The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu
Scotland is currently home to one of the largest life science clusters in Europe, with more than 700 organisations based here employing some 37,000 people. With 15 universities producing highly skilled graduates; the NHS as a massive single source of patient data; and world leading research centres in life sciences, Scotland attracts some of the brightest international scientists and life science businesses ...
SVW has, across its offices, been giving guidance to clients both under English and Norwegian law as to the Coronavirus impact on shipping contracts, including on force majeure and similar exceptions clauses, and contract frustration. Read our recent publication, touching upon these issues. The Covid19 Virus Only two months have passed since the novel coronavirus was detected in Wuhan, China ...
On 21 July 2022, Baroness Heather Hallett issued an opening statement in respect of the COVID-19 Inquiry ('the Inquiry'). As Chair, Baroness Hallett expressed her determination to “run the Inquiry as thoroughly and as efficiently as possible” and “to undertake and conclude the work of this Inquiry as speedily as possible so that lessons are learned before another pandemic strikes ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
The recent COVID-19 Inquiry's public consultation on its draft terms of reference has captured a substantial amount of public engagement; balancing the representation of all affected groups and avoiding lengthy delays looks like a real challenge. Baroness Hallett’s draft terms of reference (draft terms), published on 11 March, requested the views of individuals and organisations by 7 April on the scope of the COVID-19 Inquiry ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
The Danish Government's Growth Team has just Presented its Recommendations for how to Strengthen Denmark's International Position within Life Science. This happened at a Press Conference with the Participation of the Chair of the Growth Team, Kåre Schultz and the Minister for Industry, Business and Financial Affairs, Brian Mikkelsen ...
The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation. The purpose and scope In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology ...
The hemp industry's explosive growth following the 2018 Farm Bill has produced a number of consequences, some intended and many more almost certainly never considered by lawmakers. The development of THC acetate ester (THCO), a synthetic substance created from hemp, almost certainly falls within the latter category. Recently, THCO has gained substantial popularity. In a Feb ...
On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals ...
As workplaces continue to reopen, the U.S. Department of Labor (DOL) and Centers for Disease Control and Prevention (CDC) issued additional guidance addressing various return to work issues and leave under the Family and Medical Leave Act (FMLA) and Families First Coronavirus Response Act (FFCRA). The new DOL guidance, summarized below, appears on the DOL’s FFCRA Questions and Answers page ...
As you already know, COVID-19 changed almost everything, and some of those things are likely here to stay (or at least linger for a while longer). One widespread change is the increased use of videoconferencing. In early 2020, a videoconference was a rarity, but now we Zoom in and out of classrooms, work meetings, and court appearances. Not surprisingly, the virtual world has reached the doctor’s office ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
Last week, the Equal Employment Opportunity Commission (“EEOC”) updated its COVID-19 guidance to address workplace issues related to COVID-19 vaccines, including mandatory vaccination policies. According to the EEOC, employers may mandate vaccines, but must attempt to accommodate employees who refuse vaccination because of disability or a sincerely held religious belief, practice, or observance ...
On April 9, 2020, the Equal Employment Opportunity Commission (EEOC) issued Q&As on COVID-19 issues. The EEOC has also updated its guidance during a pandemic for employers relating to the COVID-19 pandemic. The following are some highlights from these updates. Medical Inquiries and Exams In the updated guidance, the EEOC indicated that the COVID-19 pandemic meets the definition of a direct threat ...
Dinsmore health care partner Joseph Zielinski was published in the most recent edition of New Perspectives on Health Care Risk Management, Control and Governance, the publication of the Association of Health Care Internal Auditors. His article, "The Effectiveness of Your Compliance Program," covers how to effectively audit your organization's compliance program while gaining valuable insights. An excerpt is below ...
With the COVID-19 Public Health Emergency (PHE) set to end on May 11, 2023, federal agencies have published FAQs explaining how the end of the PHE will affect previously extended deadlines relating to COBRA, HIPAA special enrollment, and claims and appeals under group health plans. This article provides (i) a recap of the deadlines, (ii) rules of thumb for determining the deadlines, and (iii) tables more specifically addressing some of the most common deadlines that arise ...
The new measures adopted by the European Commission Last Friday, the European Commission (“Commission”) has adopted an amendment to existing State aid rules to widen the perimeter of the national measures which can be authorized based on the exceptional legal framework to cope with the current crisis. a. In particular, the Commission considered the following measures:a. More support for research and development related to the current health crisis ...
The Federal Communications Commission (“FCC”) established the COVID-19 Telehealth Program (the “Telehealth Program”) on April 2, 2020 in response to the COVID-19 pandemic. The Telehealth Program provides $200 million in funding, appropriated by Congress as part of the CARES Act,[1] to assist certain non-profit and public healthcare providers in making telehealth services available to patients who cannot be seen in person ...
As the United States and countries all over the world continue to grapple with the Covid-19 pandemic, the race is on for Covid-19 treatments and vaccines. There is currently no FDA-approved therapy or vaccine for Covid-19. Given the profound urgency, life sciences companies and other researchers are prioritizing research and development of potential therapies and vaccines ...
On Thursday, November 7, 2013, the United States Food and Drug Administration (FDA) announced measures to definitively eliminate all the artificial trans fats from processed products in the United States. The purpose of the proposal, which is released for public comments for a 60-day period, is to remove trans fats from the “generally recognized as safe” (“GRAS”) category, which would allow these products to be commonly used in food products ...
The case concerns the interpretation of Article 269 of the AHL, which provides that additional or more stringent measures by Member States may be adopted concerning responsibilities for animal health in certain limited areas. (As provided for Articles 10 to 17 AHL ...
In the turmoil of adjusting and living day-to-day in this time of the COVID-19 virus, the public has become more attuned to the reality of the term “Supply Chain.” We are gaining a better appreciation that before products reach the consumer, an extensive network of shippers and transportation entities of all types and modes of commerce, as well as freight brokers and any other functions essential to the delivery cycle, are at play 24/7 ...
On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies ...
