Busy morning? You probably deserve a break. A JD Supra Corporate Brief break, that is. And a blueberry scone… Check your mailbox – the FTC is sending out COPPA compliance letters… (Mintz Levin) In the market for a municipal regulated gas division? (Saul Ewing) Appeals court reverses an $11 million False Claims Act judgment with… Read more »
“The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision.” (Sheppard Mullin) Earlier this month, the Ninth Circuit issued an opinion that sends an important warning to pharmaceutical manufacturers: the First Amendment doesn’t protect off-label marketing… Read more »
In its first advisory opinion letter issued since implementation began on the Affordable Care Act, the Federal Trade Commission indicated that it would not challenge a proposal from the Norman Physician Hospital Organization (PHO) to form a clinical integration program (CIP). For your reference, a roundup of legal commentary and analysis on the FTC opinion.… Read more »
“The definition of a data ‘breach’ was changed. The Omnibus Rules replaced the more subjective ‘harm standard’ with a more objective test that requires the covered entity to determine (based on a four-factor risk assessment) whether protected health information has been ‘compromised.’” (Snell & Wilmer) One of the key components of the new HIPAA /… Read more »
No time read all 563 pages of the US Department of Health and Human Services Office for Civil Rights’ HIPAA/HITECH Omnibus Rule? Here’s a summary of key points: Effective Date: “The Enforcement Rule changes are effective on March 26, 2013. The additional 180 days afforded for most of the provisions in the Final Rule apply… Read more »
“The Final Rule represents the most significant development in healthcare privacy law since the issuance of the final Privacy Rule and Security Rule a decade ago.” (Morgan Lewis) On January 17, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released its final omnibus rule, strengthening the… Read more »
According to incubator Rock Health, funding for digital health projects increased by 45% in 2012. It’s a hot sector – and here, in a video series, is attorney Michael Esquivel, partner in law firm Fenwick & West’s Start-ups and Venture Capital Group, to talk about the opportunities: “Digital health” is what’s happening at the intersection… Read more »
The business community as a whole can expect President Obama’s second term to be one of most intense periods of regulatory activity in nearly 40 years. But the health care, energy, and financial services industries will be the hardest hit. From law firm Venable: “Several themes will shape the regulatory process over the next four… Read more »
Welcome to 2013′s inaugural edition of the Corporate Law Report, a look at some of the top corporate news items we’ve been following this first week of the new year. You know the drill: Watch the video overview above and, for any topics that interest you, go deeper with the legal analysis and commentary below>>… Read more »
Dodd-Frank, the Foreign Corrupt Practices Act, social media in the workplace, cybersecurity, SEC regulations… all front-and-center corporate issues at the start of a new year. Your job, among many other things, is to know what to do about each of them. That’s why it helps when leading lawyers with expertise in each of these fields… Read more »
What’s on your mind? Four themes in particular, if we go by what you’ve read over the past year: Legal issues related to doing business internationally Dodd-Frank regulations and other financial reforms Intellectual property Health care, including in particular HIPAA regulations and health care reform As popular as those issues were, however, there are many… Read more »
Earlier this month, the Department of the Treasury and the Internal Revenue Service issued final rules for the new 2.3% excise tax that will be imposed on medical devices as of January 1, 2013 pursuant to the Patient Protection and Affordable Care Act. For manufacturers, producers, and importers of medical devices, here’s a brief Q&A… Read more »
“While everyone appears to be spending time on FCPA enforcement and compliance, companies need to spend more time in protecting themselves from the False Claim Act.” (Michael Volkov) The Department of Justice just announced that it recovered a record $4.9 billion from False Claims Act judgments and settlements in the 2012 fiscal year, and the… Read more »
“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 »
“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 »
