Communications & Media Health

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FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Viagra Ad Campaign Targets Women Amid Melanoma Risk

Viagra is so popular that it is a frequent target of counterfeiters. Here, a U.S. Customs and Border Patrol agent displays seized goods. Viagra (sildenafil) has featured prominently in the news over the past few months...more

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Are Non-Disparagement Clauses a Good Idea?

Creatively, some physicians have been turning to non-disparagement clauses within confidentiality agreements as a way to prevent patients and potential patients from posting negative online reviews....more

False Claims Act: 2014 Year In Review

In what is becoming an annual refrain, 2014 marked another year of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and mushrooming qui tam lawsuits by whistleblowers. Indeed, fiscal year 2014...more

Blog: FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and...more

Physician Plaintiff Bound by Arbitration Clause in Nonparty’s Contract

Today’s riddle: A physician sues defendants for defamation. The defendants move to compel the arbitration clause of a contract the physician used to have with a nonparty. The defendants win the argument. What’s the...more

Pending TCPA Petitions (Grouped by Primary Subject Matter)

As 2015 begins, we thought that providing a roundup of and the links to pending FCC TCPA petitions might be useful. The list includes most pending petitions filed since the FCC’s revised TCPA rules came into effect, with the...more

Focus on Regulatory Law - December 2014

In This Issue: - Regulatory Authorities - Energy - Public Economy Law - Contracts - Public Health - Comparative Law - Excerpt from Regulatory Authorities: French...more

In with the New: 2014 Privacy, Advertising and Digital Media Predictions – Part I

What privacy, advertising and digital media trends will make headlines in 2015? Digital Health for one, Big Data for another....more

114th Congress Review

With the 114th Congress now officially underway with the Republican Party in control of the House of Representatives and the Senate, ML Strategies will continue our tradition of offering an annual Legislative and Regulatory...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Social Media Use for Clinical Trial Recruitment

Social media can be an effective and easy way to connect with friends and professional contacts. However, it can also serve as a tool for institutions and principal investigators involved in enrolling subjects in clinical...more

Top Five Resolutions for Covered Entities and Business Associates in 2015

The New Year is here. It is time to make those 2015 resolutions, and not just those for getting fit and healthy. Resolve now to improve your organization’s compliance with the Health Insurance Portability and Accountability...more

Privacy Tuesday – January 6, 2015

Welcome to the first Privacy Tuesday of 2015! We hope that you enjoyed our 12 Days of Privacy series (and if you missed it, they are all linked in the right column of the blog…). Three things that you should...more

AZ Supreme Court Holds AZ Legislators Have Standing to Challenge AZ Law, But Media Mischaracterizing the Lawsuit

It seems that the media have become so accustomed to polarizing the topic of Medicaid expansion that reporters seem incapable of truly assessing the issues objectively and reporting accordingly. This has happened recently...more

News from the Health Law Gurus™

Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Refill Reminders and the TCPA

The Telephone Consumer Protection Act (“TCPA”) presents another challenge as health care providers continue to engage patients and seek to meet Meaningful Use reminder objectives. Over the past year, there have been several...more

FDA Issues Much Anticipated Final Rules on Menu and Vending Machine Nutrition Labeling

The U.S. Food and Drug Administration (FDA) recently published the long awaited final rules on menu and vending machine nutrition labeling. The rules implement section 4205 of the Patient Protection and Affordable Care Act...more

Florida, No Grants For You!

In November 2014, the federal government’s Distance Learning and Telemedicine (DLT) program awarded over $10 million in grants to support telemedicine and rural health research. The list of 65 DLT grant recipients included...more

October Digital Health Investments Dominated by Diagnostics and Therapeutics

Digital health companies raised just over $730 million through venture, private equity and angel investments in September, according to our latest analysis, bringing the total for the third quarter to approximately $1.3...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

Health Update - November 2014

“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA - Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more

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