As the industry waits for a landmark rule aimed at opening up access to patient data, Donald Rucker, M.D. said Wednesday that regulators are challenged with balancing data privacy and transparency.
The proposed interoperability rule will be coming out "relatively soon," Rucker, who is head of the Office of the National Coordinator for Health IT (ONC), said during a Health IT Advisory Committee meeting Wednesday.
Many have speculated that the rule will be released during the Healthcare Information and Management Systems Society conference in March.
A year ago, ONC, which is part of the Department of Health and Human Services (HHS), proposed an interoperability and information-blocking rule that defines the demands on healthcare providers and electronic health record (EHR) vendors for data sharing. The rule also outlines exceptions to the prohibition against information blocking and provides standardized criteria for application programming interface (API) development.
HHS officials say the rule, which promotes the use of application programming interfaces (APIs), will help bring healthcare into the modern app economy.
The proposed rule has created an industry rift—EHR vendor Epic, many health systems, and some privacy groups have voiced strong opposition to the rule. About 60 health systems signed an opposition letter circulated by Epic CEO Judy Faulkner that was sent to Azar. The letter cited risks to patient privacy and intellectual property if the rules are finalized now.
Meanwhile, newer technology entrants to healthcare such as Apple and Microsoft, some EHR companies like Cerner and consumer advocates are backing the rule. Google Health's David Feinberg, M.D. has met with HHS officials about the rule, Politico reported.
Rucker was asked by members of the Health IT Advisory Committee about the status of the rule.
"There are complicated issues balancing the various interests of the American public to get a good deal in healthcare, to have transparency, to do this in a way that doesn’t prevent innovation and allows vendors to be able to build products in a practical way and draws the right balance on protecting privacy, yet addressing what is ultimately the biggest issue, which is simply the vast amount of healthcare costs that are out there and lack of patients having agency."
As the lobbying battle over the rule goes on, Politico reported Tuesday that ONC's rules gained a rare endorsement from a hospital system: the University of California, San Francisco. The "nation needs ONC's proposed regulations," the leaders of UCSF and its health system wrote to HHS Secretary Alex Azar, according to Politico.
"Maybe it's had the unintended benefit of getting people to focus on how this all will play out and part of a broader dialogue about what we want to do with technology in our lives," he said.