IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
Every day in Mumbai, India, a team of 5,000 couriers deliver, collect and return 200,000 lunch boxes. This massive logistics operation is undertaken with an error rate of less than 1 in 8 million deliveries and without using any information technology. Enormous labour cost disparities enable this manual operation to be undertaken cost-effectively ...
Procuring and implementing an ICT system within an organisation can be a stressful task. High profile failures in both the public and private sectors hit the headlines all too often. The National Audit Office's report last month on the £6.2bn NHS IT upgrade in England put many of the challenges firmly in the spotlight. In the heat of the procurement process it is easy to forget some basic procurement principles ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
Open source software ("OSS") is quickly entering the mainstream and becoming increasingly widely used. In fact International Data Group analysts have predicted that the OSS marketplace will be worth £35 billion by 2008. OSS is software that is freely available (without discrimination) and can be copied, modified and redistributed ...
The IT outsourcing market has matured in the past years. Many IT outsourcing relationships are fruitful and long lasting. Nevertheless international surveys continue to show that numerous outsourcing deals are untimely terminated in the first two to four years. This paper highlights the key risk factors for failure of IT outsourcing relationships. These key risk factors will be underlined by various failed outsourcing case law. Such case law probably only represents the top of the iceberg ...
On November 9, 2006, the Minister of Justice, Yvon Marcoux, introduced Bill 48, entitled An Act to amend the Consumer Protection Act and the Act respecting the collection of certain debts (hereinafter, the “Bill”).The Bill is based on the Internet Sales Contract Harmonization Template agreed on by the provinces further to the Agreement on Internal Trade ...
Immediate access to the latest data is essential for business. The Internet and other networks ensure that data are readily accessible. But easy access to data carries with it certain risks, including the risk of unauthorised access. According to research by Gartner in 2006, 80 percent of companies will have suffered an application security incident by 2009 ...
Much has been made of the e-communication provisions set out in the new Companies Act 2006. However, less is known of a piece of legislation which came into force on 1 January 2007, the Companies (Registrar, Languages and Trading Disclosures) Regulations 2006, which affect the electronic communications of every company and limited liability partnership in the UK ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
WiMax, Worldwide Interoperability for Microwave Access, is a new product developing in Chile that promises to revolutionise Internet access. WiMax allows high speed transmission of data and multimedia services (e.g., the Internet and videos) from laptops, cell phones and other portable devices from distances greater than was possible with previous technologies. According to some preliminary tests, WiMax equipment can reach up to 40 km in open spaces ...
In recent weeks, hefty fines for data breaches have been issued in the United Kingdom and Greece. Surprisingly, these fines have not been levied by data protection authorities, but by other regulators with overlapping jurisdiction over data security. The authors, from Hunton & Williams, write that data protection enforcement in Europe appears to be entering a new phase ...
The development of online markets continues to pose challenges for legislators, who must balance the protection of IP rights owners with protecting traders against anti-competitive behaviour. Trademarks and copyright are particularly vulnerable to infringement on the Internet ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
There is a distinct (and dynamic) overlap between competition law and intellectual property rights, no more evident than from the European Commission's investigations into, and the European Court's judgement in, Microsoft. In a similar vein, the Commission is investigating each of Qualcomm and Rambus for potential abuses of a dominant position (through the allegedly unlawful exploitation of IP rights) in the standard setting arena. No doubt buoyed by U.S ...
Minnesota Federal Court finds no coverage under technology errors and omissions policy because claims did not arise out of a “Wrongful Act” as defined in the policy ...
