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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Dykema | March 2021

President Biden signed the American Rescue Plan Act of 2021 (the Act) on March 11, 2021. The Act provides COBRA premium subsidies, increases the tax-exclusion amount for employer-sponsored dependent care assistance programs and expands who may be eligible to receive premium tax credits for marketplace coverage. This alert explains how these provisions may impact your welfare benefit plans. Please contact your Dykema benefits attorney to explore the new provisions in greater depth ...

Brigard Urrutia | March 2021

Colombia updated its free trade zones regime to increase the competitivity of this investment opportunity. Among others, it now allows three new activities for free trade zones, introduces the creation of a concertation committee to discuss key topics between the Government and the private sector, and it simplified procedures to declare a free trade zone. Decree 278 of 2021 was introduced as a tool towards innovation in the free trade zone regime ...

Lawson Lundell LLP | March 2021

Now that we have persevered through one year of the COVID-19 pandemic, much has been written about pandemic fatigue and associated social isolation, mental stress, and anxiety. Employers may be seeing an increase in the incidence of mental illness claims in their workplaces ...

Dinsmore & Shohl LLP | March 2021

As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...

Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...

Brigard Urrutia | March 2021

On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1.    Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...

Dinsmore & Shohl LLP | March 2021

On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021 ...

Dinsmore & Shohl LLP | March 2021

On March 10, 2021, the Centers for Medicare & Medicaid Services (CMS), in association with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to resume visitation options during the COVID-19 pandemic. Nursing homes have been devastatingly effected by COVID-19, with outbreaks causing high rates of infection and death ...

Plesner | March 2021

In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...

Shearn Delamore & Co. | March 2021

FINANCIAL SERVICES BNM announces new funds for SMEs On 5 February 2021, Bank Negara Malaysia ("BNM") announced: an additional RM2 billion for the Targeted Relief and Recovery Facility (“TRRF”); the establishment of a RM200 million Disaster Relief Facility (“DRF”) 2021.   TRRF The TRRF was a facility announced in the Budget 2021, established to assist eligible SMEs in the services sector ...

Haynes and Boone, LLP | March 2021

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 ...

Shoosmiths LLP | March 2021

Comment from Paula Swain, Partner National Head of Commercial Recoveries and Head of the Solent office for Shoosmiths, Paula is also a Director with the Solent LEP and was part of the Freeport taskforce which was successful in its bid ...

Shoosmiths LLP | March 2021

The Chancellor announced the first eight Freeport locations: Solent, East Midlands Airport, Felixstowe & Harwich, Humber, Liverpool City Region, Plymouth and South Devon, Teesside and Thames ...

Veirano Advogados | March 2021

CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...

Lavery Lawyers | February 2021

It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...

Buchalter | February 2021

Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation ...

In 2020, telehealth went from promising ancillary issue to center stage in the healthcare industry. Regulators and law enforcement took notice. With enforcers’ attention now squarely on telehealth fraud and abuse, telehealth providers and companies are poised to be among the main targets for civil and criminal enforcement in the coming years. Webinar Recording Key Takeaways Telehealth is a key enforcement priority for federal and state enforcement agencies, including the U ...

Shoosmiths LLP | February 2021

The UK Government has published the National Security and Investment Bill – a proposed law that will introduce a screening process for certain acquisitions and investments and which is expected to come into force as early as April 2021. The National Security and Investment Bill has now had its second reading and is expected to come into force as early as April 2021. We take a look at what it will cover ...

This article has been updated based on the available information until 20th February 2021. As Government notifications are constantly revised, it is advisable to consult your attorney or visit the website of the relevant Government agency prior to travelling. Further, in additional to the guidelines published by the Central Government, passengers are also requested to refer to State specific official websites to be well informed about any additional requirements ...

As you already know, COVID-19 changed almost everything, and some of those things are likely here to stay (or at least linger for a while longer). One widespread change is the increased use of videoconferencing. In early 2020, a videoconference was a rarity, but now we Zoom in and out of classrooms, work meetings, and court appearances. Not surprisingly, the virtual world has reached the doctor’s office ...

As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...

Carey | February 2021

On February 9, 2021, Supreme Decree No. 57/2019 of the Ministry of Health, which approves the Regulation on Classification, Labeling and Notification of Hazardous Chemical Substances and Mixtures (the "Regulation"), was published in the Official Gazette ...

In its conference on Feb. 19, the U.S. Supreme Court is scheduled to consider two pending petitions for certiorari that could resolve a critical but deeply disputed issue that impacts both the False Claims Act and health care law. The cert petitions in those cases — U.S. v. Care Alternatives,[1] and Winter v ...

Waller | February 2021

WHAT IS A CON? A Certificate of Need (CON) is a permit authorizing the establishment, modification, or construction of a healthcare institution, facility, or service at a designated location. Obtaining a CON is a prerequisite to obtaining licensure from the State of Tennessee for certain enumerated health services and facilities. The Health Services and Development Agency (HSDA) regulates the healthcare industry in Tennessee through the CON program ...

Afridi & Angell | February 2021

New measures to curb the “second wave” of COVID-19 cases have been introduced by the Dubai Supreme Committee of Crisis and Disaster Management (the Dubai Committee) and the Abu Dhabi Emergency Crisis and Disasters Committee for COVID-19 Pandemic (the Abu Dhabi Committee) ...

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