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 ...
Insurance M&A: Bermuda’s change of control requirements In the complex landscape of mergers and acquisitions (“M&A”), regulatory challenges play a critical role in the success of transactions ...
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 ...
By: Melissa Groisman, Esq. As of October 1, 2024, Florida has implemented stricter flood disclosure requirements for residential real estate transactions. This means that sellers are now required to disclose a property’s flood risk to potential buyers prior to executing a purchase and sale agreement. What Does This Mean for Sellers and Buyers? Sellers: To comply with the new law, sellers must disclose any previous flood damage claims and federal assistance received due to flooding ...
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 ...
Background In January 2022, the Hordaland District Court issued a decision that authorised the Competition Authority to conduct a dawn raid and seize evidence at Kommunal Landspensjonskasse Mutual Insurance Company (“KLP”). The dawn raid was carried out in February 2022. The seizure included, among other things, electronic material produced by KLP’s in-house lawyers ...
Insurance disputes are a timeless topic. However, in difficult economic times, the number of insurance disputes tend to increase. Our Dispute Resolution practice hosted a webinar on 17 September 2024 on the current trends in insurance disputes and shared their views on the challenges different parties may face in such disputes. The webinar also addressed practical strategies for managing disputes effectively. We have summarised the key topics of the webinar in the article below ...
October 8, 2024 By: John L. Hosack and Jason E. Goldstein In a victory for all insureds who have title insurance policies, and possibly a victory for insureds under other real property related insurance policies, the California Court of Appeal in Tait v. Commonwealth Land Title Insurance Company (2024) 103 Cal.App.5th 271, 277 (rev ...
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 ...
The rules on the duration and termination of insurance contracts governed by Belgian law have often been found overly formalistic and complex, especially by consumers. Save for a few exceptions, the duration of non-life insurance contracts can, in principle, not exceed one year. Instead, such contracts are tacitly renewed for successive one-year periods, subject to a notice for termination or objection to the tacit renewal being made by one of the parties ...
By: Richard C. Giller, Esq. Late Thursday, September 29, Hurricane Helene made landfall in Florida as a Category 4 storm. Before that, Helene’s winds created a dangerous storm surge that began wreaking havoc all along Florida’s gulf coast, particularly the Big Bend region, which experienced surges up to 15 feet ...
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 ...
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 ...
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 ...
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 the 9th of July 2024, the MFSA published a Circular setting out its expectations with regards to the requirements listed in paragraph 6 ...
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 ...
Cyber reporting requirements for Bermuda insurers, insurance managers and insurance intermediaries following the CrowdStrike faulty software update Key reporting obligations Prompt notification Bermuda insurers, insurance managers and insurance intermediaries (including brokers, agents and insurance marketplace providers) (each, a "Registered Person") must forthwith notify the BMA upon coming to the knowledge, or having a reason to believe, that a cyber reporting event has occurred ...
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 ...
