of interest #15

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

Regulations / Consultations / Policy documents

• Decision of the President of the European Commission on the establishment of a Commissioners' project group on startups and scaleups
• Deadline 31 January - Single Market Strategy 2025
• Deadline 7 March - Public procurement directives - evaluation
• Commitments made at the confirmation hearings of the Commissioners-designate 2024-2029

PRE-ANNOUNCEMENT

?? Digital economy and society - https://lnkd.in/eA9nKuNa

?? Justice and fundamental rights - https://lnkd.in/eqavrBTT

?? Public health - https://lnkd.in/ec_XdxUQ

Studies

• Study on an enabling framework for IoT ecosystem development in Europe
• OECD - OCDE | Digital public infrastructure for digital governments

Topics

Artificial intelligence

• European Society of Cardiology | Trustworthy implementation of artificial intelligence in cardiology: a roadmap of the European Society of Cardiology
• ???? Kenniscentrum Data & Maatschappij | Implementing the AI Act in Belgium - Scope of application and authorities
• ???? (in Spanish) Deadline 23 January 2025 - AI Sandbox - Call for application: High risk AI systems
• ???? U.S. Department of Health and Human Services (HHS) | Strategic plan for the use of artificial intelligence in health, human services, and public health
• ???? FDA | Deadline 7 April - AI-enabled device software functions: Lifecycle management and marketing submission recommendations
• ???? FDA | Deadline 7 April - Considerations for the use of artificial intelligence to support regulatory decision-making for drug and biological products

Cybersecurity

• ???? Bundesamt für Sicherheit in der Informationstechnik (BSI) | Explainable artificial intelligence in an adversarial context: Implications for assessment procedures and digital consumer protection
• Medical large language models are vulnerable to data-poisoning attacks

Data protection and Data governance

• ???? CNIL | Deadline 28 February 2025 - Guideline regarding GDPR certification of data processors

Digital health

• World Health Organization | Deadline 29 January - Advancing the responsible use of digital technologies in global health
• World Health Organization | Taking the pulse of quality of care and patient safety in the WHO European Region: multidimensional analysis and future prospects

Health data

• ???? KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé | Rapid data collection and analysis at the start of a new outbreak

Market access and HTA

• Updated rolling plan - Implementation of the Regulation on health technology assessment
• ???? (in Dutch / in French) Remote care: telemonitoring and therapeutic assistance for chronic heart failure

Medical devices

• MDCG 2024-7 rev.1 - Preliminary assessment review (PAR) form template (MDR) + Annex
• MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746
• MDCG 2021-17 - Applied for scope of designation and notification of a conformity assessment body
• MDCG 2021-16 rev.1 - Application form to be submitted by a conformity assessment body when applying for designation as notified body under the IVDR + Annex
• Updated Q&A - Obligation to inform in case of interruption or discontinuation of supply?

Web3, virtual worlds and blockchain

• Workshop reports

?? Toward virtual world and Web 4.0 governance

?? Technology challenges and solutions for Web 4.0 and virtual worlds

?? Principles for virtual worlds and Web 4.0 governance

Other

• Bundesamt für Sicherheit in der Informationstechnik (BSI) | Status of quantum computer development

That's all for now!

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