Policies for processing of sensitive data Ronald Cornet

Policies for processing of sensitive data Ronald Cornet

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Data Management Plan • Phase 1: Study preparation • Privacy and security safeguards • Data acquisition • General • Reuse of existing data • Measured data • Data collection • Data storage • Subject identification log • Data sharing

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Data Management Plan • Phase 1: Study preparation • Phase 2: Data collection • General • Including a new subject • Reuse of existing data / use of measured data • Externally acquired data • Data collection • Quality control • Change control

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Data Management Plan • Phase 1: Study preparation • Phase 2: Data collection • Phase 3: Data processing & statistical analysis • Locking a data collection system • Export to the data processing and statistical environment • Data processing and statistical analysis • Sharing for processing or statistical analysis

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Data Management Plan • Phase 1: Study preparation • Phase 2: Data collection • Phase 3: Data processing & statistical analysis • Phase 4: Writing and publishing • Filing • Accessibility of the dataset

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Data Management Plan • Phase 1: Study preparation • Phase 2: Data collection • Phase 3: Data processing & statistical analysis • Phase 4: Writing and publishing • Phase 5: Archiving & open data • Open data • Transfer to an external party • Digital archiving • Paper archiving

The Netherlands – Amsterdam UMC • Research Code – Good research practice • Research Data Management • Reuse of care data for the purpose of research * Documents shared with Sarena

Reuse of care data for the purpose of research

FAIR 4 Health

https: //www. fair 4 health. eu/storage/files/Resource/15/ D 23%20 Guidelines%20 for%20 implementing%20 FAIR%20 Ope n%20 Data%20 policy%20 in%20 health%20 research. pdf

EJP RD - sustainable ecosystem for RD care, research and medical innovation

EJP RD policies • Driven by policies of International Rare Diseases Research Consortium (IRDi. RC) • IRDi. RC Policies and Guidelines, abridged version, April 2013 • IRDi. RC Policies and Guidelines, extended version, April 2013 • The International Rare Diseases Research Consortium: policies and guidelines to maximize impact. Hanns Lochmüller et al. , European Journal of Human Genetics, November 2017, doi: 10. 1038/s 41431 -017 -0008 z, abstract • IRDi. RC Vision and Goals

IRDi. RC – Data Sharing and Standards

IRDi. RC – Biobanks

Tools for processing of sensitive data Ronald Cornet

Tools for processing of sensitive data • Representing an international infrastructural collaboration w/sensitive data • Best practices that could have broader utilization

FAIR 4 Health

https: //www. fair 4 health. eu/storage/files/Resource/14/ D 21%20 Technical%20 recommendations%20 for%20 the%20 F AIR 4 Health%20 platform%20 and%20 agents%20 implementat ion. pdf

Elements to consider • IHE – Audit Trail and Node Authentication (ATNA) Integration Profile 10 establishes security measures which, together with the Security Policy and Procedures, provide patient information confidentiality, data integrity and user accountability • HL 7 FHIR (Audit Event) provides a means to maintain security logs • End-to-end Security Module using Asymmetric encryption

Work in Progress • Not yet published

Work in progress • Not yet published

FAIR 4 Health - Encouraging reuse of research data • Analysis on Privacy-preserving Distributed Data Mining • Horizontal partitioning: different subjects, same attributes • Vertical partitioning : same subjects, different attributes • Perturbation • Privacy-preservation Model Pros & Cons + Simple and widespread k-anonymity l-diversity t-closeness - Imperfect when records and individuals are not one-to-one - Overlooks the sensitive attributes + Takes sensitive attributes into account - Does not pay attention to distribution of sensitive values + Pays attention to distribution of sensitive values - Does not deal with identity disclosure

FAIR 4 Health • Secure communication • Semi-trusted Third Party (STTP) • Specific Secure Multi-party Communication (SSMC)

EJP RD - sustainable ecosystem for RD care, research and medical innovation

EJP RD • GDPR-compliant PPRL (Privacy Preserving Record Linkage) • Uses EUPID – European Patient IDentity management - https: //eupid. eu • EUPID based registration/pseudonymisation services for EJP partners • EUPID will be extended to provide the linkage service and connections to and between registries (JRC-ERDRI), biobanks (RD-Connect Sample Catalogue), patient cohorts (Radi. Co) and genome-phenome data (RD-Connect GPAP). • Part of virtual platform for discoverable data and resources for RD research

Submit, deadline is September 16 th http: //www. swat 4 ls. org