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 (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
The Hungarian Parliament enacted Act no CXII of 2011 on Information Rights and the Freedom of Information ("New Data Protection Act"), which will replace the currently effective Act no LXIII of 1992 on the Protection of Personal Data and the Publication of Data of Public Interest ("Old Data Protection Act") from 1 January 2012. Below, we briefly summarize the main changes brought about by the New Data Protection Act ...
The Government of Vietnam issued Decree 53/2022/ND-CP dated 15 August 2022 (“Decree 53”) detailing a number of articles in Vietnam’s Law on Cybersecurity (2018) which took effect as from 1 January 2019 (“Law on Cybersecurity”). As with most laws in Vietnam, decrees and circulars and other subordinate legislation, provide more detailed information, forms, and other guidelines to help implement the law in an efficient manner ...
As of June 1, 2023, the German Federal Ministry of Transport and Digital Infrastructure (Bundesministerium für Digitales und Verkehr, “BMDV”) published a new draft bill for a regulation on consent management services (Consent Management Regulation Einwilligungsverwaltungsverordnung, “EinwV”) under the German Telecommunications Telemedia Data Protection Act (Telekommunikation-Telemedien-Datenschutz-Gesetz, “TTDSG”) ...
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 ...
On April 10, 2020, the U.S. EPA published an interim memorandum titled “Interim Guidance on Site Field Work Decisions Due to Impacts of COVID-19,” available here, intended as guidance to EPA's regional field offices amid growing concerns regarding the impact of COVID-19 on-site cleanup activities. Specifically, the memorandum provides guidance regarding decisions to continue, reduce, or halt on site cleanup activities amid the challenges posed by the COVID-19 outbreak ...
On December 5, 2012, EPA issued revised enforcement guidance to assist agency personnel in exercising enforcement discretion regarding the treatment of tenants under Superfund’s bona fide prospective purchaser (BFPP) defense. (See here.) The revised guidance supersedes guidance the agency had issued on January 14, 2009 and expands some of the protections ...
In order to comply with a court-ordered schedule, EPA Administrator Lisa Jackson on July 28 signed a 604-page package that proposes to subject additional oil and gas operations to regulation under the New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPS) programs and to impose new and amended requirements under both programs. This proposed rulemaking has significant ramifications for the oil and gas industry ...
The ESG Disclosure Rules have been introduced in response to the increased investor appetite for socially and environmentally responsible investments and to ensure that Jersey maintains its high regulatory standards amid global concerns regarding ‘greenwashing’ (firms marketing investments which appear more environmentally and socially focussed than they are in reality) ...
Almost at the same time as the much-noticed and controversially discussed Directive on Copyright in the Digital Single Market (see Update IP No. 12: Agreement on the Reform of the Digital Copyright Law) and barely noticed by the public, another European Directive on copyright law was adopted ...
On 10 October 2011 the Council of Ministers of the European Union approved a new Directive on consumer rights in the European Union. This directive is aimed at strengthening the rights of consumers in all Member States of the European Union by bringing uniformity to the rules applicable to all European citizens with a special focus on the online shopping sector ...
On April 9, 2021, the IRS released Private Letter Ruling (PLR) 202114002 (January 13, 2021), which provides additional context to taxpayers worried about whether their Fintech or Insurtech shares represent Qualified Small Business Stock (QSBS) under Internal Revenue Code (IRC) section 1202 ...
Companies, municipalities, and water systems must now report their per- and polyfluoroalkyl substances (PFAS) use to the federal government. A new federal law requires facilities using 100 pounds per year of a listed PFAS compound to self-report to the national Toxics Release Inventory (TRI). Monitoring and reporting requirements are often prerequisites to cleanup and enforcement, and this collection of data may be a bellwether for the future regulation of PFAS ...
In August 2022, the House of Representatives’ Committee on Ways and Means approved a bill proposing a new fiscal regime for the Philippine mining industry, following the previous proposal of the Department of Finance (DOF)and which will cover existing and prospective large-scale metallic mine, regardless of location ...
Introduction Last week, the federal government took a big step toward bringing the Fisheries Act (Canada) and its application into line with the federal government’s responsible resource development plan ...
Background The EU General Data Protection Regulation (GDPR) restricts the transfer of personal data outside the EEA unless there is a legal basis for the transfer, e.g., EU standard contractual clauses or binding corporate rules (BCR) ...
The Government of Indonesia finally issued Government Regulation No. 71 of 2019 on Organization of Electronic Systems and Transactions ("GR 71/2019") on 4 October 2019, gaining momentum as the country sees the rise of ‘Unicorns’ and President Joko Widodo boasting about the country’s digital economy. GR 71/2019 replaces Government Regulation No. 82 of 2012 with the same title and came into force on 10 October 2019. GR 71/2019 has 11 chapters and an extensive scope ...
Starting tomorrow, organizations may start submitting applications for new gTLDs (generic Top Level Domains). The application window will close on April 12, 2012. The new gTLDs move well beyond the core group of generic top level domains of .com, .net, .org, .biz, .info, and .edu. Specifically, they can consist of any combination of three or more letters that an applicant chooses ...
This month the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) released new guidance for advertisements used to promote in-game purchases. This guidance applies to providers of online gaming services that offer users the opportunity to purchase virtual items in real-time, such as virtual currencies or extra lives ...
The Government issued new regulations setting the guidelines and adopting the biosecurity protocol for the operation of the manufacturing industry The Ministry of Work issued Resolution 675 adopting the biosecurity protocol for the management and control of COVID-19 risk in the manufacturing industry. This protocol is complementary to the protocol adopted through Resolution 666 of 2020 and to other measures adopted in each factory ...
On certified questions from the United States District Court for the District of New Hampshire, the New Hampshire Supreme Court has decided that New Hampshire will allocate liability for long-tail environmental claims pro rata by years and limits among triggered policies. See EnergyNorth Natural Gas, Inc. v. Certain Underwriters at Lloyd’s, No. 2006-745 (N.H. Oct. 18, 2007). BackgroundEnergyNorth Natural Gas, Inc ...
The ICO’s long-awaited guidance on how organisations can manage transfers of UK data to receivers outside the UK has arrived. What does it say about the direction this government may want to take on data protection reform? It will take time for advisers and users to digest but it’s instructive to take an early tour and try to guess what will prove useful and what are the new bones of contention ...
By means of Resolution No. 375 , dated May 3, 2021, the Ministry of the Environment has instructed a new information request for producers of priority products, in the context of Law No. 20,920 on Waste Management, Extended Producer Responsibility and Recycling Promotion ( "EPR Law") ...
The UK Government has put forward for approval by Parliament a new safeguard mechanism for international transfers, known as the International Data Transfer Agreement (IDTA), that will impact organisations transferring personal data out of the UK. If approved, the IDTA will apply from 21 March 2022, and we would encourage affected organisations to review their data transfer processes now ...
