Luxembourg. Conférence Protection des Données. 09h00

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1 Enterprise Europe Network Luxembourg Conférence Protection des Données May 25, h00 IBBL data protection in practice Dominic Allen, COO, IBBL Damien Aps, CFO, IBBL The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

2 Introduction 2008 Grand Duchy created IBBL to support biomedical research in Personalized Medicine and to work closely with the Lung Cancer Program and the newly created Luxembourg Centre for Systems Biology IBBL s mandate requires it to support a broad range of biomedical research projects and develop research collaborations internationally IBBL collected its first sample and data, for a lung cancer study, in 2009, but became fully operational only in mid 2010 In the immediate future, the IBBL needs to be collecting tissues and associated data to support research in four priority areas: Cancer Diabetes (T2) Parkinson s disease A large population cohort IBBL must ensure that its data protection policy and practice supports its strategy The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

3 Current Status - Specimens Collections Lung cancer Two hospitals Luxembourg, one Belgium, one France Colon One hospital Luxembourg Brain One hospital Luxembourg (pending) Normal population One hospital Luxembourg Blood samples for cardiovascular clinical trial 31 EU sites Bladder cancer Spanish National Cancer Research Center Types of Samples Tumour Blood/serum DNA/RNA Viable cells IBBL is extending its collection program in Luxembourg and internationally

4 Current Status Research & Collaboration GBM clonality (TGen & Niclou CRP-Santé) MSRA Develop SNPs for European strains (TGen & Even LNS) Lipid accumulating bacteria (TGen & Wilmes CRP-GL & Uni.lu) Whole genome sequence of never-smoker (TGen & Betsou/De Witt IBBL) Gene methylation in CML (TGen & Dieterich Kirchberg) (pending) Bladder cancer biomarkers in urine (Domon LCP) Pre-analytical metabolomics (Biobanque de Picardie, France) Tissue biospecimen research (Pathology group in Thionville, France) Tuberculosis biobanking, publication in preparation p (WHO, Geneva) Methodological evaluation of a population cohort, publication submitted (The Institut de Veille sanitaire, France) Quality assurance in biobanking, publication submitted (NCRI) ISBER on development and implementation of international proficiency testing IBBL is developing research collaborations internationally

5 Potential Barriers to Success Acquisition of significant volumes of biospecimens for research can only be efficient if consent and collection are part of the standard processes of diagnosis and treatment in regular medical care Electronic health records are essential, as is the continuous updating of data associated with human tissue samples stored in biobanks Efficient collection of samples and data pose important questions relating to data protection

6 TTP cornerstone of IBBL privacy protection Issue How to ensure the highest level of privacy and confidentiality of donor identity? Complete anonymization is a poor solution: Impossible to provide important feedback to donor Greatly reduces the value of the samples because follow-up data not possible IBBL Approach IBBL has contracted with an external partner, ebrc, to provide a service at arms length the Trusted Third Party (TTP) The functionalities were designed by CRP-HT with the future needs of ehealth in mind The concept uses the ORACLE Master Patient Index product Double de-identification of all data and highly secure IT links The TTP never stores donor medical data (CRF ) IBBL never stores donor identifying data (name, address, DoB) But the TTP allows continuous updates of donor data IBBL can share data and samples with a broad range of scientists without compromising privacy of donor data The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

7 TTP De-identification Process Data Source Samples Collection Site Trusted Third Party Data Management IBBL Researcher Data Consumer 1 st Level De-Identification 2 nd Level De-Identification Demographic Data Demographic Data Pseudonym Pseudonym Donor ID Message ID DID Message ID TTL DID BEN BEN Demographic Data DID Medical Data Donor ID Medical Data Donor ID Medical Data Message ID Medical Data Message ID Medical Data Message ID DID De-Identification ID BEN Bonded Execution Number TAN S Transaction Number (Source) TAN S Transaction Number (Destination) TTL Time To Live The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

8 TTP De-identification Process The TTP stores personal identifying data about subjects, but no samples or clinical data or genetic data IBBL stores samples and clinical data (as well as information generated by research such as genetic data), but no personal identifying data The link is the double de-identified ID of the donor The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

9 IT Security Policy in IBBL - guidelines Security is a process, not a state ISO27001 for IT systems ISO for laboratories Best practice HealthNet Security Policy Minimum m rights htsnecessary essar to work

10 IBBL Network

11 HealthNet Le HealthNet est une plateforme télématique dédiée au secteur de la santé, dont le but est de mettre à disposition des professionnels de la santé et des établissements du secteur: une infrastructure leur permettant de communiquer de façon sécurisée des applications spécialisées permettant l échange de résultats d'analyses médicales et dans l'avenir des applications de télémédecine Le réseau HealthNet se base sur des lignes louées auprès des opérateurs de télécommunications, des connexions DSL ou ISDN via des canaux sécurisés (VPN) Actuellement tous les hôpitaux, certains laboratoires d'analyses médicales, les centres de recherche, les caisses de maladie, le Ministère de la Santé, l'entente des Hôpitaux Luxembourgeois ainsi qu'environ 200 médecins utilisent HealthNet dans leur travail quotidien

12 External access External access is limited and possible only with an RSA token Today, with a token it is possible to access: Bio4D Bio4D (IBBL s software platform in development)

13 Internal security Firewall Zones (DMZ, Trusted, Untrusted) Vlans (Servers, Office, Sensors, Wifi, Guests, Labo ) Guests areas Active directory User rights Limited groups access Antivirus software On the user computer On the Exchange system On the file server Security Policy Passwords Limited userrightsrights

14 Next steps short term (Q2, Q3 2011) Monitoring system Log monitoring system based on Nagios Proxy server for WWW filtering Intrusion Detection/Prevention i System Internal IT procedures New backup system New IT organization in laboratories (preparing for ISO accreditation)

15 Next steps medium term (Q4 2011) IBBL Security Policy IT procedures Vulnerability assessment system IT security training for IBBL staff Full audit and penetration test prepared by external company based on ISO (in 2012)

16 Thank you The Integrated Biobank of Luxembourg (IBBL) is an independent, not-for-profit biobanking and biotechnology foundation

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