The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. This latest extension, which is now the third extension of such flexibilities originally implemented during the COVID-19 Public Health Emergency (PHE), became effective November 19, 2024 and lasts through December 31, 2025 ...
The new Network and Information Systems Directive (NIS2) came into effect on 18 October 2024 and with it comes an overhaul of the way in which cybersecurity risk management is regulated in Europe. The major changes brought about by NIS2 include stricter security measures, new incident reporting obligations and will substantially expand enforcement powers for regulators ...
United States Citizenship and Immigration Services (“USCIS”) has approved a new credentialing organization for certain healthcare workers for immigration purposes. USCIS approved the application from International Education Evaluations, LLC (IEE), which went into effect October 25, 2024 ...
Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for the Segmented Production of Biological Products" (the "Pilot Plan"), introducing a pilot initiative for the segmented production of biological products. This represents a breakthrough in the regulation of segmented production, a long-awaited achievement in the biopharmaceutical industry ...
PROOF OF INCAPACITY: ANALYSIS OF CIUSSS DE L?OUEST-DE-L?LE-DE-MONTREAL (ST. MARY?S HOSPITAL CENTER) v. RC 1 Summary The authors comment on this decision rendered on September 20, 2024, in which the Court of Appeal ruled on the capacity to consent to care in the presence of a psychiatric disorder ...
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
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Effective July 29, 2024, the Federal Trade Commission (“FTC”) has issued a final rule that expands the scope of its existing Health Breach Notification Rule (“HBNR”) to include health and wellness applications (“apps”) typically associated with wearable technologies such as smart watches ...
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule[1] outlining financial penalties, referred to as “disincentives” throughout the rule, for healthcare providers that engage in conduct that is considered “information blocking.” The 21st Century Cures Act defines information blocking as a “practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information ...
On June 28, 2024, Exempt Resolution No. 1,160 of May 31, 2024 was published in the Official Gazette, which approved the “Technical Guideline of the Public Health Institute that establishes the requirements for the application for modifications to the sanitary registration of biological products (M-MOBI)” ...
The UAE recently amended its legal framework on abortion to expand the circumstances under which abortions are permitted and ease the rules regarding the circumstances under which abortions are permissible. Cabinet Decision No. 44/2024 (the Decision) came into effect on 21 June 2024 and progressively changed UAE’s law on abortion ...
A recent appeal case upheld a breach of contract claim over a lifetime rail travel benefit delivered by a third-party provider. We examine the case and how employers can avoid such disputes through clear terms and conditions for employee benefit schemes ...
The U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) recently cited Circles of Care, Inc., a Florida behavioral health company, for failing to provide a workplace free of recognized hazards. This citation followed an incident where a patient assaulted a mental health technician at a nurse work station ...
Recently, the Ohio General Assembly passed a bill, Substitute S.B. 40, which will enter Ohio as a party to the new Dentist and Dental Hygienist Compact, and ultimately allow dentists and hygienists practicing in other compact states to practice in Ohio. This summer, the compact will form its commission, and will continue to work on operationalizing into 2025 before officially opening privilege applications ...
The Automated Vehicles Act (the Act) outlines the safety requirements that manufacturers and operators of automated vehicles will need to meet in order to deploy their goods and services on UK roads. In this article Ben Gardner outlines the key safety areas that will need to be considered ...
On 12 June 2024, the Office of Rail and Road (ORR) published its final report, ‘Railway Station Catering Market Study’. It evaluates the effectiveness of competition in station catering and whether the market is delivering value for money for passengers and taxpayers. The ORR has identified barriers to competition, such as limited space and protected leases ...
