As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
by Bryan G. Scott and Elizabeth K. Strickland Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App ...
Following the 2018 enactment of regulations governing contractual terms contained in vehicle hire-purchase agreements, the Office of the Consumer Protection Board (“OCPB”) has recently resolved to adjust such regulatory scheme as part of their initiatives to alleviate the ongoing economic downturn and financial hardships suffered by consumers as a result of the pandemic, and to prevent consumers being subject to any unfair contractual terms in this respect ...
Employment Tribunals have a duty to make reasonable adjustments where a participant is disadvantaged, for example due to disability, to ensure fairness in proceedings. We share our recent experiences of how the Tribunals apply this duty in practice ...
The Department of Health and Human Services recently released a letter that stated that using a single ventilator for two patients should be considered “an absolute last resort.” Of course, this statement assumes that a ventilator exists in the first place, and it says nothing about how to deal with several more than two patients needing the same ventilator. This, however, is only the tip of proverbial iceberg ...
New measures for state contracting for economic reactivation. Through Decree 579 of 2021, issued on May 31 by the National Planning Department, certain transitory paragraphs enshrined in Decree 1082 of 2015 or the sole Regulatory Decree of the Administrative Planning Sector, were replaced in matters of state contracting ...
Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours ...
Shoosmiths’ head of energy and infrastructure (E&I) sector, James Wood-Robertson, details and reacts to the much-anticipated E&I developments and proposals set out in the UK government’s 2022 Autumn Statement ...
Haynes and Boone, LLP Counsel Raquel Alvarenga talked with HR Magazine about continued COVID-19-related accommodations for vaccinated employees.Below is an excerpt:Many businesses have developed policies on providing reasonable accommodations to employees who refuse to get a COVID-19 vaccine for religious or disability-related reasons. Employers shouldn't forget that fully vaccinated workers may need accommodations, too.In recently updated guidance, the U.S ...
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 Government has introduced the Rail Reform Bill, a major legislation that will overhaul the UK's rail network and affect the interests of businesses across various sectors. The Bill, which was presented to Parliament on 20th February 2024, will enable the creation of a new public body, Great British Railways, that will take charge of the planning, contracting and operation of rail services across the country ...
In January, the Secretary of State for Transport announced the project for the construction of HS2, a second high speed rail network. It is to be constructed in two phases forming a “Y” shape: the first phase between London and Birmingham and the second from Birmingham, to Manchester and to Leeds. Phase 1 will link to Europe via the high speed rail line in London, HS1 and the Channel Tunnel ...
Historically there has been relatively little enforcement focus on the typical physician-ownership model used by many ambulatory surgery centers (ASCs). A qui tam lawsuit filed recently against an ambulatory surgery center company based in Nashville, however, indicates that qui tam relators are leaving no stone unturned as they look for cases. Although the federal government has declined to intervene in U.S. ex. rel Thomas Reed Simmons v. Meridian Surgical Partners, et ...
On April 23, 2024, the Federal Trade Commission (“FTC”) voted to issue a final rule banning non-compete provisions in most industries in the United States (“Final Rule”). Dinsmore attorneys were quick to publish the details and impact of the Final Rule, which is available here. This supplement focuses on the impact of the Final Rule on the healthcare industry ...
This new Workplaces Manual covers all General Preventative Measures set for the by the following: Governmental Agreement 79-2020 Ministerial Agreement 146-2020 Presidential provisions in force Provisions of the Ministry of Public Health and Social Assistance Guide to the identification of occupational hazards by Covid-19 and preventive measures in the workplace - IGSS Regulation of Occupational Health and Safety The Manual covers the specifics of all factors involved in halting
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
Florida transportation officials and the private sector have fine-tuned a financing structure that allows the state to use private-sector financing to advance projects to build roads and bridges and fulfill other essential infrastructure needs. The timing is right. The infrastructure of Florida, like the rest of America, is in critical need of maintenance and overhaul ...
Last January 14, the Communications and Transportation Ministry published the prequalification rules pertaining the international open tender number PO-009000988-N1-2015 awarding the construction of a high speed train project that will run in the route Mexico, D.F. - Santiago de Querétaro, Querétaro, including the definitive executive program, construction, supply, set up and extended testing of a railway track, rolling stock, equipment, systems and other components ...
Last January 14, the Communications and Transportation Ministry published the prequalification rules pertaining the international open tender number PO-009000988-N1-2015 awarding the construction of a high speed train project that will run in the route Mexico, D.F. - Santiago de Querétaro, Querétaro, including the definitive executive program, construction, supply, set up and extended testing of a railway track, rolling stock, equipment, systems and other components ...
On October 29, 2021, the following resolutions were published in the Official Gazette: Exempt Resolution No. 1,080 of the Undersecretary of Public Health amending Exempt Resolution No. 994, of 2021, of the Ministry of Health, which establishes the fourth Step-by-Step Plan; and Exempt Resolution No. 1,079 of the Undersecretary of Public Health, which amends Exempt Resolution No. 672, of 2021, of the Ministry of Health, which establishes the Protected Borders Plan ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
