FDA once again steers clear of health IT, finalizes plans to stop regulating some medical software

Bravo for not impeeding innovation.

“The MDDS guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data,” wrote Jeffrey Shuren, the head of the FDA’s device arm (CDRH), and Bakul Patel, its associate director for digital health, last week on the FDA’s blog.

The European agencies should take a page out of FDA’s book on digital health regulation.