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PLMJ | May 2021

The Proposal for a Regulation of the European Parliament and of the Council on markets in cryptoassets, which amends Directive (EU) 2019/1937, ("Regulation on Markets in Crypto-assets", or the "MiCA Regulation" for short) was published on 24 September 20201. The Proposal is part of the Digital Finance Package adopted on the same date by the European Commission as part of the Digital Finance Strategy for the EU financial sector2 ...

AELEX | May 2021

Robo-Advisors (sometimes spelt as Robo-Advisers) are digital investment advisory platforms that provide automated, algorithm-driven financial planning services with little to no human supervision. In this article our Oluwapelumi Omoniyi takes a cursory look at the Securities and Exchange Commission’s new rules on Robo-Advisors and highlights the rationale behind the move to regulate Robo-Advisors ...

Shoosmiths LLP | May 2021

The negative impact of COVID-19 across the social and economic spectrum is undeniable. We reflect on the findings from the Social Mobility Commission and consider how employers can help give a much-needed boost to social mobility moving forwards. Research recently published by the Social Mobility Commission has given a snapshot of public perceptions of where and whom the pandemic has impacted most ...

On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...

Shoosmiths LLP | May 2021

Following Prime Minister Boris Johnson’s recent announcement in Parliament, it is now certain that there will be a Public Inquiry into the handling of the pandemic. What is the planned Inquiry likely to consider, and who might be involved? For over a year now, the government’s focus has been on the here and now - managing and responding to the rollercoaster that is the COVID-19 crisis ...

Shoosmiths LLP | May 2021

The internet may be global, but enforcement is always local—and there are plenty of (expensive) ways to find out the wrong way that you should have been doing something where you might not expect it. A typical example is the legal requirement to appoint an EU data protection representative if you’re not based in the EU, or a UK representative if you’re not based in the UK ...

Knowing what to expect when going into the sale process and teaming up with experienced advisors is critical to making the sale of your business the crowning achievement of all of your hard work. This article discusses several steps in certain business sales, using a hypothetical company named ABC Manufacturing, and provides tips for success at each stage ...

AELEX | May 2021

Recently, several African startups have been making positive impact in their communities leading to a number ofcountriesenactingor planning to establish a Startup Act. In this article, our Oluwapelumi Omoniyi examines the benefits of a Startup legislation and considers if Nigeria’s nascent startup ecosystem needs a startup Act ...

AELEX | May 2021

Recently,companies that offer platforms for the purchase of shares in foreign companies (“investment tech” or “wealth tech”)to Nigerians have been in a tussle with the Securities and Exchange Commission, Nigeria (“SEC”) over their business activities ...

On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing ...

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...

On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities ...

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...

For those of us in the dispute resolution world in construction, one cultural trait that is seen with nearly all contractors is a strong sense to do the job right. Most businesses are small, and closely held. And most contractors carry significant pride in their work product and in keeping their clients happy. That character extends not only to work in progress, but also to resolution of issues related to the work after it is complete ...

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The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...

Plesner | May 2021

The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...

ENS | May 2021

The Competition Commission has published an invitation to comment on its amended guidelines on small merger notification. The guidelines extend the notification of small mergers to those taking place in digital markets, where at least one of the stipulated criteria is met ...

ENS | May 2021

On 1 April 2021, the Department of Communications and Digital Technologies published the Draft National Data and Cloud Policy (GG No. 44389). The vision of the policy is move "towards a data intensive and data driven South Africa" ...

Shoosmiths LLP | May 2021

For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...

Buchalter | May 2021

By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...

Shoosmiths LLP | May 2021

Those of us who grew up in the 70’s or 80’s may recall the excitement of Marty McFly wandering around in the then distant future of October 2015. Yes, 2015. Just over 5 years ago. ‘Where are the flying cars?!?’, you might be forgiven for asking. ‘And why don’t our Hover Boards, you know, hover?’ It's a common theme. George Orwell’s 1984 never happened as predicted and there’s no Big Brother watching us from a screen on the wall ...

On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...

More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...

The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...

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