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

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

Hearing Aid Deregulation to Affect Wireless Device Industry and Create Compatibility Issues

Within the last week, both the U.S. Senate and the U.S. Food and Drug Administration (FDA or the Agency) have taken significant steps to deregulate a large portion of hearing aid devices. Despite the benefits that hearing...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

Product Regulations: What You Don't Know Can Hurt You - and Could Destroy Your Business

What do the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Federal Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) have in common? Each is, of...more

Health Care Update - February 2016

Are Lawmakers and Stakeholders Ready for the Silver Tsunami? - Last week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade...more

Government Forces Awaken: The Rise of Cyber Regulators in 2016

As the sun sets on 2015, but before it rises again in the New Year, we predict that, in the realm of cyber and data security, 2016 will become known as the “Rise of the Regulators.” Regulators across numerous industries and...more

Advertising Law - December 2015 #2

Game's Over: Jordan, Grocers Settle Publicity Rights Suits - To avoid a second trial in litigation initiated by Michael Jordan challenging the use of his likeness in a commemorative issue of Sports Illustrated, the...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Alert: Key Regulatory Considerations for Digital Health Companies

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's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

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

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 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

Proposed health IT strategy aims to promote innovation

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft...more

House committee questions authority of a DHHS staff division to regulate health IT

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...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

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...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

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...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

A Report From Affiliate Summit East, 2013

Since 2003, online marketers and merchants have been gathering twice a year to take part in the Affiliate Summit Conferences. In recent years, Ifrah Law has become a fixture at these shows, and our associate Rachel Hirsch is...more

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

Advertising Law -- May 09, 2013

Harsh Criticism for Ad Industry Over DNT - The advertising industry faced harsh criticism at a hearing held by Sen. Jay Rockefeller (D-W.V.). He addressed the implementation of a federal Do Not Track program and...more

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