Interconnecting health data - ethical, legal and social challenges: the OMEGA Linkage Use Case
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1 Interconnecting health data - ethical, legal and social challenges: the OMEGA Linkage Use Case Dr Sandra van den Belt (NKI-PALGA) Coordinator OMEGA-Study & Mr dr J.A. Bovenberg (Lawyer)
2 Use of pseudonymized BSN in record linkage of epidemiological cohorts and biobanks with disease registries A.W. van den Belt-Dusebout1, A.H. Gijsbers-Bruggink2, O. Visser3, J.L. van Vlaanderen4, J.A. Bovenberg5, G. van Grootheest6, F.E. van Leeuwen1 1 Antoni van Leeuwenhoek-The Netherlands Cancer Institute, 2 The nationwide network and registry of histo- and cytopathology in the Netherlands (PALGA Foundation), 3 Netherlands Comprehensive Cancer Organisation (IKNL), 4 ZorgTTP, 5 jurist, 6 GGZ ingeest
3 Use of pseudonymized BSN in record linkage of epidemiological cohorts and biobanks with disease registries Background: Record linkages are based on personal identifiers (NAW) because the Dutch Privacy Protection Act prohibits the use of BSN for research purposes Aim: To develop an improved linkage procedure to ensure valid linkages with optimal privacy protection
4 National OMEGA cohort IVF group: n = 30, Control group: n = 10,000 Subfertile, no IVF: Data collection: Mailed questionnaire/informed consent (63%) Medical records Follow-up through record linkage with NCR and PALGA Biobank: Toenail clippings providing DNA Tumor tissue blocks of hormone-related cancers ZorgTTP: Encrypted personal data to enable anonymized linkage
5 Methods NKI/OMEGA Informed consent VUmc BSN UMCU BSN ZorgTTP PALGA pseudonymized BSN NCR NAW ZorgTTP PALGA NCR pseudonymized NAW NKI/OMEGA Comparison of PALGA and NCR results:
6 Results Contracts of earlier Biolink project adjusted/updated. VUmc: approval will provide pseudonymized BSNs shortly. UMCU: approval is expected soon. PALGA: pseudonymized BSN for large part of database, approval NCR: pseudonymization and linkage approaches discussed, approval is expected soon. ZorgTTP: pseudonymization by TRES application (search images) PALGA and NCR linkages will be performed. Linkage results will be validated Linkage results from NCR and PALGA will be compared, using OMEGA identification numbers.
7 OMEGA Linkage under the GDPR I. General provisions (Scope) II. III. IV. Principles Rights of the data subject Controller and processor V. Transfers of personal data to third countries or international organisations VI. Provisions relating to specific processing situations
8 OMEGA Linkage under the GDPR I. General provisions (Scope) II. III. IV. Principles Rights of the data subject Controller and processor V. Transfers of personal data to third countries or international organisations VI. Provisions relating to specific processing situations
9 OMEGA Linkage under the GDPR: Controller and/or Processor? Article 4 Definitions (7) controller means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; (8) processor means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller; Article 28 Processor 10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes and means of processing, the processor shall be considered to be a controller in respect of that processing. NKI/OMEGA Informed consent VUmc UMCU BSN BSN PALGA NCR pseudonymized BSN NAW NCR PALGA pseudonymized NAW NKI/OMEGA Comparison of PALGA and NCR results:
10 OMEGA Linkage under the GDPR: Joint Controllers? Article 26 Joint controllers 1.Where two or more controllers jointly determine the purposes and means of processing, they shall be joint controllers. They shall in a transparent manner determine their respective responsibilities for compliance with the obligations under this Regulation, in particular as regards the exercising of the rights of the data subject and their respective duties to provide the information referred to in Articles 13 and 14, by means of an arrangement between them (..). The arrangement may designate a contact point for data subjects. NKI/OMEGA Informed consent VUmc UMCU BSN BSN PALGA pseudonymized BSN PALGA Action: NCRto be adjusted to comply NAW with GDPR NCR pseudonymized NAW NKI/OMEGA Comparison of PALGA and NCR results:
11 OMEGA Linkage under the GDPR I. General provisions (Scope) II. III. IV. Principles Rights of the data subject Controller and processor V. Transfers of personal data to third countries or international organisations VI. Provisions relating to specific processing situations: research x
12 OMEGA Linkage under the GDPR: Provisions relating to specific processing situations: research Article 89 Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes appropriate safeguards, in accordance with this Regulation, for the rights and freedoms of the data subject. Action: Researcher those measures erequest may include for joint DAC pseudonymisation assessment provided of request that those to access and link purposes can be fulfilled in that manner. multiple registries How about approval Data Access Committees? How to align review by Data Access Committees?? Omega Researcher(s) request to access and link multiple registries: Multiple Data Access Committees
13 80% GDPR = 80% Current law The GDPR and Health RI: No need to panic You are probably 80% compliant already (and if not..) You just have to SHOW it.
14 The GDPR and Health RI GDPR = research friendly Purpose limitation Storage limitation Consent must be specific Data subject rights Etc. Not for science Exemptions for science
15 The GDPR and Health RI: GDPR Opportunities Free movement of data across EU (including post Brexit UK?) Control rights for patients and data subjects Health RI could help enforce individual control rights: use the right to data access, copy and portability of personal data to help patients ride the Personal Health Train organise Class Actions to enforce individual control rights
16 Health RI and GDPR - Discussion Data protection is joint responsibility of all who make up Health RI: 1. How to get together? 2. How to use the exemptions for research? 3. How to turn the GDPR into an opportunity to enable Health RI? Much GDPR Working Being Done
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