With the release of several proposed rules on Monday, the U.S. Department of Health and Human Services (HHS) outlined new provisions around advancing interoperability and giving patients easier access to their health data, signaling that open APIs and FHIR will be core components.
The Office of the National Coordinator for Health Information Technology finally unveiled its information blocking rule (PDF), which was sent to the Office of Management and Budget for review in September. The Centers for Medicare & Medicaid Services also released a proposed rule (PDF) on Monday morning, which also takes aim at data blocking. The agency is suggesting that Medicaid, the Children’s Health Insurance Program (CHIP), Medicare Advantage plans, and Qualified Health Plans (QHPs) be required to make enrollee data immediately accessible by 2020.
With the proposed rules—which are separate but connected—ONC and CMS officials have outlined their approach to information blocking, the role of application programming interfaces (APIs) in interoperability and the use of FHIR (Health Level Seven’s Fast Healthcare Interoperability Resources) standards.
The proposed rules
The ONC rule, which was mandated by the 21st Century Cures Act, defines exceptions to data blocking and fines that may be associated with the practice. In its proposed rule, ONC is calling on the industry to adopt standardized APIs, specifically FHIR, to help allow individuals to securely and easily access structured electronic health information using smartphone applications.
CMS is proposing to require Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and QHP issuers in FFS programs to implement, test, and monitor openly published FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.
CMS Administrator Seema Verma said the agency is investing in projects with FHIR standards and doubling down on the need for additional standards. “The success of data sharing relies on our ability to standardize on structure and semantics, or a common meaning on medical terms. We took a strong step to make this a reality," she told the crowd at HIMSS. "By identifying the FHIR standard to implement our policies, we are promoting scalable data sharing and a model that supports the flow of information across the entire healthcare system."
During Tuesday morning’s keynote panel, Aneesh Chopra, the former U.S. chief technology officer under the Obama administration and now president of Care Journey, said the ONC and CMS proposed rules would drive interoperability forward and the requirement that stakeholders embrace open APIs and the FHIR standard helps to set up the road map.
“The embrace of FHIR APIs now means that we’re not going to have a Betamax-VHS fight in healthcare,” Chopra said. “We now have an approach to adding more content on the data model.”
The use of FHIR-based standards for APIs can lower healthcare costs and also decreases the burden on physicians by “moving the fax machine out of the doctor’s office,” Verma said. Moving to the FHIR standard shouldn’t result in additional cost to providers, she said.
In the proposed rule, CMS references APIs that enable data to be extracted, or read capabilities, but not APIs that put data into the system or write capabilities, but the agency did signal that it’s an important capability.
“We’re looking at that,” Verma told FierceHealthcare. “Our purpose today was to unleash the data. The claims data, in particular, has a lot of great information and helps to create an understanding of the patient’s record.”
Steven Posnack, executive director of ONC’s Office of Technology, said ONC has proposed, in the information blocking rule, the adoption of FHIR release 2 as a baseline standard requirement, although FHIR release 4 was recently published. Noting that the regulatory process often does not keep pace with innovation, Posnack noted that there would be a subregulatory process to recognize new standards as the FHIR standard evolves.
It was designed to affect as little as possible, said Don Rucker, M.D., national coordinator for ONC.
"The fundamental requirement is providing a FHIR endpoint, and it comes with security mechanisms," he said. "What we’re proposing here is something that is remarkably modern and a remarkably straightforward provision of transparency. There is work involved and processes involved, but this is not a heavily invasive thing, like some of the Meaningful Use provisions.”
ONC and CMS officials also said they were prioritizing the security and privacy of patients’ electronic health records and that will require ongoing focus, as well as ensuring that patients’ information is not misused. Health data belongs to the patients, Verma noted, and patients will need to control who they share their electronic health records with.
“What will happen is apps will develop reputations, and that’s what the consumer market is all about,” Rucker said. “This will allow powerful, pro-consumer markets to develop as opposed to markets geared toward provider convenience, which is what American healthcare is today.”