Wednesday, July 23, 2014

mHealth App Developer ? Contact the FDA first for Guidelines

Serious mobile health app developers would do well to contact the Food and Drug Administration regarding proposed regulations for mobile health applications.

Health care providers, patients and others are concerned about the safety and reliability of some applications. HPAA regulations forbid identifying data to ensure privacy and confidentiality for many HIT applicatioins.  As applications increase in number the offerings are often duplicated and complex.  There are a bewildering number of health apps currently on the market. 

The FDA is currently in the early phases of studying this area and is proposing "rule making"  This is a precursor to the process and a period of open comments for those interested in approval processes.


Many  developers such as Apple, Google, Microsoft are investing in health technology experts to guide health app development.

                                     Apple has added Divya Nag, 

With experience in managing product launches, gaining FDA approval, and partnering up with existing healthcare industry behemoths, Nag could be the key to Apple being able to launch devices such as the iWatch and Healthbook software that could track the likes of blood sugar, pulse, sleep patterns, and blood pressure. Apple has previously met with the FDA on multiple occasions to discuss upcoming “Mobile Medical Applications.” 

Nag’s experience in medical product testing could also be valuable to the testing process for Apple’s future medical products. Apple job listings indicate that the Cupertino-company has been seeking engineers experienced in designing and executing tests of health-oriented products. 



No comments:

Post a Comment