Responding to criticism that the U.S. Food and Drug Administration's regulatory approval process is lagging behind software development cycles, the FDA is standing behind the timeframes its takes the agency to review and approve mobile medical applications. Speaking at a HIMSS14 pre-conference symposium, FDA senior policy advisor Bakul Patel told the audience that in 80 percent of the cases the agency has met the statutory 90-day timeframe under the 510(k) process. 

Patel, who is the primary author of the FDA's final guidance on mobile medical applications released in September 2013, argued that the regulatory agency's oversight is "risk-based" and focused on a small subset of apps that present the greatest risk to patients. He said that under a "narrowly tailored approach" the vast majority of apps do not require active FDA oversight because they do not meet the definition of medical device under the federal Food, Drug and Cosmetic Act. 

And, for those apps that do meet the definition of a medical device but pose minimal risk to consumers, Patel asserted that the FDA will exercise "enforcement discretion"--meaning the regulatory agency will not enforce requirements under the Federal Food, Drug and Cosmetic Act.

"That's what we've done with our final guidance [on mobile medical apps]. We're limiting our focus and oversight on things that really matter," said Patel. "We're really focusing on the EKGs of the world."

To date, the FDA has reviewed more than 100 mobile medical apps, including remote blood pressure, heart rhythm and patient monitors, as well as smartphone-based ultrasounds, EKG machines and glucose monitors. Last year, the regulatory agency testified before Congress that on average it has taken 67 days for the FDA to review mobile medical apps.

Nevertheless, Congress is turning up the heat on the FDA and its oversight of mobile medical apps. Two pieces of legislation seeking to amend the Federal Food, Drug and Cosmetic Act and limit the FDA's regulatory authority have been introduced in the U.S. House of Representatives and U.S. Senate--the SOFTWARE Act and PROTECT Act, respectively. 

Earlier this month, Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) co-sponsored the PROTECT Act to bring "clarity to FDA’s regulatory process to focus on products that pose a legitimate risk to human health" and to create a "more effective, risk-based framework boosts patient safety by prioritizing FDA’s attention to technologies that pose the greatest health risk."

Both the SOFTWARE Act in the House and the PROTECT Act in the Senate would exempt so-called "health software" and "clinical software" from FDA oversight. For its part, the PROTECT Act would make the National Institute of Standards and Technology the federal agency with oversight responsibility for technical standards used by clinical software.

"At the agency, we want to promote innovation," said Patel. "By the same token, we also want to protect patient safety and promote patient engagement. They're all equal goals and equally important." 

In a HIMSS14 panel session scheduled for Tuesday, Feb. 25, Patel and senior executives from the U.S. Federal Communications Commission and Office of the National Coordinator for Health IT will discuss a FDASIA-mandated report to Congress on a risk-based regulatory framework for health IT that is expected in the first quarter of 2014. Among other topics, the upcoming report will cover clinical decision support software which wasn't addressed by the FDA's final guidance on mobile medical apps last year. 

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