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 ...
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 ...
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 ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
The introduction of mandatory pre-installation of applications developed by Russian market players, caused by a wave of cases of abuse by global companies of their dominant position in digital markets, is a significant innovation in Russian antitrust and consumer protection law. To reduce the risks of restricting competition and balance the bargaining power of global corporations with small domestic application developers, amendments to the Law dated February 7th 1992 No ...
We would like to inform you that several laws, that will have a significant impact on IT and data protection regulation, were adopted at the end of 2020 (“Amendments”). Further rules for blacklisting Internet resources The first amendment to Russian law is aimed at securing guarantees, for citizens’ rights, to freely search, access and disseminate information ...
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 ...
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 ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
For the time being, there are no specific laws governing the use of artificial intelligence in Canada. Certainly, the laws on the use of personal information and those that prohibit discrimination still apply, no matter if the technologies involved are so-called artificial intelligence technologies or conventional ones ...
In recent years, Russia has focused on regulating its IT area. In particular, this has been needed due to the increasing number of cases, when prohibited information has been distributed on various large Internet resources, such as a social network. However, according to Russian government agencies, despite the risks of possible sanctions, many foreign companies still do not respond quickly enough to government requests, or ignore the demands to remove prohibited information ...
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 ...
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 ...
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 ...
Not surprisingly, COVID-19 business interruption insurance disputes dominated media headlines for most of 2020. Nonetheless, there were a number of other insurance rulings that will undoubtedly shape the coverage landscape. Policyholders enjoyed a number of significant wins including significant victories related to COVID-19 business interruption cases. The start of a new year gives us an opportunity to highlight some of 2020’s most notable coverage decisions ...
All indications are that the evolution of privacy laws and their impact will continue to evolve, perhaps even at a greater pace, in 2021. In celebrating Privacy Day, January 28, 2021, we would like to share four things businesses should be keeping their eyes on, and planning for, in 2021. 1. Significant changes to privacy legislation in Canada. Canadian federal and provincial governments have tabled and proposed sweeping changes to privacy laws in Canada ...
In a scenario that has played out across the country for nearly a year now, a group of restaurants based in Ohio were ordered by government authorities to close their on-site dining operations to abate the spread of the coronavirus. However, when the restaurants sought insurance coverage for their loss of business income, their insurer, Zurich American Insurance Company, denied coverage. Last week, the U.S ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
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 ...
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 ...
Over the last several years, banks of all sizes have successfully partnered with emerging fintech companies to offer innovative loan products to a broader range of customers. Under a typical form of this partnership, a fintech, which is subject to the policies of the partner bank, will market loan products, take and process loan applications, and will service those loans once they are funded ...
This article forms part of our ‘New How: Perspectives’ report: ‘Can real estate help solve the productivity puzzle?. To access this free report, please click on the download link to the right of this page. The Covid pandemic has clearly had a significant impact on our society, the economy and everyday life, with numerous sectors having found life in lockdown incredibly challenging ...
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 ...
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 ...
Safe at Home Address Confidentiality Programs (ACPs) have been adopted in many states to protect domestic violence victims’ addresses and other personal information from collection and disclosure. Financial services institutions are taking strides to protect the data of participants in ACPs, but the financial services industry also faces some of the most complex issues with ACP compliance ...
