HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...
On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
With the third wave of COVID-19 in full swing in South Africa, it has never been more important for South African employers to anticipate and prepare for the various COVID-19 related disputes that may lie ahead. It is vital to learn from the challenges already confronted by employers worldwide concerning issues such as vaccination, occupational health and safety, and flexible working arrangements and their approaches to such matters ...
A PowerPoint presentationcovering the following: Senate Report on Board's Role in Enron's Collapse Typical Accounting Allegations Reasons for Restatements 1997-2000 Securities Suit Catalysts Messages to the Market... ...
This week marks Children's Mental Health Week (6-12 February 2023). The focus on mental health has been increasing in recent years, with one in six children aged between five and 16 likely to have experienced mental health challenges. As a result, there are a growing number of workdays lost by parents, guardians, carers, and those with childcare responsibilities, to support and manage such challenges ...
Chloe, the assistance cat, has hit the headlines of several newspapers over the past few weeks, following her owner (Mr Fenn) bringing a claim under the Equality Act 2010 against Sainsbury’s supermarkets after they refused Chloe’s entry to the store. Mr Fenn has autism; a consequence of his autism is that he experiences sensory overload in busy places such as the supermarket and he states that Chloe helps him to focus ...
How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
The White House has completed the final review to clear a path for the Department of Health and Human Services (HHS) to publish the final rule to modernize and clarify regulations promulgated for the Stark Law and Anti-Kickback Statute. In June 2018, HHS Deputy Secretary Eric Hargan announced a regulatory reform initiative entitled the “Sprint to Coordinated Care ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
Key Points On Aug. 25, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with a comment period (IFC) establishing new Long-Term Care Facility COVID-19 Testing Requirements for Staff and Residents. CMS has added 42 CFR §483.80(h), which requires that the facility test all residents and staff for COVID-19. Noncompliance related to this new requirement will be cited at new tag F886 ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
As the use of telehealth continues to increase, providers need to be mindful of the liability laws in the jurisdictions that they operate in. Similar to in-person medical practices, telehealth services carry liability and malpractice risks. Once a provider virtually crosses a state line, he or she becomes subject to the liability laws of the other state ...
Blood donation plays a critical role in healthcare, and with the continuous increase of the Maltese population, staff blood donation is becoming all the more important. Malta relies heavily on blood donations to meet the needs of its healthcare system. While voluntary blood donation is always encouraged, staff blood donation can help spur those who would otherwise be hesitant about donating blood or who might even have never donated blood before ...
October is Breast Cancer Awareness Month, an annual campaign to raise awareness about the impact of breast cancer and to raise funds for research into its cause, prevention, diagnosis, treatment and cure. The firm held an event last week at its offices with staff in order to raise awareness about breast cancer and to raise funds for the cause. The firm is once again making a contribution to the Action for Breast Cancer Foundation ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments. Out-of-network providers scored a legislative victory as Medicaid managed care organizations will have to pay them regular Medicaid rates if use of their services exceeds new benchmarks ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...
On April 27, 2022,Republic Act No. 11712, or thePublic Health Emergency Benefits and Allowances for Health Care Workers Act(“RA 11712”), was signed into law in recognition of the critical role of health care workers in providing quality health care and ensuring disease prevention in the general population, especially during the pandemic. It seeks to promote the welfare of health care workers through the grant of mandatory benefits and allowances with utmost efficiency ...
