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
In a recent article we looked at some of the employment risks for customers associated with cloud computing. Following on from Cloud computing: Employment law implications, we now consider how best to assess the other risks associated with cloud computing ...
In the second of a two-part look at issues arising out of the tender process we consider what can happen when that process is poorly run. Part 1 of the series can be found at IT tendering: Leveraging the benefits. A typical tender process involves the customer analysing and documenting its requirements in a Request for Proposals (RFP) to which interested suppliers will prepare a response ...
1. How can the government’s attitude and approach to internet issues best be described? The attitude of the Belgian government can be described as positive and their approach is proactive. In 2003, the Belgian authorities announced the introduction of ‘egovernment’ ...
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 Federal government’s legislation to control spam and other ills of the electronic age with the oh-so-catchy title of An Act to promote the efficiency and adaptability of the Canadian economy by regulating certain activities that discourage reliance on electronic means of carrying out commercial activities, and to amend the Canadian Radio-television and Telecommunications Commission Act, the Competition Act, the Personal Information Protection and Electronic Documents Act and
Concents : * Technology Licences in the Event of Bankruptcy * New Quebec Business Corporations Regime * The Shareholder Agreement: the "Specifications" of the Private Corporation Shareholder Technology Licences in the Event of Bankruptcy Sive Burns [email protected] The owner of a technology protected by an intellectual property right (copyright or patent) or protected by secret (trade secret) may grant a licence to a licensee ...
Website accessibility is a requirement of the Equality Act 201. The first of a two-part article explaining Equality Act 2010 to websites. In our last article, Website accessibility: Industry standards and best practice, we considered how the Equality Act 2010 would be implemented, and considered what the new BSI Standard for website accessibility might look like ...
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 ...
In the latest in a series of legal challenges around internet keywords and particularly the Google AdWords system, the special adviser to the Court of Justice of the European Union, Advocate General Jaaskinen, has issued his opinion ...
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 ...
All businesses possess confidential information - trade secrets, customer lists, staff records - which could mean loss of business, reputational damage, or give competitors an advantage if leaked, whether deliberately or accidentally.Depending on the type of information disclosed and the type of organisation, there are potential consequences regarding public policy and data protection ...
Imitation is the sincerest form of flattery — so they say. Boosters in Wellington, New Zealand, call themselves “Silicon Welly.” And Texas Gov. Rick Perry said somewhere in America “Silicon Valley will be replicated. I want it to be in Austin” — even though central Texas dubbed itself “Silicon Hills” long ago. There’s also the Silicon Forest, Prairies, Alleys and other Valleys. Not to mention the No. 1 Silicon Alley — in New York City ...
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”) ...
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 ...
The Social Network did not just tell the fascinating story of Facebook's rise to a social media power house. It showed how society is increasingly using social platforms as one of its primary channels for communication. Social media is broader than social networking sites such as Facebook or Linked-In ...
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 ...
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 ...
The Supreme Court ruled last week in Microsoft Corporation v. i4i Limited Partnership that “clear and convincing evidence” is still the standard of proof required to invalidate a patent. Section 282 of the Patent Act states that “a patent shall be presumed valid” and that “[t]he burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity ...
