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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Data protection and privacy laws are relevant to current responses aimed at preventing the spread of the coronavirus. An important response to limit the spread of the infection is the practice of identifying and monitoring anyone who may have been in contact with an infected person ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
As of March 19, 2020, the requirement to receive a certificate of need (CON) prior to increasing bed capacity has been temporarily suspended byTennessee Executive Order No. 15(the “Order”) ...
Late Tuesday night, the Department of Labor issued an official Frequently Asked Questions in regards to the recently passed Families First Coronavirus Response Act. READ NOW: Our complete Families First coverage Here are a few key takeaways: The effective date of the Act is April 1, 2020 ...
Waller’s Financial Technology practice has been providing advice to processors, banks, ISOs, financial technology providers, merchants and other participants in the payment processing ecosystem for over forty years ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced updates to its survey process in response to COVID-19 (press release,press release, andmemo). Specifically, as authorized pursuant to section 1135(b)(5) of the Social Security Act, CMS is prioritizing certain surveys and exercising enforcement discretion for all certified provider and supplier types for the next three weeks ...
An updated version of this article is available ? On March 20, 2020, the Internal Revenue Service (IRS) and the U.S. Department of Labor (DOL) jointly issued guidance regarding the tax credits available to certain small employers who are required to provide new types of paid leave to employees under the Families First Coronavirus Response Act (Act), enacted on March 18, 2020 ...
Coronavirus Disease (COVID-19) is affecting companies across the nation and around the world in a variety of ways. Dykema is closely monitoring the legal ramifications of the crisis and evaluating the potential impact on businesses in a wide variety of industries ...
