HHS releases final interoperability rules

Hospital Safety Insider, March 12, 2020

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By Mandy Roth, HealthLeaders Media

The U.S. Department of Health and Human Services (HHS) has finalized two interoperability rules to give patients direct access to their healthcare data. The first provisions of the rule will impact healthcare systems in as soon as six months.

The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), were announced last year, and the final rules were issued today. They are expected to "empower patients around a common aim—giving every American access to their medical information so they can make better healthcare decisions," according to a release issued by CMS.

The final ONC rule and the final CMS rule are available online.

"Americans will now have electronic access to their health information on their smartphone if they choose," said ONC National Coordinator Don Rucker, MD, during a White House media briefing this morning. "Our rule requires hospitals and doctors to provide software access points—end points, if you will—to their electronic medical record databases so that patients can download these records to their smartphones."

One key deadline for health systems occurs six months from today, said CMS Administrator Seema Verma. "We are changing the conditions of participation for hospitals to ensure Medicare- and Medicaid-participating hospitals are supporting care coordination for patients by sending admission, discharge, and transfer notifications so patients receive a timelier follow up, supporting better care and better health outcomes," she said.

The CMS rule also impacts payers. Starting in 2021, Verma said, "all health plans doing business in Medicare, Medicaid, CHIP, and the federal exchanges [must] share their health data with their patients through a secure standards-based API (application programming interface), which represents the link between the data on various systems and [the] consumer's phone."

The rule also requires payers to make their provider directories publicly accessible through a provider directory API starting in 2021, said Verma. "This will allow innovative third parties to design apps that will help patients evaluate which plan networks are right for them and potentially avoid surprise billing by having a clear picture of which clinicians are in network," she said.

HHS Secretary Alex Azar said he expects the rules to spawn a new era of innovation in healthcare. "We hope to see a whole ecosystem of condition- or disease-specific apps to help patients monitor and improve their health in real time, in part, by using data made available from their electronic health record via an API," said Azar.

Rucker further commented: "We're going to see a growth in patient-facing healthcare IT markets from an entirely new app ecosystem that's going to be fueled by transparency about both product and price. We think this health app economy is going to have new services and we see the smartphone—not just as a smartphone—but as a tool to connect other devices to it."

In a statement issued to HealthLeaders, Verona, Wisconsin, EHR vendor Epic Systems said, "The rule is very important to health systems and their patients, so we will read it carefully to understand its impact before making judgments." Earlier this year Epic launched an initiative to delay the ONC final rule until certain patient privacy issues were addressed. The company marshalled its health system clients to write a letter to Azar to request the delay. In Epic's statement today, among the issues it said it would closely scrutinize was "transparency for patients into companies’ data use and data handling practices.”

During today's media briefing with reporters, Azar said, "I want to emphasize that we're taking these actions while maintaining and strengthening patient privacy protections. Patient privacy should never stand in the way of patient control."

Brent Shafer, CEO of EHR company Cerner, based in North Kansas City, Missouri, also issued a statement to HealthLeaders, saying in part, "Today marks an important milestone in a decades-long pursuit of improving consumers access to their own personal health data and clearing unnecessary hurdles that have stood in the way. The rules announced today will support a seamless and connected health care world were patients are more empowered than ever before."

Mandy Roth is the innovations editor at HealthLeaders.

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