Knowledge Centre - AI, Research, Agreements and Data Protection
Reliable resources and guidance on AI, research compliance, agreements and GDPR.
Explore clear explanations, official references and practical downloadable tools designed to help your organisation meet regulatory requirements efficiently and confidently.
AI Compliance and Governance
Explore the resources below to deepen your understanding of EU AI Act requirements, AI governance and practical compliance measures. Additional materials will be added as the regulatory framework evolves.
Regulyn Resources
AI Act Requirements: Full overview covering AI risk levels, roles and key obligations
Regulation and Official Guidelines
Artificial Intelligence Act (EU 2024/1689, “EU AI Act”): Regulation governing AI systems, broad territorial scope.
Additional Resources and Upcoming Changes
Digital Omnibus on AI Regulation: a proposal to simplify AI Act
Research and Development
Browse the resources below for guidance on research compliance, research law, secondary use of data and other regulatory requirements in R&D projects. Additional materials will be added to support lawful, ethical and compliant research activities.
Regulyn Resources
To be updated
Regulation and Official Guidelines
Clinical Trials Regulation (EU 546/2014, “CTR”): Regulation governing clinical trials
Medical Devices Regulation (EU 2017/745, “MDR”): Regulation governing development, testing and safety of medical devices
In Vitro Diagnostics Regulation (EU 2017/746, “IVDR”): Regulation governing in-vitro diagnostic medical devices, applicable from 26.5.2022 in updated form
Act on Secondary Use of Social and Health Data: A Finnish Regulation governing secondary use of data, imposing data permit and security requirements
ICH GCP Guidelines for Good Clinical Practice (EMA Approved): an international guideline for good clinical practice. A recently updated version came into effect on 23 July 2025.
Additional Resources and Upcoming Changes
European Health Data Space Regulation (EU 2025/327, “EHDS”): A comprehensive regulation governing health data use within EU. This new regulation is already in force and will start to apply from 26 March 2026.
Regulation on standards of quality and safety for substances of human origin intended for human application (EU 2024/1938, “SoHo Regulation): A comprehensive regulation governing samples of human origin (SoHo) for human application. This new regulation entered into on 7 August 2024, and will apply after a transitional period (7 August 2027).
Agreements
Explore the resources below for guidance on agreement risk management, research agreements, data sharing agreements and AI agreements.
New materials will be added to help organisations draft and negotiate better agreements.
Regulyn Resources
To be updated
Regulation and Official Guidelines
EU Standard Contractual Clauses: standard contract terms for international personal data transfers from EU/EEA to certain third countries
EU Research and Development (R&D) Block Exemption Regulation (EU 2023/1066, “R&D BER”): Regulation providing a limited exemption for specific R&D agreements from the general ban on agreements limiting competition.
Additional Resources
EU DESCA Consortium Agreement: a widely used consortium agreement model for EU consortiums
Data Protection
Explore the resources below to deepen your understanding of EU GDPR, data protection in research and privacy requirements in EU.
Additional materials will be added to help organisations safeguard personal data and protect trust.
Regulyn Resources
Can pseudonymisation make data anonymous? Analysis of a recent EU court ruling
Regulation and Official Guidelines
General Data Protection Regulation (EU 2016/679, “GDPR”): Regulation governing personal data processing in the EU.
European Data Protection Board Guidelines: Official EDPB Guidelines on various aspects of the GDPR and its interpretation
Additional Resources and Upcoming Changes
Digital Omnibus: EU proposal to simplify data protection and data use regulations
