In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and DevelopmentAct 51 of 2008 - which only came into force on 2 August 2010– governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
The Comelec promulgated Resolution No. 9615 on 15 January 2013. This Resolution implements the provisions of Republic Act No. 9006, more popularly known as the Fair Election Act, for purposes of the 2013 national and local mid-term elections ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
On February 12, 2013, in conjunction with the release of the Executive Order on Improving Critical Infrastructure Cybersecurity (the Executive Order), President Obama signed a Presidential Policy Directive/PPD-21 on Critical Infrastructure Security and Resilience. The PPD revokes the 2003 Homeland Security Presidential Directive-7 (issued by President George W ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
On February 12, 2013, the Obama Administration released an executive order, Improving Critical Infrastructure Cybersecurity (the "Executive Order"), which is focused primarily on government actions to support critical infrastructure owners and operators in protecting their systems and networks from cyber threats ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
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 ...
Some favourable news on the global economic front has been trickling in. Markets around the world rallied as the US avoided the fiscal cliff-dive by a nanosecond; China's economy is showing signs of renewed strength, with the powerful manufacturing sector now performing at its best levels in almost two years; and share prices in most of Europe, Britain and even Japan have been trading solidly higher over the past few months ...
In September, the National Customs and Tax Authority - DIAN - presented the third draft of the new Customs Statute, which will regulate most of Colombia’s customs law. Although scholars and business associations have presented their comments to the project, the draft seems to be definitive for the most part ...
The Iran Freedom and Counter-Proliferation Act of 2012 (IFCPA), enacted this week by Congress as part of the National Defense Authorization Act for Fiscal Year 2013, further ratchets up U.S. economic sanctions against Iran. U.S. persons or entities (hereafter "persons"), including their foreign subsidiaries, or persons in the U.S., are already prohibited from virtually all transactions involving Iran. Under IFCPA, U.S ...
In a Federal Register notice dated December 26, the Office of Foreign Assets Control (OFAC) of the Dept. of the Treasury updated its regulations to include prohibitions on foreign subsidiaries of U.S. corporations from doing business with Iran. 77 F.R. 75848. The amended regulations also make clear that penalties for trading with Iran by a foreign subsidiary can be imposed on its U.S. parent. Such penalties will not be applied if the U.S ...
On 17 December 2012 Treasury released a Consultation Paper on minimum governance standards for entities registered with the Australian Charities and Not-for-profits Commission (ACNC), as well as draft Regulations and an Explanatory Memorandum on financial reporting obligations and annual information statements for such entities ...
On November 22nd a law referred as Law against Corruption was published on the official Gazette (Decree number 31-2012 of Guatemalan Congress), which entered into force on November 30th, 2012. This law mainly incorporates amendments to the Criminal Codes, Law Against Organized Crime and Property Forfeiture Law ...
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 ...
The America Invents Act of 2011 (AIA) authorizes the U.S. Patent Office to create a new third tier of fees for patent prosecution and maintenance — "Micro Entity Status" — where fees may be reduced by up to 75 percent. Micro entities are eligible to pay fees 50 percent lower than those paid by small entities and 75 percent lower than those paid by large entities ...
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 October 31, 2012, the California Court of Appeal affirmed a finding that two chemicals classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic pursuant to the Labor Code do not meet the standard for inclusion on the Proposition 65 list ...
The UK Information Commissioner’s Office (“ICO”) recently published a questionnaire to gather feedback on how privacy seals might be used to improve data protection compliance and customer privacy awareness. The questionnaire is available online until November 30, 2012 ...
On November 22, 2012, the UK Ministry of Justice released a written ministerial statement (“Statement”) announcing the publication of its Government Impact Assessment on the European Commission’s legislative reform package on the EU data protection framework. The European Commission has claimed that a regulation implementing a single set of data protection rules across the European Union would save businesses around €2.3 billion a year ...
On November 28, 2012, the UK Information Commissioner’s Office (“ICO”) issued monetary penalties totaling £440,000 to two owners of a marketing company that sent millions of unlawful spam SMS text messages over a period of three years.Following an 18 month investigation, Christopher Niebal and Gary McNeish, the owners of Tetrus Telecoms (“Tetrus”), have been ordered to pay £300,000 and £140,000, respectively ...
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 ...
In late October 2012, California Attorney General Kamala D. Harris began sending letters to approximately 100 mobile app operators, informing them that they are not in compliance with the California Online Privacy Protection Act (“CalOPPA”) ...
