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Fiduciary Regulation and How Recent Cybersecurity Government Publications Impact HIPAA Security Compliance and the New Audit...

Fiduciary Regulation - The Office of Management and Budget released the final Fiduciary or Conflict of Interest regulation and related prohibited transaction exemption modifications from its review today. The next...more

The Demise of Valeant Pharmaceuticals: A Case Study in Rotten Culture and Business Ethics

Showing my age again, Woody Allen’s Take the Money and Run included a hilarious scene when Woody’s parents wearing Groucho Marx glasses talk about their criminal son (Woody/Virgil Starkwell), his dad exclaimed “He’s rotten,...more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

OCR Kicks Off HIPAA Audits After Issuing Two Major Settlements

On March 21, 2016, the HHS Office for Civil Rights (OCR) launched phase two of its much-anticipated audit program for covered entities and business associates. The announcement comes in the wake of OCR's issuance of two major...more

US District Court in Southern California Rules No Coverage for HIPAA Investigation

The District Court for the District of Southern California was asked to reconsider its prior decision issued on motions for summary judgment in coverage litigation between Millenium Labs, Inc. (“Millenium”), and its insurer,...more

Seven-Figure Settlement Reinforces Necessity of Business Associate Agreements

On March 16, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that North Memorial Health Care of Minnesota (“Memorial”) agreed to pay $1.55 million to resolve allegations that...more

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products

On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was...more

The Olympus Debacle: Why Internal Whistleblowing is a Good Thing for Compliance

The U.S. Department of Justice announced last week that Olympus Corporation of the Americas (OCA) agreed to pay $646 million to resolve three cases relating to its longstanding practice to bribe doctors and hospitals in the...more

Medical Device Subsidiary Agrees to DPA with DOJ Related to Health Care Bribes

On March 1, a Miami-based medical device company entered into a deferred prosecution agreement (DPA) to resolve charges of conspiracy to violate the FCPA and violating the FCPA in connection with improper payments and...more

5 Questions About France’s New Health-related Class Action Law

The number of eligible associations and the law’s broad scope could portend a significant number of health-related class actions. A new law, referred to as Loi Santé No. 2016-41 and enacted on 26 January 2016, contains...more

Developments in Cybersecurity: Privacy Laws, Hacking Beyond Customer Data, and Communicating with Corporate Boards

I. Legal Exposure to Federal and State Privacy Laws - A. Federal Statutes and Enforcement - 1. Federal Trade Commission Act, 15 U.S.C. §§ 41-58 - The Federal Trade Commission (FTC) has emerged as the leading...more

Health Update - February 2016

Better Late Than Never: CMS Provides Much-Needed Clarity on the 60-Day Overpayment Refund Requirements - On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the long-awaited final rule (Final...more

Health Alert (Australia) - February 22, 2016

IN THIS ISSUE: In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland 12 February 2016 - Gobus v State of Queensland (Cairns and Hinterland Hospital and...more

Health Law Alert: Pharmacies and Prescription Drug Dispensers...Are You Ready for The March 1, 2016 DSCSA Compliance Deadline?

In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business...more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

California Imposes Controversial Cost-Sharing Restrictions to Facilitate Patient Access to Expensive Drugs

In response to public discontent over surging drug prices, federal and state lawmakers are scrambling to introduce drug price reform legislation. While many of these reforms have targeted drug manufacturers, a few state...more

Amgen v Apotex - 180-Day Advance Notice of Biosimilar Marketing is Mandatory

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway “patent dance” made the 180-day advance-notice provision mandatory; however, it left open the...more

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more

The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

Promoting Antitrust Compliance – The Antitrust Division’s Subtle Shift Regarding Corporate Compliance: A Step Toward Incentivizing...

INTRODUCTION: A surprising feature of many corporate compliance programs is their limited emphasis on antitrust. Compliance efforts are a key feature of modern corporate governance initiatives, and it stands to reason...more

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