Senate bill imposes limits on FDA regulation of apps, software

Industry response positive, but AMIA wants focus on health IT safety, says Doug Fridsma.

The Senate health committee on Wednesday approved a bill that would exempt low-risk medical software and mobile apps from regulation by the Food and Drug Administration, so as not to stifle innovation by developers.

In a March 9 executive mark-up session, the committee passed by voice vote the bipartisan Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), designed to limit and clarify the FDA’s role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and clinical decision support software.

The MEDTECH Act (S. 1101) will “make sure that uncertainty regarding the definition of medical devices, which dates all the way back to 1976, doesn’t deter companies from innovations such as Fitbits or watches that help people keep up with their health,” said Sen. Lamar Alexander (R-Tenn.), chairman of the committee.

“If you’re trying to lose weight and are hoping to use a helpful tool like the Weight Watchers application on your iPhone to count calories or a Fitbit watch to log the steps you take, this bill will encourage companies to develop these sorts of products free from unnecessary FDA oversight and red tape,” Alexander added.

Industry response to approval of the legislation was generally positive. Health IT Now commended the Senate committee for approving the bill—a similar version was passed last year in the House of Representatives as part of the 21st Century Cures Act.

“We are pleased to see the bipartisan support for S. 1101 and we encourage the Senate to consider this integral piece of legislation,” said the organization in a written statement. “Congressional action on this issue will allow the Administration to focus its limited resources, staff and expertise on ensuring the safety of new medical technologies that pose the highest potential risk to patients, and will promote a new era of medical innovation that will improve care and lower costs. We look forward to working with both chambers of Congress to ensure a bill addressing this issue reaches the President’s desk this year.”

However, while the American Medical Informatics Association praised the Senate committee’s passage of the MEDTECH Act, the group called the legislation prohibiting FDA regulation of EHRs “incomplete” and urged Congress to put additional focus on health IT safety.

“Now that both the House and the Senate have reached an agreement on the limitations of what the FDA can regulate, we must have an honest discussion about how to ensure health IT is safe and effective,” said AMIA President and CEO Douglas Fridsma, MD.

“As a way to address pre-market barriers to innovation, we agree with the approach taken by MEDTECH, but we are concerned the legislation is incomplete,” Fridsma added. “The legislation is silent on how the safety and effectiveness of health IT should be managed absent regulatory oversight, despite our growing awareness of how even benign functionality can harm patients.”

Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who supports the MEDTECH Act, argues that the uncertainty with regard to the scope of FDA regulation has meant that many developers have needed to shelve promising projects because they couldn’t tell investors whether the products required regulatory clearance or not.

“Compliance with FDA requirements, both premarket as well as quality system requirements, is a major driver in the cost of developing software,” contends Thompson, who serves as general counsel for the Clinical Decision Support (CDS) Coalition—which includes software developers, patient advocacy organizations, clinical societies, providers, and payers. “Not knowing such an important factor has scared off many investors.”

When it comes to decision support software, Thompson acknowledges that there are many factors impacting the risk that a piece of software represents, including the diseases at issue, the role of the software, the ability of the user to access the underlying data and clinical logic, as well as the sophistication of the end user.

“Figuring out where to draw the lines is admittedly a difficult task,” he says. “Part of FDA's dilemma is trying to regulate a fast-moving industry. Innovation in this space is amazing, but that also presents a challenge for FDA in that the software they look at today may be quite different from the software developed six months from now. They simply don't know how to deal with the constant change.”

For its part, an FDA spokesman in response to a query said that the regulatory agency does not comment on proposed or pending legislation such as the MEDTECH Act.

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