HHS finalizes interoperability, algorithm transparency final rule

Photo: Al David Sacks/Getty Images

The U.S. Department of Health and Human Services, through the Office of the National Coordinator for Health Information Technology, today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule.

This follows the release of the HTI-1 proposed rule in April. The HTI-1 final rule advances patient access, interoperability and standards, said HHS.

WHAT'S THE IMPACT?

One of the areas of focus is algorithm transparency, with the agency saying the rule establishes first-of-its-kind transparency requirements for artificial intelligence and other predictive algorithms that are part of certified health IT. ONC-certified health IT supports the care delivered by more than 96% of hospitals and 78% of office-based physicians around the country, said HHS.

The administration expects this regulatory approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision-making and to assess such algorithms for fairness, appropriateness, validity, effectiveness and safety.

The final rule also adopts the United States Core Data for Interoperability (USCDI) Version 3 as the new baseline standard within the ONC Health IT Certification Program as of January 1, 2026. Developers of certified health IT will also have the ability to move to USCDI v3 sooner.

USCDI v3 includes updates to prior USCDI versions focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities and support public health data interoperability, said HHS.

The rule revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).

In addition, it implements the 21st Century Cures Act's requirement to adopt a Condition of Certification – the "Insights Condition" – for developers of certified health IT to report certain metrics as part of their participation in the Certification Program. These metrics, said HHS, will give more insight into how certified health IT is used in support of care delivery.

The HTI-1 final rule is posted at HealthIT.gov/HTI-1 and will be submitted to the Office of the Federal Register in the coming days.

THE LARGER TREND

Interoperability continues to improve among hospitals, ONC said earlier this year. As of 2021, 88% of hospitals engaged in electronically sending and obtaining patient health information, through either querying or electronically receiving summary of care records. 

The number of hospitals engaged in integrating patient health information into EHRs grew by 40% since 2017, with about three-quarters of hospitals engaging in this activity in 2021.

These trends show progress in interoperable exchange, found ONC, though rural hospitals are still lagging.
 

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com