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 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 ...
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 ...
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 ...
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” ...
The British Standards Institution (BSI) has released a new workplace standard relating to menstruation and menopause. The BSI standard (BS 30416) aims to support the health and well-being of all employees who menstruate or experience peri/menopause. The standard suggests that there are many actions that employers can take to improve the accommodation of all its employees ...
On May 31, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a Final Rule (the “Final Rule”) that withdraws the mandatory vaccination requirement for employees of CMS-certified healthcare facilities, which includes hospitals, critical access hospitals, long term care facilities, home health agencies, hospices, and ambulatory surgical centers ...
On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
May 31, 2023 By: Marissa Alkhazov Governor Jay Inslee signed HB 1047, Washington State’s Toxic-Free Cosmetic Act (the Act) into law on May 15, 2023. The Act bans some of the most concerning chemicals added into cosmetic and personal care products, including PFAS, phthalates, formaldehyde and formaldehyde releasing agents ...
On May 16, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $350,000 settlement with MedEvolve, Inc., a practice and revenue cycle management and practice analytics software services company, to resolve alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations ...
As we gear up for the UK Covid-19 Inquiry’s first full public hearing on 13 June, here is a reminder of what has been covered to date, followed by a list of issues to be covered within the scope of the first (Module 1) investigation. Inquiry to date the Inquiry was formally established by the Chair (Baroness Heather Hallett) on 28 June 2022, at which time the final Terms of Reference were published by the Government (UK COVID-19 Inquiry: terms of reference - GOV.UK (www.gov ...
