HHS proposes new rules for Cures Act implementation to move the needle on interoperability, algorithm transparency

The federal government's healthcare tech arm released proposed provisions (PDF) of the 21st Century Cures Act and enhancements to the certification program for health IT technology.

The U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) refers to the new planned regulation as Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing, or the HTI-1, proposed rule.  

The proposal includes the implementation of the electronic health record reporting program, modification in information blocking regulations and revising of the ONC Health IT Certification Program. Provisions were designed to increase interoperability, transparency, trust in predictive decision support interventions and overall use of electronic health information. The proposed rules will enter a public comment period until June 20.

“A lot of the work that we’ve done is trying to improve the transparency to users of algorithms that may be made available to them through certified electronic health record technology,” said Micky Tripathi, Ph.D., ONC national coordinator, at a press conference. “Additionally, we're seeking public comment on several requests for information to inform potential future rulemaking around enhancements to information, sharing the adoption of standards and the certification of health information technology."

Tripathi said the HTI-1 rule is a key component of ONC’s progress in support of the care continuum comprised of four priorities: building the digital foundation of health record information, making interoperability easy, promoting information sharing and ensuring proper use of digital information and tools.

Individual proposals within HTI-1 itself focus on increasing interoperability and information sharing while improving algorithm transparency in order to increase the use and improve equity of care. Notable proposals include expanding exceptions in the information blocking regulations to support information sharing.

The United States Core Data for Interoperability version 1 will be given an expiration date to usher in version 3 as a standard within the certification program. Under the certification program, health IT functionality standards will be updated and implementation specifications will be adopted. A total of 15 discrete changes have been proposed.

ONC collaborated with federal partners including the Agency for Healthcare Research and Quality, the Food and Drug Administration (FDA), the HHS Office for Civil Rights, the U.S. Department of Veterans Affairs and the Federal Trade Commission to ensure that all guidance was in alignment.

“We’ve worked very closely with the FDA—as well as other federal partners—but certainly very closely with the FDA on making sure that we’ve got alignment and complementary authorities and guidance that we’re giving to the industry on this,” Tripathi said.

While the ONC maintains authority over electronic health records, the FDA oversees software and related algorithms while determining the safety and efficacy of such tools. ONC designed its proposed regulations to ensure that information regarding algorithms is available to users within EHR systems.

This way, Tripathi said, “the information allows users to assess the applicability of an algorithm that comes through an EHR system for a particular patient population or clinical circumstance.” ONC’s proposed rules function as a governing process determining which algorithms are available within an EHR system.

When it comes to quality, Tripathi says the ONC may help make determinations of the efficacy of algorithms further down the road depending on coordination with other governing authorities.

“From our perspective in relation to EHRs, we wanted to make sure that we have a consistent definition of what an algorithm is, and we’ve explicitly included health equity considerations in what needs to be made available to users through the requirements that are in the regulation itself,” Tripathi said. “That helps a user know where there might be issues that could lead to potential discriminatory output.”

These proposed rules are congruous with HHS Section 1557, which addresses anti-discrimination in algorithms, according to Tripathi. HHS’ Office of Civil Rights crafted the section to prohibit algorithms that discriminate, an issue HTI-1 addresses further downstream by providing tools to avoid algorithms becoming discriminatory.

ONC is developing two additional proposed rules also addressing interoperability and information blocking. The first would disincentive healthcare providers who have committed information blocking and the second would build on policies adopted in the Cures Act by increasing information sharing.

ONC will be hosting information sessions regarding HTI-1 in the coming weeks.