HCI-DC 2014: Government as facilitator of consensus standards

“You have to be grounded in the things you want to accomplish. It has to be incremental over time,” said Doug Fridsma, MD, PhD, chief science officer and director of the Office of Science & Technology, Office of the National Coordinator for Health IT (ONC), in summarizing his agency’s take on interoperability.

Federal agencies should work as facilitators to consensus standards so the technology supports the policy and vice versa, Fridsma said at the Health Care Innovation Day on Feb. 6, a joint ONC and West Health Institute event.

Interoperability entails not only the ability of two systems to exchange information, but the information to use the data that are exchanged, he said. “You can’t define interoperability in the absence of what you want to do with interoperability.”

Aligning incentives across the healthcare system is one part of spurring interoperability. “Once business drivers are aligned, people will own the problem and solution,” he said.

Fridsma said the electric industry, for instance, uses very few regulations because its players were driven by safety to make sure they have something that works together.

ONC listens to the CMIO, provider and consumer community to solve specific user problems. “We use that to guide standards development organizations,” he said.

Fridsma emphasized that technology always changes and that standards that are developed need to be sensitive to that. The Internet is hardly what people expected years ago when AOL was the largest player, he said. “We have to be humble that we aren’t going to be able to predict the future. We need to take the path of least regret. What the best solution seems like now may be the one that we regret.”

Fridsma added that top-down solutions don’t always work, as evidenced by experiences in Europe.

“We can push for regulatory control, but it’s more effective when there is a pull,” he said.

Speaking from the FDA’s perspective, Jeffrey E. Shuren, MD, JD, director of the Center for Devices and Radiological Health, said they are not looking to build more regulatory requirements for interoperability, but to develop consensus standards and nurture test beds to ensure they can play out in the real world.

Shuren said that testing environments allow for opportunities to experiment with different approaches. “That will drive value proposition and that is where the dollars will follow.”

Incentives are an area in which the FDA is “really moving forward,” he said, noting that last year the agency developed 21 standards for interoperability and now it is reviewing more.

In April, the agency will publish a draft guidance on interoperability with recommendations for medical device development, he said.