FDA’s EHR Guidance Provides Welcome Clarity to Device Community

Michelle Hoiseth, Corporate Vice President for Real-World Data Services, PAREXEL

Michelle Hoiseth, Corporate Vice President for Real-World Data Services, PAREXEL

Medical device clinical trial practitioners might be under pressure to further raise their game, as evidenced by recent U.S. Food and Drug Administration (FDA) guidance and other moves.

“There is a trend in more [FDA enforcement] rigor in devices,” says Michelle Hoiseth, corporate vice president for Real-World Data Services at PAREXEL.

Hoiseth sees a number of factors driving this new regulatory scrutiny. She cites advances in data collection technology and the lack of predicate devices on the market for “some of the real areas of innovation” in medical device development.

When it comes to new data management challenges, Hosieth views the situation as less about the increased volume and more about how to handle new data sources. Many in the medical device industry were hesitant to go too far down the road crafting new data management practices, in part because the FDA had not offered much direction, she says. The fear? A manufacturer and/or a contract research organization might confidently craft a solution, only to find the FDA going down a different road, putting their solution in peril in terms of meeting agency requirements and expectations.

It appears the FDA has listened, Hosieth says. The new guidance on use of electronic health records (EHRs) is “huge,” she notes. She believes industry will use it in a research context when it comes to handling rare disease products and label expansions, among others.


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The new guidance “gives us a roadmap to get through those kind of territories,” Hosieth says. “I’m really loving the general direction of the guidance,” she adds.

For Hosieth, it’s worth noting what the current guidance doesn’t cover as much as what it does cover. It doesn’t significantly address observational research, postmarketing research, or the use of EHRs to evaluate feasibility.

“It really focuses on sourcing EHR data in a true clinical research context,” Hosieth explains. What the guidance does focus on “gives us intra-operability, but in a practical way.”

The guidance provides important direction on data transmission and control, and other important areas. It allows stakeholders to “step boldly and say ‘okay, however we construct [our compliance program], we’ll have a dialogue with the FDA [and] know we’ll be in the right direction,’” Hosieth says.

Author: Michael Causey