Regulation of Medical Apps Debated at FDA Medical Apps Workshop

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This appears to be growing in popularity as a matter of discussion.  There is little doubt that the government will step in an regulate medical apps they way they regulate everything else in the healthcare industry.  What remains to be seen is what exactly that regulation will entail.

One of the points that I found interesting from this article was the thought the consumers should simply regulate quality apps through their purchasing power.  Simply put, if an app is garbage, people won’t buy it, and it will disappear.  While this would be the easiest way, it would also be the lazy way, and in the end would likely result in more work do to the magnitude of lawsuits that are bound to appear.

Some seem to believe that regulation similar to that put on other medical devices would be more appropriate.  This just doesn’t make sense to me, and creates somewhat of a slippery slope.  How can we possibly consider x-ray machines and sophisticated surgery equipment to be on the same level as something that measures you blood pressure through your phone?

If we do start to regulate these apps on the same scale, you open up the need to regulate everything that even remotely relates to healthcare.  What makes more sense to me is to provide guidelines for development, and maybe even classification groups so that developers can have a clear understanding of what would be expected for certain levels of devices.

As is mentioned in the article, regulation ultimately comes back to liability.  No one wants to pay a huge price for developing a small app that was intended to help people.  In this day and age, it is increasingly important to cover your bases to ensure your original intent to do good doesn’t end up in a lawsuit where nobody wins.

I understand the FDA’s lack of direction at this point since the market has developed so rapidly.  Only a few years ago the most complicated apps would give you the news and some sports scores.  Now they can do just about anything, and more are being developed everyday.  What I would like to see is the FDA do or say something.

If a reasonable set of regulations can be established now, then there will be much less heartache later.  I have to think that there are numerous developers out there who are anxious to take advantage of this opportunity but are afraid to do so because they don’t know where the boundaries are.  The really quality developers will want to do it right the first time, and these are the people who will provide us with the best apps in the long run.