Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in mHealthIntelligence, in “Will Telehealth and mHealth Fulfill Their Potential in 2019?” by Eric Wicklund.
Following is an excerpt:
With 2019 on the doorstep, healthcare leaders are looking for clues as to what the coming year will hold for telehealth and mHealth. And while most of the experts have long since tossed out the time-worn “tipping point” terminology, they do see a big year ahead for connected health. …
A Big Year Ahead For the FDA and Digital Health
Bradley Merrill Thompson, a partner with Epstein Becker Green and one of the nation’s top digital health experts, says the US Food & Drug Administration will be on many minds as the agency works to implement a precertification program for software.
“We are expecting the program to be released in draft form sometime before the end of this year, and … in 2019 they will pilot it with nine volunteer companies,” he says. “The goal then is to put together a finished program by the end of 2019. In a sense, this is both very good and very bad.”
“The very good is that FDA is at least promoting this new program on the basis that it will significantly accelerate market introduction of new digital health products,” Thompson says. “It is focused on software-only medical devices – no hardware included. FDA’s goal – and we will have to see if they truly meet this goal – is to exempt more of these products from premarket review, and for those that need to undergo premarket review, accelerate that process significantly. But until we see it in action, we really have no idea just how much it will accelerate the process.”
Thompson also sees more FDA interest in AI technology, as it will have the ability to monitor safety and effectiveness and remove the technology from the marketplace if it’s not up to par.
But there are costs and disadvantages, he says.
“In terms of cost, FDA has – in moments of candor – acknowledged that the excellence appraisal that will be required for companies that want to participate in this program will be very rigorous,” Thompson says. “FDA offers the view that the vast majority of companies now would not pass the standards required for organizational quality. So companies that want to participate are going to have to invest in new quality-related processes. If companies hate GMPs – as many software companies do—they will certainly hate this excellence appraisal process. Another cost is the required monitoring of the products over their lifecycle, and sharing that data with FDA.”
In disadvantages, Thompson says: “FDA says that it’s only willing to do this if it can have much greater power post-market to both monitor the performance of software products, and direct the software vendors to take corrective action. I’ve been doing FDA work for almost 35 years, and while companies get frustrated if their products don’t get approved quickly, that frustration is nothing compared to the angst that companies feel when FDA requires them to conduct a recall that the company doesn’t believe is appropriate. But that’s what FDA is asking for: heighten powers to order a recall whether the company agrees are not.”
“The other main disadvantage is heightened transparency,” he adds. “Transparency sounds lofty, and how can anyone argue that transparency is not good? But the simple fact is that medicine and software are both very complicated, and it is easy for people who are not well versed in both to misunderstand data on the performance of software products. If data on the software performance has to be released not just to FDA but the public, and if the FDA and the public do not have the context to understand what is going on that the company has, there will be many folks who overreact to what they perceive to be safety signals.”
“At any rate, this is high-stakes stuff,” Thompson concludes. “If FDA proceeds with it, it will change the digital medical device industry profoundly. And the process will be interesting, because FDA seems to be suggesting that it does not need congressional authority to proceed. But as an attorney, I can’t fathom that position. The statute is very specific about the current 510(k) process, and changes to that cannot be implemented without Congress amending the legislation.”