On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...
Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with L.A. Health Care Plan. With more than 2.7 million members, L.A. Care is the nation's largest publicly operated health plan, that offers Medicaid, Medicare and plans through the Affordable Care Act. Under the settlement, L.A. Care agreed to pay $1 ...
In an increasingly digital age, paper documents are often regarded (at best) as quaint and (at worst) as unnecessary and expensive. But when it comes to international trade, paper documents have been fundamental in terms of giving the holder of that physical document the benefit of valuable rights. This has now changed. From 20 September 2023, the Electronic Trade Documents Act 2023 places certain electronic trade documents on an equal footing as their paper counterparts under English law ...
The International Organization of Securities Commissions (IOSCO) has published its policy recommendations for decentralised finance (DeFi) as a consultation paper. Responses are due by 19 October 2023 ...
Decentralized Finance (DeFi) represents an emerging financial model that utilises distributed ledger technologies to provide functions like borrowing, investing, or trading digital assets, all without the need for conventional centralised intermediaries. Here is a quick update with what is occurring on the international stage ...
On September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...
PCC Issues Motu Proprio Merger Review Guidelines for Digital Markets On 21 August 2023, the Philippine Competition Commission (“PCC”) issued the Guidelines for the motu proprio review of Mergers and Acquisitions in Digital Markets (the “Guidelines”) to provide greater transparency and predictability over the PCC’s power of motu proprio review of mergers and acquisitions (M&As) within the digital market ...
The 5th Circuit Court of Appeals in New Orleans upheld parts of a Texas District Court ruling by restricting the use of Mifepristone, while allowing Mifepristone to remain on the market.[1] This is the latest ruling in an ongoing legal battle that has left the future of abortion medications in a state of flux. Dinsmore previously discussed the original April 2023 ruling that led to the most recent development ...
August 21, 2023 By: Akana K. Ma On August 14, 2023, pursuant to a Presidential executive order issued several days earlier, the U.S. Department of the Treasury released an Advance Notice of Proposed Rulemaking (the Proposed Rulemaking) announcing a ban on investment by U.S. persons, including U.S.-registered business entities, in three advanced technology sectors in China – quantum computing, artificial intelligence, and semiconductors ...
Recently, China's healthcare industry has been subject to a rigorous inspection and rectification initiatives focusing on anti-corruption. These initiatives have attracted widespread attention in the industry, and we have received numerous media and customer inquiries regarding such issues ...
Anton Dzhuplin, Partner of ALRUD Corporate/M&A practice and Co-Head of Crisis Management, Economic sanctions and Compliance practice, was re-elected as Vice Chair for the Year In Review of the International M&A Joint Venture Committee of the American Bar Association International Law Section. Within the Committee, world leading experts specializing in M&A share best practices and update information in the international law, raising their professional expertise ...
Anton Dzhuplin, Partner of ALRUD Corporate / M&A practice, Co-Head of Crisis Management, Economic sanctions and Compliance practice, edited the “International M&A and Joint Ventures” part of the American Bar Association International Law Section annual publication “The Year In Review” ...
Blood donation plays a critical role in healthcare, and with the continuous increase of the Maltese population, staff blood donation is becoming all the more important. Malta relies heavily on blood donations to meet the needs of its healthcare system. While voluntary blood donation is always encouraged, staff blood donation can help spur those who would otherwise be hesitant about donating blood or who might even have never donated blood before ...
December 2015 By: Bailee Pelham "Previous research on the mental health of firefighters has shown that they are at a greater risk than the majority of the population to develop various mental disorders, such as depression, anxiety, alcohol abuse, suicidal ideation, and post-traumatic stress disorder ...
The Centers for Medicare & Medicaid Services (“CMS”) has announced its proposed rules for the Hospital Outpatient Prospective Payment (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment Systems, as well as its calendar year (CY) 2024 proposed Physician Fee Schedule (“PFS”), (collectively the “Proposed Rules”) ...
In its second tranche of major standards reduction, The Joint Commission will eliminate or consolidate 210 accreditation standards across many of its programs. The modification to the affected standards will be effective August 27, 2023. The reduction is part of a major review effort of Joint Commission requirements announced in September of 2022 ...
The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...
This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes. First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...
On July 9, 2023, the State Council of the People's Republic of China[1] promulgated the Regulations on Supervision and Administration of Private Investment Funds ("Regulations"), which will take effect from September 1st, 2023 ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
On 13 July 2023, the UK government planned increases to fees across a range of immigration and nationality routes including the immigration health surcharge. The immigration health surcharge (IHS) is set to see a huge increase of around 66%. The current standard IHS rate is £624 per person per year of leave to remain granted and this will increase to £1,035. Similarly, the discounted rate for students and under-18s will increase from £470 per year to £776 ...
Today's judgment from the European Court of Justice ("ECJ") in the case Commission v CK Telecoms (C-376/20 P) provides insight into how the EU merger control provisions should be assessed in consolidated markets, such as telecommunications. Understanding the judgment may be relevant for consolidation plans in many industries with tendencies towards oligopoly ...
We look at the latest events concerning the dispute between the UK Covid-19 Inquiry and the Cabinet Office over the former Prime Minister’s WhatsApp messages and diaries ...
As the latest signal in the priority of the Duty to Report in Ohio, the State Medical Board has updated its Duty to Report video.[1] The video is offered by the Board for physicians to fulfill the mandatory continuing medical education (CME) component of the license renewal process in Ohio. Introduced in a new regulation on May 31, 2021,[2] the Board began mandating one hour of CME on the topic of the legal duty to report misconduct ...
A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...
