The U.S. Department of Health and Human Services finalized a rule Monday that removes 14 health-technology certification requirements and revises seven others, narrowing the compliance work required of software developers in the federal certification program.
The rule, known as HTI-5, leaves 39 of the program’s 60 certification criteria unchanged. HHS projects more than $1.5 billion in regulatory cost savings. That is the department’s estimate, not money already saved by hospitals, nursing homes or software customers.
The changes affect the Office of the National Coordinator for Health Information Technology’s certification program, which evaluates capabilities of health IT products. They are not an announcement of a new nursing-home staffing standard or a change in Medicaid reimbursement rates.
In its final-rule overview, ONC said it removed or reduced longstanding requirements involving functions already well established in the market or requirements it considers an obstacle to innovation. The 39 unchanged criteria include new and revised requirements adopted in the earlier HTI-4 rule on electronic prior authorization and real-time prescription benefits.
The agency’s criteria table lists removals involving family health history, care plans, patient health information capture and certain older application-access functions. Other criteria, including transitions of care and clinical information reconciliation, are revised rather than removed.
Those changes have different implementation dates. The table places removal of family health history and patient health information capture requirements on January 1, 2027, while the transition-of-care revision is listed for January 1, 2030. Several other changes are tied to the final rule’s effective date. The announcement therefore does not mean every listed requirement disappears immediately.
ONC is also scaling back requirements for real-world testing plans and results and reducing reporting under its Insights program. The agency said it is retaining the measure covering use of FHIR bulk-data access. FHIR is a standard for exchanging health information through software interfaces.
HHS said the changes are intended to let developers devote more resources to their products instead of compliance. In its October 26 announcement, the department said ONC plans additional proposals involving interoperability standards, application programming interfaces and certification conditions. Those future proposals are separate from the rule finalized Monday.
One closely watched part of the earlier proposal remains unsettled: information blocking. HHS said comments on the proposed information-blocking changes remain under consideration. The final announcement should not be read as finalizing those proposed changes to electronic health-information access and use.
JBizNews Desk | Washington, D.C.
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