A new bill aimed at calling off the FDA on over-regulation of medical apps is taking some heat. It seems some industry experts feel the bill won’t accomplish what drafters of the bill intended.
The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, introduced earlier this month by Sens. Angus King (I-Maine) and Deb Fischer (R-Nebraska), seeks to clarify the extent to which the U.S. Food and Drug Administration can regulate health IT. Its sponsors say the bill would prioritize the FDA's attention to technologies that pose the greatest health risk, rather than giving the agency broad authority over "low-risk health IT" and thus hindering innovation.
But Bradley Merrill Thompson, a Washington, D.C.-based attorney who advises the mHealth Regulatory Coalition, calls the proposed bill a "meat cleaver" that would, if passed into law, do a lot of damage, particularly to clinical decision support apps.
"The PROTECT Act (would declare) all such mobile apps unregulated regardless of risk," he said in an e-mail exchange with mHealth News. "That is a colossally bad idea, both for patients who would be put at risk, but also for (an) industry that would be dragged down by apps that don't work and destroy the credibility for the industry."
"What we need is a more refined approach that distinguishes high-risk apps from low-risk and allows the FDA to continue its role with high-risk apps," Thompson said. "No one yet has come up with the right conceptual approach for distinguishing clinical decision support apps based on risk, and in my opinion we ought to continue to work with the experts at the agency to develop that more nuanced parsing. It is not the right time for legislation."
Thompson said the proposed legislation is similar to the SOFTWARE Act of 2013, proposed last October in the House by U.S. Rep. Marsha Blackburn (R-Tennessee). Both, he said, look to curb the FDA's regulatory powers by deregulating what legislators feel is less risky health IT, such as electronic health records, scheduling software and wellness apps. That would theoretically enable the health IT industry to continue with new innovation and care improvement.
Thompson says both pieces of legislation go too far in the other direction, freeing mHealth technology that needs to be regulated.
"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain stand-alone software used for such things as guiding therapeutic decision-making," he said. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program."
In response to the PROTECT Act, Thompson created a six-page document highlighting software that would be removed from FDA regulation. They include:
1. Apps and other software that guide untrained users to make very complex medical decisions, such as consumer-use melanoma apps, sports concussion injury apps, drug dose calculators and disease managers for patients
2. Software used in a setting that doesn't give a doctor sufficient time to analyze the software's veracity, such as emergency care predictive analytics software and hospital patient monitoring software
3. Software that takes a complicated calculation and produces a result without revealing how that result was reached, such as a radiation dose calculator or burn victim fluids assessment software
Thompson called the drafters of both the SOFTWARE Act and the PROTECT Act to task for, basically, FDA-bashing. In particular, he said the PROTECT Act "suffers from a number of factual weaknesses, claiming that (the) FDA is imperialistically expanding its regulatory scope when, in fact, the agency is trying to do just the opposite."
"The agency is trying to reduce the territory it regulates through such avenues as the (mobile medical app) guidance and the exercise of enforcement discretion," Thompson said. "The findings paint (the) FDA as some sort of innovation killer when, in fact, (the) FDA has been trying very earnestly over the last couple of years to identify ways to encourage innovation in health information technology."
The PROTECT Act has so far found support from health IT vendors like athenahealth, IBM and McKesson, as well as the Software & Information Industry Association and the Newborn Coalition.
"As these technologies develop, it's critical to implement a clear, risk-based framework that would protect patient health and ensure that FDA rules are appropriately targeted to support and not stifle innovation," Sen. King said in a statement. "The PROTECT Act would provide important regulatory clarity that will safeguard patient safety, make the health care sector more efficient, and allow businesses across Maine and the nation to continue developing groundbreaking ideas."
Sen. Fischer added in a press release that overregulation is already holding entrepreneurs and job creators back in Nebraska and around the U.S.
"While economic growth remains sluggish, it's critical we prevent these costly and time-consuming bureaucratic hurdles from hurting one of the fastest growing sectors of our economy – technology," Fischer said. "The PROTECT Act increases regulatory efficiency over health IT to promote innovation, expand consumer access to information, and improve patient safety."
The question of whether the FDA should be regulating mHealth has a long history, and it came to a head last year when the FDA, after more than two years of study, released its final guidance document on the regulation of mobile medical apps.
Prior to that release, a coalition of roughly 120 health IT stakeholders had asked the government to delay the FDA's final guidance due to concerns about competing interests between the FDA, the ONC and other agencies caught up in HIT regulation. That group urged officials to wait until a workgroup created by the FDA Safety Innovation Act of 2012 finishes its review of the HIT regulatory framework.
That FDASIA workgroup completed its review, also in September, and recommended that the FDA move forward with its guidance. The FDA did so just a few weeks later.