RT Journal Article
SR Electronic
T1 Assessing data protection and governance in health information systems: a novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA)
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP e23
OP e23
DO 10.1136/medethics-2019-105948
VO 47
IS 12
A1 Concetta Tania Di Iorio
A1 Fabrizio Carinci
A1 Jillian Oderkirk
A1 David Smith
A1 Manuela Siano
A1 Dorotea Alessandra de Marco
A1 Simon de Lusignan
A1 Paivi Hamalainen
A1 Massimo Massi Benedetti
YR 2021
UL http://jme.bmj.com/content/47/12/e23.abstract
AB Background Data processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union (EU) General Data Protection Regulation (GDPR). We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health.Methods Computerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results.Results A total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage (median, range of adoption: 45%, 30%–80%), access and accuracy of personal data (50%, 0%–100%) and anonymisation procedures (56%, 11%–100%). A high variability was noted in the application of privacy principles.Conclusions A comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy.Data are available upon request.