Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...
According to statistics, 76% of the leading 100 UK retailers have plans to replace at least one of their core IT systems in 2008. Ensuring that your IT system is up to date is vital. Using outdated software packages often results in poor service delivery and inefficient business management. Many old systems are not capable of meeting current legislation requirements or are not able to deliver reports to demonstrate compliance ...
Introduction On June 1, 2023, the Minister of Justice, Simon Jolin-Barrette, tabled and presented Bill 29 entitled An Act to protect consumers from planned obsolescence and to promote the durability, repairability and maintenance of goods 1 (hereinafter the ?Bill?) before the National Assembly ...
Physicians and medical professionals throughout the world are facing and attempting to treat one of the most serious and deadly viruses that has affected the world in our lifetime. Medical professionals are on the front lines and in a position, despite their best efforts to protect themselves, to contract the disease. Medical professionals do not only fear for their own lives but also for the lives of their family members if they unintentionally bring this disease home ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...
The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
On May 23, 2022, the Oregon Medical Board (OMB) is hosting a public hearing on rules that propose major changes to the way physician assistants (PAs) practice in Oregon. The rules were written in response to House Bill 3036, which supporters have dubbed the “Physician Assistant Modernization Bill.” More broadly, the rules were written in response to mounting concerns about health care access and equity, especially for rural and minority populations ...
In September 2021, the House of Representatives of the Philippines approved House Bill (HB) 7425 upon its third reading. HB 7425 seeks to impose a 12% value-added tax (VAT) on digital transactions in the Philippines ...
Introduction Republic Act No. 11697, or An Act Providing for the Development of the Electric Vehicle Industry (EVIDA Law), became effective on 15 April 2022. The EVIDA Law outlines the regulatory framework and creates a comprehensive roadmap for the operation of electric vehicles (EVs) in the Philippines. It governs "the manufacture, assembly, importation, construction, installation, maintenance, trade and utilization, research and development, and regulation of electric vehicles" ...
In March 2021, the Philippine Bureau of Internal Revenue (BIR) issued Revenue Memorandum Order No. 014-21 (the Memorandum), which streamlines the procedures for non-resident corporations and other juridical entities (collectively "non-resident taxpayers") to access Philippine tax treaty benefits ...
Jack Wills, the clothing company that markets itself as “outfitters to the gentry” has enjoyed recent success in its action against House of Fraser regarding the use of its logo. Jack Wills complained that the rights in its logo comprising a silhouette of a pheasant wearing a top hat and holding a cane had been infringed by House of Fraser’s use of a logo on its own Linea brand of casual clothing that comprised a profile of a pigeon wearing a top hat and bow-tie ...
On July 1, 2021, B.C. moved into Step 3 of its COVID-19 Restart Plan. As part of this phase, B.C. employers are no longer required to maintain a WorkSafeBC approved COVID-19 Safety Plan. Instead, they are required to transition to a Communicable Disease Prevention Plan. What is a Communicable Disease Prevention Plan? It is a plan that outlines the steps an employer is taking to reduce the risk to their workers from communicable diseases in their workplace ...
Food labelling in SA was given a much needed overhaul in 2011 with the introduction of new regulations relating to the labelling and advertising of foodstuffs, replacing outdated seventies-era regulations ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
Last year, the European Commission initiated an inquiry into the pharmaceutical industry, claiming that there were indications that competition in the industry was not working as well as it should. Although responses to the preliminary report have been rather critical, from both the legal community and the industry itself, there are a few conclusions worth noting ...
In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania ...
Beginning July 1, 2020, Pennsylvania’s Act 46 of 2019 (Act 46)[1] will require most Pennsylvania health insurers to cover medication synchronization services (MedSync) provided to patients taking two or more maintenance medications (i.e., medications for chronic long-term conditions, including diabetes, high blood pressure, and heart disease) ...
