FDA regulating software, what a dumb idea.

Kevin MD: “There’s a storm brewing around the regulation of medical apps. The FDA has been skirting the issue for too long and it’s having detrimental effects on the potential for such apps. Recent FDA hearings have revealed that the agency is watching the apps stores for potential alarms and that they are drafting guidance. Whatever that means.”

The thought of the FDA regulating software is a bit of a joke. That’s like allowing a Software Developer to prescribe medications. Sure, we could do it, but it wouldn’t be nearly as effective as someone trained to deal with it.

How in the world would the FDA propose to evaluate applications? Here’s how it would work. They’d start with great intentions. After a while companies would become buddy-buddy with someone responsible for evaluation and before you know it one company has a competitive advantage over another, even if that company is not worthy.

Let the market decide. If Pharmacists, Doctors, and Nurses use the software daily and notice mistakes they’re not going to put up with it for very long. If medical care professionals don’t know enough about their industry to notice a mistake then shame on them. Software, like the human body, is quite simple, yet it can become quite complex. Regulation is not the answer. It will reduce choice and competition in the marketplace, and that’s not a great model for success.