By Bradley Merrill Thompson
More than three years have passed since I wrote the first edition of this e-book for MobiHealthNews, and much has changed. Among other things, FDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content is new. Download here
Not only have I updated the regulatory analysis, but I’m also covering a few new topics like FDA regulation of pharmaceutical apps. I also convinced my good friend and colleague in Amsterdam, Erik Vollebregt, to write on EU regulation of mHealth.
The first edition was basically a collection of MobiHealthNews posts that I had already written. In this edition, partly because of the new FDA guidance, I wanted to tell the story of FDA regulation of mHealth in a more holistic and methodical manner.
My hope is that app developers will now have the certainty they need to make business decisions about how to enter the mHealth space. To be sure, as I explain throughout the book, there are still many open issues, including how FDA ought to improve its regulatory scheme for those apps that are regulated, as opposed to just clarifying the threshold question of what FDA does regulate. Nonetheless, with this recent action by FDA, we hope and expect that mHealth technologies that address some of the greatest needs, but also with some risk, will flourish.
The mHealth Regulatory Coalition, where I serve as General Counsel, is organizing a significant educational effort in partnership with leading engineering schools to train innovators on complying with the FDA requirements. We plan to use this book as the primary text, but one objective of the meetings is to give people an opportunity to meet face-to-face and develop relationships. These engineering schools serve as regional innovation hubs, and make an ideal setting for the meetings, which will be inexpensive and open to the public. There are some mHealth entrepreneurs out there who you really should meet—pioneers who have figured out some emerging best practices in dealing with FDA regulation that they are willing to share.
While it was clearly time to write this second edition, I would also caution you that FDA regulation of mHealth will continue to evolve quickly. At the end of the book, I discuss numerous policy initiatives that are likely to produce change in 2014 and beyond. Through blog posts on MobiHealthNews, I plan to keep you up-to-date on those developments.
In the meantime, I hope you find this new edition useful and please let me know if you spot any areas where I can improve it in the future. Download here