The Trump administration's top health IT official on Tuesday said privacy concerns, while important to consider, shouldn't stand in the way of a proposed interoperability rule from the HHS' Office of the National Coordinator for Health Information Technology.
"There's been a huge marketing campaign on the risks of this data," ONC chief Dr. Donald Rucker said during keynote remarks at the agency's 2020 annual meeting in Washington, D.C. "But I don't think we can let the risks—that are real—prevent all of us, as citizens and members of the United States, from having all of our data."
HHS Secretary Alex Azar on Monday also voiced frustration over stakeholders he said were "fiercely" pushing back against the proposed rule.
"Scare tactics are not going to stop the reforms we need," he said during keynote remarks.
The ONC's interoperability proposal, released in early 2019 and yet to be finalized, has received pushback from provider and technology groups alike, who have cited issues related to patient privacy.
The concern, shared by groups like the American Hospital Association and the American Medical Association, centers on the proposal's focus on allowing patients to download their health data using smartphone apps by linking up an app of their choice to a provider's electronic health record system.
Epic Systems Corp. on Monday issued a statement arguing that by requiring health systems to share patient data with third-party apps, the ONC's proposal "inadvertently creates new privacy risks." Politico reported last week that Judy Faulkner, Epic's CEO and founder, said the EHR giant might sue HHS if the department finalizes the interoperability proposal without addressing concerns over privacy protections.
Epic in a statement told Modern Healthcare that they want to work with HHS to "fix the proposed rule and make sure it's a good one" and that the company has "no interest in pursuing a lawsuit."
Developers of health apps aren't held to the same privacy standards—such as HIPAA—that providers and payers are required to follow. That means those third-party apps could conceivably sell patient data or use it to target advertisements.
To address that possible gap in oversight, healthcare stakeholders have asked the agency to implement some type of privacy program—such as a certification, framework or guidelines—for developers of apps and application programming interfaces to follow. APIs are the technology used to link IT systems, such as EHRs, with apps.
But while Rucker said the ONC's rule will take steps to help ensure patients are aware of how their data will be used, he stressed that the agency's vision is for patients to choose what apps to use. APIs are designed to be "straightforward" and require "minimal effort" to implement, and he said providers shouldn't be required to vet them.
Deven McGraw, chief regulatory officer at data-sharing startup Ciitizen and former deputy director for health information privacy at HHS' Office for Civil Rights, voiced support for the ONC's interoperability proposal during a separate panel discussion on patient privacy. Improving patient privacy is important, but she said it's on technology companies to build patient trust and on Congress to pass privacy legislation.
"The policymakers in Congress should look at this and lay some guardrails," she said of privacy concerns related to health apps. "All of the folks who are complaining that, oh, they're not covered by HIPAA—I'm listening for their voices on encouraging Congress to step up and get into this space and do this without too much delay."
According to Rucker, the benefit of requiring providers to adopt standardized APIs will not only open the door for app developers to create patient-facing technologies, but also creates an opportunity to develop better provider-facing technologies, such as tools that help to automate administrative processes and ease burdensome reporting.
"There should be an app economy, and the entrepreneurial juices of the country should be allowed to be unleashed in healthcare to give patients choice on that," he said Tuesday.
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