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Read Consumer Protection updates, news, and legal commentary from leading lawyers and law firms:

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Seventh Circuit Finds Exclusive Dealing in Hospital-Payer Case Pro Competitive

“But what is more common than exclusive dealing?” Affirming summary judgment for defendant Saint Francis Medical Center, the Seventh Circuit recently held that the hospital’s contracts with health care insurers—though...more

Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that...more

FDA Extends Compliance Dates for Nutrition and Supplement Facts Label and Serving Size Final Rules

by Baker Ober Health Law on

On Tuesday, June 13, the United States Food and Drug Administration (FDA) announced it was extending the compliance dates for its final rules for Nutrition and Supplement Facts Labeling and Serving Sizes....more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

by Arnall Golden Gregory LLP on

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

by Kelley Drye & Warren LLP on

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements. The rule initially set a...more

Marketer In Hot Water for Inconspicuous TCPA Consent Language

by Klein Moynihan Turco LLP on

A recent decision issued by the United States District Court for the Northern District of Illinois has brought renewed emphasis to the importance of prominently displaying TCPA consent language in Internet marketing. In a...more

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

by Knobbe Martens on

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

Eighth Circuit Court of Appeals Affirms Dismissal of TCPA Claims on Grounds of Prior Express Consent

by Stinson Leonard Street on

In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more

HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more

No-Fault vs. health insurance: What’s the better choice for crash victims?

by Michigan Auto Law on

Health insurance is full of landmines for unsuspecting car crash victims, who are subject to ‘auto exclusions,’ coverage limitations, managed care, HMOs and medical pre-approval requirements and ERISA liens....more

(Un)Protected Health Information Held for Ransom

by Snell & Wilmer on

Recent experiences of major health care companies offer a reminder of the importance of data security and following a well-written policy for compliance with the HIPAA Privacy Rule....more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

TCPA Class Action Tossed out After Hospital Provides Records Indicating Consent

Central Florida Regional Hospital (the Hospital) was released from a proposed class action last week for its alleged violations of the Telephone Consumer Protection Act (TCPA). The Hospital’s debt collector, Transworld...more

HIPAA spring check-up: Your obligations to safeguard third-party patient health information in medical records produced in...

You’ve had your apple a day, but you can’t keep the subpoenas away… And, if your organization is facing a request seeking records or other materials that may contain patient health information (“PHI”), it bears...more

HIPAA Settlement With Wireless Health Services Provider Is Less Than Meets The Eye

by King & Spalding on

On April 24, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a $2.5 million HIPAA settlement with CardioNet, a wireless health services provider. CardioNet provides remote mobile...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

Are Healthcare Systems Being Held Hostage by Ransomware?

by Revision Legal on

Healthcare ransomware is one of the biggest cybersecurity concerns in existence and it may have particularly serious implications for healthcare systems. Ransomware is a form of malicious software code that is somehow...more

Romaine Calm: FSVP is Approaching

Does FSVP Apply to You? Are you the importer, consignee, or agent for food imported into the United States? If so, the Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP), a key...more

Health Care Providers Pay $1.35 Million in TCPA Fax Settlement

by Reed Smith on

Although the spotlight is usually on unwanted phone calls and text messages when it comes to class actions under the Telephone Consumer Protection Act (TCPA), a recent settlement over the sending of faxes is a reminder to...more

New York Attorney General Announces Settlements with Three Mobile Health Application Developers

by Jones Day on

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

by Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

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