Can the current regulatory structure in place within the federal government keep pace with health IT without inhibiting innovation, or not?

A difficult question to answer, indeed, particularly in light of what Farzad Mostashari, MD, the national coordinator for health IT called a “seismic shift” underway in three aspects of healthcare: how it’s paid for, how it’s delivered, and how patients engage in their own care.

In terms of setting standards for electronic health records and the work ONC has done with other agencies, such as NIST, to harness technology as an enabler, “I think we’ve been, on balance, in the right place,” Mostashari said. “Sometimes regulations don’t stifle innovation.”

Not all of Mostashari’s fellow panelists at Politico’s Tech Intersection: Healthcare of the Future event Tuesday morning were quite so optimistic. 

Joel White, executive director of the Health IT Now Coalition said that the current regulatory structure “needs a re-think. We need to come up with a new regulation strategy to keep pace,” White added, pointing to an estimated 97,000 mobile medical applications as creating an environment with near infinite technologies to regulate.

There’s a push-and-pull scenario in which some people and healthcare organizations are excited about innovation while others are assuming the “you’re not dragging me there” stance, said Politico health editor Joanne Kenen, one of the event’s moderators.

Mostashari explained that one of the things holding back the stereotypical West Coast Bay Area entrepreneurs is that they don’t understand regulations particular to healthcare. “The rules are much more enabling than they realize,” Mostashari said.

Christy Foreman, director of the FDA Office of Device Evaluation, said that a “lack of standards and interoperability holds back innovation.”

When asked by Politico health care reporter Brett Norman, also a moderator, when the FDA will issue its eagerly-anticipated guidance on mobile apps and devices, Foreman answered that it “should be out by October.”

Evoking the meme that rules, regulations and especially standards can be “oxygen for innovators,” Mostashari said “there will be this ecosystem,” built on top of medical knowledge and patient data that fuels innovation and emerges with Stage 2 of meaningful use. “There is a whole ecosystem that will come out. There’s just a lot more oxygen in the environment today.”
 

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