Health Data Resources

Data protection  

Main principles  

• Data Protection in the EU, European Commission (EC)
• EU Handbook on European data protection law, European Union (EU) 
• Guidelines to data protection and Guide to the UK General Data Protection Regulation (UK GDPR), UK Information Commissioner's Office (ICO)   
• Ethics checklist and guidance, European Union (EU) 
• Guidance to help medical researchers making best use of personal information while respecting the people it is about, emphasising the importance of consent and transparency, The Association of the British Pharmaceutical Industry (ABPI) 
• Framework for digital health ethics that is applicable to medical research charities, Association of Medical Research Charities (AMRC)
• Key ethics and regulatory documents, European Joint Programme on Rare Diseases (EJP RD) 
• Generic Informed Consent Forms, European Joint Programme on Rare Diseases (EJP RD) 
  • in 20+ European languages for ERN (European Reference Networks) patient registries

Self determination

Lawfull, fair and transparent

Purpose limitation

Data minimization

Accuracy

Storage duration limitation

Integrity and confidentiality

FAIR (Findable, Accessible, Interoperable, Reusable) 

• The FAIR Guiding Principles for scientific data management and stewardship

Data classification 

Personal data 

• Special Categories of Personal Data, GDPR EU
• GDPR personal data – what information does this cover, GDPR EU

 Anonymised data

• Anonymisation and Pseudonymisation, University College London (UCL)
• Anonymisation: managing data protection risk, UK Information Commissioner’s Office (ICO) 

Data protection authorities 

European data protection board 

• European Data Protection Board (EDPB) 
• UK Information Commissioner’s Office (ICO)

National data protection authorities

• Find your National Data Protection Authority, European Data Protection Board (EDPB) 

Regional DPAs

Data collection and storage 

Research data – human centered   

• Guidance notes on the management of safety information and product complaints from digital activities,The Association of the British Pharmaceutical Industry (ABPI) 

Clinical trials databases 

• Clinical research metadatabase repository
  • an online tool, freely available, to help scientific researchers find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results 
• ASGCT clinical trials finder, American Society of Gene and Cell Therapy (ASGCT)
  • sourced from clinicaltrials.gov
• European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)
  • the European database for all interventional clinical trials on medicinal products authorized in EU  
• EU Clinical Trials Register 
• Netherlands Trial Register 
• Australian New Zealand Clinical Trials Registry 
• International Standard Randomised Controlled Trial Number Register (ISRCTN Register)  
• ClinicalTrials.gov 
  • database of privately and publicly funded clinical studies conducted around the world
• Gene Therapy Clinical Trials Worldwide
  • The Journal of Gene Medicine clinical trial site presents charts and tables showing the number of approved, ongoing or completed clinical trials worldwide 
• Find National Cancer Institute (NCI)-Supported Clinical Trials

Cell line database / cell banks   

• The European Bank for induced pluripotent Stem Cells (EBiSC)
• Human Pluripotent Stem Cell Registry (hPSCreg)
• European research infrastructure for biobanking (BBMRI-ERIC) network map
  • Search for data and samples
• EuroBioBank 
• UK Biobank  
  • UK Biobank research analysis platform  
• database for clinical grade iPSCs, The Global Alliance for iPSC Therapies (GAiT)
  • currently under construction   
• RD-Connect online Registry and Biobank Finder and Sample Catalogue

Patient / Subject Clinical & Genetic Databases

• The European Genome-phenome Archive (EGA)  
• RD-Connect online Genome-Phenome Analysis Platform      
• Database of Genomic Variation and Phenotype in Humans Using Ensembl Resources (DECIPHER)
  • for the clinical community to share and compare phenotypic and genotypic data 

Research data – manufacturing centered   

Methods  

Equipment and materials   

SOPs  

• Qualitative Research: Data Collection, Analysis, and Management
• Commonly used data-collection approaches in clinical research
• Remote data collection for public health research in a COVID-19 era: ethical implications, challenges and opportunities  

Data platforms 

Health Data Hubs and Pharmacovigilance Databases 

• Clinical Practice Research Datalink (CPRD) (UK)  
• National Cancer Registration and Analysis Service (NCRAS) (England)  
• HealthData.gov (USA) 
• Health Data Hub (France)  
• Health Data Research Hubs, Health Data Research UK (HDR UK)
  • each focusing on a different area of research 
• VigiBase
  • the WHO global database of individual case safety reports (ICSRs)
• EudraVigilance
  • manages safety report data created by EMA on adverse reaction reports (ADRs) for medicines  
  • this database is not public available, but its data is published in the European database for suspected adverse drug reaction reports  
• Uses of pharmacovigilance databases: An overview 
• French pharmacovigilance: Missions, organization and perspectives 
  • figure 2 shows a process flow chart for pharmacovigilance procedures in France

Data acquisition / processing / controlling 

• Adaptive Platform Trial Toolbox, European Clinical Research Infrastructure Network (ECRIN)
  • a practical and guided toolbox to facilitate planning and conduct clinical trials in any therapeutic area
• PedCRIN project, European Clinical Research Infrastructure Network (ECRIN)
  • on supporting the setup and the management of multinational neonatal and paediatric clinical trials in Europe

Automated / manual processing 

AI techniques

• Good Machine Learning Practice for Medical Device Development: Guiding Principles, Medicines & Healthcare products Regulatory Agency (MHRA)
• Practical guidance on artificial intelligence for health-care data 
• Do no harm: a roadmap for responsible machine learning for health care 
  • the authors presents a framework, context and ultimately guidelines for accelerating the translation of machine-learning-based interventions in health care 
• Editorial article: Medicine in the digital age 
  • see links within article
• High-performance medicine: the convergence of human and artificial intelligence 
• A guide to deep learning in healthcare 
  • a guide by google on deep learning techniques and how they are used in healthcare 
• Predicting the Future — Big Data, Machine Learning, and Clinical Medicine 
  • perspective on how the ‘AI’ technologies will transform the field of medicine 
• Privacy in the age of medical big data 
  • describes the legal and ethical challenges big data bring to patient privacy 
• Artificial intelligence in healthcare: past, present and future 

Data reuse

• Big data and data reuse: a taxonomy of data reuse for balancing big data benefits and personal data protection 

Data sharing / Open Data 

• Open practices – open standards, open data, open access, open source and open innovation, Health Data Research UK (HDK UK)
  • includes open source software and datasets for health data research
• Bioinformatics tools registry for biomedical science research, bio.tools
  • registry of software and database for researchers in life science
• Clinical research metadatabase repository, European Clinical Research Infrastructure Network (ECRIN)
  • an online tool, freely available, to help scientific researchers find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results

Mission creep / data misuse 

• Ethics and data protection, European Commission (EC)