Telehealth, telemedicine and mobile or wireless health are growing rapidly, at least in terms of devices and services being announced and offered. Aside from reimbursement, the largest area of uncertainty for vendors is potential regulation, particularly by the Food and Drug Administration. The FDA’s definition of a medical device is quite broad and most telehealth, telemedicine and mobile health products would appear to meet at least the literal language of the definition. Bradley Merrill Thompson is an exceptionally well-informed and thoughtful attorney specializing in FDA regulation and he has written a series of excellent posts regarding FDA and mobile health. The most recent one focuses on the likely future of such regulation. (MobiHealth Post)
Mr. Thompson identifies two primary dimensions affecting FDA regulatory decisions: protection against adverse events (patient safety) and freedom to innovate (desire to encourage products that can improve health outcomes). How these two are balanced and how that balance changes over time depends on forces impinging on the FDA like Congress, industry itself, media and the culture or mindset of the FDA. Industry obviously generally wants the least onerous regulatory regime consistent with encouraging customer confidence in the safety of products and creating some barrier to new entrants; Congress just always wants to look like its doing something; the media tend to focus on safety issues, which are more sensational than new, beneficial products and today at least, the FDA, because of recent issues, is in a mode of trying to prove that it is on top of safety issues. Mr. Thompson doesn’t address this, but we suspect that the FDA is also becoming a tool to slow the introduction of expensive new products which tend to always add to total health spending.
Mr. Thompson notes that while some in industry want to try to avoid the FDA altogether, that is not likely to happen. There are legitimate patient risks associated with more and more IT use. Information can be inaccurately collected or transmitted and algorithms can make mistakes or be poorly written. To the extent that patients use mobile health to self-manage care, that also has risks. Mr. Thompson recommends and is involved in having the industry proactively identify and propose a regulatory scheme that balances the ability to quickly get new products to market with legitimate safety concerns. What is most important is that there is a very clear regulatory pathway that provides certainty to companies and their funding sources.