASTP/ONC to collaborate with CDC to identify a funding mechanism to aid public health agencies with procurement of certified health IT modules.

HIMSS is encouraged by ASTP/ONC’s proposed steps to deliver nationwide interoperability. HIMSS welcomes an ongoing dialogue with ASTP to digitally transform the healthcare ecosystem of the United States through the power of information and technology.