Catching up in the back file of articles is another in Bradley Merrill Thompson’s (Epstein Becker Green) series in Mobihealthnews on how the FDA is biased, by its very structure, against novel healthcare technology even if low risk. He further reflects on what’s truly novel, and what’s not. ‘Novel’ means Class III clearance and potentially millions of dollars. to gain it. He reckons that 80 percent of new digital health technology doesn’t qualify as ‘new’ in a regulatory sense–it may be ingenious in transferring the color reading of a test strip to, for instance, a smartphone and an analytic back end. All the new technology has to do is to demonstrate equivalence to the clunky traditional test–in other words, incremental improvement. What he’s worried about is the 20 percent that don’t fit any FDA classification, in particular software that automates what professionals do, repurposing non-healthcare technology for healthcare use (e.g. videogames for ADHD) or algorithms that automate what’s been done manually through a different method. The social cost is that the most in need, who would benefit from novel health tech that cuts cost and improves quality for individuals and populations (that old Triple Aim), will forever be blocked from having it by regulation. “We need a new paradigm where new technology is quickly evaluated for potential risk, and placed promptly into an appropriate regulatory category.”
There are certainly regulatory parallels ex-US. Much more here to ponder for your Weekend Reading.
Previously and related by Mr Thompson: Avoiding the FDA health IT-medical device regulatory trap for general IT companies, FDA, new technology approval and the Ossification Tango