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Health Consumer Protection

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

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

New Mexico Enacts Data Breach Notification Law

by King & Spalding on

On April 6, 2017, New Mexico became the 48th state to enact a data breach notification law; the Data Breach Notification Act (the “Act”) will go into effect on June 16, 2017. The good news for many in the health care...more

D.C. Circuit Affirms Decision Enjoining Anthem-Cigna Merger; Will the Supreme Court Weigh In?

UPDATE: On May 11, 2017, the Delaware Chancery court denied Anthem’s motion for preliminary injunction to prevent Cigna from withdrawing from the proposed merger, citing Anthem’s slim chance of success and the adequacy of...more

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

by McDermott Will & Emery on

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

“Pre-Approval” Design Defects - No Such Thing

by Reed Smith on

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims. Recent cases finding preemption of design defect claims due to...more

HHS to Launch Cybersecurity Center

The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more

OCR Settlement Lessons - Failing to Perform an Electronic Access Risk Analysis Before an Unauthorized Access Occurs

by Ruder Ware on

Failure to conduct a risk assessment before a hacking incident occurred resulted in a $400,000 settlement between the Office of Civil Rights (OCR) and a Federally Qualified Health Clinic (FQHC). The FQHC filed a breach...more

Senate Expected to Vote on Gottlieb Nomination Next Week

by Kelley Drye & Warren LLP on

On May 4, 2017, Senate Majority Leader Mitch McConnell (R-KY) filed cloture on the nomination of Dr. Scott Gottlieb to be the next FDA Commissioner. A cloture vote to end debate will occur Monday afternoon, with 50 votes...more

OCR Announces First HIPAA Settlement with Wireless Health Services Provider

by Morgan Lewis on

The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more

The State AG Report Weekly Update

by Cozen O'Connor on

Consumer Financial Protection Bureau- CFPB Files Lawsuit Against Four Online Lenders for Allegedly Collecting on Voided Debts- The Consumer Financial Protection Bureau (“CFPB”) filed a lawsuit against online...more

Lessons from OCR HIPAA Settlements - Mobile Device Security Standards

by Ruder Ware on

In the first known case involving a wireless provider, a cardiology service provider agreed to pay a $2.5 million settlement based on the impermissible disclosure of unsecured electronic protected health information (ePHI)....more

Antitrust Division’s Spring Update 2017: Insights Regarding DOJ’s Enforcement and Policy

The Antitrust Division recently issued its 2017 annual spring update. The update emphasizes the Division’s recent litigation victories, particularly in the merger context. In his introductory remarks, Assistant Attorney...more

Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

by McDermott Will & Emery on

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on...more

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

by Jones Day on

A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more

FDA Extends Compliance Date for Menu Labeling Rule (Again)

by Faegre Baker Daniels on

The U.S. Food and Drug Administration (FDA) announced on May 1, 2017, that it is extending the compliance date for the menu labeling rule by a year, from May 5, 2017 to May 7, 2018. According to FDA, “this extension allows...more

Mylan Sued For Illegally Protecting EpiPen®’s Market Share

Last Monday Sanofi brought an antitrust suit against Mylan, alleging that Mylan engaged in illegal conduct to suppress competition in the epinephrine auto-injector (“EAI”) market, which is dominated by Mylan’s billion-dollar...more

Menu Labeling On Hold – Again

It appears the FDA is again pushing back the compliance date for its menu labeling regulations, which had been set for May 5, 2017. Although the agency has not yet made an announcement of the 11th-hour delay, on Thursday it...more

Rite Aid Wins Summary Judgment in TCPA Action Involving Prerecorded, Automated Call for Flu Shot Reminder

In an outright win for pharmacies, the U.S. District Court for the Southern District of New York, in the attached opinion, granted Rite Aid’s motion for summary judgment in a class action alleging violations of the TCPA....more

FDA Commissioner Nominee Gottlieb Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer...

by Kelley Drye & Warren LLP on

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5. As a follow up to our April 13...more

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