of interest #14

A brief overview of recent news, articles and reports that may be of interest.

Regulations / Consultations / Policy documents

• Cybersecurity Act | Commission Implementing Regulation (EU) 2024/3143 of 18?December 2024 establishing the circumstances, formats and procedures for notifications pursuant to Article?61(5) of Regulation (EU)?2019/881 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification
• EUCC Cybersecurity Certification Scheme | Commission Implementing Regulation (EU) 2024/3144 of 18?December 2024 amending Implementing Regulation (EU)?2024/482 as regards applicable international standards and correcting that Implementing Regulation
• HTA | Commission Implementing Regulation (EU) 2024/3169 of 18?December 2024 laying down rules for the application of Regulation (EU)?2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level
• Medical devices | Deadline 21 March 2025 - Targeted evaluation EU rules on medical devices and in vitro diagnostics
• Poland25.eu - Website of the Polish Presidency of the EU (starting 1 January 2025)
• European Parliament | List of intergroups
• European Parliament | EP to establish two new standing and two special committees

Studies

• European Innovation Council and SMEs Executive Agency (EISMEA) | 2024 EIC Tech Report identifies a watch list of 34 emerging technologies that could change future European competitiveness
• Imaging the future - Horizon scanning for emerging technologies and breakthrough innovations in the field of medical imaging and AI
• AI and GenAI adoption by local and regional administrations
• Perceptual hasing on images encrypted with a homomorphic scheme - Study of the feasibility of detecting CSAM shared via end-to-end encrypted messages

• ???? A new era in Belgian healthcare: Key findings and collaborative insights towards implementation of value-based healthcare
• ???? Department for Science, Innovation and Technology | Public attitudes to data and AI

Topics

Artificial intelligence

• Second draft General-Purpose AI Code of Practice
• ???? Autoriteit Persoonsgegevens (Dutch DPA) | (in Dutch) Deadline 7 February 2025 - Prohibition of AI systems for social scoring
• HIMSS | AI adoption in healthcare report 2024
• Bertelsmann Stiftung | The AI Act between Digital and Sectoral Regulations

Cybersecurity

• European Union Agency for Cybersecurity (ENISA) | Annual report - Trust services security incidents 2023
• An ontology of health impacts and value chain enablers of digital health solutions - Towards a toolbox for characterising cyber incidents in health
• Jaros?aw Greser | Cybersecurity framework for synthetic data in training medical AI
• eCAN Joint Action | Guidelines & recommendations on legal/ethical framework and cybersecurity in organisational issues of telemedicine

Data protection and Data governance

• European Data Protection Board | Opinion 28/2024 on certain data protection aspects related to the processing of personal data in the context of AI models
• European Data Protection Board | Opinion 27/2024 on the Brand Compliance criteria of certification regarding their approval by the Board as European Data Protection Seal pursuant to Article 42.5 (GDPR)
• ???? Information Commissioner's Office | Response to the consultation series on generative AI
• ???? Information Commissioner's Office | Deadline 14 March 2025 - Draft updated guidance on the use of storage and access technologies
• Ada Lovelace Institute | Participatory and inclusive data stewardship: A landscape review

Digital health

• European Medicines Agency & Heads of Medicines Agencies | Big Data Steering Group 2024 report
• 2024 Open Data Maturity Report
• Enhancing digital health innovation in the EU with effective industrial strategy policies - A focus on wearable medical devices
• ???? Updated guideline regarding the national health identity number

Health data

• HealthData@EU Pilot | WP5 IT Infrastructure - Architecture definition document
• HealthData@EU Pilot | WP6 Metadata standards - Recommendations on further development and deployment for possible EU-wide uptake
• Are EU Member States ready for the European Health Data Space? Lessons learnt on the secondary use of health data from the TEHDAS Joint Action
• Nordic pilot study launched to improve health data practices and patient care
• ???? (in Dutch / French) Royal Decree regarding access to health data
• ???? (in Dutch) Letters to the House of Representatives on the progress of the health information system

?? Data availability in health Programme

?? National strategy for health information

?? Progress on the Law of electronic exchange of health data

?? Progress on Personal Health Environments and development of a Health Viewer

?? Towards a framework for the use of AI in health administration

• ???? NHS | Governance considerations for the use of synthetic data in health and care research
• ???? FDA | Center for Drug Evaluation and Research establishes new Center for Real-World Evidence Innovation

Market access and HTA

• ???? (in Dutch / French) Reimbursement for telemonitoring in case of chronic heart failure, as from 1 January 2025

Medical devices

• MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies
• Updated Q&A - Obligation to inform in case of interruption or discontinuation of supply
• Team-NB | MDR Certification Process (including pre-application, application and post application phases) - Consensus document
• ???? Medicines and Healthcare products Regulatory Agency | Medical Devices Regulatory Reform - Roadmap to implementation

Web3, virtual worlds and blockchain

• European Blockchain Services Infrastructure (EBSI) | Survey - Reimaging legal entity verification
• INATBA - International Association for Trusted Blockchain Applications | AI Regulation and Blockchain: Bridging ethics and governance
• Impact of the metaverse on infringement and enforcement of intellectual property

Other

• ???? Digital Switzerland Strategy 2025

That's all for now!

#artificialintelligence #blockchain #cybersecurity #datagovernance #dataprotection #digitalhealth #healthdata #HTA #marketaccess #medicaldevices #virtualworlds #web3