The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
On January 4, 2013, the United States District Court for the Northern District of Illinois, Eastern Division (the “District Court”) issued a Memorandum Opinion and Order1 that seems demonstrably at odds with the majority of cases analyzing the § 546(e) safe harbor provision.2 General Background Facts Sentinel Management Group, Inc ...
Coming as a surprise to some, the European Parliament approved rules creating a Unified Patent Court and a Unitary Patent on December 11, 2012, after lengthy consideration ...
Employment Conditions of Foreign Workers (2) Share Ownership: An Overview (3) Certificate of Intellectual Property Pertaining to Software. Employers frequently resort to the use of foreign workers. In some industries, this is practically unavoidable. Faced with the new reality of foreign workers, many companies have questions about how to manage the workers they hire and the specific conditions applying to them ...
In light of a recent federal court order, companies – especially those at risk of False Claims Act suits – should revisit their protocol for handling communications with in-house counsel. In United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, a federal magistrate judge ordered Halifax Hospital to produce communications involving in-house lawyers in an ongoing FCA suit against the hospital ...
The European Commission recently fined seven international company groups with a total fine of around 1.47 billion EUR for two distinct cartels related to cathode ray tubes (CRT) used in colour television sets and computer monitors. The investigation was initiated after a leniency application by one of the cartel members. The cartel concerned price-fixing, market-sharing, production quotas and prohibited information exchanges ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
On November 14th, the Securities and Exchange Commission (the "SEC") and the Department of Justice (the "DOJ") released their jointly developed "Resource Guide to the U.S. Foreign Corrupt Practices Act" (the "Guide"). Long awaited and much anticipated, the Guide brings together in a single, 120-page document the agencies’ interpretation of the FCPA and approach to enforcement activities ...
On November 28, 2012, the United States Court of Appeals for the Fifth Circuit published an opinion affirming the bankruptcy court’s ruling that the Mexican Plan of Reorganization (the “Concurso Plan”) of the Mexican glass-manufacturing company, Vitro, S.A.B. de C.V., approved by the Federal District Court in Mexico, should not be enforced under Chapter 15 of United States Bankruptcy Code ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
The British Virgin Islands (“BVI”) is a British overseas territory situated to the east of Puerto Rico between the Caribbean Sea and the North Atlantic Ocean. The country consists of the main islands of Tortola, Virgin Gorda, Anegada, and Jost Van Dyke and over fifty other smaller islands and cays clustered around the aquamarine waters of the Sir Francis Drake Channel.Interestingly the country’s official name is simply the “Virgin Islands ...
On November 14, 2012, the Department of Justice and the Securities and Exchange Commission released the much-anticipated Resource Guide to the U.S. Foreign Corrupt Practices Act (the “Guide”) ...
On November 9, 2012, a federal District Court in Washington certified a national class and a Washington state sub-class in an action alleging that Papa John’s International, Inc. (“Papa John’s”) violated the Telephone Consumer Protection Act (“TCPA”) by sending unsolicited text messages advertising its pizza products. The court determined that plaintiffs had standing and satisfied all other requirements for class certification ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
Bloomberg Law’s Lee Pacchia interviewed Lisa J. Sotto, partner and head of the Global Privacy and Data Security practice at Hunton & Williams LLP, to discuss the recent data security incident involving Barnes & Noble stores. Sotto discussed life in the modern world of technology where there is an increased risk of data security incidents, and many companies only reach out to counsel after a data breach occurs ...
Issues surrounding the election of Directors of Public Companies gained the attention of Canadian Securities Regulators in the last years due to concerns expressed be large institutional directors that current Canadian Rules regarding the election of Directors were not Democratic nor aligned with current practices in other countries ...
Federal statutes and regulations impacting the banking industry run the gamut from a basic forgery to fraud and insider trading. Financial institutions need to be informed and know where to turn if illegal activity is discovered by bank management or if the bank is the focus of a federal investigation ...
On October 29, 2012, the UK Information Commissioner’s Office (“ICO”) served private sector financial services company The Prudential Assurance Company Limited (“Prudential”) with a monetary penalty of £50,000 in connection with a serious violation of the Data Protection Act 1998 (“DPA”). The violation concerned a mix-up involving Prudential customer details ...
What is an illegal contract and is it enforceable? If an illegal contract is unenforceable, does the party who received its benefit get to keep that windfall? The short answer to the first question is that a contract is illegal when it is either contrary to a statute or is contrary to public policy. Generally, illegal contracts are not enforceable. The answer to the second questions is “it depends” ...
A new Regulation on Corporations has recently entered into force in Chile (the “New Regulation”). It aims essentially to complement the provisions of the Law on Corporations, updating the rules established in the prior Regulation on Corporations, clarifying or specifying certain articles that raised questions, adjusting the applicable provisions to the latest legal amendments and making certain practical aspects easier ...
On 18 October the Department for Business, Innovation & Skills (BIS) released a set of draft regulations designed to reduce the complexity involved in narrative reporting for large British companies and increase transparency. Changes will take effect from October next year, meaning quoted companies with reporting years ending on or after 1 November 2013 will need to change the form and content of their reports ...
As part of the new Flex BV Act that came into force in the Netherlands as per 1 October 2012, also a revised statutory dispute settlement procedure (wettelijke geschillenregeling) was introduced. This procedure can be used in two ways. Firstly, the procedure offers shareholders, under certain circumstances, the opportunity to force a shareholder to sell its shares (‘squeeze-out’ or uitstoting) ...
On 1 August 2012, the Indonesian Capital Market and Financial Institution Supervisory Board (“Bapepam-LK”) issued a new regulation on Annual Reports of Public or Listed Companies, Bapepam-LK Regulation Number X.K.6. The regulation requires information on the primary and directly or indirectly controlling shareholders of listed companies, up to individuals, to be provided in the form of a scheme or diagram in their annual reports ...
