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 ...
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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 July 3, 2023, Ohio’s biennial budget bill[1] was signed into law by Governor Mike DeWine. In addition to major budget provisions, the bill also includes notable changes to Ohio’s Medical Marijuana Control Program (“MMCP”), the state program that regulates and licenses cultivators, processors, testing laboratories, dispensaries and medical marijuana cardholders. Beginning January 1, 2024, the MMCP will be under new management ...
On July 13, 2023, Law No. 21,586 was enacted. This law amends Law No. 21,435 to extend the term to fulfill certain requirements set forth therein, and also amends the Water Code to introduce an administrative procedure to clarify and complete titles of water rights (“WR”). Amendments to Law No ...
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 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
UK REACH (Registration, Authorisation, Evaluation and Restriction of Chemicals) is the UK’s post-Brexit chemicals regulatory framework for the Great Britain (GB) market. It is regulated by the Health and Safety Executive (HSE) and has the overall aim of ensuring the protection of human health and the environment from the use of chemicals. UK REACH places responsibility for understanding and managing the risks associated with the use of chemicals on those who place them on the market (i.e ...
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 ...
Michelle Craven-Faulkner, Partner and Rail Sector Lead participated in a roundtable in Birmingham last month hosted by Insider Media Limited, which was focused on the challenges, obstacles and opportunities supply chains face when looking at how manufacturing is adapting and innovating to bring forward the green revolution in transport. Michelle joined a team of experts and leading players from the mobility sector covering rail, automotive and aerospace ...
On June 14, 2023, the National Congress approved the bill that creates the Biodiversity and Protected Areas Service and the National System of Protected Areas (the "Bill"). The purpose of the Bill is the conservation of biological diversity and the protection of the national natural heritage through the preservation, restoration and sustainable use of genes, species, and ecosystems ...
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 ...
After a rollercoaster of a ride, the Retained EU Law (Revocation and Reform) Bill has received Royal Assent and is now an Act of Parliament. From the initial proposal of an all-singing, all-dancing automatic revocation of thousands of retained EU laws by the end of this year, to a more restrained revocation of just under 600 irrelevant or redundant laws, the Bill will not deliver the big bang that it initially promised ...
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 ...
Over the past few years, the United Arab Emirates has witnessed an increase in awareness and significance of environmental, social and governance (ESG) issues. While businesses in the UAE have begun to acknowledge that conscious efforts towards ESG compliance is imperative for growth and longevity of their business, the question remains whether ESG compliance can truly be said to now form a part of the UAE compliance ecosystem ...
In a recent survey conducted by Fertility Network UK, 40% of patients undergoing fertility treatment admitted to experiencing suicidal feelings, with the majority feeling that they would benefit from counselling. Sadly, this support is not readily available and reportedly only half of those in need have access. Often, the only option is to go private, but with sessions estimated to be between £10-£70 per session, that is not always feasible for everyone ...
We look at the legal framework within which the dispute between the UK Covid-19 Inquiry and the Cabinet Office over the former Prime Minister’s WhatsApp messages and diaries has developed, and possible consequences for the Inquiry depending on the outcome. What has the Cabinet Office been asked to provide? On 21 April 2023, Baroness Heather Hallett, Chair of the UK Covid-19 Inquiry (‘the Inquiry’) issued a Section 21 Notice to the Cabinet Office (‘the Notice’) ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
“Why don’t I own this?” The words of oil prospector Daniel Plainview to his property advisor, querying the land rights for his oil pipeline to the California coast in the Oscar winning film ‘There Will Be Blood, and a blunt, single sentence reminder of the need for early due diligence on large scale developments ...
