HHS Introduces New AI Transparency Rule for Healthcare Tech Firms

HHS unveils a transformative rule enhancing health tech transparency, mandating AI disclosure. Effective 2024, it sets the bar for certified tools, fostering innovation and patient-centric healthcare.

The US Department of Health and Human Services (HHS) has introduced a new rule to safeguard data interoperability and patient access in the healthcare sector. Notably, the rule encompasses a pioneering provision, establishing transparency requirements specifically tailored for AI in health software.

Under this initiative, developers of clinical decision support and predictive tools, certified by the agency’s Office of the National Coordinator for Health Information Technology, are mandated to enable a limited set of identified users to access information.

Steven Posnack, deputy national coordinator for Health Information Technology, emphasised that the regulations surrounding health clinical decision support software and predictive tools are designed to enhance transparency and mitigate risks in the industry.

The HHS's HTI-1 rule, a significant leap in the regulatory landscape, achieves several key objectives:

Establishes unprecedented transparency requirements for AI and other predictive algorithms within certified health IT

Adopts the United States Core Data for Interoperability Version 3 as the new baseline standard within the ONC Health IT Certification Program, effective January 1, 2026

Revises information-blocking definitions and exceptions to facilitate information sharing, introducing a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement

Implements the 21st Century Cures Act’s mandate, requiring developers of certified health IT to report specific metrics as part of their participation in the certification program.

Micky Tripathi, PhD, national coordinator for Health Information Technology, commenting on the immense public feedback and participation in the HTI-1 process, said, "Guided by the HTI-1 final rule, the imminent HTI-2 proposed rule, and extensive initiatives, ONC persistently advances its crucial mission to establish the digital infrastructure of healthcare.”

The ONC-certified health IT, supporting care delivered by over 96% of hospitals and 78% of office-based physicians nationwide, positions the United States at the forefront of digital healthcare transformation.

The rule's requirements are set to take effect at the end of 2024, marking a pivotal step toward a more transparent, interoperable, and patient-centric healthcare ecosystem.