Re:In a word: yes. (Score 1)

Totally agree.

The reason for FDA and EU guidelines and regulations are to prohibit the sale of "snake oil". As has already been noted in other comments, yes, this is also needed among apps.

The way the law goes in EU is that if you manufacture or sell a product to people with a clinical health disadvantage, you are an intervention or a tool to help in therapy. The CE mark carried by all meds sold in Europe tells you that the product has been developed, is produced and managed in a standardised way, following guidelines, regulations etc. If it does not carry the CE mark, it cannot say that it brings a benefit to the customer.

The same goes for apps. Saying: "We cure acne", "We help you manage your diabetes", "Our app cures cancer" you need proof of this. Or you should be put off the market. There are some exceptions here: data management without interpretation or "smartness" is ok. Shovelling data from an iPad into a hospitals IT system is not a "medical device" even if the system interfaces with medical devices. So apps simply made for management of data and such in a medical setting, well they're not to be regulated. If your app is made for diabetics, for management of diabetes data, then you may not be a medical device – if it's just a really dumb one: data in, view in a list. If you go in the direction of graphical interpretation, recommendations, color coded lists well now you are actually entering a more critical area.

At my company (mySugr.com) we have developed an app for the iPhone in accordance with EU regulations. So what I write is based on real experience, even if I don't tell you all that there is to it. It is possible to go this route, but it will cost you time, money and effort to get through the hoops. If you wish to go in this direction, then google ISO 13485, 14961, 62304 and read through those to get started. Those are some of the norms you need to fullfil. In many countries, your CEO also needs to be licensed to sell and develop apps like these. The whole company, from email traffic, design processes, innovation, chats, meetings, customer service etc is affected. All good fun! :) In the US of A, you need to get through the FDA approval process. This implies some more requirements on processes and quality assurance/management. Part of it would be the usability engineering required by the FDA – where you actually have to try your stuff with "real live Americans". Or you won't come through. There are a hundred or so fine points to all of the issues facing you if you wish to develop a regulated app, and in this reply I simply breathe on the tip of an iceberg.

To finish off, I can simply state my opinion that these regulations are needed. When it comes to medical devices, be they apps or MRI's, we cannot allow an industry to smack consumers in the face with empty promises and low quality products.