Last month, the Office of the National Coordinator for Health Information Technology (ONC) finalized its HTI-1 rule. The regulations seek to boost interoperability in the healthcare sector and increase patients’ access to their health data.

While Jill DeGraff had some reservations about HHS’ initial proposal, she believes the department’s finalized rule is a step in the right direction that will improve data exchange for providers, health tech vendors and patients. DeGraff is well versed in the regulatory momentum surrounding information blocking and interoperability and currently serves as B.well Connected Health’s senior vice president of regulatory.

“We are moving towards the elimination of fragmentation and the siloed healthcare experience where data gets locked into legacy infrastructures. Infrastructures should instead support interoperability to create an ever-more connected health ecosystem that can be powered by applications,” she declared.

When the ONC published the final HTI-1 rule, DeGraff said she was pleased to find that the Trusted Exchange Framework and Common Agreement (TEFCA) had been preserved as a voluntary framework.

TEFCA, which was originally outlined in the 21st Century Cures Act, finally went live last month. The initiative seeks to establish a nationwide health information exchange network that shares a common set of principles, terms and conditions to facilitate the secure and seamless exchange of data across disparate health information systems. 

Before the ONC finalized its rule, the agency proposed that if an entity was participating in TEFCA, it had met its information sharing requirements and was therefore exempt from any fines, DeGraff noted.

“We found that to be an extremely troublesome condition because TEFCA was always supposed to be voluntary. We thought it would diminish the independent obligations that FHIR APIs had already established, which significantly prioritize patient access,” she explained.

B.Well, a startup that brings together patients’ health records and helps them navigate their benefits, commented against that aspect of the rule, as did many other healthcare organizations, DeGraff added. 

In an interview with MedCity News last month, former ONC Chief Don Rucker pointed out that TEFCA is built on a “90s-era” IHE document exchange-only interchange protocol that was not built for the computable data formats and programming languages of today’s Internet.

Instead of using TEFCA’s archaic data exchange protocol, patients and other healthcare entities should be able to ask for data using FHIR-based APIs, DeGraff stated. She applauded that the ONC’s final rule allows for that, and she also commended what she called the rule’s “all manners exhausted” exception.

“That exception basically says an organization doesn’t have to take a gazillion different bespoke requests asking for data in funny little formats. As long as they offer at least two manners, and one of those is a FHIR-based option, they have satisfied the requirements,” DeGraff explained.

This not only gives providers clarity about how far they have to go to accommodate patients’ requests, but it also establishes FHIR-based interoperability as the industry’s de facto standard, she declared.

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