In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...
On June 13, 2019, the Mine Safety and Health Administration (MSHA) announced it had completed its upgrade of its Mine Data Retrieval System (MDRS). Under the new system, mine operators will have new tools to help review compliance with MSHA regulations as well as assessing employment and production records. The upgraded system will also enable mine operators to track accidents, inspections, violation history, and health sampling data ...
The House narrowly passed the Build Back Better bill on Nov. 19 with a vote of 220 to 213, after an overnight delay. The $1.75 trillion social spending bill includes the ability for Medicare to negotiate drug prices, new hearing benefits for Medicare beneficiaries, and extended Affordable Care Act subsidies. The bill will still have to pass the Senate, and Senate Democrats are expected to make revisions ...
On Monday the White House announced that the COVID-19 travel restrictions imposed on passengers from the UK and most of the EU would be eased, allowing fully vaccinated passengers to enter the country from early November. This will be welcomed by families that have been kept apart as a result of the ban first imposed by President Trump 18 months ago. The UK moved to end similar restrictions on US travellers in July, and both sides of the pond are once again open for business ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
As we await a formal announcement about how the UK COVID-19 Inquiry will be structured, we compare the different approaches that have been adopted by other public inquiries. Introduction Public inquiries are an important and increasingly utilised vehicle for change in society, but they are sometimes criticised for delay, for inefficiency and for providing recommendations that are not ultimately implemented ...
On Sept. 22, 2021, the U.S. Health Resources and Services Administration (HRSA) publicly referred six matters involving drug manufacturers to the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) for possible imposition of civil monetary penalties (CMPs) ...
On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
In light of the COVID-19 National Health Emergency, U.S. Citizenship and Immigration Services (USCIS) introduced temporary policies related to H-1B-sponsored physicians who are completing their three-year J-1 waiver service commitment requirements. The temporary policies relate to full-time work requirements and the ability of J-1 waiver-approved physicians to provide telehealth services ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
Can a patent be infringed even if the patented product is not manufactured, assembled, or even used? Indeed, such infringement is possible. In fact, this is known as the theory of inducement of infringement. Naturally, acts of ?inducement? must meet certain conditions before inducement of infringement can be found. The Federal Court of Appeal recently clarified these conditions ...
On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
MP Dr Liam Fox provided his support to a draft bill recently placed before parliament focusing on individuals with Down’s Syndrome. He has been working on the bill with a Down’s Syndrome Association in Portsmouth. If the draft bill passes through parliament and receives royal assent, the Down’s Syndrome Act will come into force. Its focus is on improving provision for those with Down’s Syndrome which includes education, health, social care and employment ...
In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
Dinsmore employment law attorney Alyson St. Pierre authored an article for The Indiana Lawyer regarding a recent Indiana law that does not automatically grant religious exemptions from COVID-19 vaccinations and instead allows employers to investigate the validity of religious exemption requests. An excerpt is below ...
We are increasingly being asked: “Is it more likely that individuals rather than companies will be prosecuted under the new Health and Safety Offences Act 2008?”. The new Act, which came into force in January 2009, did not introduce any further duties on either organisations or individuals, but it did dramatically increase the penalties that can be imposed for breaches of existing health and safety legislation ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
