Mobile Medical Applications: Titanic Chairs

I've often believed that the number of idioms and quirky phrases describing a particular characteristic, event, or circumstance is mostly equivalent to its frequency in everyday life.

Something is easy = piece of cake, easy as pie, easy peasy lemon squeezy, a particular quip about neanderthals made popular by GEICO which I won't write for fear of copyright infringement, etc.

My prime example for today's post is when we become too focused on the details, the minutiae, to see the entirety of a scenario. Phrases along these lines include a wonderful list of phrases, none the least include: "can't see the forest for the trees", "has his/her blinders on", "chasing rabbits", "being penny-wise and pound foolish", or my particular favorite "rearranging the deck chairs on the Titanic". And, truth be told, those deck chairs can cost software developers if they don't look at the larger picture with regard to their regulation.

Acknowledgement of mobile medical application regulation is now mainstream thanks to all of the press it has received over the last calendar year; however, what isn't getting enough attention is who is actively regulating the industry at the moment. The danger facing software developers is their sole focus on the FDA, when the immediate regulatory threat (including heavy fines) comes from the FTC and the FCC.

Quite conveniently, these regulations have been mentioned previously on our blog with the Acne Apps post (FTC) and another post about Medical Body Area Networks (MBANs) (FCC). That isn't to say that the FDA could not and would not impose fines or take action against non-compliant software developers. The reality is that other organizations, like the FTC and FCC, have given more definition to their requirements and interpretations of the industry segment than the FDA has in its guidance document. For example, as recently as September 2012, the FTC published its guidance document on how to correctly market mobile medical applications. It requires that developers are honest about the functions of the application, disclose key information clearly and conspicuously, build in data security from the beginning, emphasize usability of the tools offered, honor privacy promises, protect children's privacy, and collect information with consent.

The deck chairs are important - no one wants to cruise without comfy deck chairs, right?! The FDA must be considered with any mobile medical application (or any medical software for that matter). Just make sure to reinforce your hull against the threat of FTC and FCC icebergs in parallel.

- RTK

Image Credit: Cliff (Cliff1066[TM]) on Flikr