Topic: Health Care

Stricter California Pregnancy Disability Leave Regulations Take Effect December 30, 2012

“The Fair Employment and Housing Commission (FEHC) recently issued revised regulations that govern pregnancy disability leave (PDL) in California. The new regulations take effect December 30, 2012, and include changes that will affect employers’ pregnancy leave of absence policies. California employers with five or more employees are covered by PDL.” (Wilson Sonsini) California employers take… Read more »

Off-Label Marketing Conviction Violates First Amendment

“In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, ‘We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an… Read more »

HIPAA Update: How to Turn Protected Health Information into Research Data

“HIPAA places tight restrictions on the use and disclosure of protected health information, but there are many ways to ‘de-identify’ it, freeing it from HIPAA’s constraints. Covered entities and business associates can use de-identification to reduce their exposure to HIPAA and expand their use of health data.” (Davis Wright Tremaine) On November 26, 2012, the… Read more »

Feds Propose New Guidance on Wellness Programs. Feel Better Now?

“Wellness programs take many forms; however, the common feature of all wellness programs is that they are designed to encourage healthier lifestyles, often by rewarding participants for attaining or improving certain health factors. Most wellness programs are subject to HIPAA’s nondiscrimination rules … [h]owever, the HIPAA nondiscrimination rules contain an exception whereby group health plans… Read more »

Doing Business in China: A JD Supra Legal Reader

A cautionary tale kicks off this latest edition of Doing Business in China: Sixing Liu, a Chinese national with U.S. residency, was arrested and charged with export control violations when returning from a trip to China one year ago. From law firm Miller Canfield: “Liu allegedly took export-controlled technical data on military technology (Controlled Data)… Read more »

Medicine is Mobile. What Does That Mean for Security?

“New medicine is mobile, miniature and you can play angry birds on it. But what does that mean for security and privacy?” (Jo Ellen Whitney of law firm Davis Brown) The Massachusetts Eye and Ear Infirmary (MEEI) received a $1.5 million lesson in HIPAA and mobile device security earlier this month. Not because MEEI lost… Read more »

IRS Defines “Full-Time” Employees for Health Care Benefits

Earlier this month, the Internal Revenue Service issued important guidance for employers on the rules for identifying “full-time” employees for the purposes of the Affordable Care Act. It’s an important clarification, write employment attorneys Josh Bobrin and Edward Leeds (Ballard Spahr), because: “Effective January 1, 2014, employers with 50 or more full-time equivalent employees are… Read more »

DNA Eligible for Patent Protection, Court Rules in Myriad (Again)

“Isolated DNA molecules are patent-eligible, reaffirmed the U.S. Court of Appeals for the Federal Circuit in Ass’n for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., lifting a cloud of uncertainty over DNA composition patents. ‘The isolated DNA molecules before us are not found in nature. They are obtained in laboratory and are… Read more »

Pfizer Settles FCPA Charges for $60 Million

[Link: The Pfizer DPA Enhanced Compliance Obligations-the New Normal? by Thomas Fox] Earlier this month, global pharmaceutical company Pfizer Inc. agreed to pay $60 million to the U.S. Securities and Exchange Commission and the U.S. Department of Justice to settle charges that the company violated the Foreign Corrupt Practices Act. From law firm Warner Norcross… Read more »

Ignorance Is Not Bliss: Feds Hold Executives Criminally Liable for Corporate Misdeeds

[Link: Responsible Corporate Officer Doctrine: Executives Who Allow Misdeeds Face Career-Ending Consequences – LXBN] Corporate executives who fail to notice – and put an end to – criminal misdeeds that happen on their watch can pay a high price for their lack of oversight. Case in point: Purdue Pharma’s fraudulent marketing of OxyContin, which led not… Read more »

HIPAA Audit Report Gives Providers New Roadmap to Compliance

In late June 2012, the Department of Health and Human Services Office for Civil Rights published its long-awaited HIPAA compliance audit protocol. For covered entities and business associates, the protocol serves as a roadmap of practices and procedures that help ensure compliance and avoid fines and other sanctions. Law firm Mintz Levin: “The protocol addresses… Read more »

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »

Most Popular Corporate Law Posts – June 2012

What’s on your mind? ICANN’s generic top-level domain names, HIPAA compliance and violations, the SCOTUS RadLAX ruling, the EU Cookie Directive, that’s what (and more!). For your reference, the most-read Corporate Law Report posts in June, 2012: 1. HIPAA Compliance: 6 Audit Questions (and Answers) for Covered Entities “Late last year, members of the Senate… Read more »

Doing Business in Italy: A JD Supra Legal Reader

From lawyers and law firms on JD Supra, recent advisories on a range of legal considerations: High Noon: The Italians try to play solo the Health Claims game (K&L Gates LLP): “On November 27, 2009, the Italian Government notified a draft regulation on the use of substances other than vitamins and minerals in food supplements… Read more »