So far this year, three False Claims Act defendants have challenged judgments against them based on the Excessive Fines Clause of the Eighth Amendment. Remarkably, two were successful, as the District of Minnesota more than halved a large award, and the Eighth Circuit vacated and remanded a much smaller award in which the penalties substantially outpaced the actual damages ...
The EU's comprehensive data and AI regulatory package is about to become operational. This year, the Krogerus Data Symposium will highlight some of the most impactful changes of the Data Act and the AI Act, which will profoundly influence the application of AI, how companies and communities can utilise IoT data, and how data usage agreements are formed ...
The Ministry for Home Affairs, Security and Employment (MHSE) published the proposed Maltese draft order for the transposition of the EU Network and Information Systems Directive II (‘NIS 2’) on 6 September 2024 ...
In August 2024 the European Commission published draft guidelines on the application of Article 102 of the Treaty on the Functioning of the European Union (“TFEU”) to abusive exclusionary conduct by dominant undertakings. Rather than the current guidance on enforcement priorities, this document has taken the shape of guidelines proper, similar to those found in respect of Article 101 TFEU ...
The UK Cabinet Office has just announced, in a brief statement that the date for the Procurement Act 2023 to enter into force has been postponed. At less than 2 months from the planned “go live” date which was slated for 28 October 2024, in a surprise announcement, the new Government has decided to push this back. The reasoning for the decision stems directly from the change in administration following this year’s General Election ...
The Court of Justice of the European Union (the “CJEU”) has issued a decision (C-109/23) on a reference for a preliminary ruling requested by a German court in relation to a potential breach of restrictive measures issued against Russia ...
This newsletter features a look into notable recent case law and other developments in Finnish competition law and other regulatory issues. The Finnish Competition and Consumer Authority proposes a first ever fine for an alleged obstruction of a dawn raid In May 2024, the Finnish Competition and Consumer Authority (FCCA) proposed that the Market Court imposes an infringement fine of approximately EUR 4.4 million for an alleged obstruction of the FCCA's unannounced inspection ...
On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued theNotice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector(hereinafter referred to as the "Notice"), announcing that,effective immediately, foreign-invested enterprises are permitted to engage in the development and application of human stem cells, gene diagno
In recent years, the emphasis on sustainable and responsible investment has grown significantly. This shift is driven by increasing awareness of environmental, social, and governance (“ESG”) issues among investors, regulators, and the public ...
On August 28, 2024, the National Medical Products Administration (NMPA) released the Medical Device Administration Law (Draft for Comment) (hereinafter referred to as the "Draft") for public comments ...
In this article, Shoosmiths and KPMG explore some of the key policy and business implications for organisations deploying connected and automated mobility (CAM) in the UK market. The Automated Vehicles Act (the AV Act) came into force on 20 May 2024. This important piece of legislation signals a major step towards the widescale adoption and use of CAM within the UK ...
The Council of Europe has recently published a guidance note to the general public considering the best practices for the effective implementation of restrictive measures. This guidance note sets out to provide a non-exhaustive list of recommendations for the effective implementation of restrictive measures. The first set of recommendations relates to the designation and identification of persons and entities which are subject to restrictive measures ...
The European Union's NIS2 Directive is a significant update to the original NIS Directive which was implemented in 2018 and which the NIS2 Directive is set to repeal this autumn. The original NIS Directive was the first EU-wide legislation focusing on network and information system security. The deadline for member states to transpose NIS2 Directive into national law is just around the corner (17 October 2024), and the implementing provisions will be applicable from 18 October 2024 onwards ...
Novel technologies that seek to improve quality of life or simplify complex processes offer great promise. For example, medical technologies that detect or cure disease or supply chain technologies that allow for real time understanding of the location or destination of a specific product — make our lives easier and safer. They also pose potentially unforeseen complications ...
On the 9th of August 2024, the Health and Safety at Work Act, Act XXXIII of 2024 (Chapter 646 of the Laws of Malta) (hereinafter referred to as the ”Act”) was published by Parliament. Upon coming into force, the Act shall repeal the Occupational Health and Safety Authority (“OHSA” or “Authority”) Act (Chapter 424 of the Laws of Malta) and its subsidiary legislation ...
Introduction By: David Balfour The Medical Board of California investigates physicians for potential violations of the Medical Practice Act. If an investigation results in findings of violations, the Board will refer the case to the Attorney General’s Office recommending the filing of an Accusation seeking disciplinary action against the physician’s license ...
On July 22, 2024, the European Commission approved revised Interpretative Guidelines (the “Guidelines”) on Regulation (EC) No 261/2004 (“Regulation 261/2004”), which address air passenger rights concerning compensation and assistance for denied boarding, cancellations, and delays and on Regulation (EC) No 2027/97 on air carrier liability in case of accidents ...
On July 26, 2024, the Ministry of Natural Resources ("MNR") promulgated the Notice of the Ministry of Natural Resources on Strengthening the Administration of Surveying, Mapping and Geoinformation Security of Intelligent Connected Vehicles ("Notice 139"), reiterating the importance of the security of surveying, mapping and geoinformation ...
China's pharmaceutical industry is witnessing a notable surge in "pipeline spin-off projects", a model commonly referred to as the "Spin-off-NewCo" or "SON" model. Within the past two months, we've been advising on nearly ten SON projects. Leading pharmaceutical companies in China are more frequently adopting the SON model to separate parts of their pipelines into new, independent companies ...
August 14, 2024 By: Wendy Lee A little more than a year ago, on July 23, 2023, the Washington My Health My Data Act (WMHMDA) was passed into law. The law originally went into effect on March 31, 2024, however the compliance deadline for small businesses was June 30, 2024. This law was passed as a reaction to the Dobbs v. Jackson Supreme Court ruling and was designed to protect consumer health data ...
Introduction On July 11, 2024, the Court of Appeal1 rendered a decision that, for the first time, addresses the question of whether the elected domicile appearing in the Québec Enterprise Register (the ?REQ?), established under the Act respecting the legal publicity of enterprises,2 can provide a basis for the Superior Court?s territorial jurisdiction within the meaning of article 41(3) of the Code of Civil Procedure ...
On August 1, 2024, the Department of Justice (“DOJ”) rolled out its Corporate Whistleblower Awards Pilot Program after announcing the initiative in March. Described as “[s]upercharging DOJ’s corporate investigations and prosecutions,”[1] the Pilot Program dramatically expands the pool of would-be whistleblowers and underscores the importance of robust compliance and reporting programs ...
The Supreme Court's recent decision in Loper Bright Enterprises v. Raimondo, abolishing the Chevron doctrine, provides the False Act Claims defense bar with a potent new weapon. Two critical elements of any FCA claim are the falsity of the claim and scienter, which requires proof that the defendant acted knowingly. The government and relators' counsel often rely heavily on regulatory guidance issued by administrative agencies to establish these elements of their FCA claim ...
