Presentation Transcript

1. BioMedBridges:WP 5 – Secure AccessSecurity and privacy requirements of biomedical infrastructure services

   Sebastian Seufert, UDUS, Germany FIM4R 02 October 2013, Helsinki
2. What is BioMedBridges?Building data bridges between biology and medicine EU-project (FP7) between the 10 ESFRI BMS Research Infrastructures € 10.6 million 4 years (01.01.2012 - 31.12.2015) 21 partners in 9 countries 12 work packages 3 construction, 5 use cases, outreach + training, technology watch
3. The 10 ESFRI BMS RIs: strongerthroughcommon links
4. BioMedBridges: 4 Central Aims Provide computational ‘data and service’ bridges between the BMS RIs, linking basic biological research and data to clinical research and associated data Provide secure, robust and ethical access to data for a wide range of users Allow interoperability between data and services in the biological, medical, translational and clinical domains Bring together the ESFRI BMS RIs with the European computer ‘hardware’ e-Infrastructures: GÉANT, DANTE, EGI, PRACE & CERN
5. WP 5 – Secure Access: 2 main Working Tasks Develop a security and ethical / legal framework for the envisioned Data Bridges between different e-Infrastructures (UDUS, Christian Ohmann) Developa comprehensivesecurityinfrastructure(TUM, Klaus Kuhn)
6. Del 5.1: Report on Regulations, Privacy and Security Requirements Background: International data and biomaterial sharing between the different e-Research Infrastructures (RIs) Gives rise to complex ethical, legal and regulatory issues, resulting from Different types of shared data (e.g. clinical trials data, human / mouse data) Different legal frameworks which apply to international sharing of different data / biomaterial in different nations
7. Del 5.1: Report on Regulations, Privacy and Security Requirements Aim:Guarantee that BMB data sharing is compliant with applicable law and regulations on all different legal levels European, e.g. EU data protection directive National, e.g. national data protection laws Regional, e.g. German LDSG Local, e.g. hospital law Joint development of rules for international data sharing covering different types of data, thus allowing the use of data bridges Problem: The character of the data bridges was initally not been decided in detail by use case members
8. Del 5.1: Necessity for Usage Scenarios Use cases will be available only after Del 5.1 completion Thus, necessary information is missing to develop the ethical / legal requirements and the security infrastructure for the Data Bridges Joint development of the usage scenarios to gather basic information and specifications of the envisioned Data Bridges Usage scenarios are simplified use case descriptions, which contain the necessary information for mapping security and ethical / legal requirements to the Data Bridge description
9. Del 5.1: The 5 UsageScenarios (US) Imaging Bridge PhenoBridge Personalized Medicine Structural Data Bridge Biological Sample Data Integration databridgesforUS Imaging Bridge
10. WP 5: Approach forUsage Scenarios Description of usage scenarios and actors, actor´s roles, databases, data types via a survey of use case members to provide information for the corresponding usage scenarios (11.2012) Request for additional specifications about data sources and provision of data flow diagram Improvement and better understanding via Individual TCs with use case members selected data source providers (04.2013) to collect specific requirements for data access, data linkage and data use
11. Del 5.1: Scenario driven Approach Privacy / Data protection Data security Security ofbiosamples Security ofanimals IP / licences
12. Incorporation of Del 5.1 into the Legal Assessment Tool
13. Del 5.1: Requirementsfor Linking and Sharing Restricted Access Data andOpen Access Data
14. WP 5: Next Steps WP5-Workshop on Security (Munic, TUM, 11.10.2013) Del 5.3: WT5- Security requirements for an e-infrastructure addressing the use cases and WT6 - Threat and risk analysis for sharing data or biomaterials (started; end 06.2014)
15. UDUSCRI - Clinical Research Informatics
16. Acknowledgment: BMB membersThankyou Sebastian Seufert: sebastianseufert@med.uni-duesseldorf.de
17. Appendix
18. Working Tasks ofDel 5.3 WT 5 Security requirements for an e-infrastructure addressing the use cases (leader: TUM-MED) extend usage scenarios to use cases (UCs) overview of systems involved in UCs WT 6 Threat and risk analysis for sharing data or biomaterials (leader: TUM-MED) identifying threats based on systems in UCs risk analysis  security and privacy requirements WT 7 Design of the security architecture and framework (leader: EMBL-EBI)
19. WP 5: Roadmap (Next steps) Beta versionand final usertestofthetool Final Version (Tool) Final version ofthematrix Conceptof thetool 10/2013 First draftof thematrix 05/2013 12/2013 Del5.2 Deadline for the deliverable report First prototype andusertestofthetool Review ofthe templates WP 5 - Workshop in Berlin Roadmap update Del. 5.2 and scheduling of contribution among partners Categoriesand listoftemplates Final Version (Templates and Report) 06/2013 12/2013 06/2014 Del5.3 Deadline for the deliverable report requirements clusters analysis for Del 5.1 finished extension of usage scenarios to use cases overview of systems involved in UCs, focusing on threats WP5 workshop Munich overview of threats overviewof risks identified initial version of security and privacy requirements, start of architectural design process draft design of the security architecture, internal review refinement of security architecture, based on refined risk and threat analysis 05/2013
20. WP 5: Roadmap
21. Imaging Bridge Flow Diagram
22. * * From: http://www.infrafrontier.eu/mousemodels.php (11.07.2013)
23. BioMedBridges: Benefits for the ESFRI BMS Research Infrastructures BBMRI: improvement of integration of biobanks with molecular data and access to meta-data; improved sample description; improved data security EATRIS: improvement of integration of information from multiple analysis platforms and reference resources to support decision making about treatments ECRIN: improvement of linkages between bio-molecular data and clinical trials data; annotation of clinical trial data by links to basic biology ELIXIR: enrichment of bio-molecular data by establishing linkages to clinical data, biobankdata and image data; improved sample description Infrafrontier: implementation of ontologies to improve standardised description of samples and phenotypes; improvement of linkages between mouse models and humans; thus, increased relevance of mouse studies for the clinic
24. BioMedBridges: Benefits for the ESFRI BMS Research Infrastructures INSTRUCT: integration of structural data with clinical data; links from X-ray data to EM (electromicroscopy) data; better integration of NMR (nuclear magnetic resonance) ERINHA: increased resolution of the analysis of bio-molecular data for distinguishing strains of known species and types of unknown species of pathogens EU-OPENSCREEN: enhancing screening strategies by integration of chemoinformatics data with bio-molecular and clinical data EMBRC: linkage to chemo-informatics data of relevance to activity of natural products Euro-BioImaging: improved integration for images as research tools by enabling comparison with bio-molecular data
25. WP 5: Progress achieved so far WP5-Masterplan (August 2012, updated April 2013) WP5-Consensus document: “Points to consider” (July 2012) WP5 data survey: security and ethics-related questions (September 2012) Del 5.1: Report on regulations, privacy and security requirements (final version, 30.06.2013)
26. Del 5.1: Scenario driven approach
27. Del 5.1: Scenario driven approach
28. Del 5.1: Scenario driven approach
29. * * From: http://www.infrafrontier.eu/mousemodels.php (11.07.2013)
30. 05/2013 06/2013 Del5.1 Beta version Deadline for the deliverable report Final Candidate Final Version Preparation of final version for formatting External Expert Review Usage and Scans completed Internal Review (WP 5) Beta versionand final usertestofthetool Final Version (Tool) Final version ofthematrix Conceptof thetool 10/2013 First draftof thematrix 05/2013 12/2013 Del5.2 Deadline for the deliverable report First prototype andusertestofthetool Review ofthe templates WP 5 - Workshop in Berlin Roadmap update Del. 5.2 and scheduling of contribution among partners Categoriesand listoftemplates Final Version (Templates and Report) 06/2013 12/2013 06/2014 Del5.3 Deadline for the deliverable report requirements clusters analysis for Del 5.1 finished extension of usage scenarios to use cases overview of systems involved in UCs, focusing on threats WP5 workshop Munich overview of threats overviewof risks identified initial version of security and privacy requirements, start of architectural design process draft design of the security architecture, internal review refinement of security architecture, based on refined risk and threat analysis 05/2013 01/2016 Not yet started Del5.4 Deadline for the deliverable report
31. Roadmap 06/2013 12/2013 06/2014 Del5.3 deadline for the deliverable report requirements clusters analysis for Del 5.1 finished extension of usage scenarios to use cases overview of systems involved in UCs, focusing on threats WP5 workshop Munich overview of threats overviewof risks identified initial version of security and privacy requirements, start of architectural design process draft design of the security architecture, internal review refinement of security architecture, based on refined risk and threat analysis
32. Questionstodiscuss Focus on privacy (including genomic privacy)? General or specific approach? Use Cases are still in an early stage: Is a Threat and Risk Analysis specific to Use Cases possible? Iterative/Incremental approach? Security Architecture/Framework: Collection of different tools? …?
33. Working Tasks ofDeliverable 5.3 WT 5 Security requirements for an e-infrastructure addressing the use cases (leader: TUM-MED) extend usage scenarios to use cases (UCs) overview of systems involved in UCs WT 6 Threat and risk analysis for sharing data or biomaterials (leader: TUM-MED) identifying threats based on systems in UCs risk analysis  security and privacy requirements WT 7 Design of the security architecture and framework (leader: EMBL-EBI)
34. WT 5.4 – Del. 5.2. Coordination WT leader: Krister Helbing and Roland Krause (TMF e.V.) deliverable 5.2 development of a tool for assessment of ethical and legal requirements and supporting documents need for a easy and simple tool for researchers to assess ethical, IP, security requirements based on bridged data (online interactive tool) establishmentoftaskforces requirementsmatrix & assessment ontology tooldevelopment contracts & template expectedcontributors Roland K., Krister H., Töresin K, Astrid W., Sebastian S., Christian O., Sabine B., Stefan K., Ugis S., Wolfgang K. WHO ELSE?
35. Task Force Tool Development Lead: Töresin K. Members Krister H., Stefan K., Astrid W., Sabine B., Sebastian S. Aims Development of an online interactive legal & ethical guidance and assessment tool Activities Stakeholder and user identification (Astrid, Sebastian) Who will use the tool? Eventually user workshop to gather requirements  usability testing Use case & workflow descriptions (high level description of the intended usage of the online interactive tool, subset of envisaged functionality provided by TF knowledge base) Showcase development (Krister, Töresin & Stefan) Tool development(Töresin, ..) Milestones (Deadline) Stakeholder and user group identified Initial set of use cases and envisaged workflow established Online interactive tool: alpha version Usability testing accomplished Beta version User acceptance testing accomplished Final release
36. Task Force Knowledge Base - Requirements Matrix & Assessment Lead: Krister H. Members Astrid W., Sabine B., Töresin K. Aims Defining a matrix as a knowledge base structure for the online interactive legal & ethical guidance and assessment tool Activities Identifying the dimensions of the matrix (Krister, Astrid, Sabine) Organising all requirements (identified in D5.1) within the matrix (Krister, Astrid, Sabine) Workflow definition for assessment & guidance based on the matrix and requirements (Krister, Astrid, Sabine, Töresin) Milestones Draft version of the matrix Matrix with all requirements available Final version of the matrix
37. Task Force Templates & Contracts Lead Roland K. Members Astrid W., Wolfgang K., Sebastian S., Sabine B., Ugis S. Aims Identifying and generating templates to support the user fulfilling the legal & ethical requirements Activities Defining template categories based on the requirements (Roland and Astrid) Identifying and generating relevant templates (Roland, Astrid, Wolfgang, Sebastian, Sabine and Ugis) Linking the templates or part of the templates to the requirements. (Roland and Astrid) Milestones Template categories are defined List of identified documents and templates available Final version of documents and templates available
38. TF Interdependencies TF: Tool Development Domain Analysis TF: Contracts & Templates Foundation KnowledgeBase TF: Ontology Domain Analysis Workflows Content WT 5.4 Coordination TF: Requirements Matrix & Assessment
39. Imaging Bridge Contributors Tanja Nikovic,Jean Ellenberg and Stefan Klein (EURO-BioImaging) Aims and motivations Provide ubiquitous access to stored data and images, as well as to advanced analysis algorithms Status Final version databridge
40. PhenoBridge Contributors Philipp Gormanns (Infrafrontier) Aims and motivations Connecting the different ontological phenotypic annotations of mouse and human to facilitate interspecies analysis of disease datasets Status Advanced version available Action Provide final version databridge
41. Personalized Medicine (PM) Contributors Henrik Edgren (EATRIS) Aims and motivations Solve problem of access to and integration of data on patients to enable better treatment decision for individual patients Status Final version databridge
42. Structural Data Bridge Contributors Astrid Woollard (INSTRUCT) Aims and motivations Access to infrastructures that will provide structural and protein interaction data to gain better understanding of e.g. multi-protein complexes Status Final version databridge
43. Biological Sample Data Integration Contributors UgisSarkans (EMBL-EBI), ElkeWitt, Roland Krause, (EATRIS) Aims and motivations Large patient cohorts which can be enlarged by sharing data via the Data Bridge Status Advanced version available Action Provide final version databridge
44. The 10 ESFRI BMS Research Infrastructures BBMRI - Biobanking and Biomolecular Resources Research Infrastructure EATRIS - European Advanced Translational Research Infrastructure in Medicine ECRIN - European Clinical Research Infrastructures Network ELIXIR - European Life Science Infrastructure for Biological Information Infrafrontier - European Infrastructure for Phenotyping and Archiving of Model Mammalian Genomes INSTRUCT - Integrated Structural Biology Infrastructure for Europe EMBRC - European Marine Biological Resource Centre ERINHA - European Research Infrastructure on Highly Pathogenic Agents EU-OPENSCREEN - Biology European Infrastructure of Open Screening Platforms for Chemical Biology Euro-BioImaging - European Biomedical Imaging Infrastructure  
45. WP 5: Members
46. BioMedBridgesProject Partners