FDA's Bakul Patel took the stage at the WLSA Wireless Convergence Summit 2013 using an iRobot RP-VITA to speak with the audience on the status of FDA's mobile health application regulations.
Get Started for FREE
Sign up with Facebook Sign up with X
I don't have a Facebook or a X account
![]() ![]() |
eMedToday's curator insight,
May 31, 2013 8:26 PM
Key points:
"While final guidelines and determinations remain to be seen, the FDA has offered the following: Lifestyle apps, such as pedometers, will not be regulated.Similarly, apps that serve as personal or electronic health record systems will also avoid regulation.Mobile app developers will not need to seek federal re-evaluation for minor changes.There are no plans at this time to tax apps under the Affordable Care Act."
Relatris's curator insight,
June 2, 2013 8:12 AM
Looking at the alarming numbers of apps that do NOT provide correct results (e.g. opiod converting apps as showed earlier on this site or around 50% OF ONCOLOGY APPS (see our next entry)) it is highly important that there is some control. We can see multiple attemps starting right now, including one of the FDA. Unfortunately, in all the information we could found, the main issue seems to be privacy and which which apps will NOT be regulated.
Fortunately, there are some other initiatives like the Happtique Health App Certification Program:
Apps that meet all of the Technical Standards will then be evaluated for the Content Standards, which will be conducted under the auspices of internationally recognized third party organizations, such as the Association of American Medical Colleges (AAMC) and CGFNS International, and performed by clinical specialists selected based on the mobile app’s specific subject matter. Happtique will continue to expand its HACP Content Review Partners and is currently in discussions with a number of organizations with various areas of clinical expertise. http://www.happtique.com/app-certification/ We will introduce more of these control processes and other criticism of the use of medical apps here on this site in the next days.
|