FDA Regulations On Mobile Apps

The use of mobile apps is growing. Many medical applications have been released to help patients and physicians become educated, monitor health, or communicate with others. However, governmental regulations for these apps has been slow to catch up, mainly because of how quickly the releases are occurring. A recent article looked into this issue and the need for approvals to be streamlined.

At present count, there are 40,000 medical apps available and this number is growing. However, it's hard to determine which apps are giving proper medical advice and which can be harmful. Without the presence of governmental regulations, users are left on their own to determine which app is best. The FDA has started to cover the gap, releasing preliminary regulations, but the approval process is costly and slow. With waiting periods of 6-20 months, the process simply cannot keep up with the ever-changing technology that is happening in app development.

"The FDA's current regulatory process was created when the floppy disk was around...We're seeing mobile apps updated and created on a daily basis. The life cycle is dramatically different." ~ Joel White, Executive Director (Health IT Now Coalition)

However, some sort of regulations are necessary to protect the public health. With app developers making medical claims that are unfounded or untested, how can consumers know what to trust? The FDA is pushing for a final list of guidelines so that they can clearly state how to gain approval, and hopefully do so in a timely manner. Already some app developers have gained FDA approval, which goes far in helping those apps to stand out as being more trustworthy. The need for clear guidelines and fast turnaround is present. The FDA just has to make sure it can keep up.