by Bryan G. Scott and Elizabeth K. Strickland Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...
In our final procurement update of 2009 we report on two important administrative changes: new advertising thresholds, and new OJEU notices. New advertising thresholds published These will apply for two years from 1 January 2010. As predicted, because Sterling has been so weak against the Euro, the Sterling thresholds have actually gone up significantly (meaning slightly fewer contracts will be caught by the full Regulations) ...
Under the Tobacco acT (r.s.Q., c. t-0.01), employers mUst prohibit their employees from smoKing inside their establishments. howeVer, the act is mute on no smoKing oUtside, on the company’s land ...
The U.S. Department of Justice recently announced an enforcement initiative targeting the pharmaceutical industry for investigations and prosecutions under the Foreign Corrupt Practices Act (FCPA). The FCPA prohibits improper payments to foreign government officials for the purpose of obtaining or retaining business and mandates that companies that issue securities take affirmative measures to prevent such payments ...
Is a recession good for innovation? History seems to suggest that it may be and numerous notable inventions have emerged from recessions, for example James Dyson's vacuum came out of the last recession in the 1990s. Innovation is a key priority for the Scottish Government in these difficult times and politicians have described innovation as "essential" to create a more successful Scotland through sustainable economic growth ...
Providers of a advanced diagnostic imaging services, including physicians, who bill for the technical component must become accredited by a designated accreditation organization by Jan. 1, 2012 in order to be reimbursed by Medicare, according to a notice from CMS published in the Federal Register ...
Referring to Newsletter Issue No. 12 in relation to the Health Bill, the new Health Law No. 36 of 2009 was finally issued on 13 October 2009. Under the Health Law, mothers must breastfeed their babies exclusively from birth until 6 months old. It is expected that family members, the Government, Regional Governments and communities will support lactating mothers by providing time and space for them to breastfeed their babies in work places and public areas ...
On 19 October 2009, the Minister of Communications and Informatics issued Regulation, No. 42/PER/M.KOMINFO/10/2009, regarding The Procedures for Obtaining a Licence for a Foreign Based Broadcast Company Conducting Activities in Indonesia, as an implementing regulation of Government Regulation No. 49 of 2005 on Foreign Based Broadcast Companies. A foreign based broadcast company is a broadcast company established according to foreign laws and/or having offshore headquarters ...
Google France, Google Inc. -V- Louis Vuitton Malletier and others, European Court of Justice Cases C-236/08, C-237/08 And C-238/08 The European Court of Justice ruled this week that Google did not infringe trademark rights by letting advertisers purchase keywords corresponding to their competitors’ trademarks in Google’s AdWords program ...
The music, film and broadcast industries look set to get the robust protection from illegal peer-to-peer (P2P) file-sharing they crave, as the Digital Economy Bill moves closer to becoming law. It passed its third reading at the House of Commons on 7 April ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
After decades of debate, US healthcare reform became a reality in 2010 when President Obama signed the Patient Protection and Affordable Care Act (ACA) in March. Yet public opinion remains sharply divided on the merits of this sweeping legislation, both in terms of its ability to address the problems of access to, and the rising cost of, healthcare services and in terms of the financial burden on the federal and state governments of implementing ACA ...
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 ...
As part of the Medicare hospital outpatient prospective payment system and ambulatory surgery center payment system final rule for calendar year 2011 (the “Final Rule”), the Centers for Medicare and Medicaid Services (CMS) recently issued final regulations that implement the changes that were made to the whole hospital exception by the Patient Protection and Affordable Care Act and the Health Care Education and Reconciliation Act of 2010 (collectively, the “Acts
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 ...
The AGCOM (the Italian Media Authority) has recently published (on December 28th, 2010) two resolutions concerning the broadcasting services of audio and/or video contents (so-called “audiovisual media services”) in “linear” mode (“streaming” or “simulcast” services: Resolution n ...
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 ...
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 ...
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 ...
As we stated in our bulletin last week, on March 31st, the federal government outlined proposed actions relating to Accountable Care Organizations (ACOs), a key component of the healthcare reform legislation (the Affordable Care Act, or ACA) enacted in March 2010. In this bulletin, we provide some additional information regarding each of the March 31st releases ...
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 ...
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 ...
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”) ...
