The legal implications of mobile health apps and devices

I'm neither a doctor nor a lawyer, but you don't have to have an MD to realize that medical apps are becoming an ever-more-important tool in managing our healthcare choices, costs and overall wellness. In a similar vein, medical accessories to our iDevices could make home medical care cheaper and easier.

Whether you're monitoring your blood sugar, looking up first aid advice or trying to find an emergency clinic, mobile medical apps are going to be huge; that is, they will be if the legal system doesn't stifle innovation in the space. As for hardware -- where are the devices we were promised?

There's very little case law around the liability of medical apps should something go wrong, ditto hardware and regulatory issues. Remember 2009, when Apple brought Johnson & Johnson's folks on stage for them to announce the LifeScan app for glucose monitoring, and then in 2010 when sanofi-aventis showed off the iBGStar? Both products replicate the functionality of existing glucose meters on the market, yet neither one has made it to the approval stage yet. There could be technical hiccups, there could be problems on the marketing front... or maybe there's a liability angle. We're still waiting on the Withings blood pressure cuff, although the iHealth unit has actually shipped -- a notable exception in the realm of iDevice health attachments.

This article from TechNewsWorld raises the point that liability for a medical app has yet to be determined in the courts. Who takes the blame if your first aid app winds up giving you incorrect advice on CPR -- the carrier, the developer or the distributor? Josh McKoon, a Georgia Senator and lawyer at a firm specializing in healthcare legal issues said "they all could be sued." Of course, you can sue anyone, any time. Luckily apps have disclaimers, and in reality anyone who (at this point) is solely dependent upon a smartphone app for their health is likely going to lose a lawsuit.

As the article points out, there are lots of issues at play here. FDA regulations, murky legal rulings, pending litigation: they all make medical apps a legal minefield should something go wrong and your disclaimer provide less-than-adequate coverage. In other words, it's a mess. Medical apps are cranking out all the time, but medical devices you dock with your iOS device, not so much. We'll have to wait and see how case law shapes this emerging market. Read the article from TechNewsWorld for a comprehensive breakdown of where this market is at now, and consider the future up for grabs.

Original Source: http://www.tuaw.com/2011/05/05/the-legal-implications-of-mobile-health-apps-and-devices/