How should mobile medical apps be regulated by the FDA?

Last year the FDA released a proposed set of guidelines for the regulation of certain mobile health apps that control a regulated medical device, or manipulate patient data from a medical device.

This has been a source of some controversy and anxiety for many medical app developers.

Some argue that too strict regulation may stifle innovation, while others argue it is crucial for ensuring quality apps and protecting patients.

Tonight, June 6, at 9pm EST please join us for a special edition of the #mHealth chat on Twitter, in which we will discuss the FDA regulations and medical app development. Also participating will be our special guest, Mr. M. Jason Brooke, J.D., an experienced attorney on FDA regulations and policy.

Mr. M. Jason Brooke works for the firm Epstein Becker Green in Washington D.C. An associate in the Healthcare and Life Sciences practice, he develops policy on the FDA regulation of mobile health technology and counsels mobile health companies on FDA  regulations. Mr. Brooke also has an extensive scientific research background and advises drug and device developers on clinical research.

You can follow him on Twitter at @MJasonBrooke.

We invite you to participate in this exciting discussion! Come share your opinions, concerns, and questions about this important topic that will affect the entire mobile medical industry.

What’s a Tweet Chat?

If you haven’t participated in a Tweet Chat before, it is a way to have a discussion with people in real time via Twitter.

A moderator, in this case one of the iMedicalApps staff, will lead the chat and pose topics or questions to the participants. Participants will then tweet in response to the topics using a designated hashtag in all their tweets during the chat. We will use the hashtag #mHealth. The rules of the Tweet Chat are flexible.

Though we have a set start time, you may come and go as you please. You may even “lurk”–though we’d love to hear your thoughts! You can expect the chat to last anywhere from thirty minutes to an hour.

Of course, you are encouraged to continue the conversation with others even after the chat is officially over.

How can I participate in the Tweet Chat?

  1. If you don’t have a Twitter handle already, sign up here.
  2. Follow @iMedicalApps.
  3. Every Wednesday, at 9pm/8pm central, go to Log in with your Twitter handle and enter the hashtag #mHealth in the field marked “Enter hashtag to follow.” The stream of tweets from people talking about #mHealth will appear below.
  4. Enjoy a stimulating conversation about mobile health in medical practice! See you tonight!