1. International anti-corruption conventions To which international anti-corruption conventions is your country a signatory? Chile is a signatory to and has ratified the Inter-American Convention against Corruption, the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, and the United Nations Convention against Corruption. 2 ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...
The new Immigration Bill was passed by the Indonesian Parliament on 7 April 2011. It will pass into law on the day it is signed by the President or within 30 days of its passage, whichever occurs earlier.The bill covers a range of basic matters relating to immigration, including entry to and exit from the Indonesian territory, travel documents, visas, stay permits, etc ...
Are donations of counterfeit goods to charities socially acceptable? - Despite calls for seized counterfeit goods to be donated to charity, a number of conditions should be met in order to protect both IP rights holders and those receiving the goods Nobody would dispute that in today’s world, the social and environmental impacts of our actions must be taken into consideration whenever we make a decision ...
The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...
Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
On April 4, 2011, the U.S. Patent and Trademark Office (USPTO) issued a Final Rule implementing the prioritized examination track (“Track I”) of its new examination timing control procedures.1 Under Track I, patent applicants can accelerate examination of certain patent applications that are filed on or after May 4, 2011 ...
Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...
The USPTO has declared that the aftermath of the March 11, 2011 earthquake and tsunami in Japan constitutes an “extraordinary situation” under 37 C.F.R. §§ 1.183 and 2.146 that justifies certain measures of relief from patent regulations. While the PTO cannot declare this extraordinary situation a “postal emergency” to grant stronger relief, it has elected to recognize the difficulties of its innovation customers in the affected areas of Japan ...
How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...
It's that time of year when municipalities send out tax accounts to their citizens. In certain cases, they may contain a very unpleasant surprise. For citizens living in municipalities whose property assessments are for the years 2010 to 2012, now is the time to do some double-checking ...
In a recent decision of the court of appeal, the Honourable Pierre J. Dalphone confirmed that a secured creditor may ust its debt to acquire the assets which are charged with its security interests in the context of a sale process monitored by the court under the companies creditors arrangement act (CCAA) background. White Birch Paper Inc. and several of its subsidiaries (collectively, the “White Birch Group”February 24, 2010)obtained an initial order under the CCAA ...
HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
A ‘Battle of the Forms’ commonly arises where each of the parties, in the course of the negotiation process, forwards to the other its own standard form of contract, with the aim of getting the other party to adopt such terms and conditions. The question as to which set of terms and conditions constitute the contract often depends on the ‘last shot’ – that is, which form of contract was the one last ‘fired’ to the counter-party ...
On January 18, 2011, the West Virginia Supreme Court of Appeal decided State ex rel. West Virginia Citizens Action Group, et al. v. Earl Ray Tomblin, et al., Docket No. 101494. In this case, the Citizens Action Group and others were seeking an order from the court to compel Earl Ray Tomblin, et al ...
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
KSB partner Martin Šolc, who specializes in advisory on transactions in the field of mergers and acquisitions, has also been performing professional activities for a long time with the International Bar Association (IBA), a leading organization of international legal practitioners, bar associations and law societies, bringing together more than forty thousand attorneys and one hundred and ninety-seven chambers of attorneys on all continents ...
On April 28, 2005, the Chambre des notaires du Québec filed a petition to declare unconstitutional and of no force and effect requirements issued by the Canada Revenue Agency (CRA) under sections 231.2 and 231.7 as well as subsection 5 of section 232(1) of the Income Tax Act, R.S.C. 1985, c. 1 (5th Supp.) (ITA) to obtain documents or information prima facie protected by professional secrecy ...
Recent Federal Circuit Decision on Section viii Carve Outs and Inducement By C. Kyle Musgrove, Partner On November 1, 2010, a divided 2-1 panel of the Federal Circuit issued a decision in AstraZeneca LP v. Apotex, Inc. that addresses inducement of infringement in the context of a Section viii "carve out" under 21 U.S.C. § 355(j)(2)(A)(viii) and 21 C.F.R. § 314.92(a)(1) ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
