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Practice Industry: Healthcare & Pharmaceuticals, Industrial & Manufacturing, Life Sciences
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Hanson Bridgett LLP | April 2020

You’ve read the qualifying language before: across the country, construction projects are being impacted by the COVID-19 pandemic. We thought it important to prepare guidelines to assist contractors in navigating the situation from a risk management perspective. The situation is dynamic and will change quickly. A one-size-fits-all solution does not exist, and this global challenge continues to evolve. What works today may not address tomorrow’s needs ...

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 ...

Waller | April 2020

The Centers for Medicare & Medicaid Services hasrecently announced an unprecedented “Hospitals Without Walls” program to aid in the fight against COVID-19. The goal of this program is to ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites including other, non-affiliated healthcare providers and even unlicensed locations such as community centers and schools ...

On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the physician self-referral law or Stark law ("Stark Law") ...

Gianni & Origoni | April 2020

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 ...

Afridi & Angell | April 2020

This supplements our inBrief dated 3 April 2020, which reported on measures implemented by the UAE authorities in response to COVID-19 up to 9:00 a.m. that day. Many new measures have been introduced since then. We now report on new measures taken up to 9:00 a.m. on Monday 6 April 2020 ...

Haynes and Boone, LLP | April 2020

Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...

Afridi & Angell | April 2020

Below is a summary of key new measures, as well as clarifications on previous measures we reported on, that have been implemented by various UAE authorities since 5 April 2020 and the time of this inBrief, 6:00 p.m. on Tuesday, 7 April 2020 ...

Cechova & Partners | April 2020

Since the publication of our legal update on COVID-19 Legal Challenges for Pharmaceutical Companies on 31 March 2020, new important measures were adopted or announced on both national and EU level ...

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 ...

Brigard Urrutia | April 2020

Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions ...

Dykema | April 2020

Nursing homes have been on the front lines throughout the COVID-19 pandemic as they care for the persons most at risk. In an effort to improve safety and curb the spread of COVID-19, federal and state authorities are relaxing certain compliance obligations. Despite this regulatory latitude, nursing facilities should remain aware that federal and state agencies continue to closely monitor nursing home compliance ...

Afridi & Angell | April 2020

Below is a summary of key new measures and initiatives that have been implemented and announced by various UAE authorities since 6 April 2020 and the time of this inBrief, 6:00 p.m. on Wednesday, 8 April 2020 ...

Today, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities ...

Dinsmore & Shohl LLP | April 2020

The U.S. Department of Justice (DOJ) has issued a series of memoranda that discloses the department’s enforcement priorities and provides public guidance related to the ongoing coronavirus crisis ...

Dinsmore & Shohl LLP | April 2020

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 ...

Waller | April 2020

On April 6, the Food and Drug Administration (FDA) issued five warning letters chastising companies for their unapproved products related to the novel coronavirus disease 2019 (COVID-19). Two days later, the FDA issued another four warning letters for similar reasons. Two of the five warning letters issued on April 6 were issued to companies in connection with their CBD products, and one of the warning letters issued on April 8 was issued to a CBD company as well ...

Waller | April 2020

On April 6, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule in the Federal Register that, among other initiatives and changes to existing policy, allows certain inpatient hospital services to be provided “under arrangements” outside of the hospital. The “March 2020 IFC” is intended to give healthcare providers increased flexibility to respond to the public health emergency created by COVID-19 ...

Asters | April 2020

On 30 March 2020, the Ukrainian Parliament adopted the Law "On Amendments to Certain Legislative Acts Aimed to Ensure Additional Social and Economic Guarantees Due to the Coronavirus Disease (COVID-2019) Spread" (the Law), which introduces to the Ukrainian legislative environment new complex rules aimed at minimizing the negative impact of the spread of the COVID-19 in Ukraine. The below summary focuses on key changes introduced by the Law ...

PLMJ | April 2020

INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...

Haynes and Boone, LLP | April 2020

Does the COVID-19 pandemic (or actions taken to counter the spread of COVID-19) constitute Force Majeure and is there any implied remedy (e.g. implied force majeure relief) arising as a result of the COVID-19 pandemic? Under English law, unlike civil law systems, force majeure is neither defined nor automatically applicable to commercial contracts ...

Waller | April 2020

On April 10, Health and Human Services (“HHS”) began providing a $30 billion portion of the latest COVID-19 relief fund to healthcare providers. Information on this funding may be found here. While the government announced this funding as coming with “no strings attached” in its April 7 briefing, the relief payment (the “Payment”) does come with certain terms and conditions that a provider must certify compliance with ...

Makarim & Taira S. | April 2020

Upon the ongoing spread of coronavirus disease (“COVID-19”) pandemic, the Indonesian Government has declared the COVID-19 as a national emergency situation. Following the nation’s COVID-19 emergency, the Indonesian Government have issued sets of regulations and policies in various sectors in order to control and mitigate the adverse impacts of the COVID-19 pandemic ...

Dinsmore & Shohl LLP | April 2020

Under the CARES Act that was signed into law on March 27, 2020, $100 billion was allocated to “eligible health care providers” to provide financial relief for health care organizations in relation to the COVID-19 public health emergency ...

Afridi & Angell | April 2020

Below is a summary of key relief and operational measures implemented by the DIFC since 1 April 2020 and the time of this inBrief, 6:00 p.m. on Saturday, 11 April 2020. Dubai Financial Services Authority (DFSA) announces relief measures On Tuesday, 7 April 2020, the DFSA announced a number of relief measures to support their clients during this time of stress and uncertainty. These measures are aimed at both new firms setting up in the DIFC as well as existing authorised firms ...

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