Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "Part 2: Set FDA's Mobile Medical App Guidance Free."
Following is an excerpt:
In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I'd like to offer a few reactions.
As I said in my original post, it's important for us all to keep in mind that FDA is already regulating mHealth and the purpose of this guidance is to reduce the scope of that regulation. So the question is — is it useful for FDA at this time to come out with a final guidance on mobile health?
I will explain further why I think it clearly is.
Mr. Haley offers the view that FDA guidance is unnecessary at this point because there will be a new statutory scheme within about a year. After consulting his blog that he referenced in his prior comments, it appears that Mr. Haley is a government affairs professional and an attorney, so I know that he well-understands the process for creating new statutes, but let me recite it for everyone's benefit.
