Useful information
To facilitate and support you! Here you will find additional information on legal, regulatory and compliance requirements. Guidelines for access, top news sites, related initiatives and projects, and EIT Health contacts.
Legal information and compliance
- Denmark:
Danish Health Data Authority (Sundhedsstyrelsen)
The Danish Data Protection Act
The Danish Health Act (Sundhedloven) - Estonia:
Human Genes Research Act - Sweden:
Swedish Biobanks in Medical Care Act (SFS 2002:297)
On access to Nordic biobanks
Guidelines and strategies
- EU policy action plan: Transformation of Health and Care in the Digital Single Market
- European Commission Staff Working Document: Liability for emerging digital technologies
- Biobanks for Europe, A challenge for governance
- The eTRIKS code of practice ‐ secondary use of medical data in Scientific Research projects
- NIH report: Consent to use human tissue and linked health data in health research
- NIH report: Preparing the healthcare workforce to deliver the digital future
OECD Guidelines on Human Biobanks and Genetic Research Databases
Danish National Strategy for Personalized Medicine 2017-2020
Personalised medicine programmes and initiatives
- Nordic Society for Precision Medicine (NSPM)
- Nordic Alliance for Clinical Genomics (NACG)
- Feasibility Study for Personalised Medicine in Estonia: Clinical Approach
- Global Alliance for Genomics and Health (GA4GH), policy-framing and technical standards-setting organization, seeking to enable responsible genomic data sharing within a human rights framework
- GA4GH Catalogue of Genomic Data Initiatives (200)
Related projects
- EU-funded Research and Innovation in the field of ICT for Health, Wellbeing and Ageing: an overview
- EHR4CR platform (IMI project outcome, Open IT platform that unlocks the information stored in Electronic Health Records for improving clinical research while fully respecting patient privacy and ensuring a high level of security.)
- eTRIKS Code of Practice (IMI project outcome, Code of practice on secondary use of medical data in scientific research projects.)
- EUPATI (IMI project outcome, Guidance for patient involvement in industry-led medicines R&D, but also webinars, courses)
- GetReal (IMI project, Review of different stakeholders’ policies and perspectives on using Real World Data (RWD) for early drug development and clinical effectiveness assessment.):
- RADAR-base (IMI project, a platform to support wearable device data)
- U-BIOPRED (IMI project, A short guide to successful patient involvement in EU-funded research. Available in 10 languages.)