Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.” Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).
The UK followed a subtly
October 17, 2023, Covington Alert
What You Need to Know
On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft guidance, and as a result,
On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert
On 3 October 2023, the UK Information Commissioner’s Office (“ICO”) finalized its Employment practices and data protection − Monitoring workers guidance (“Guidance”) to account for new types of work, including work from home, and the use of more sophisticated technologies for monitoring. In November 2022, we published a detailed blog post on the ICO’s public
Only one claim survived dismissal in a recent putative class action lawsuit alleging that a pathology laboratory failed to safeguard patient data in a cyberattack. See Order Granting Motion to Dismiss in Part, Thai v. Molecular Pathology Laboratory Network, Inc., No. 3:22-CV-315-KAC-DCP (E.D. Tenn. Sep. 29, 2023), ECF 38.
On August 22, 2023, the Spanish Council of Ministers approved the Statute of the Spanish Agency for the Supervision of Artificial Intelligence (“AESIA”) thus creating the first AI regulatory body in the EU. The AESIA will start operating from December 2023, in anticipation of the upcoming EU AI Act (for a summary of the AI
On September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act (“CMIA”). Specifically, AB 254 expands the scope of the CMIA to expressly cover reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from
On 9 October 2023, the European Parliament’s Internal Market and Consumer Protection Committee (IMCO) and Committee on Legal Affairs (JURI) agreed revised wording to amend the European Commission’s (the “EC”) proposed new Product Liability Directive (the “Directive”). The vote was passed with 33 votes in favour to 2 against. If adopted, the Directive will replace
Covington is proud to be a signatory to the Charter of Diversity (Charta der Vielfalt). The Charta der Vielfalt, launched in 2006 in Germany, seeks to promote diversity in companies and institutions and has the support of the Commissioner for the Federal Government for Migration, Refugees and Integration, State Minister Reem Alabali-Radovan. The initiative has