The Centers for Medicare and Medicaid Services (CMS) announced on March 13, 2020 enhanced penalties for infection control survey non-compliance amid the COVID-19 pandemic.[1] On June 1, 2020, CMS announced significant changes related to nursing home surveys. The new changes require states to complete 100 percent of their Focused Infection Control nursing home surveys by July 31, 2020 ...
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) have responded to the U.S. Senate’s request for information on physician-owned distributorships (PODs). Earlier this summer, a bi-partisan U.S. Senate committee asked CMS and the OIG to study the proliferation of PODs, citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
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 a highly-anticipated and extremely significant pair of decisions for businesses and consumers alike, the Supreme Court of Canada (“SCC”) ruled on Thursday (October 31, 2013) that the ultimate consumers at the end of a supply chain can effectively leap-frog the supply chain by having direct legal recourse in a class action against a manufacturer who illegally overcharged for the product supplied ...
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") ...
On August 28, 2024, the National Medical Products Administration (NMPA) released the Medical Device Administration Law (Draft for Comment) (hereinafter referred to as the "Draft") for public comments ...
On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued theNotice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector(hereinafter referred to as the "Notice"), announcing that,effective immediately, foreign-invested enterprises are permitted to engage in the development and application of human stem cells, gene diagno
In less than a decade, China has become the largest e-commerce market in the world, accounting for over 40% of global e-commerce according to a recent report by McKinsey. The breath-taking speed of development has left law makers scrambling to regulate the booming e-commerce industry ...
On October 25, 2013, the Standing Committee of the National People’s Congress of the People’s Republic of China passed an amendment to the P.R.C. Law on the Protection of Consumer Rights and Interests (the “Amendment”) ...
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 ...
Did you know? China’s new patent law, which comes into effect on 1 June 2021, will significantly change the design patent regime and will see the introduction of partial design protection, the extension of the design patent term from 10 years to 15 years and the acceptance of domestic Chinese design patent filings as a basis for priority ...
Did you know? After more than a decade of discussion, China finally published the 4th amendment to the Patent Law on 17 October 2020. The amendments will come into effect on 1 June 2021. Why does this matter to you? Patent enforcement in China has long been criticised for being ineffective at deterring infringers. The new law enhances the enforcement of patent rights. The amendments introduces punitive damages in patent infringement cases ...
A focus for Chinese trademark law and practice in recent years has been strengthening the fight against malicious trademarks ...
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 ...
The Chilean Economic Development Agency, Corfo, and the Foreign Investment Promotion Agency, InvestChile, have announced the opening of the first call for national and foreign companies, to express their interest in manufacturing lithium products, such as battery cathodes and electrolytes. Companies that are selected will be guaranteed 25 per cent of US producer Albemarle’s lithium production at the lowest cost available in the market ...
In the BlackFriday event, from November 25th to 28th 2022, will be fully in force the reforms to Law No. 19,496 on Consumer Rights Protection in the field of e-commerce, introduced mainly by the "Pro-Consumer" Law and the Electronic Commerce Regulation. The following are the main aspects and obligations to be taken into consideration for the event: Promotions, offers, contests and sweepstakes must disclose the terms and conditions governing them and their term of duration ...
“Who steals my purse steals trash; ’tis something, nothing; ’twas mine, ’tis his, and has been slave to thousands; But he that filches from me my good name Robs me of that which not enriches him, And makes me poor indeed ...
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 ...
