FDA is Not the Bogeyman

There has been a lot of talk and, frankly, a lot of uninformed fear about possible forthcoming regulations from the U.S. Food and Drug Administration (FDA). As FDA explores its role in the changing world of health technology there has been a lot of talk about how the agency may require certification of every cell phone or every laptop that may be used in some way for provide medical assistance. Fears that FDA regulation may cause innovation in healthcare technology to come to a standstill are just plain silly. Medical devices that are used in providing healthcare to an individual are, and should be, regulated.

Over the past couple of years a lot of entrepreneurs have looked at the growth of healthcare costs, now above a trillion dollars a year, and decided to try and get a piece of the action. Many have decided to jump into the telemedicine market. An especially attractive part of telemedicine is mHealth with low entry requirements to create a new application for a digital phone. This Spring ATA sponsored a webcast with mobihealthnews where they reported on a recent survey that identified over 6,000 applications for health and wellness for digital phones. My guess is that the number is probably over 7,000 by now.

This is a welcome development and a great sign of progress but the new entrants need to understand the realities of healthcare and medicine. It is naive to assume that medical devices will not be regulated. It is not the same as creating a new video game.

I don’t believe increased scrutiny by FDA of health applications will appreciably slow development of the quality devices and applications that will really impact the delivery of health care. In fact, regulatory approval will help gain public and clinical acceptance of these new innovations as FDA approval implies a stamp of approval. However, it will slow down those with innovations that may not be appropriate.