FCC, Healthcare, Digital Health

Regulatory Challenges for the New Frontier of Medical Imaging: Terahertz Spectrum

Mintz - Health Care Viewpoints on 11/16/2018

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC). While the Food and Drug...more

Alert: Key Regulatory Considerations for Digital Health Companies

Cooley LLP on 9/11/2015

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on 7/27/2015

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

McDermott Will & Emery on 6/26/2014

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

FCC Will Work to Implement mHealth Task Force Report

Mintz on 10/5/2012

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

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

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

Mintz - Health Care Viewpoints on 2/18/2010

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

Mintz - Health Care Viewpoints on 7/20/2009

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: FCC Proposes Rules ofr MBAN

Mintz - Health Care Viewpoints on 7/2/2009

The Federal Communications Commission (FCC) has proposed to allocate radiofrequency spectrum and establish service and technical rules for the operation of Medical Body Area Network (MBAN) systems. The FCC envisions that...more

mHealth Alert: mHealth Raise New FCC and FDA Issues

Mintz - Health Care Viewpoints on 6/25/2009

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

The United States Federal Communications Commission › Healthcare › Digital Health

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