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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

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

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

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

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

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

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

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

‘Health Care’-Related Calls: Ambiguity at the Intersection of HIPAA and TCPA

The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer Protection Act (TCPA) for health care messages regulated under the Health Insurance Portability and...more

Eleventh Circuit Holds That Debt Collector Had “Prior Express Consent” From Debtor Whose Wife Provided Number on Hospital...

This week the Eleventh Circuit held that a debt collector had “prior express consent” from a debtor whose wife had provided his wireless number on a hospital admission form. Mais v. Gulf Coast Collection Bureau, Inc., No....more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

TCPA Plaintiff Loses—Express Consent Given to Health Insurance Plan Trumps Claim

In a recent case in the U.S. District Court for the Eastern District of Missouri, the district court held that the plaintiff’s Telephone Consumer Protection Act (“TCPA”) claim should be dismissed. The court ruled that the...more

The New Normal: Big Data Comes of Age

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more

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