On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy).
...more
7/17/2025
/ Biotechnology ,
Clinical Trials ,
EU ,
Healthcare ,
Innovation ,
Investment ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Research and Development
On April 9 2025, the European Commission published the AI Continent Action Plan (the Action Plan), which outlines the EU’s strategy to enhance innovation, competitiveness and regulatory compliance in artificial intelligence...more
On March 24 2025, the European Commission (EC) adopted the final draft Delegated Regulation setting out Regulatory Technical Standards (RTS) for subcontracting ICT services supporting critical or important functions under the...more
4/16/2025
/ Cybersecurity ,
Data Protection ,
Digital Operational Resilience Act (DORA) ,
EU ,
European Commission ,
Financial Institutions ,
Information Technology ,
Regulatory Requirements ,
Risk Management ,
Subcontractors ,
Third-Party Service Provider
On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more
On February 11 2025, the European Commission (the EU Commission) released its 2025 work programme in which it published its AI and privacy initiatives for 2025 (the Work Programme) in order to boost competitiveness, enhance...more
2/27/2025
/ AI Act ,
Artificial Intelligence ,
Data Privacy ,
Data Protection ,
EU ,
European Commission ,
General Data Protection Regulation (GDPR) ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector
When the AI Act was first proposed by the European Commission in 2021, the concept of “general purpose AI” was nowhere to be found. These rules were introduced during the legislative process to align the AI Act to the...more
Highlight of the week - On 21 May 2024, the Council of the European Union (the Council) issued a press release announcing it had approved the Proposal for a Regulation of the European Parliament and of the Council Laying Down...more
The UPC decides that the defendant’s financial situation and location matter.
On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more
12/20/2023
/ Enforcement Actions ,
EU ,
Ex Parte ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Fees & Costs ,
Patent Litigation ,
Patents ,
Revocation ,
UK ,
Unified Patent Court
The European Parliament (the Parliament) and the Council of the European Union (the Council) reached a compromise on the Artificial Intelligence Act (the AI Act) on 8 December 2023. Although the final text is not yet...more
12/18/2023
/ Artificial Intelligence ,
Enforcement Actions ,
EU ,
European Commission ,
European Parliament ,
Intellectual Property Protection ,
Legislative Agendas ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management ,
Technology Sector
On 18 October 2023, the Düsseldorf local division of the UPC in myStromer vs. Revolt Zycling (UPC_CFI_177/2023) imposed a EUR26,500 penalty on Revolt for breaching a preliminary injunction. This is the first penalty payment...more
We are delighted to present our view of the most important developments in EU digital market regulation. We present our perspective on those developments as a snapshot of the current state of regulatory progress, and it will...more
11/8/2023
/ Artificial Intelligence ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Machine Learning ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Technology Sector
On 3 October 2023, the European Commission announced a public consultation regarding the draft implementing regulation (Draft Regulation) establishing the European Common Criteria-based cybersecurity certification scheme...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
9/8/2023
/ Environmental Policies ,
EU ,
EU Directive ,
European Commission ,
European Court of Justice (ECJ) ,
Genetically Engineered Seed ,
GMO ,
Legislative Agendas ,
Life Sciences ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Assessment
When the European Commission first released its proposal for an Artificial Intelligence Act in April 2021, generative AI was far from being an immediate concern of regulators. That of course all changed with the recent surge...more
8/25/2023
/ Artificial Intelligence ,
Enforcement ,
EU ,
European Commission ,
European Parliament ,
Intellectual Property Protection ,
Legislative Agendas ,
Machine Learning ,
Proposed Regulation ,
Proposed Rules ,
Regulatory Requirements ,
Supervision ,
Technology ,
Training Requirements
On 14 June 2023, the European Parliament voted on its approach to the draft Artificial Intelligence Act (the AI Act).
The AI Act is a proposal for a Regulation issued by the European Commission (the Commission) in April...more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
4/26/2023
/ Algorithms ,
Anticompetitive Agreements ,
Artificial Intelligence ,
Connected Items ,
DATA Act ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Facilities ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Proposed Legislation
On 25 November 2020, the European Commission announced in its Communication for a Pharmaceutical Strategy for Europe a thorough review of the EU pharmaceutical legislation, which was originally planned for 2022....more
On 7 July 2022, the Court of Justice of the European Union (the CJEU) issued a preliminary ruling on a regional law banning a Genetically Modified Organism (GMO) previously authorised in Europe....more