News Feature | March 24, 2014

FDA Announces HIT Plan On The Way

Katie Wike

By Katie Wike, contributing writer

FDA HIT Plan

FDA Commissioner Hamburg says the anticipated health IT report will be issued by April

The FDA’s health IT report, originally due in January, is now scheduled for publication before the end of this month. According to mHealth News, the report will be written by the FDA Safety and Innovation Act (FDASIA) workgroup, in collaboration with the Federal Communications Commission and the Office of the National Coordinator for Health IT.

"Implementing FDASIA is a considerable undertaking, requiring detailed planning to integrate these tasks with the rest of FDA’s workload. All told, the 140-page law called for multiple deliverables of all types, including more than 30 proposed and final rules, more than 40 draft and final guidance documents, more than 20 reports to Congress, and many other additional reports," according to FDA Commissioner Margaret Hamburg's testimony before the Senate Health, Education, Labor and Pensions Committee.

Health Data Management reports the risk-based regulatory framework will include more mobile medical applications as well as promote innovation, protect patient safety, and avoid duplicative regulation.

"Complementary to the FDASIA section 618 report in development, on September 25, 2013, FDA published its final guidance on mobile medical applications," Hamburg testified before the Senate committee. "FDA issued the mobile medical apps guidance to provide clarity and predictability for manufacturers of mobile apps. This guidance informs manufacturers, distributors, and other entities about how FDA intends to apply its regulatory authorities to software applications intended for use on mobile devices that perform the same functions as traditional medical devices."

Mobile devices are at the heart of another battle in Washington; both Congress and the FDA believe they should be in charge of regulating mobile devices. In September, the FDA released its final guidance for mobile medical devices which caused some legislators to say it was just not enough.