The United States Federal Communications Commission The United States Food and Drug Administration Medical Devices

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 -
News & Analysis as of

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

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

FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing

On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio...more

Cybersecurity Litigation Monthly Newsletter

In August, Paytime, Inc., a payroll services company, moved to dismiss a putative class action filed in the wake of a data breach in which the personal and financial information of more than 230,000 people was compromised. ...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

FDA seeking comments on Health IT report

Exchange of information in an electronic environment (health IT) has provided and continues to provide opportunities to improve the quality, safety, cost and efficiency of health care and encourage patient involvement. ...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...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 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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