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”) ...
On November 13-15, 2012, delegates at the IAPP Europe Data Protection Congress in Brussels were given insight into how discussions with key policymakers are progressing. As European Parliament rapporteur and Member of the European Parliament Jan Philipp Albrecht aims to finalize the reform of the EU Data Protection Directive by the end of the current European Parliament’s mandate in 2014, this ambitious goal faces numerous hurdles ...
On November 20, 2012, the UK Information Commissioner’s Office (“ICO”) published “Anonymisation: Managing Data Protection Risk Code of Practice” (the “Code”). The purpose of the Code is to provide organizations with a framework for assessing the risks of anonymization ...
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 ...
Reporting from Washington, D.C., Hunton & Williams partner Frederick Eames writes: Elections have consequences. What are the consequences of the 2012 election on U.S. federal privacy, data security and breach notice legislation? We outline some key developments in the U.S. House of Representatives and Senate and explain how these developments might affect legislative priorities and prospects for the 113th Congress beginning in 2013.U.S. House of RepresentativesThree committees in the U ...
On November 7, 2012, the Federal Trade Commission announced that it had settled charges against payday lending and check cashing companies alleged to have improperly disposed of consumers’ personal information. In its complaint, the FTC maintained that PLS Financial Services, Inc ...
On October 26, 2012, three resolutions were adopted by the closed session of the 34th International Conference of Data Protection and Privacy Commissioners and have been published on the conference website. Below we provide an overview of these resolutions ...
The Federal Attorney-General has released a Discussion Paper seeking comment on whether to introduce laws to make notification of data breaches by government agencies and large private sector entities mandatory in Australia. The Government is calling for submissions by 23 November 2012, asking what the triggers should be and what penalties should apply for failure to comply ...
