Liveblog: Congressional hearings on FDA regulating apps

By Brian Dolan
06:16 am

We are live blogging old school today: Hit the refresh button every few minutes for updates! (Live blog is now concluded.)

12:24PM: Rep. Ellmers very quickly concludes the hearing. That's a wrap! Next hearing is slated for tomorrow at 10AM ET.

12:22PM: Rep. Ellmers asks if medical device tax will hamper innovation. Thompson, Dagi, and Ford all said yes. Others said unclear. Rep. Ellmers says she is a nurse and understands the need for patient safety. She asks all panelists that if an app is regulated as a medical device by FDA should the medical device tax be applied? Thompson said his group opposes it being applied. Most said it was unclear. Ford said it was two totally different questions.

12:20PM: Rep. Ellmers asks Thompson how long it takes to secure 510(k) clearance. He says it depends but usually between 90 days and 1.5 years. (MobiHealthNews found average time for mobile medical apps clearance has historically been about 110 days).


12:18PM: Rep. Gardner says this is not clarity to him. Dagi says we do not have the necessary clarity. Jarrin says it depends. Gardner says if it depends then it is not clarity. Jarrin says there is insufficient clarity for low-risk medical devices. Spalter says clearly there is not sufficient clarity. This panel of expert witnesses is having trouble, imagine what the developers who are trying to dream up these innovations is going through. Let's put down on paper what needs to be understood and once we do the hockey stick of medical apps will go into the hundreds of thousands of medical apps.

12:17PM: Dagi nails it. Gives the CHF use case. Says a weight scale at an arcade is not a medical device.

12:15PM: Rep. Gardner asks if connected weight scales are going to be regulated as medical devices if they have Bluetooth. Jarrin says it depends. Jarrin says it's a scale so it depends if it is being marketed as a medical device. (Scales get FDA clearance when they use BIA for body fat composition or when used for congestive heart failure patients to determine if they have gained weight, an indication of fluid collecting in the heart.)


12:12PM: Rep. Shimkus says that as Dagi noted we should look at alternatives to FDA regulation. This is a concern that we are going to slow down mobile medical apps. He asks Dagi if he believes FDA is the right place. He says yes with right advisors, yes.

12:10PM: Rep. Shimkus says we have so many apps because there is no process to get it into market (Apple might disagree). Rep. Shimkus says the apps he has on his iPad are getting updates all the time. He wonders how regulated apps would work when it comes to updates. Rep. Shimkus claims that the hockey stick growth in apps is because they have grown in the absense of ObamaCare.


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