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 ...
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") ...
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 ...
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 ...
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 ...
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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 ...
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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 June 7, 2023, the Minister of Finance of Quebec tabled and presented Bill 30 before the National Assembly, an omnibus bill entitled An Act to amend various provisions mainly with respect to the financial sector (hereinafter the ?Bill?). The Bill includes certain amendments to the provisions of the Insurers Act (?IA?) and the Act respecting the distribution of financial products and services (?DA?) ...
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 ...
On 25 April 2023, Guernsey introduced the Preferred Debts (Insurance Policyholders) (Bailiwick of Guernsey) Amendment Ordinance, 2023. That Ordinance effects changes to the Preferred Debts Law, 1983, which accords priority to certain preferred creditors in the event of insolvency. Full details of Guernsey's insolvency regime can be found here ...
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 ...
On September 17, 2022, Exempt Decree No. 63 of the Ministry of Health was published in the Official Gazette, approving Technical Standard No. 226 of the Ministry of Health, which set forth the obligation to implement a data registration system that allows the traceability of medical devices when they are received by institutional healthcare providers ...
As part of Rail Safety Week 2023, Health and Safety specialist Hayley Saunders looks at personal liability and how employees across all levels of a business can make a difference by positive individual contribution to workplace culture. Below is a summary of key takeaways from the webinar. Responsibility for workplace safety rests with employers and employees alike ...
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The United States Supreme Court has held an individual’s private right of action to sue a public nursing home for violations of federally protected rights in Health and Hospital Corporation of Marion County v. Talevski. The Court held that a private individual could sue for rights protected by the Federal Nursing Home Reform Act (“NHRA”), which sets the federal minimum quality standards for nursing homes to ensure that seniors receive quality care ...
