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PLMJ | March 2020

Decree-Law 10-A/2020 of 13 March created exceptional public procurement rules on spending authorisations and administrative authorisations. These rules are intended to ensure the immediate availability of the goods and services needed to respond to the current state of emergency. However, under article 7(6)(c) of Law 1-A/2020 of 19 March, it seems that all administrative time limits in favour of private parties are suspended ...

Haynes and Boone, LLP | March 2020

Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick 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 ...

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 ...

Haynes and Boone, LLP | March 2020

As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...

Haynes and Boone, LLP | March 2020

Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance applicable during this public health emergency. HIPAA Enforcement Discretion for Telehealth ...

Haynes and Boone, LLP | March 2020

Seemingly overnight, flights and hotels emptied, and state and local governments began ordering restaurants, gyms, bars, and other “non-essential” businesses to close or to significantly curtail operations. Unemployment skyrocketed, and businesses began calling out for relief. In response, the government has proposed multiple initiatives to help stabilize businesses hit hard by current events, especially those in the hospitality industry, many of which are also franchises ...

Haynes and Boone, LLP | March 2020

The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...

Haynes and Boone, LLP | March 2020

The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...

Haynes and Boone, LLP | March 2020

To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...

Wardynski & Partners | March 2020

Will the need to seek state aid due to the COVID-19 pandemic encourage sports unions to implement good governance principles? According to press reports, work is underway at the Ministry of Sport on abill to aid the sports sector, including financial support, as sport is one of the sectors hardest hit by the COVID-19 pandemic. Cancellation of league matches, events and tournaments is causing heavy losses for all participants in the sector ...

PLMJ | March 2020

Order 3547-A/2020 of the Office of the Minister for the Environment and Climate Action was published on 22 March 2020 and it went into force at midnight the next day. This Order creates the rules that give effect to the declaration of a state of emergency in Portugal made by Decree of the President of the Republic 14-A/2020 of 18 March ...

Gianni & Origoni | March 2020

The 22 March Decree was anticipated by two ordinances issued on 21 March 2020 by, respectively, the Lombardy Region1, subsequently amended on 22 March 2020 (the “Lombardy Ordinance”), and the Piedmont Region 2 (the “Piedmont Ordinance”). The ordinances provide for even more stringent restrictions for the regions concerned, and will remain in force until 3 April 2020 (for the Piedmont Region) and 15 April 2020 (for the Lombardy Region) ...

Dykema | March 2020

Federal authorities have recently issued a large number of new policies, guidance, etc., in response to the coronavirus pandemic. These include the following: Flexibility in Submitting Required Signatures on Applications The USCIS has announced it will accept application forms with reproduced original signatures ...

Dykema | March 2020

Households and businesses across the country continue to take safety precautions in response to the COVID-19 pandemic. At the same time, the federal government is preparing an unprecedented federal response to the health, safety and economic challenges. In the coming weeks, we expect a wide variety of private businesses to partner with federal agencies and receive funds to address the health crisis ...

The COVID-19 pandemic has hit small businesses particularly hard. And, the Small Business Administration’s disaster loan program can offer many of those small businesses a lifeline. But, it can be daunting to know what relief is available (and for what purpose), who qualifies, and how to apply. This is what you need to know. The SBA has two types of disaster loan programs—one through banks and one directly from the SBA via the U.S. Treasury ...

As of Monday, March 23, Virginia Governor Northam announced all public K-12 schools will remain closed through the end of the school year and many – but not all – non-essential businesses will be required to close their doors. By the end of Tuesday (11:59 p.m. on March 24) some non-essential services, including all recreation and entertainment services, are to close ...

North Carolina The Executive Order prohibits mass gatherings that bring together more than 50 persons in a single room or single space (including any indoor or outdoor space) at the same time.  However, the prohibition against mass gatherings does not include airports, bus and train stations, medical facilities, shopping malls and centers, office environments, factories, grocery stores, and child care facilities ...

A trend is emerging with recently filed litigation involving the COVID-19 pandemic. Spilman attorneys are committed to providing information that allows businesses to react as quickly as possible to avert civil litigation threats or to protect your interests through litigation. Monitoring these litigation trends will allow organizations to prepare to defend against such threats in the future or to identify and pursue civil remedies when needed ...

The COVID-19 pandemic has hit small businesses particularly hard. And, the Small Business Administration’s disaster loan program can offer many of those small businesses a lifeline. But, it can be daunting to know what relief is available (and for what purpose), who qualifies, and how to apply. This is what you need to know. The SBA has two types of disaster loan programs—one through banks and one directly from the SBA via the U.S. Treasury ...

Delphi | March 2020

Since the outbreak of the epidemiological crisis caused by the new coronavirus, the disease associated with it, Covid-19, has been spreading fast across the world, reaching the territory of the EU. According to the Commission, the virus might have an enormous public health impact with substantial fatal outcomes in high-risk groups and significant economic and societal disruptions ...

Waller | March 2020

Earlier this month, the Securities and Exchange Commission (SEC)adopted amendmentsto the accelerated filer and large accelerated filer definitions set forth under Rule 12b-2 of the Securities Exchange Act of 1934 ...

Waller | March 2020

Given the rash of moment-by-moment challenges presented by the COVID-19 pandemic, it is understandable that many companies have not been focused on what is likely coming when the crisis subsides: a flood of litigation related to the devastation left in the wake of the virus ...

Waller | March 2020

In the midst of the coronavirus outbreak, the Centers for Medicare & Medicaid Services (CMS) has taken steps to make healthcare services more accessible through telehealth, particularly for those who are at high-risk of complications from the virus. CMS and commercial payors have opened a viable path for healthcare providers to continue to provide care to high risk patients and other patients and receive reimbursement for services to current and new patients ...

Waller | March 2020

As Democrats and Republicans continue to negotiate the terms and conditions of a “Phase 3” COVID-19 bill, the implementation of a large-scale expansion of the Small Business Administration (“SBA”) Section 7(a) Loan Program appears to have widespread bipartisan support and should pass in some form in the next few days. The existing 7(a) Program currently operates to provide access to capital to small businesses that might not otherwise be eligible for bank loans ...

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