Main Session
Sep
28
PQA 03 - Digital Health Innovation and Informatics, Patient Safety & Quality, and Radiation and Cancer Biology
2553 - Early Results of the Study on Use of IT and Legal Constraints for the Collection, Exchange and Sharing of Medical Data and Biological Material during International Collaboration between Radiation Oncology Departments
Presenter(s)
Miroslawa Mocydlarz-Adamcewicz, PhD - Wielkopolskie Centrum Onkologii, Poznan, Wielkopols
M. Mocydlarz-Adamcewicz1, O. F. Coza2, O. Nouri3, R. Piñeiro-Retif4, D. Tesanovic5, D. Martin6, L. Tama?-Bobocea6, S. Wicem7, N. Fourati7, and J. Malicki8; 1Greater Poland Cancer Centre, Poznan, Poland, 2Oncology Institute "Prof. Ion Chiricuta, Cluj-Napoca, Romania, 3Habib Bourguiba Hospital, Sfax, Sfax, Tunisia, 4Hospital Universitario "Jose Eleuterio Gonzalez" UANL, Monterrey, Mexico, 5Institute of Oncology Vojvodine, Sremska Kamenica, Serbia, 6Institutul Oncologic "Prof. Dr. I. Chiricuta", Cluj-Napoca, Romania, 7Habib Bourguiba Hospital, Sfax, Tunisia, 8Department of Electroradiology, Poznan University of Medical Sciences, Poznan, Poland
Purpose/Objective(s):
To study IT technologies and the legal framework for the collection and exchange of medical data (including patients’ records and biological material) in the context of international collaboration.Materials/Methods:
The study was part of the project « Application of information technology for the collection, exchange and sharing of medical data in the context of patients’ privacy rights and data protection” - acronym ATTICA. Study type included review of legal acts, research of general documents not related to particular patients’ records, and not involved access to specific medical records. Works on sample documents with no names or identification were conducted. Research of clinical practice was done using questionnaires (Q1, Q2) and followed by discussions with staff. Staff members (radiation oncologists, radiotherapy technologists, and information technologists) at radiation oncology departments in participating departments in Latin America, Europe and Africa were surveyed to assess practices related to data protection and exchange. The Q1 questionnaire consisted of 19 questions related to legal framework, guidelines, inter-institution organisation and practice of data and biological material exchange. National regulations were reviewed to identify key issues related to the processing of patient data. Results: In all studied hospitals a set of rules were in place referring to national, regional laws or/and to EU Protection Regulation (GDPR), wherever applicable. International exchange of medical data or biological material is highly regulated and strict provisions apply. Anonymization of the data is key issue for obtaining approvals from designated bodies on different levels. From practical points of view specific tools to facilitate the practical exchange of data between countries have to be proposed and accepted showing compliance with existing provisions.Conclusion:
Due to differences in internal regulations on various levels in the studied institutions and countries formal agreements between collaborating institutions are needed (or highly recommended) before initiation of the collaboration. Ways and methods to prepare applications differed significantly between studied institutions. Strictly described technical solutions are needed to obtain approval for international data and biological material sharing.