) Linked2Safety Project (FP7-ICT – 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, John Keane, Aristos Aristodimou, Christa Philipou, Andreas Constantinou, Christos Georgousopoulos, Federica Tozzi, Kyriacos Kyriacou, Andreas Hadjisavas, Maria Loizidou, Christiana Demitriou and Constantinos Pattichis

FP7, ICT-2011 – 5.3 Page 2  Why Share Data?  What are the current legal and ethical limitations?  How have scientists shared medical data so far?  Key Problems  Perturbation  Cell Suppression

FP7, ICT-2011 – 5.3 Page 3 Why share data:  Replication Testing  Statistical Power  Multiple Testing Problem Legal and Ethical Issues  Anonymization vs Pseudoanonimization  Limitations derived from consent form signed by subjects  Other, regional, study, or subject specific issues.

FP7, ICT-2011 – 5.3 Page 4 aaaAAA CaseU 00 U 01 U 02 ControlU 10 U 11 U 12

FP7, ICT-2011 – 5.3 Page 5 A paper that analyzes data from a specific study reports: Marital Status Age MarriedWidowedSingle ~601520

FP7, ICT-2011 – 5.3 Page 6 A paper that analyzes data from a specific study reports: Marital Status Age MarriedWidowedSingle ~601520

FP7, ICT-2011 – 5.3 Page 7 A paper that analyzes data from a specific study reports: Marital Status Age MarriedWidowedSingle ~601520

FP7, ICT-2011 – 5.3 Page 8 Paper 1 that analyzes data from a specific study reports: Marital Status Age MarriedWidowedSingle 0-16NA ~ Marital Status Age MarriedWidowedSingle 0-16NA ~ Paper 2 that analyzes data from the same study reports:

FP7, ICT-2011 – 5.3 Page 9 Original Data Marital Status Age MarriedWidowedSingle ~ Marital Status Age MarriedWidowedSingle 0-16NA ~ Perturbation (+-1) and Cell Suppression (<5)

FP7, ICT-2011 – 5.3 Page 10 Most common parameters testedMost common parameters tested Perturbation:[0], [-1,1], [-3,3], [-5,5], [-10,10] Cell Supression: <0, <=1, <=3,<=5,<=10 Standard main effect test using Chi SquareStandard main effect test using Chi Square Pearson’s Correlation Coefficient used to evaluate deviation of each parameter combination to original results.Pearson’s Correlation Coefficient used to evaluate deviation of each parameter combination to original results. A-priory defined threshold for Pearson’s correlation coefficient <=0.95.A-priory defined threshold for Pearson’s correlation coefficient <=0.95.

FP7, ICT-2011 – 5.3 Page 11

FP7, ICT-2011 – 5.3 Page 12 We were able to identify for this dataset, the maximum noise that can be added to the data without significantly affecting the outcomes. Results only relevant to MASTOS, all other datasets need to repeat the analytical approach described. Further investigation is necessary to identify the minimum parameter settings to satisfy legal and ethical requirements.

FP7, ICT-2011 – 5.3 Page 13 Athos Antoniades University of Cyprus