In recent years, China is continuously exploring the regulations of LDT (Laboratory Developed Tests, as defined below). With the introduction of a series of new regulations, many outstanding multinational and local companies have participated in the research of LDT. At this stage, general provisions can no longer meet the demand of the practice of LDT industry ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...
Key Points Skilled nursing facilities must ensure their medical directors are certified within five years of the date of hire or by January 1, 2027, for medical directors already working in a SNF SNFs must report medical director certification status to CDPH by June 30, 2022 SNFs must report medical director changes to CDPH within 10 days of the change Effective January 1, 2022, a skilled nursing facility (SNF) will be prohibited from contracting with a medical director unless
Today, the federal government enacted the Paycheck Protection Program and Health Care Enhancement Act (the “PPP/HCE Act”) to provide additional funding for loan and grant programs in response to the COVID-19 pandemic. The PPP/HCE Act modifies and increases funding for the Paycheck Protection Program and the Small Business Administration Economic Injury Disaster Loan program, as discussed in greater detail here ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
As highlighted in our previous article, the Infected Blood Inquiry’s first interim report established considerable liabilities in relatively short order, recommending that £100,000 be paid “without delay” to victims and partners bereaved by infections transmitted by blood transfusions and blood products. Sir Brian Langstaff, former High Court judge and current Chair of the Infected Blood Inquiry, released his second interim report on 5 April 2023 ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
Recently the “guideline for the supervision and regulation of the nutritional composition of foodstuff and its advertisement (“the guideline”) was published by the Undersecretary of Health.The guideline´s main objective is to, “guide the process of supervision and regulation of foodstuff”, taking into consideration the upcoming implementation of Decree No. 13 (June 27, 2016), which modifies the Health Regulations for Food Products ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules) ...
OSHA Adopts CDC Vaccine Guidance. On May 17, 2021, the federal Occupational Health and Safety Administration (“OSHA”) updated its online COVID-19 portal to announce that OSHA is revising its employer materials to reflect recent interim guidance from the Centers for Disease Control and Prevention (“CDC”). In the meantime, OSHA recommends that employers “refer to the CDC guidance for information on measures appropriate to protect fully vaccinated workers ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
The U.S. Department of Justice (DOJ) has issued a series of memoranda that discloses the department’s enforcement priorities and provides public guidance related to the ongoing coronavirus crisis ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
Please be informed that a new Counter-Sanctions Regime of Making Payments in IP-Related Agreements in Russia was established by the Presidential Decree No. 322 dated May 27th, 2022 “On the temporary procedure for fulfilling obligations in respect of certain right holders” (“Decree No. 322”). It came into force on the date of signing. Download the file to see more. https://alrud ...
The UAE authorities have taken a number of measures to reduce the costs that businesses are facing during the current crisis. We now report on some of the measures that have been introduced, current as of 12:00 noon on Thursday, 16 April 2020. Abu Dhabi Department of Economic Development (ADDED) Administrative Resolution No. 92 of 2020 On 14 April 2020, the ADDED issued Administrative Resolution No ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
The Chartered Institute of Personnel and Development (CIPD) has issued a report which provides guidance on supporting employees who are experiencing fertility issues. The report surveyed 300 workers who experienced difficulties with fertility while in employment within the last five years, as well as over 2,000 senior HR professionals and decision makers ...
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
Key Points Starting Jan. 1, 2021, California skilled nursing facilities must have a full-time, dedicated Infection Preventionist. Infection Preventionists must be an RN or LVN, but their hours may not count in minimum direct patient care staffing calculations ...
Key Points Effective Jan. 1, 2021, most California employees — even those who work for very small businesses — will be entitled to 12 weeks of job-protected time off work under the CFRA for qualifying reasons. Qualifying reasons for leave are broadly defined to include caring for a family member — including grandparents, grandchildren, adult children and siblings — with a serious health condition ...
