On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations. The proposed rules were released in October of 2019 ...
As concern over cybersecurity continues to grow,[1] defense contractors have been waiting for the Department of Defense (DoD) to roll out its Cybersecurity Maturity Model Certification (CMMC) program. That rollout has occurred, with DoD’s recently published interim rule Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)[2] (“Interim Rule”), effective Nov. 30, 2020, and providing for a five-year phase-in of CMMC ...
The German Federal Commissioner for Data Protection and Freedom of Information (BfDI) sees the decision as a success: On November 11, 2020, the District Court of Bonn reduced the fine imposed on 1&1 Telekom GmbH for a data protection breach from an original EUR 9.55 million to EUR 990,000.00, thereby fundamentally calling into question the fine practices of the German supervisory authorities ...
The Court of Justice of the European Union delivers judgments regarding the concept of “communication to the public” faster than legal scholars can read and dissect them. While we are eagerly awaiting the Court’s analysis of different types of hyperlinking, it has taken less than two months to follow Advocate General Hogan’s opinion regarding the emailing of evidence containing copyrighted works to a court in legal proceedings ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
The debt collection restrictions and requirements in the FDCPA, which was enacted in 1977, have failed to keep up with or even contemplate modern technologies. In particular, as methods and forms of communication have evolved, the industry has had little guidance on how it can utilize newer communication channels such as emails, text messages, or social media. In many cases, the industry has had to grapple with different and often conflicting court interpretations ...
The United States Trademark Office formally announced it will raise the vast majority of its trademark filings fees and implement some new fees as of Jan. 1, 2021. These higher costs will impact every aspect of trademark prosecution, including appeal, cancellation and opposition proceedings before the Trademark Trial and Appeal Board. Trademark owners would be wise to take a look at their upcoming deadlines and potentially take action on them before the end of the year ...
This article has been published in PLI Chronicle. The market for consumer products derived from cannabis and its components, including cannabidiol (CBD), is exploding. U.S. sales of CBD products is expected to exceed $20 billion by 2024, up from just $1.9 billion in 2018. TheCBD market is expected to develop across diverse industries such as cosmetics and skin care, health products, food and beverage, pet products, and pharmaceuticals ...
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” Slip op. at 3 ...
On Nov. 9, 2020 the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) issued a risk alert detailing its series of examinations of investment advisers operating from numerous branch offices and with operations geographically disbursed from the adviser’s main office. This examination initiative focused on the compliance and supervisory practices relating to advisory personnel working within the advisers’ branch offices ...
The new issue of Legal Insight magazine includes a timely article by Anastasia Kayukova, Senior Associate at ALRUD Law Firm, and Anastasia Sidorenko, Junior Associate at ALRUD Law Firm. It is dedicated to the difficulties of determining the criteria, by which the FAS of Russia (Federal Antimonopoly Service) assesses the need to approve transactions related to the acquisition of “de facto” control rights ...
The Government proposes to consult the Panel of Financial Affairs of the Legislative Council on the introduction of a statutory corporate rescue procedure and insolvent trading provisions to the Legislative Council in the first quarter of 2021. The Companies (Corporate Rescue) Bill was originally introduced in 2000, but was never enacted and has since lapsed ...
The Copyright Office of the Department for Promotion of Industry and Internal Trade (DPIIT) has invited comments and suggestions to amend the Copyright Act before November 30, 2020. Mid last year, the DPIIT proposed a set of amendments to the Indian Copyright Rules. While these amendments sought to increase transparency and provide clarity for right holders, many other essential modifications were overlooked ...
On Nov. 3, 2020, California voters approved Proposition 24, marking a significant shift in the U.S. privacy landscape. Proposition 24 enacted the California Privacy Rights Act of 2020 (CPRA),[1] a major expansion of the existing California Consumer Privacy Act (CCPA), which many businesses continue to grapple with since becoming effective in January 2020. Most notably, the CPRA establishes a stand-alone privacy regulator, the first U.S. state to do so ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
The Government of India has been very active in putting in place the necessary framework to implement the objectives of the ‘Atmanirbhar Bharat Abhiyan’. The ‘Atmanirbhar Bharat Abhiyan’ or a program of self-reliance announced by the Government of India intends to focus on the five key pillars of economy, infrastructure, system, vibrant demography, and demand ...
The Copyright Office of the Department for Promotion of Industry and Internal Trade (DPIIT) has invited comments and suggestions to amend the Copyright Act before November 30, 2020. Mid last year, the DPIIT proposed a set of amendments to the Indian Copyright Rules. While these amendments sought to increase transparency and provide clarity for right holders, many other essential modifications were overlooked ...
What will UK data protection look like after Brexit 2.0 on 31 December 2020? Regime 1: the 'UK GDPR': the UK's new bespoke version together with the Data Protection Act 2018 The UK GDPR will be the UK data protection regime based on the 'EU GDPR' (see below) ...
Under the Medicare Secondary Payer Act (MSPA), a Medicare Secondary Payer is the entity which has an obligation to pay medical expenses before Medicare. In the face of rising costs, legislation was passed in 1980 making Medicare a secondary payer to various primary plans in order to shift medical expenses to those Medicare believed should be the primary source of payment ...
On 19 October 2020 the Federal Council's Cyber Committee adopted a report on the advancement of the 2018-2022 national strategy for the protection of Switzerland against cyber risks (2018-2022 NCS) and its gradual implementation. The report focuses mainly on the progress made in supporting small and medium-sized enterprises (SMEs) and promoting research and training ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
During recent years, we have been accumulating our experience of advising clients on data protection issues, that companies face when doing their business in Russia. Many of our clients do their business in other CIS countries as well and usually face quite similar issues there. However, the level of regulation and, more importantly, enforcement, in different jurisdictions of the post-Soviet Union territory, varies significantly ...