As providers and vendors continue to embrace HL7’s Fast Healthcare Interoperability Resources to share health data, supporters are calling on federal agencies to make the standard a requirement.

Micky Tripathi, manager of the Argonaut Project, an industry-wide effort to accelerate the development and adoption of FHIR, contends that the open health data standard is now mature enough to be leveraged by the Department of Health and Human Services—specifically the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health IT.

“When we started the Argonaut Project less than four years ago on the building blocks created by the SMART on FHIR program, we believed strongly in FHIR and (application programming interfaces), but we were concerned that the standard was too immature,” says Tripathi. “We were especially concerned that FHIR not become an ONC EHR certification requirement before the industry was ready for it.”

However, he observes that the “rapid embrace of FHIR by the industry in three years, from major EHRs to Apple iPhones, has been faster than we could have hoped and is a testament to what can happen with strong industry collaboration and leadership coupled with judicious regulatory action.” As a result, Tripathi believes that ONC and CMS can now “safely build requirements based on FHIR to help give focus to FHIR API implementations across our fragmented healthcare delivery landscape.”

Stan Huff, MD, chief medical informatics officer at Intermountain Healthcare, also would like to see the federal government make FHIR a requirement—but with a caveat.

“If possible, ONC, CMS, FDA and others should require the use of FHIR but not specify a particular version because that would tend to freeze FHIR at its current state, and block future improvements and innovations,” says Huff.

CMS’s final Meaningful Use Stage 3 rule requires certified EHR technology to provide an API through which patient information can be viewed, downloaded and transmitted to a third party. However, of all the federal agencies, arguably the one most suited to codify FHIR is ONC—that’s because the agency’s 2015 Edition of Health IT Certification Criteria requires certified EHRs to demonstrate the ability to provide a patient-facing app access to the Common Clinical Data Set via an API.

ONC’s 2015 Edition didn’t specify that the API has to be FHIR, but going forward, the agency could make the standard a requirement if it wants to, says Tripathi.

Earlier this month, ONC released data on the growing use of the FHIR standard. Specifically, the agency found that 32 percent of health IT developers are using FHIR Release 2 to meet 2015 Edition certification requirements. ONC’s assessment is that the United States “might be at a turning point” when it comes to the adoption and implementation of FHIR.

Also See: FHIR standard adoption in the U.S. is at a turning point

“ONC should safely feel like they can now say to the industry that it’s time to use a FHIR API,” adds Tripathi.

Nonetheless, the agency is not willing to discuss any hypotheticals on the regulatory front or any potential plans it might have for the interoperability standard.

“ONC supports the use of FHIR, but it’s not going to comment on making it a requirement,” said an agency spokesman. “With respect to the standard’s maturity, FHIR Release 2—on which the Argonaut specifications are built—progressed to a point where this version was stable and specified enough to be deployed in production to support certain uses.”

At the same time, the ONC spokesman emphasized that it’s “important to remember that FHIR Release 3 was published over a year ago, and FHIR Release 4 is expected in the coming months—so, like the WiFi standard, we expect FHIR to keep being refined and improved so that it will address new business needs as well as the overall complexity of healthcare.”

Regarding this point, Chuck Jaffe, MD, CEO of HL7, observes that it’s precisely because of the fact that FHIR continues to evolve that makes any potential effort on the part of the federal government to codify the standard so difficult.

“If they mandate FHIR, they’ll have to mandate it at a certain point in time,” says Jaffe. “I don’t know how the government could word the regulatory language without specifying a version of FHIR. What version they require is important so it doesn’t put the brakes on the really good stuff that’s coming down the pike. And I don’t know how they get it into regulation without stifling the advancements.”

Yet, Huff maintains that “people need to expect and plan for continued evolution and improvement in the FHIR standard—it is pretty stable, but it continues to change, and that is a good thing.”

Josh Mandel, MD, chief architect for Microsoft Healthcare and a strong supporter of FHIR, points out that ONC has sent a proposed rule to the Office of Management and Budget for review that seeks to implement certain provisions of the 21st Century Cures Act, including requirements for health IT developers under the agency’s certification program.

According to Mandel, ONC’s proposed rule—which has not yet been released for public comment—could modify the 2015 Edition certification criteria to comply with the 21st Century Cures Act’s interoperability provisions, among them a mandate from Congress requiring certified HIT to have an API that enables health information to be accessed, exchanged and used “without special effort” and to provide access to “all data elements of a patient’s electronic health record,” as permitted by law.

“We've seen great convergence, even from ‘functional requirements’ like the patient access provisions in the 2015 certification rule,” comments Mandel. “Over time, there's an opportunity to start layering on more specific technical requirements. But we need to keep in mind that there will always be a gap between well-standardized-and-growing ‘core data’ definitions and the long tail implied by the Cures provision for ‘all data elements.’ ”

He concluded that “regulations will need to ensure that standards like FHIR can be used to capture core data with increasing specificity, while there’s still a strong functional mandate to expose the entire record, beyond what is well standardized.”

