Mobile Apps, mHealth, Food and Drug Administration (FDA)

AGs Weave Themselves Into Patchwork of Digital-Health Regs

Troutman Pepper on 7/13/2017

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Healthcare Legal News Volume 5 Number 2

Dickinson Wright on 4/10/2015

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

Morgan Lewis on 3/26/2015

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Social Media and Medicine

Pillsbury - Internet & Social Media Law Blog on 12/11/2012

The Federation of State Medical Boards recently adopted Model Policy Guidelines for use of social media in medical practice. The use of social media by medical practitioners and the number of mobile medical and wellness...more

Venture Investment in Digital Health Effectively Doubles in H1 2012

Fenwick & West Life Sciences Group on 7/30/2012

Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Fenwick & West Life Sciences Group on 6/29/2012

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

The Regulatory Future of mHealth: FCC, FDA and the United States Congress

Fenwick & West Life Sciences Group on 6/19/2012

As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more

Mobile Apps › mHealth › Food and Drug Administration (FDA)