On April 21st, 2023, the Public Health Institute ("ISP") issued Exempt Resolution No. 1020, which approves the "Technical Guidelines on recommendations for the labeling of cosmetic products" (the "Guide”) ...
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") ...
On February 14 of this year, the Public Health Institute ("ISP") approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the "Guideline") ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...
April 19, 2022 By: T. Mark Tubis The U.S. Department of Health and Human Services (“HHS”) has renewed the January 31, 2020 determination that a public health emergency (“PHE”) exists nationwide. Each determination renews the PHE for 90 days, so all HHS/CMS waivers and flexibilities applicable during the PHE will continue until at least July 15, 2022, unless the PHE is terminated sooner ...
With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury. In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal ...
Persons using medical services in Poland are subject to special legal protection. Regardless of their nationality, all patients have the same rights. Our guide explains the key patient rights and legal solutions concerning citizens of Ukraine. A guide prepared by Małgorzata Sokołowska and Natalia Falęcka-Tyszka from the firm’s Healthcare practicehttps://wardynski.com.pl/upload/2022/04/realizacja-swiadczen-opieki-zdrowotnej_en ...
The Coronavirus Aid, Relief, and Economics Security Act (the “CARES Act”) added an additional $100 billion to the Public Health and Social Services Emergency Fund (the “Relief Fund”) to provide funding to healthcare providers responding to the coronavirus pandemic ...
India, being a common law country, enjoys certain privileges when it comes to Trademark Law. In addition to priority rights for “first to use”, and the remedy of “passing off’’ for unregistered marks, there exists another age-old common-law right, not typically considered in global strategy - the transborder reputation of an extra territorial trademark ...
As of today, July 26 the Chilean borders will open so that all those who have a “Mobility Pass” can exit the country, although current restrictions for non-resident foreigners have been maintained. The is subject to modification in view of the development of the Covid-19 outbreak in the national territory ...
On 3 December 2012 Guernsey brought into force its new image rights legislation which allows, for the first time anywhere in the world, for such rights to be registered. Gary Assim, Shoosmiths In essence this law has created a new form of intellectual property right for anyone, anywhere in the world, who is famous, or might be in the future, to protect their image by registering it ...
Three proposed rules for the establishment of Affordable Insurance Exchanges – intended to create competitive marketplaces for private health insurance and a key component of the healthcare reform legislation enacted in March 2010 – were released today by Departments of Health and Human Services and Treasury ...
Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
In one of the first concrete developments related to the Affordable Care Act (ACA) changes following Dr Thomas E Price’s approval as Secretary of the Department of Health and Human Services (HHS), a Notice of Proposed Rule making was recently released by HHS. The recent release by HHS stated a goal of helping to stabilize the individual and small group marketplaces established by the ACA ...
In December of 2019, the State of Ohio Board of Pharmacy (“Board”) proposed rule changes for medical marijuana dispensaries. These proposed rule changes came on the heels of increased regulatory scrutiny of ownership structures and consulting arrangements in recent months.1 The proposed rules ostensibly seek to revise and clarify the Board’s position on changes of ownership and control of medical marijuana dispensaries ...
The regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...
By: Anne Marie Ellis, John Epperson and Peter McGaw OEHHA is proposing a significant change to the Proposition 65 “short-form warning” to require that this warning identify a specific Proposition 65 (“Prop. 65”) chemical. Currently, the short-form warning requires identification of a toxicological endpoint (i.e. cancer or reproductive harm) but not the chemical that has triggered the warning requirement ...
The Colombian government, aware of the need to improveinfrastructure in order to reduce logistical costs and thereby promote the country’s growth and development, is currently in the process of selecting contractors for the fourth generation road concessionprogram, which envisages the award of approximately 25 concession contracts, with total investment of close to €18,300 million ...
Module 5 will assess the robustness and effectiveness of procurement processes, the adequacy of items obtained (including their specification, quality, and volume) and the effectiveness of their distribution. It will also consider the UK-wide procurement of lateral flow and PCR tests. The provisional scope for this module lists three key areas of investigation ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
