Is the FDA Even Capable of Regulating 21st Century Medical Devices?

The pace of innovation in medical devices is breathtaking. The most exciting developments are in mobile health. One year ago this month, the Food and Drug Administration (FDA) issued its final regulations on mobile medical apps. So far this year, the FDA has approved 23 medical apps that the editors of MobileHealthNews define as “notable.”

The role of the FDA in preventing such apps from reaching patients is of great concern. Mobile technology is so well integrated with other technologies that we now take for granted that FDA regulation of these apps risks giving the FDA power over tools that we’ve used conveniently for years. Many were relieved when the South Korean FDA announced in March that it would not regulate Samsung’s latest Galaxy smartphone!

Well, the whole issue may become irrelevant. Ordinary citizens are hacking medical devices to improve them, ignoring the FDA completely:

Jason Adams, a business-development executive by day and a molecular biologist by training, had never considered himself a hacker. That changed when he discovered an off-label way to monitor his 8-year-old daughter’s blood-sugar levels from afar.

His daughter Ella has Type 1 diabetes and wears a glucose monitor made by Dexcom Inc. DXCM +1.01%  The device measures her blood sugar every five minutes and displays it on a nearby receiver the size of a pager, a huge advantage in helping monitor her blood sugar for spikes and potentially fatal drops. But it can’t transmit the data to the Internet, which meant Mr. Adams never sent Ella to sleepovers for fear she could slip into a coma during the night.

Then Mr. Adams found NightScout, a system cobbled together by a constellation of software engineers, many with diabetic children, who were frustrated by the limitations of current technology. The open-source system they developed essentially hacks the Dexcom device and uploads its data to the Internet, which lets Mr. Adams see Ella’s blood-sugar levels on his Pebble smartwatch wherever she is. (Kate Linebaugh, “Citizen Hackers Tinker With Medical Devices,” Wall Street Journal, September 26, 2014)

It reminds me of the “home-brew” computers that people built at home in the 1970s, which gave rise to PCs. What would have happened to personal computing if some federal regulator had stuck itself into that innovative environment?

Let’s hope the FDA leaves these innovators alone.

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  1. Liam says:

    Do the innovations in reference speak to the extrinsic value of EHRs?