Health Communications & Media

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News from the Vermont Statehouse An - Analysis from DRM’s Government & Public Affairs Team - March 2017 #2

The House Ways and Means Committee is considering a proposal from the Vermont Department of Taxes to reduce the amount of use tax a person can pay without providing records to prove his or her tax liability. The rate would...more

FDA’s Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food Products – A Summary of Key Points

On March 9, 2017, the Food and Drug Administration (FDA or Agency) held a public meeting in Rockville, MD, which FDA officials described as a way to engage in a dialog with the public and regulated industry and allow for...more

Tennessee Rule Change: Prohibition on Prescription Transfer Incentives

Tennessee pharmacies can no longer offer patients financial rewards in exchange for the transfer of the patient's prescriptions. Effective February 20, 2017, the Tennessee Board of Pharmacy enacted a new rule providing that...more

Health Company Fined by UK’s Information Commissioner Office

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

CMS Begins Enforcement of New State Surveyors Requirement-Resident Abuse through Photography

On August 5, 2016 CMS issued new guidance advising survey teams to request and review facility policies and procedures that prohibit staff from taking, keeping and/or distributing photographs and recordings that demean or...more

Your Cyber Minute: Importance of the GDPR to the global business community [Video]

Ambitious and broad-reaching, the Global Data Protection Regulation is impacting companies around the world. Listen as Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran talk...more

Your Cyber Minute: Current GDPR regulatory and enforcement landscape  [Video]

The conversation continues with Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran as they go deeper into what clients need to know when it comes to compliance around the...more

W2 Phishing Scam Hits Citizens Memorial Hospital

We continue to see all industries hit with W2 phishing scams, including the health care industry. Citizens Memorial Hospital, located in Bolivar, Missouri, was hit with the scam when one of its employees believed that an...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

TCPA Violations Claimed Against Rady Children’s Hospital in San Diego

Rady Children’s Hospital-San Diego (Rady) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls...more

Plain Packaging and Warning Labels—While the WTO is Examining the Legality of Packaging and Labeling Requirements that Prohibit...

There have been several pieces of research recently calling for the use of plain packaging and graphic health warnings, similar to those used on tobacco products, on soft drinks and alcoholic beverages as a means of...more

Borderline products: Marketing food supplements in the UK following the glucosamine case

In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of...more

Blue Shield Of California Avoids TCPA Class Action Over Pre-Recorded Call

On January 13, 2017, the United States District Court for the Central District of California granted Blue Shield of California’s motion for summary judgment in a case on whether the insurer violated the Telephone Consumer...more

Big Tobacco Still Manipulating into the 21st Century

A doctor at his desk takes a drag off a Camel, deliberately deceiving the public about the dangers of the drug. Fred Flintstone fires up a Winston in front of Wilma and rattles off the company’s slogan, “Winston tastes...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Privacy and Data Security: 2017 Year in Preview

Few issues keep executives awake at night more than Privacy and Data Security. New regulations and threats alike are plentiful, varied, and evolving. The rate of change for cybersecurity and information governance continues...more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Response to Biosimilar Naming Petitionx Just Issued

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission...

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to...more

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Blue Shield Avoids TCPA-Related Liability

A federal court in California recently granted a summary judgment motion filed by Blue Shield of California (“Blue Shield”), allowing it to avoid liability for alleged violations of the Telephone Consumer Protection Act...more

Do Routine Calls by Health Plans to Patients and Health Plan Members Constitute “Telemarketing” Under the Telephone Consumer...

Covered entities have a long list of laws and regulations governing their conduct, including their communications with patients, customers, and members. Specifically, the Health Insurance Portability and Accountability Act...more

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