Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
The Department of Defense (DoD) and the Civilian Agency Acquisition Council (CAAC) have both issued new Class Deviations from the FARs that implement Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors (i.e., the federal contractor vaccine mandate) ...
Quebec is a fertile ground for class actions, with over 550 active cases and between 50 to 100 applications for authorization filed each year. While 2023 marked the fifth anniversary of the ?new? class action division: what is there to watch in 2024? Read on to find out. Opioids and the State: Sanis Health v ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
On October 8, 2023, theScientific and Technological Ethics Review Regulation (Trial)("Scientific and Technological Ethics Regulation") was jointly published by the China's Ministry of Science and Technology ("MOST"), the Ministry of Education, the Ministry of Industry and Information Technology, and other seven (7) departments/institutions, which was followed by a press conference held next day by the MOST to respond to media inquiries ("Press Conference") ...
Did you know? The Chinese National Intellectual Property Administration (CNIPA) revised Patent Examination Guidelines came into force on 15 January 2021. The changes significantly relax the patentability requirements for inventions in the pharmaceutical, chemical and biotech field. Why does this matter to you? The revised guidelines focus on the examination criteria for novelty and inventive step in relation to the rapidly developing field of chemical and biotech inventions ...
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 ...
Introduction: On June 9, 2005 the Supreme Court of Canada released its landmark decision in Chaoulli v. Quebec (Attorney General) in which a majority of the Court struck down provisions of Quebec’s Health Insurance Act and Hospital Insurance Act which prohibit private insurance for health care services that are available in the public health care system ...
Effective Oct. 17, 2019, hospital outpatient departments (HOPDs) and other facilities which previously were exempt from the Ambulatory Surgical Facility (ASF) licensure requirement may now meet the criteria of an ASF. Governor Mike DeWine’s budget bill contained provisions which modified the definition of an ASF and will expand the number of facilities subject to regulation under Ohio law as an ASF ...
Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law ...
The focus on the response to the Coronavirus (COVID-19) has primarily centered around prevention and containment but the government and commercial payors have also addressed healthcare operational matters that encourage prompt diagnosis, treatment and monitoring through billing and reimbursement modifications and expansion of telehealth services ...
October 12, 2022 By: Michael Flynn On September 27, 2022, the Consumer Financial Protection Bureau (CFPB) issued a Request for Information Regarding Mortgage Refinances and Forbearances. The Request indicates that the CFPB is considering making the COVID emergency relief foreclosure/loss mitigation requirements a permanent requirement for mortgage lenders and servicers when dealing with temporarily distressed borrowers ...
Key Points: New CDPH mandate requires action by skilled nursing facilities within 21 calendar days of issuance of All Facilities Letter. CDPH to conduct onsite visits to skilled nursing facilities every 6 to 8 weeks to verify compliance with facility's approved COVID-19 Mitigation Plan. New Mitigation Plan requirement is in addition to any local requirements for COVID-19 planning ...
On May 11, 2020, the California Department of Public Health ("CDPH") issued an All Facilities Letter (AFL 20-52) requiring skilled nursing facilities ("SNF") to develop and implement a facility specific COVID-19 mitigation plan (the "Plan") with six different, complicated elements. The CDPH requirement is in addition to any local requirements for COVID-19 planning and may or may not track the requirements already in place in some local jurisdictions ...
On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing ...
The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery ...
On April 13, 2020, the Centers for Disease Control and Prevention (“CDC”) issued guidelines on safety practices for critical workers who may have had exposure to a person with suspected or confirmed COVID-19 ...
On Oct. 21, 2020, the Centers for Disease Control and Prevention (CDC) released a new definition for “close contact.” The new definition was expanded to account for the cumulative amount of exposure one might have had with a person infected with COVID-19. Under the new definition, close contact is defined as being “within six feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period beginning two days before illness onset ...
Earlier this year, the Congressional Budget Office (CBO) released its report on the direct spending and revenue effect of H.R. 1628, the American Health Care Act of 2017 (AHCA), as passed by the House of Representatives. CBO made this estimate in conjunction with the Joint Committee on Taxation ...
CHALLENGE Promise Healthcare Group, LLC was one of the nation’s largest healthcare providers focused on post-acute care services. The investor-owned company operated two freestanding medical-surgical hospitals, 14 long-term acute care hospitals (LTACHs), and two skilled nursing facilities. The company also had 45 affiliates across eight states ...
It seems logical that when a claimant requests that a claim be amended to include an additional condition based upon a theory of substantial aggravation, the easiest element to prove would be that the condition pre-existed the date of injury. Recently, in Houlihan v. Hamilton County, 2021-Ohio-3087, the Ohio First District Court of Appeals found that a claimant must prove a condition existed at the time of the injury before they can establish a substantial aggravation ...
