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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals

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Life Sciences & Healthcare January/2021
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"...

Bulletin Real Time: Latest News
Brigard Urrutia, March 2021

Norms are issued for individual selective isolation with responsible distancing. The National Government issued a new decree to regulate selective distancing, individual responsibility and economic reactivation that will govern until May 2021...

COVID-19 Products: Health Canada and Competition Bureau Watch Out for Misleading Claims
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 COVID-19 Client Alert: Cal-OSHA Wins First Round in Major Court Challenge to its COVID-19 Emergency Regulation
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...

Telehealth Fraud and Abuse: What’s Next in Compliance and Enforcement for Healthcare’s Hottest Area?
Bradley Arant Boult Cummings LLP, February 2021

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...

National Security & Investment Bill
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...

Travel to India during COVID-19
Kochhar & Co. Advocates & Legal Consultants, February 2021

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...

The Doctor Will See You Now: FMLA and Telehealth Visits
Bradley Arant Boult Cummings LLP, February 2021

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...

Bulletin Real Time: Latest News
Brigard Urrutia, February 2021

1. Historic: First vaccine administered in Colombia. A nurse in the Caribbean region of Sincelejo was the first Colombian to be vaccinated in the country. The original plan had been to begin the nationwide vaccination program on Saturday (February 20), but things have moved faster. Sincelejo and Montería began vaccinating today. Bogotá, Medellín, Cali, Barranquilla, Bucaramanga and Cartagena begin tomorrow...

Justices Should Weigh In On FCA Objective Falsity Standard
Bradley Arant Boult Cummings LLP, February 2021

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...

Understanding the Certificate of Need CON Process in Tennessee
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...

COVID-19 Measures in Dubai and Abu Dhabi
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)...

Bulletin Real Time: Latest News
Brigard Urrutia, February 2021

Modifications to the obligation to disclose information by issuers of securities The National Government issued a new rule that modifies the provisions relating to the obligation to disclose information by issuers of securities, in accordance with the parameters set by the International Organization of Securities Commissions...

March 1 is HIPAA Day with Reporting Required for Some and Reflection Recommended for All
Waller, February 2021

To the extent that there is such a thing as a “HIPAA Day,” it’s coming up soon. And, no, it’s not a HIPAA Holiday. Instead, March 1 is the deadline to report all HIPAA breaches of fewer than 500 affected individuals. HIPAA requires all breaches to be reported to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS)...

Must AstraZeneca Supply the European Union with Sufficient COVID-19 Vaccines under Belgian Law?
ALTIUS/Tiberghien, February 2021

Introduction On 27 August 2020 the European Commission, on behalf of EU member states, entered into an advance purchase agreement (APA) with AstraZeneca for the production, purchase and supply of the Anglo-Swedish company's COVID-19 vaccine in the European Union.(1) The APA provides for: AstraZeneca's supply of 300 million doses of its COVID-19 vaccine (the initial Europe doses); and an option for the European Union to order an additional 100 million doses (the optional doses)...

Occupational Doctors' Enhanced Role in Combating COVID-19: Contact Tracing, Quarantine Certificates and Testing
ALTIUS/Tiberghien, February 2021

Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace...

Coronavirus: Restrictions on Exports of Vaccines Against COVID 19
PLMJ, February 2021

Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union...

The Second Month after Brexit: Insights for Business
Ellex Valiunas, February 2021

February marks the start of the second month after Brexit materializing. The Member States have finally understood that the United Kingdom (UK) is no longer in the Europen Union (EU) so that the  fairy-tale of the Single Market that has lasted for decades is now over. Although many businesses resolved various legal or regulatory issues before 1st January, new challenges inevitably keep arising now, when Brexit is a reality...

Indonesia’s Newly Established Sovereign Wealth Fund: A New Chapter in Indonesia’s Economy
Makarim & Taira S., February 2021

As a developing country, Indonesia is still considered to have limited Government fiscal capacity and limited state-owned enterprise (Badan Usaha Milik Negara – “BUMN”) and financial sector funding capacity indicating that domestic capacity is not sufficient to meet what is needed to finance development and support economic growth and opportunities...

Indonesia’s Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents
Makarim & Taira S., February 2021

On 4 January 2021, the President of Republic of Indonesia issued Regulation No. 2 of 2021 on the Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents (“PR 2/2021”) (the convention is hereinafter referred to as the “Apostille Convention”). The Apostille Convention was concluded on 5 October 1961 and is intended to simplify a series of formalities for documents signed overseas for the contracting states...

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?
Dykema, February 2021

The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code...

X-Waiver Changes Axed: Federal Government Backtracks on Previously Announced Rescission of Waiver Requirements
Dinsmore & Shohl LLP, February 2021

Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex...

Coronavirus: Restrictions on Exports of Vaccines against COVID-19
PLMJ, February 2021

Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union...

German Cyber Security Act 2.0: Federal Cabinet Presents New Draft
Heuking Kühn Lüer Wojtek, February 2021

On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015...

New Stark Law Makes Practical Changes to Key Concepts
Dinsmore & Shohl LLP, February 2021

On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective...

 

 

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