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Practice Industry: Crossborder Trade & Investment, Dispute Resolution, Healthcare & Pharmaceuticals
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Makarim & Taira S. | February 2013

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 ...

Makarim & Taira S. | February 2013

After lengthy discussions among regulators and politicians on ownership of commercial banks, Bank Indonesia issued its Regulation No. 14/8/PBI/2012 regarding Ownership of Shares in Commercial Banks (“BI Regulation No. 14”) which came into effect on 13 July 2012.In general, BI Regulation No. 14 provides rules that restrict ownership of commercial banks by individuals or corporations either on an individual or joint basis. BI Regulation No ...

Here are select December 2012 rulings of the Supreme Court of the Philippines on criminal law and procedure: 1.            REVISED PENAL CODE Rape; Pruna Guidelines ...

Here are select December 2012 rulings of the Supreme Court of the Philippines on commercial law:Corporations; liability of corporate officers. Settled is the rule that debts incurred by directors, officers, and employees acting as corporate agents are not their direct liability but of the corporation they represent, except if they contractually agree/stipulate or assume to be personally liable for the corporation’s debts, as in this case.  Ildefonso S. Crisologo vs ...

Shoosmiths LLP | February 2013

The Scottish Courts: The largest volume of litigation takes place in the Sheriff Courts located throughout Scotland, which are similar to the County Courts in England & Wales in that they typically handle disputes which are relatively straightforward and low value ...

Haynes and Boone, LLP | January 2013

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”) ...

Haynes and Boone, LLP | January 2013

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 ...

Dykema | January 2013

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 ...

Hunton Andrews Kurth LLP | January 2013

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 ...

Waller | January 2013

Legislators filed bills before the official start date of the 83rd Texas Legislative  Session; many of the bills already filed  address healthcare issues. 1. The Budget. Texas legislative leaders  recently approved a self-imposed  budget cap for the 2014-2015  biennium based on a conservative  estimate of growth in the state’s  economy, holding lawmakers to not  more than a 10 ...

Waller | January 2013

Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...

Waller | January 2013

A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...

Krogerus | January 2013

With a law enacted on 17 December 2012, the Finnish parliament moved forward on the longstanding plan to house intellectual property rights disputes in the Market Court. This legislative reform has a significant impact for all companies operating in Finland. The Market Court will start to hear these disputes in the autumn of 2013 ...

Shoosmiths LLP | December 2012

As we embark upon the season of goodwill, those wishing to embrace the Christmas cheer may wish to consider settlement of an ongoing commercial dispute bringing peace and goodwill to all - besides saving their business time and money in the process.Should you settle? Parties settle disputes for a variety of reasons ...

Hunton Andrews Kurth LLP | December 2012

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 ...

Hunton Andrews Kurth LLP | December 2012

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 ...

Wardynski & Partners | November 2012

A Polish company enters into a contract with a German company. Which country’s law will govern the contract? Monika Hartung: To start with, under Art. 3 of the Rome I Regulation (Regulation 593/2008 of 17 June 2008 on the law applicable to contractual obligations), the parties themselves may select the law governing the contract. The previous version of Poland’s Private International Law required the existence of a link, e.g ...

Hunton Andrews Kurth LLP | November 2012

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 ...

Waller | November 2012

On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...

Waller | November 2012

Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...

DFDL | November 2012

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 ...

Makarim & Taira S. | November 2012

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”) ...

Makarim & Taira S. | November 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”) ...

Makarim & Taira S. | November 2012

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 ...

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