On March 25, 2020, Governor Jim Justice signed into law House Bill 4497, which shall be known as The Alex Miller Law. The Alex Miller Law will take effect June 5, 2020, but the mandated requirements do not take effect until the 2021-2022 school year. Alex Miller, was a Roane County football player who collapsed and died during a high school football game. The Alex Miller Law (W. Va. Code 18-5-25c) requires defibrillators (AED devices) at certain events by the 2021-2022 school year ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
In an effort to streamline the provision of COVID-19 patients’ Protected Health Information (PHI) to public health authorities, the United States Department of Health and Human Services Office for Civil Rights (OCR) recently published practical guidance explaining the methods by which Health Insurance Portability and Accountability Act (HIPAA) Covered Entities may disclose COVID-19 patient PHI to law enforcement, first responders, and public health authorities ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...
The spread of the highly contagious coronavirus has reach pandemic status. Over 550,000 cases have been confirmed across more than 175 countries, and the United States now has over 86,000 confirmed cases across all 50 states and four territories. In other countries, the threat of coronavirus has already impacted prison operations — lockdowns have been implemented in Italy and thousands of prisoners were released in Iran ...
On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced a temporary policy on its enforcement of environmental obligations during the COVID-19 pandemic. Many facilities are experiencing unexpected constraints arising from the pandemic, including limited availability of key staff, contractors, and laboratories ...
As a growing number of the workforce is being affected by the COVID-19 pandemic, employers are raising several benefit related questions, particularly with respect to group health plans. The Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...
On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced a temporary policy on its enforcement of environmental obligations during the COVID-19 pandemic. Many facilities are experiencing unexpected constraints arising from the pandemic, including limited availability of key staff, contractors, and laboratories ...
The British government has adopted stringent measures to reduce the spread of the novel coronavirus effective from 23 March 2020[1], including a nationwide lockdown, closure of non-essential shops and public venues and mandatory social distancing. The general rule is that people should stay at home, but workers can travel to and from work if they cannot perform their work from home[2] ...
The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals ...
In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...
INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...
Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
The offence of spreading coronavirus From what point exactly is the spreading of COVID-19 a criminal offence? Is it only intentional spreading that is punishable or is negligence also a criminal offence? What is at stake? What are the aggravating circumstances and when do the penalties increase? And can these criminal offences also be committed by a legal entity? The Government of the Czech Republic adopted, as a part of emergency measures due to health threat, Regulation No ...
Significant responsibility for ensuring compliance with directives to stop the spread of the Covid-19 virus has been delegated to the law enforcement authorities of the UAE. Last week, the Cabinet promulgated Resolution No. 17 of 2020, requiring all natural and juristic persons to comply with the measures mandated by the concerned authorities to combat Covid-19 ...
The Ministry of the Interior issued Communication 015 of 2020, through which the Ministry set made recommendations for the prevention, containment, and mitigation of the coronavirus COVID19 in ethnic groups: indigenous peoples, the NARP communities (Black, Afro-Colombian, Raizales, and Palenqueras) and the PROM people ...
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 ...
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
Superintendence of Environment orders the suspension of terms and enforces virtual channels in the context of Covid-19 The Superintendence of Environment has suspended all of sanctioning proceedings and implemented virtual channels to receive consultations, complaints and replace its reception office ...
