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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...

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...

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...

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...

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...

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...

Interagency Fraud Enforcement Action Highlights Telepharmacy Compliance Risks
Dinsmore & Shohl LLP, February 2021

In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S...

Alabama on the Brink of Adopting Medical Cannabis
Bradley Arant Boult Cummings LLP, January 2021

When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis...

What Changes Are in Store for the FDA Under the Biden Administration?
Dykema, January 2021

A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives...

Enhanced Role for the Occupational Doctor in Combatting Covid-19: Contact Tracing, Quarantine Certificates and Testing
ALTIUS/Tiberghien, January 2021

A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus...

Intellectual Property Update and Year in Review
Dykema, January 2021

CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use...

HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Dinsmore & Shohl LLP, January 2021

The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021.  At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules...

California Proposes Significant Change to Limit Use of Short-Form Proposition 65 Warning For Consumer Products
Hanson Bridgett LLP, January 2021

Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018...

Massachusetts Health Care Bill Makes Several Significant Changes
Verrill, January 2021

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s months of work to address various health care delivery system and social equity issues that the COVID-19 epidemic has hastened...

International Air Travelers Entering the United States Must Have a Negative COVID-19 Test
Dinsmore & Shohl LLP, January 2021

Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline...

Brexit and MedTech, Part 1: Research and Development
Shoosmiths LLP, January 2021

This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK...

Breach Impacting 9.3M People Leads to $5.1M HIPAA Settlement
Waller, January 2021

The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative...

Federal Government Announces Provider Relief Fund Reporting Extension
Waller, January 2021

The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates...

CDC to Require Negative COVID Tests for All International Air Passengers
Dykema, January 2021

The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery...

 

 

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