February 2019

President Trump tweeted out on Sunday what sounds like good news:  based upon “substantial progress“ in trade negotiations with China, he was postponing a March 2 increase from ten to twenty-five percent tariffs on some $200 billion in U.S. imports from China.  The President even declared expectations of further progress and a “signing summit” at…

The Section 809 Panel recently concluded its monumental analysis of defense acquisition law and regulations and released its third volume of recommended changes.  As we have written previously, the Panel’s work stands out from previous acquisition reform efforts with the appendices of detailed legislative and regulatory changes that accompany the commissioners’ analysis and recommendations.

Given…

The most recent decision in the ongoing Sun Capital saga provides no relief from pension withdrawal liability for private equity funds.  The federal district court for the District of Massachusetts recently reaffirmed its 2016 ruling that two private equity funds were responsible for the unfunded pension liabilities of a bankrupt portfolio company.  Consequently, private equity…

On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators.

The Taskforce has sought…

This month, the Government Accountability Office (“GAO”) released a report recommending that Congress consider enacting a federal internet privacy law in the United States.  The 56-page independent report was requested by the House Energy and Commerce Committee, which has scheduled a hearing on data privacy on February 26, during which it plans to discuss the…

Ten months ago the California Supreme Court rendered its unanimous decision in Dynamex Operations West, Inc. v. Superior Court, a case that articulated a new standard for classifying employees and independent contractors.  Given the importance of this decision, we provided analysis on this case when it was first decided.  However, once issued, this new Dynamex…

EPA published today in the Federal Register its final rule governing hazardous waste pharmaceuticals.  This rule adopts a novel scheme under the Resource Conservation and Recovery Act (“RCRA”) for the management of hazardous waste pharmaceuticals that are discarded by healthcare facilities or managed by “reverse” distributors.  It also applies to other types of products…

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that 2018 was an all-time record year for Health Insurance Portability and Accountability Act (“HIPAA”) enforcement activity.   Enforcement actions in 2018 resulted in the assessment of  $28.7 million in civil money penalties.  Enforcement activity focused primarily on breaches of electronic protected…