Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
Exactly one year from now, on September 12, 2025, the EU Data Act will enter into application. This new regulation provides harmonized rules on data access, switching cloud providers, and interoperability requirements across...more
The European Union (EU) Artificial Intelligence Act (AI Act), Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending...more
In this blog post, we will focus on the identification of “high-risk AI systems” under the Artificial Intelligence Act (“AI Act”) and the requirements applying to such systems. As explained in our previous blog posts, the AI...more
On 24 April 2024, the EU adopted a new directive (Directive (EU) 2024/1226 of the European Parliament and of the Council) which establishes EU-wide rules for defining criminal offences and penalties related to the violation...more
On April 24, 2024, President Biden signed into law an emergency supplemental appropriations law, H.R. 815 (Public Law 118-50), that provides substantial military aid to Ukraine, Israel, and Taiwan and could force the sale of...more
The "Agreement amending the various regulations by which the Ministry of Economy issues General Rules and Criteria on Foreign Trade" (Agreement) was published in Mexico’s Official Gazette of the Federation on April 15, 2024....more
The proposed revision is ambitious in scope and aims for a greater harmonization of national FDI regimes. On January 24, 2024, the European Commission (EC) adopted five initiatives to strengthen the EU’s economic...more
On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more
On March 8, 2023, China acceded to the Convention Abolishing the Requirement of Legalization for Foreign Public Documents (the “Convention”, also known as the Apostille Convention). On October 23, 2023, the China...more
On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more
On 22 December 2023, the EU published Regulation (EU) 2023/2854, the Data Act, in the Official Journal of the EU. The Data Act is a new regulation providing harmonised rules on access to data, switching cloud providers and...more
The long-awaited update of the table of occupational diseases was published on Dec. 4, 2023, in the Official Gazette of the Federation of Mexico. The update includes work-related health conditions such as "mental disorders"...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more
On October 4, 2023, U.S. interested parties filed a petition (“Petition”) seeking to impose antidumping (“AD”) and countervailing duties (“CVDs”) on imports of certain aluminum extrusions from China, Colombia, the Dominican...more
Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more
On the heels of the United Kingdom (UK) announcing its first global summit on artificial intelligence (AI) safety, British Prime Minister Rishi Sunak predicted that London could be the future epicenter of AI regulation. The...more
In May, I had the opportunity to participate in a panel discussion on the harmonization of American and European approaches to compliance and ethics at the 7th Compliance & Technology Conference of the Institut du Risk &...more
On June 14, 2023, the European Parliament adopted its negotiating position regarding the proposal of the European Commission for a regulation laying down harmonized rules on artificial intelligence. This is the most recent...more
Key Points - The EU aims to harmonize patent protection rules and flexibilities with a layer on top of national rules. This is in line with long-term efforts by the EU institutions to harmonize patent rules and motivated,...more
Insurance Ordinance amendments would create a risk-based capital regime aligned with international standards. On 6 April 2023, the Hong Kong government introduced the Insurance (Amendment) Bill 2023 into the Legislative...more
Organisations should expect increased scrutiny and enforcement activity around the role of data protection officers in the coming year. The European Data Protection Board (EDPB) has announced that its coordinated...more
A 2018 European Union Directive provided additional protections to trade secrets and harmonized laws between EU member states. Jones Day Madrid Partner-in-Charge Marta Delgado Echevarría and London Partner Rebecca Swindells...more
The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...more
Proposed amendments are intended to reduce regulatory burden by aligning over-the-counter (OTC) derivatives data reporting requirements with international standards developed by the Committee on Payments and Market...more