Rural and community hospitals could fill a major gap in a healthcare system that will likely be overloaded, in varying degrees, for at least the next 18 months due to the COVID-19 global pandemic. Congress is in the process of passing the Coronavirus Aid, Relief, and Economic Security Act (“the Cares Act”) that provides unprecedented relief designed to help business in general, but specific allocations for hospitals ...
The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate. The policy applies to actions for which EPA has federal enforcement authority ...
We knew this year was going to be an especially bad one for the flu. In its November 2019 issue, Scientific American, one of the country's leading science publications, included a twenty-page article titled "The Influenza Outlook", which highlighted the escalating threat of influenza for the year 2020. Unfortunately, at present, the emergence and spread of the novel coronavirus makes the flu pale by comparison ...
The identification of the food and drink sector as key in the response to the COVID-19 (C19) crisis seems obvious and unquestionable. Scratch the surface though and questions emerge, perhaps unsurprisingly because of the haste with which the emergency legislation was passed. The starting point recognised in the Coronavirus Bill was that the food supply chain involved not just producers but also intermediaries ...
INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
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 ...
Restaurateurs and their employees don’t need anything else to worry about these days. It is challenging enough to operate a restaurant in this time of quarantines, curbside and delivery-only options, and social distancing added to the attendant drops in revenue and worries about making sure employees are cared for. Maybe the absolute last thing any restaurant wants to focus on are food safety regulations such as the Food Safety Modernization Act (FSMA) ...
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 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 ...
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 U.S ...
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 ...
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 ...
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 ...
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) ...
As of March 11, 2020 the World Health Organization declared COVID-19 as an international pandemic, which besides the unfortunate health implications, it will produce a wide range of legal and economic impacts and challenges ...
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 ...
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 ...
