Linked2Safety Project (FP7-ICT-2011-7 – 5.3)A NEXT-GENERATION, SECURE LINKED DATA MEDICAL INFORMATION SPACE FOR
SEMANTICALLY-INTERCONNECTING ELECTRONIC HEALTH RECORDSAND CLINICAL TRIALS SYSTEMS
ADVANCING PATIENTS SAFETY IN CLINICAL RESEARCH
12th International Conference on Bioinformatics and Bioengineering, Larnaka
Linked2Safety: A secure linked data medical information space for semantically-
interconnecting EHRs advancing patients’ safety in medical research
Presenter: Athos Antoniades
Partners: Intrasoft International SA, Univresity of Cyprus, Cyprus University of Neurology and Genetics, National University of Ireland, Univresity of
Manchester, Gottfried Wilhelm Leibniz Universität Hannover, Centre for Research and Technology Hellas, Siveco Romania, Ubitech, Zeincro, Hospices
cantonaux CHUV
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Content
Introduction
Legal and Ethical Issues
Linked2Safety Platform
Linked2Safety Architecture
Usage Scenarios
Conclusion
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Introduction
Electronic Health Records (EHRs) contain an increasing wealth of medical information
European healthcare information space is fragmented
Linked2Safety provides: homogenized access to anonymised distributed
EHRs a secure semantic interoperability framework
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Legal and Ethical Issues (1)
Legal Issues: Study of the corresponding national and European legislative
framework Protect the data against:
Accidental or unlawful destruction Accidental loss Alteration Unauthorized disclosure or access All unlawful forms of processing
The data subject has rights such as: The right to be informed The right of access The right of rectification The right of erasure or blocking The right to object
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Legal and Ethical Issues (2)
Ethical Issues:
Processing of health data at EU level requires the consent of the data subject
Some national laws declare that it is possible without a consent form if: It is for research purposes Data are properly anonymised The analysis is done in aggregated level
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Requirements
Key outcomes of the Requirements analyses and legal and ethical review: Not possible to transfer or copy patient data from the originating institutions. All machines that hold patient data are, and need to remain off-line. We need to strictly adhere to consent form requirements and all ethical and legal issues.Legal issues are diverse and different between countries, institutions and studies.
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Data Cube Example
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Linked2Safety Platform
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Linked2Safety Architecture
1. Data cube generation space
2. Interoperable EHR data space
3. Linked medical data space
4. Genetic analysis space
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Usage Scenarios
Three usage scenarios:
1. Subject Selection for a Phase III Clinical Trial
2. Phase IV Post Marketing Surveillance trial
3. Identification of Relations between Molecular Fragments and Specific Adverse Side Effect Categories (Chemoinformatics)
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Conclusion
Innovative use of data cubes to address legal and ethical issues
Legal and ethical issues addressed but vigilance required
Enable merged analyses of aggregated electronic health data from multiple providers
Usability of the platform will be demonstrated through it’s application on diverse usage scenarios
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Linked2Safety SIG event TODAY!
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Who to Contact
Athos AntoniadesUniversity of Cyprus
email: [email protected]