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Food and Drug Administration (FDA) Digital Health mHealth

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

Troutman Pepper on

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

Robins Kaplan LLP

[Webinar] The Digital Health Update: Recent Developments in the Regulation of Medical Devices and Health Apps - Sept. 22nd, 1:00...

Robins Kaplan LLP on

Tuesday, September 22, 2015, 1:00 P.M. CST -- Both the FDA and the FTC have been busy this summer. Just this month, both agencies took their strongest actions to date relating to cybersecurity and the regulation of medical...more

Cooley LLP

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

Cooley LLP on

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

Mintz

FCC Will Work to Implement mHealth Task Force Report

Mintz on

In a move he says will improve the quality of health care and cut health system costs, FCC Chairman Julius Genachowski announced the Commission will work toward implementing recommendations proposed by the mHealth Task Force,...more

Fenwick & West Life Sciences Group

Venture Investment in Digital Health Effectively Doubles in H1 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

Fenwick & West Life Sciences Group

FDA to Finalize Mobile Medical App Rules Following Bill Passage

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

Fenwick & West Life Sciences Group

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

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

Mintz - Health Care Viewpoints

mHealth Alert: Text4baby: Texting Health Messages to Pregnant Women and New Moms

Furthering the use of commercial wireless networks to deliver health information, the Obama Administration recently announced its new Text4baby campaign, which sends free regular text messages with health information to...more

Mintz - Health Care Viewpoints

mHealth Alert: FCC Extends Boston Scientific's Authority for Implanted Cardiac Devices

The Federal Communications Commission (FCC) recently granted a rule waiver requested by Boston Scientific Corporation (Boston Scientific), allowing it to continue to manufacture and market its Contak Renewal TR product line...more

Mintz - Health Care Viewpoints

mHealth Alert: mHealth Raise New FCC and FDA Issues

Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new “mHealth” (mobile...more

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