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Due to emergence of the Omicrom variant, the new year brought with it some now familiar guidance: the government asked workers to avoid the office and to work from home where possible. In anticipation of returning to the office in early 2022, the Health and Safety Executive (the HSE) and the Scottish Government have issued guidance emphasising the importance of good ventilation and the role that plays,alongside other measures, in helping to reduce the spread of COVID-19 ...

Haynes and Boone, LLP | February 2016

After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...

Shoosmiths LLP | June 2021

Many people have used their time at home to consider their health and well-being. Some have taken up exercise, yoga or getting a dog. Others have decided to find out more about their health in order to make healthier choices and use online portals like 23andMe (saliva test), Thriva (blood test) or Pharmacy2u (blood or urine test) to point them in the right direction ...

MinterEllison | August 2021

From 4 August 2021, there are differing restrictions placed on the ability of workers in locked down areas in Queensland to attend work in a hospital, aged care or disability setting, even if that work would ordinarily be essential work. Importantly, the Direction is one of the first in Australia to draw a distinction between a vaccinated person (being a person who has received the prescribed doses of a TGA approved COVID-19 vaccination) and an unvaccinated person ...

Haynes and Boone, LLP | September 2017

Hurricane Harvey has radically impacted every industry in southeastern Texas, including healthcare providers, who continue to analyze potential next steps in ensuring operations can resume so that they can further assist those in need of healthcare services. Below are several links to resources that may be helpful for healthcare providers attempting to navigate through their options ...

Brigard Urrutia | April 2020

In order to avoid the shortage of antiseptic and disinfectant products for external use, the Colombian Ministry of Health issued Resolution 520 of March 28, 2020 in order to establish new requirements for the manufacture of the above-mentioned products within the Colombian territory ...

ALTIUS/Tiberghien | July 2020

With the exit from lockdown in full swing, many companies are recalling their staff to the workplace. This article answers 10 FAQs that employers, business managers and HR specialists must consider during employees' return to work. FAQs Must employers respect health and safety measures on their employees' return to work and, if so, which ones?Yes, to the extent possible, social distancing (ie, maintaining a distance between people of at least 1 ...

Update: On July 28, 2021, an Interim Final Rule on COVID-19 Revenue Reduction Score, Direct Borrower Forgiveness Process, and Appeals Deferment was posted. That Interim Final Rule conforms the applicable PPP rules to provide that a timely appeal by the PPP borrower of a final SBA loan review decision extends the deferment period of the PPP loan until the Office of Hearings and Appeals’ decision becomes final.  See below: “Consequences of an Appeal ...

Afridi & Angell | April 2020

Many employers are facing diminishing revenues during the current Covid-19 epidemic. Many of those employers also face the need to reduce overhead. To provide some relief for employers, the Minister of Human Resources and Emiratisation promulgated Ministerial Resolution No. 279 of 2020 (the “Resolution”) on Employment Stability in Private Sector during the Period of Application of Precautionary Measures to Curb the Spread of Novel Coronavirus ...

ALTIUS/Tiberghien | April 2020

  With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines ...

Haynes and Boone, LLP | March 2020

As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...

PLMJ | February 2022

Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022. The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date ...

Delphi | May 2014

Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs.  However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...

Shoosmiths LLP | January 2022

Private healthcare provider Bupa has been ordered to pay a purported record £1.04 million penalty (fine and costs combined) after admitting fire safety failings. London Fire Brigade, prosecuting, said it was the "highest ever fine for fire safety breaches in the UK, [highlighting] the seriousness of Bupa's failure to protect a vulnerable resident in its care ...

Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...

Afridi & Angell | June 2020

On 30 May 2020, the Abu Dhabi Media Office posted through Twitter that the Department of Government Support has eased restrictions on some activities and issued a set of guidelines for working from and visiting government entities in Abu Dhabi. The guidelines below come into effect from today, 1 June 2020, and are limited to individuals between the ages of 12 and 60 ...

Beccar Varela | March 2014

As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...

Haynes and Boone, LLP | September 2015

In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...

by Bryan G. Scott and Elizabeth K. Strickland         Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...

The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies.  The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...

Hanson Bridgett LLP | September 2019

Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App ...

Shoosmiths LLP | December 2023

Employment Tribunals have a duty to make reasonable adjustments where a participant is disadvantaged, for example due to disability, to ensure fairness in proceedings. We share our recent experiences of how the Tribunals apply this duty in practice ...

Waller | April 2020

The Department of Health and Human Services recently released a letter that stated that using a single ventilator for two patients should be considered “an absolute last resort.” Of course, this statement assumes that a ventilator exists in the first place, and it says nothing about how to deal with several more than two patients needing the same ventilator. This, however, is only the tip of proverbial iceberg ...

Brigard Urrutia | June 2021

New measures for state contracting for economic reactivation. Through Decree 579 of 2021, issued on May 31 by the National Planning Department, certain transitory paragraphs enshrined in Decree 1082 of 2015 or the sole Regulatory Decree of the Administrative Planning Sector, were replaced in matters of state contracting ...

Shoosmiths LLP | March 2021

Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours ...

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