Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) took their legislative fight to limit the FDA's authority on mHealth to the American people in a Feb. 15 opinion piece on the editorial page of USA Today.
Coming just days after the two senators introduced the PROTECT Act bill in the Senate seeking to amend the Federal Food, Drug, and Cosmetic Act so that clinical and health software would not be subject to regulation, Senators Fischer and King appealed directly to the American electorate in their newspaper column. What consumers and innovators need, they say, is a new framework for FDA oversight.
Entitled "FDA's slow process hurts innovation," the op-ed argues that software development cycles move faster than the existing regulatory approval processes. What the senators don't tell you is that 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. Over the past few years, on average, it has taken 67 days for the FDA to review mobile medical apps, which is far below the statutory 90-day timeframe under the 510(k) process.
The senators also write in their column that the FDA's "arcane, one-size-fits-all framework defies reason" and that "it isn't hard to figure out that smartphone apps shouldn't be subject to the same oversight as MRI machines." Absent from the senators' editorial is the fact that the focus of the FDA's oversight is only on a small subset of mobile medical apps that present the greatest risk to patients.
The regulatory agency's narrowly tailored approach does not require active FDA oversight of many apps that do not meet the definition of medical device under the the Federal Food, Drug and Cosmetic Act. And, the FDA has clearly stated that it will exercise enforcement discretion--meaning it will not enforce requirements under the Federal Food, Drug and Cosmetic Act--for the majority of mobile apps as they pose minimal risk to consumers.
However, alleged "heavy-handed moves" by the FDA to "slow down the development" of low-risk health technology, including mobile wellness apps that the senators specifically call out in their editorial, shouldn't be worried about.
I highly recommend the position paper put out last week by the CDS Coalition and mHealth Regulatory Coalition regarding the PROTECT Act sponsored by Senators Fischer and King. In the document, the two coalitions make the case that the proposed legislation would remove from FDA regulation high-risk clinical decision support (CDS) software, mobile medical apps and other medical device functionality currently falling under the oversight of the regulatory agency.
Does that sound alarming? You bet it does, especially when you consider the list of high-risk CDS software that would no longer be regulated by FDA under the PROTECT Act. What we're talking about are apps and other software that "guide untrained users to make very complex medical decisions," including consumer melanoma apps, drug dose calculators and disease managers for patients.
But, the regulatory fallout isn't just restricted to consumer apps. Emergency care predictive analytics software and hospital patient monitoring software used by physicians would also no longer be regulated by FDA if the PROTECT Act were to be passed into law.
Ironically, the senators end their op-ed stating that (by passing the PROTECT Act) Congress should send the message that entrepreneurs "don't need costly corporate counsels and hired guns on K Street to navigate the FDA and open the right political doors." That statement comes from lawmakers representing powerful special interests in the health IT industry who are more concerned with enabling companies to cash in on an exploding mHealth market, unencumbered by regulations, than protecting patient safety.
Nevertheless, patient safety must always come first. In the end, the so-called PROTECT Act would only serve to protect app developers in their zeal to make a quick buck free of government regulation. Senators Fischer and King have made their views known to the American people. Now, it's your turn to voice your concerns to legislators in Congress. mHealth is too important an area of healthcare to be left to Washington's power politics. - Greg (@Slabodkin)