Regulation of mHealth Apps is one of the biggest ongoing hot topics in healthcare. Earlier this week we posted about regulation, and how it may very well be warranted in some areas, but may be less necessary in others. Apparently, this is something that is even catching the eye of Congress.
Just last month, members of Congress sent a letter to the FDA and FCC asking them to clarify what exactly they are currently doing with regulation, and what they are planning to do in the future. The letter expresses their concern that excessive regulation may slow the growth of this developing industry, which grew by 250% on iTunes alone last year.
I think it is great that Congress sees the value of this industry and is concerned with not creating any unnecessary hoops for developers to jump through. That being said, I also don’t understand how Congress sticking their nose in everything does anything but slow the process down even more.
Is writing a response to their letter a big deal? Probably not, but who honestly thinks that these congressmen will be satisfied with a simple response? They will naturally want regular updates of exactly what is being done. They will likely want to insert their two cents about every little decision that is being made. Given the chance, they will probably try to use this as another way to create jobs for their constituents, even if it makes no real sense to do so.
I agree with Katie’s article earlier this week that there is some definite value to regulation in many cases; which is ultimately where I think the FDA will end up. What scares me, is that Congress will force themselves into the process which will only make it that much slower and create the very delay that they are trying to avoid.