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Notifications and Names: FTC Workshop Explores Effect of State Legislation and Naming Conventions on Follow-On Biologic...

Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

FTC’s 50th Data Security Settlement Sends a Message: Be Careful with Overseas Contractors

The Federal Trade Commission (FTC) sent a message about the importance of imposing appropriate security measures on—and monitoring—vendors with access to confidential consumer information. The FTC issued a 20-year consent...more

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening of...more

HIPAA Covered Entities Subject to FTC Act Enforcement of Data Security Practices

On January 16, 2014, the Federal Trade Commission (FTC) unanimously ruled that it has authority to regulate a healthcare provider’s inadequate data security programs in order to protect consumers from business’ failure to...more

Failure To Protect Data May Be an Unfair Business Practice

The Federal Trade Commission (FTC) has announced settlement of charges against Accretive Health, Inc. The FTC had alleged that Accretive engaged in an unfair business practice when it failed "to employ reasonable and...more

Accretive Health Data Breach Leads To Twenty-Year Settlement With The FTC

On December 31, 2013, the Federal Trade Commission ("FTC") announced that Accretive Health, Inc., ("Accretive") agreed to settle charges that the company's inadequate data security measures exposed sensitive consumer...more

2013 – The Health Law Year in Review

As 2013 draws to a close, we are pleased to look back on the year that was and highlight some of the key developments in the ever-changing field of health law. While a great deal of attention was focused on the implementation...more

Reverse payment deals under the microscope in the EU

Lessons from the latest Commission decision on agreements affecting generic entry: - The European Commission’s crack down on so-called “reverse payment” agreements continues. - In the EU these agreements may...more

FTC Focuses Enforcement Efforts on Health Care, Technology and Energy Sectors

On November 15, 2013, Chairwoman Edith Ramirez testified on behalf of the Federal Trade Commission (FTC) before the House Subcommittee on Regulatory Reform on the topic of antitrust oversight and enforcement. Ramirez...more

Privacy Monday – November 18, 2013

The month of November is quickly slipping by – this is the time to be looking at the 2014 cybersecurity and data privacy goals and updates and planning ahead. Our selected bits and bytes for this Monday...more

Beware Of That Leased Photocopier: The PHI You Didn't Know You Had

You might be rejoicing at the thought of returning your old worn down leased photocopier and replacing it with the latest state of the art improvement in photocopier technology. But, little did you know that your old...more

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

FTC Releases Complaint Alleging LabMD Failed to Protect Consumer Privacy

In August 2013, the Federal Trade Commission filed a petition in federal court to investigate Atlanta based medical testing laboratory LabMD, Inc. on suspicion that the company failed to reasonably protect the security of...more

Protecting Your Business with Strong Operational Privacy Controls

For decades basic requirements to secure business records have been rooted in various legal silos, from corporate governance to rules of evidence to the discrete privacy rules that govern select technologies. Today, however,...more

FTC Files Complaint Against Lab Over Failed Health Information Security

In a reminder that the U.S. Department of Health and Human Services (“HHS”), with its HIPAA security requirements and enforcement authority, is not the only game in town when it comes to health information privacy, the...more

FTC Complaint Against Medical Laboratory Signals Agency’s Continued Intent to Assert Authority in Data-Security-Breach Actions

In taking action against medical laboratory LabMD, the U.S. Federal Trade Commission demonstrated its continued intent to assert authority through the Federal Trade Commission Act in data-security-breach actions. On August...more

China’s Life Sciences Regulatory Crackdown: September 10 Update

The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We...more

The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin [Video]

Attorney Karen Lovitch, Practice Leader of Mintz Levin's Health Law Practice, discusses the challenges facing pharmaceutical and medical device manufacturers in complying with the Sunshine Act....more

Privacy: The FTC Takes Action And Warns Private Industry

If you had asked me ten years ago whether privacy would become the focus of government enforcement actions, I would have brushed aside the issue with a cavalier – “No Way!!” In the aftermath of 9/11, there was always a focus...more

FTC Investigations of Pharma and Medical Device Transactions – Am I at Risk?

A recent article in the Antitrust Law Journal titled “A Survey of Evidence Leading to Second Requests at the FTC,” by Darren S. Tucker, an attorney advisor to a FTC Commissioner who reviewed non-public information on the...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

Justices say pay-for-delay deals with generic drug makers subject to antitrust 'rule of reason'

In Federal Trade Commission v. Actavis, the Supreme Court held 5-3 that trial courts must apply the traditional "rule of reason" to determine whether reverse-payment settlement agreements between Pharmaceutical Brand...more

French Autorité de la Concurrence Fines Sanofi €40.6 Million for Denigrating Competing Generics"

On May 14, 2013, the French Autorité de la Concurrence (Autorité) issued a decision imposing a fine of €40.6 million on French company Sanofi-Aventis France (Sanofi) for an abuse of dominance in the market for the...more

"Eye on Privacy" Newsletter - May 2013

In this issue: - FTC Issues New Guidance for Disclosures in Online Advertising - European Regulators Opine on "Purpose Limitation" Principle – What Constitutes "Compatible Use" in the Context of Big Data?...more

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