Dive Brief:
- The HHS’ Office of the National Coordinator for Health Information Technology finalized a sweeping rule on Wednesday aimed at boosting data interoperability and patient access, including a provision to establish transparency requirements for artificial intelligence in health software.
- Under the rule, developers of clinical decision support and predictive tools certified by the ONC should enable a limited set of identified users to access information like the value of the intervention, how it should be used, known risks or inappropriate uses, and how the tool is maintained and updated. The requirements will go into effect at the end of next year.
- The final regulation also included a number of information blocking updates and exceptions, including for actors sharing data under the TEFCA framework — which just went live this week.
Dive Insight:
Artificial intelligence’s role in the healthcare sector has become an increasingly significant issue for the industry, as lawmakers and experts mull the potential benefits to drug discovery, medical documentation and data analysis.
But some are concerned the rapid rollout of new tools — including generative AI products that aim to reduce the number of healthcare workers’ administrative tasks — could perpetuate inaccuracies or bias.
The new regulations surrounding health clinical decision support software and predictive tools aim to boost transparency and mitigate risk in the industry, said Steven Posnack, deputy national coordinator for health information technology, during a Wednesday media briefing.
“It's been a long time in the making to have an update to this certification criterion to be reflective of technical evolution in industry, as well as in response to some of the new challenges posed by artificial intelligence and machine learning and other types of large language models and the like,” he said.
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, or HTI-1, rule also added a number of provisions for interoperability and data sharing.
The rule adopts an updated standard for interoperability — the United States Core Data for Interoperability Version 3 — starting at the beginning of 2026. The industry is currently using Version 1, and the regulation creates a “predictable step” for the sector to move toward and build new services and connectivity, Posnack said.
The standard includes updates that expands the data elements and classes that can be exchanged, which the ONC said will help promote equity, reduce disparities and promote public health data interoperability.
The rule details some exceptions to information blocking regulations too. Actors who don’t fulfill information sharing requests in any matter besides the Trusted Exchange Framework and Common Agreement, or TEFCA, aren’t considered to be information blocking.
TEFCA, which sets a governance framework and technical requirements for nationwide data exchange, went live with five Qualified Health Information Networks this week. It marked a significant milestone in the yearslong effort, HHS leaders said. But the framework needs industry buy-in to succeed.
“We make it a kind of clear set of guidelines and approaches associated with this information blocking exceptions for those actors to be responsive, and to either make that electronic health information accessible, exchangeable or usable through TEFCA, in order to promote its use and provide convenient incentives for TEFCA participation,” Posnack said.
