1. ) Linked2Safety Project (FP7-ICT-2011-7 – 5.3 ) A NEXT-GENERATION, SECURE LINKED DATA MEDICAL INFORMATION SPACE FOR SEMANTICALLY-INTERCONNECTING ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS SYSTEMS ADVANCING PATIENTS SAFETY IN CLINICAL RESEARCH 12 th International Conference on Bioinformatics and Bioengineering, Larnaka Athos Antoniades, Christos Georgousopoulos, Nikolaus Forgo, Aristos Aristodimou, Federica Tozzi, Panagiotis Hasapis, Konstantinos Perakis, Thanasis Bouras, Dimitris Alexandrou, Eleni Kamateri, Eleni Panopoulou, Konstantinos Tarabanis, Constantinos Pattichis

2. FP7, ICT-2011 – 5.3 Page 2  Introduction  Legal and Ethical Issues  Linked2Safety Platform  Linked2Safety Architecture  Usage Scenarios  Conclusion

3. FP7, ICT-2011 – 5.3 Page 3  Electronic Health Records (EHRs) contain an increasing wealth of medical information  European healthcare information space is fragmented Linked2Safety will provide:  homogenized access to anonymised distributed EHRs  a secure semantic interoperability framework

4. FP7, ICT-2011 – 5.3 Page 4 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

5. FP7, ICT-2011 – 5.3 Page 5 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

6. FP7, ICT-2011 – 5.3 Page 6 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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10. FP7, ICT-2011 – 5.3 Page 10 Three usage scenarios: 1. 1.Subject Selection for a Phase III Clinical Trial 2. 2.Phase IV Post Marketing Surveillance trial 3. 3.Identification of Relations between Molecular Fragments and Specific Adverse Side Effect Categories (Chemoinformatics)

11. FP7, ICT-2011 – 5.3 Page 11   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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13. FP7, ICT-2011 – 5.3 Page 13 Athos Antoniades University of Cyprus email: athos@cs.ucy.ac.cy