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 ...
A client asks, "Can I say ‘Made in USA’ for my product if it has some imported content"? While the question seems simple enough, the proper response requires the advisor to inquire into the reason for the question and the company’s specific objective. Depending on the client’s response and the pertinent facts, the resulting analysis and legal conclusion may differ considerably. If the company wants to assert a "Made in USA" or other U.S ...
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 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 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 ...
Burma’s Union Parliament has finally passed a much awaited foreign investment law, which has now been signed into law by President Thein Sein (the “MFI Law”) and published in local newspapers on November 3, 2012. The review of the MFI Law by parliament has drawn to the fore a number of issues in particular in respect of the share in a venture that can be held by foreigners ...
On 14 August 2012, the Minister of Industry of the Republic of Indonesia issued Ministerial Regulation Number 81/M-IND/PER/8/2012 of 2012 on The Registration of Cellular Phones and Handheld Computers (“Regulation 81/2012”) ...
Importers are likely to welcome the Minister of Trade’s (MOT) latest move in the import license saga which commenced with a Supreme Court decision of June 2011 striking down MOT Regulation No. 39 of 2010 regarding the import of finished goods by producers. Following the issuance of MOT Regulation 27/2012 (“Reg 27”), and in response to the several concerns which ensued, the MOT recently issued MOT Regulation No. 59/2012 (“Reg 59”) ...
On 24 August 2012, the Minister of Trade (“MOT”) issued Regulation No. 53/M-DAG/PER/8/2012 on Organizing a Franchise Business (“Regulation 53”). Regulation 53 revokes Regulation No. 31/M-DAG/PER/2008 (“Regulation 31”). Direct or Indirect control of Franchise Regulation 53 prohibits franchisors to appoint franchisees with which they have a direct or indirect control relationship ...
Traditionally investors have looked towards developed countries for investment opportunities and, more often than not, investment decisions have been based on the economic development and growth of such countries. However, recently investment strategies have shifted towards emerging markets rather than established markets and for this reason an ever increasing number of investors are turning their attention to the African market ...
The law holds trustees, like any other fiduciary, to a particularly stringent standard of care. As the famed Judge Benjamin Cardozo wrote in 1928, “A trustee is held to something stricter than the morals of the market place. Not honestly alone, but the punctilio of an honor the most sensitive . . ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
The much anticipated Trade Marks Bill (“the Bill”) was recently circulated to the industry for comments. The Bill, which when enacted will be known as the Trade Marks Act, 2012, promises to introduce much needed change to the trademark industry in the British Virgin Islands and place the jurisdiction in line with other modern jurisdictions ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
Long gone are the days when discussions about customs and foreign trade in Mexico was always in reference to opening borders and policies to promote the development of local industries in a global economy. Today we find that the focus is more on new topics concerning security of the supply chain and compliance with customs regulations, as the key elements that determine the success of a business ...
This article will discuss a type of international audit intended on verifying compliance with international trade rules that indicate when a good is made in a specific country or region. These rules are called “Rules of Origin” and the type of audit is generally called “Origin Verification” ...
The Closer Economic Partnership Arrangement ("CEPA") is a free trade agreement between Mainland China and Hong Kong that offers Hong Kong products, companies and residents preferential access to the Mainland market. Many of the preferences go beyond China's WTO concessions. CEPA is not a closed agreement and both sides hold regular meetings on further concessions and the details for implementation ...
Between 22 May 2012 and 4 June 2012, staff teams from the European Commission, European Central Bank and International Monetary Fund (“IMF”) visited Lisbon to conduct the fourth review (the “Review”) of Portugal’s economic programme (the “Programme”). A copy of the initial statement can be downloaded here:http://ec.europa.eu/economy_finance/articles/financial_operations/2012-06-04-portugal_en.htm And a copy of the full report can be downloaded here: http://ec.europa ...
China has traditionally restricted foreign investment in the retail and wholesale sectors with the aim of nurturing strong domestic players before their foreign counterparts would be allowed to enter the country. Since becoming a member of the World Trade Organisation, China has gradually opened up its distribution sector to foreign investment ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
In the history of the Eurozone crisis, Spain has been a special case. It was always the "teachers pet" when it came to sovereign debt, that is, until recently. On 9 June 2012, Spain received an offer of up to EUR 100 bn in financial support from the EU for its ailing banking sector. What does that mean for Spain and the rest of the Eurozone and how did Europe’s fourth-largest economy find itself in this state? BACKGROUND Spain has been unlucky in many respects ...
