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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

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

Will the Recent Scientific Attack on Vitamin Use Spawn a New Wave of False Advertising Litigation?

For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness. Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering...more

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

FDA Submits Final Guidance on Mobile Medical Apps

Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more

Labor & Employment E-Note - January 2013

In This Issue: - NLRB Protects Workers' Rights to Post About Job on Facebook - 6 States Ban Companies from Asking for Social Media Passwords - Health Law Requires Employers to Offer Family Care to All - Fiscal...more

Are Your Mobile Devices HIPAA Compliant? Practical Steps to Ensure Compliance

Mobile device use is becoming more commonplace in health care. Health care professionals use text messaging to communicate with each other about patient status. Medical schools now provide residents tablets to use as...more

FCC Establishes New Healthcare Connect Fund

The Federal Communications Commission (FCC) has created a new Healthcare Connect Fund (Fund), designed to expand health care provider (HCP) access to broadband technologies and to encourage the creation of broadband health...more

Keep An Eye On Those Shiny, New Mobile Devices!

As physicians, nurses, therapists and health care providers continue to utilize new smart phones, tablets, and laptops in caring for patients, the Department of Health and Human Services (“HHS”) has responded with educational...more

FCC Creates an Annual $400 Million Healthcare Connect Fund for Broadband Services and Infrastructure

On Dec. 21, the FCC released its long-awaited Report and Order reforming its funding mechanisms for rural health care by creating a Healthcare Connect Fund (HCF) of $400 million annually....more

HHS Creates Mobile Device Privacy and Security Website: High Expectations for Mobile Device Security

The U.S. Department of Health and Human Services recently posted a website focusing on mobile devices and health information privacy and security at http://www.healthit.gov/mobiledevices. The website includes five videos on...more

Question of the Week: Under Prop 37, how long do companies have to bring their products into compliance with the new labeling...

As we’ve previously discussed, Prop 37 has two important labeling components: (1) a requirement that foods made with genetic engineering are labeled as genetically engineered, and (2) a restriction on labeling genetically...more

In The FDA Crosshairs: Composite Scores In Drug Ads

Originally published in Law360, New York on October 19, 2012. On Aug. 23, 2012, the U.S. Food and Drug Administration published a notice announcing proposed research titled “Communicating Composite Scores in...more

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100...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

‘Health Claim’ Definition to Be Interpreted Widely, EU Court Rules

In its first judgment on Regulation 1924/2006 on nutrition and health claims made on foods, the Court of Justice of the EU adopted a broad interpretation of the definition of “health claim” by ruling that claims for merely...more

Safeguarding Patient-Generated Health Information Created or Shared Through Mobile Devices

Mobile health technologies are increasingly becoming a valuable tool for improving the quality and efficiency of healthcare. A current example of work in this area involves The Robert Wood Johnson Foundation's Project...more

D.C. Circuit Holds That Former Purdue Pharma Executives Who Pleaded Guilty to Misdemeanor Misbranding May Be Excluded From...

On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs...more

President Obama Signs Bipartisan FDA User Fee Legislation

On July 9, 2012, President Obama signed legislation that reauthorizes the U.S. Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs (including biologics)...more

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...more

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