We’ve talked about the FDA regulating mobile apps several times here on Smart Phone Health Care.
And now, a new debate on this topic has surfaced — Who should regulate mHealth apps?
Currently, the question is should the FDA’s Center for Devices and Radiological Health be in charge of regulation, or should an entirely new department be created? Some believe that special attention needs to be given to mHealth, including Rep. Mike Honda. He is introducing a bill called “Healthcare Innovation and Marketplace Technologies Act,” which proposes creating the “Office of Mobile Health.” Several sources state that this bill will “ensure that competition, innovation, and entrepreunership in the mobile app market” won’t be subject to the “regulatory issues” that are usually applied to “traditional, non-software device types.”
As is expected, there are mixed feelings on this, but according to The FDA Law Blog, this “proposed bill is likely to be welcome by many mobile app developers – in particular the same or startup ones who still wonder why their products would be subject to FDA regulatory oversight at all.”
The article finishes with this:
So the question still remains as to whether medical mobile apps should be regulated by FDA’s CDRH, another office independent CDRH, or simply an office separate from FDA altogether.”
They option they failed to mention though, is the possibility of no regulation at all. Regulating mHealth apps could very well stifle creation. If there are a whole bunch of rules and regulations put in place, many would-be app creators may not want to go to the effort of getting approved, and some ideas may never go further. It’s definitely something to think about. Personally, if the only options are to be regulated by the CDRH, or have an mHealth office created, the mHealth office would be more preferable. Then there would be more focus on getting apps and devices regulated quickly and efficiently, and hopefully more willingness to work with app creators. And, if it is true that competition and innovation won’t be affected negatively, it might not the worst thing ever. We’ll see.
