Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Can't Hold Back Stream of Mobile Health Apps."
Following is an excerpt:
It was bound to happen. As smartphones, tablets and all those wearable computer gizmos get more and more powerful — and just as important — become ever more constant in our lives, they will enable apps that no one anticipated. Not even the fine people of the Food and Drug Administration. ...
Expect a lot more to come from startups and medical industry heavy-hitters.... But you can also expect most of the action to happen outside the United States, at least initially, if the FDA can't decide on regulations to govern so-called mobile health (or mHealth) applications.
It raises an interesting problem when Apple can approve an app before the FDA is certain it meets its guidelines. To be fair, the FDA staff seem to be promoting this kind of health science innovation rather than stifling it, but the future has arrived and keeps speeding forward in synch with the number of apps on our phones. The FDA needs to catch up, and officials have been strongly encouraged by Congress to get guidelines in place for mobile health devices and applications this year. They had better.
As attorney Bradley Merrill Thompson points out in commentary on MobiHealthNews, without clear guidance big money is likely to stay out of space. "Right now the vast majority of apps are free pieces of software that don't accomplish nearly what could be accomplished in mHealth with more serious investment," Thompson writes.
