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
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 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
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
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
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
The European Commission has presented its draft Data Act, which will affect a broad range of companies and heavily emphasizes data accessibility and fairness. Companies should begin to evaluate their current practices and...more
On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more
The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more
Today (25 November 2021) the European Commission (the Commission) released the results of its evaluation of the Alternative Investment Fund Managers Directive (AIFMD) which forms part of a Capital Markets Union legislative...more
The EU-US Insurance Dialogue Project (“Project”) began in early 2012 as an initiative by the European Commission, the European Insurance and Occupational Pensions Authority (EIOPA), the Federal Insurance Office (FIO) of the...more
Equivalence decisions for EEA states, green finance and fintech initiatives are at the forefront of the UK government’s priorities. On 9 November 2020, the UK Chancellor of the Exchequer, Rishi Sunak, delivered a statement...more
The European Parliament recently adopted a new regulation on crowdfunding platform activity. This regulation will apply across the board to all European Union countries. The regulation’s adoption sprang from the desire to...more
Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed....more
Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed replacing the main pre-GDPR legislation...more