COVID-19: health and safety protocol - Last night the Italian Government and National representatives of employers’ associations and unions have reached an agreement over a COVID-19 health & safety protocol that employers need to implement to ensure the maximum possible protection of their employees against the COVID-19 virus. This protocol is a crucial step to allow business continuity for manufacturing companies and professional service providers ...
The COVID-19 pandemic has had a disproportionate impact on skilled nursing and assisted living facilities. While the following CMS recommendations and guidelines identify nursing homes as the target recipients, they are applicable to all facilities that receive Medicare and Medicaid funds, and are therefore subject to CMS's oversight ...
The coronavirus is making a significant impact to our daily lives in every respect. This includes a growing impact on the global economy and the day-to-day business activities of pharmaceutical and medical device companies. This legal alert summarizes the evolving situation and its implications on the operations of life sciences companies. HHS Declaration of Liability Immunity Issued The U.S ...
The continuing COVID-19 pandemic has caused an unprecedented disruption of business worldwide, and many businesses and organisations will be scouring their current contracts to identify avenues of relief. In many cases, the pages containing the force majeure clause will be the first to be turned ...
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 ...
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) ...
Following the Scottish Government’s statement on 15 March 2022 regarding COVID-19 restrictions, organisations should take time to review the status of recently eased restrictions, and those which are to be eased in the coming weeks. These changes will be of particular relevance to businesses and employers throughout Scotland, who should follow the up-to-date guidance when dealing with employees and customers alike ...
Following the Scottish Government’s statement on 15 March 2022 regarding COVID-19 restrictions, organisations should take time to review the status of recently eased restrictions, and those which are to be eased in the coming weeks. These changes will be of particular relevance to businesses and employers throughout Scotland, who should follow the up-to-date guidance when dealing with employees and customers alike ...
On June 25, 2020, the U.S. Center for Disease Control and Prevention (CDC) broadened its guidance on who’s at risk of severe illness from COVID-19 due to underlying medical conditions and age. Under the new guidance, the CDC departs from previous guidance stating that only individuals over 65 years of age were at increased risk of COVID-19 due to age, and now states that risk from severe illness from COVID-19 increases with age ...
The Federation's Official Gazette of May 29, 2020, the Ministry of Health, jointly with the Ministry of Economy, the Ministry of Labor and Social Welfare and the Mexican Institute of Social Security (“IMSS”), published specific technical guidelines ...
The Ministry of Health, jointly with the Ministry of Economy, the Ministry of Labor and Social Welfare and the Mexican Institute of Social Security (“IMSS”), recently published specific technical guidelines for companies and work centers to resume activities ...
In order to allow the importation of medicines and other products for human health,during the State of Emergency, the National Directorate of Pharmacy and Drugs (DNFYD) of the Ministry of Health, has issued Resolution 280 of April 6, 2020 published in Official Gazette No ...
COVID-19 came upon us all like a tsunami, leveling life as we knew it and causing an entirely new paradigm of behavior to be necessary. No segment of the population was hit harder than seniors, both in our communities and in senior care facilities. Long-term care facilities were on the frontlines of the battle, being one of the first industries to be required to wholly alter traditional behaviors to try to stop the inevitable spread of this deadly virus ...
Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
The Health Insurance Portability and Accountability Act (“HIPAA”) contains minimum security standards that Covered Entities and Business Associates must employ to safeguard protected health information (“PHI”). As part of HIPAA’s security standards, Business Associates are obligated to report all security incidents to the Covered Entity ...
According to press reports, most Germans are willing to accept limitations on the extent of the protection of their personal data vis-à-vis public authorities and agencies in order to tackle the coronavirus crisis. However, that alone is not an adequate justification for measures that employers may take during a coronavirus pandemic to prevent an outbreak in their company ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services (HHS) announced a Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Second Extension”) ...
About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...
The Plurinational State of Bolivia, within the framework of its governmental powers and in accordance with the Declaration of Sanitary Emergency and Quarantine established in recent days, has determined to strengthen the latest measures. The government has conviniently declared that the total quarantine, extends until April 30, 2020, maintaining the suspension of public and private activities ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
