The United States Federal Communications Commission The United States Food and Drug Administration Digital Health

The United States Federal Communications Commission is an independent federal agency established by the Communications Act of 1934. The Commission is charged with regulating interstate and international... more +
The United States Federal Communications Commission is an independent federal agency established by the Communications Act of 1934. The Commission is charged with regulating interstate and international communications by radio, wire, satellite, and cable. less -
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FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

mHealth and the FCC: What Does the FCC Have to Do with Medical Devices?

Originally published in mHealth Newsletter on November 14, 2012. One might not associate the Federal Communications Commission (FCC) with mHealth issues. Yet, the FCC has a vital role to play in this field, and if...more

FCC Will Work to Implement mHealth Task Force Report

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

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

mHealth Stakeholders: Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

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

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

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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