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Legal and Ethical Framework

Legal and Ethical Framework. Ass. iur . Fritz-Ulli Pieper Institute for Legal Informatics Leibniz University Hanover. Table of Contents. Introduction Legal Implications of the Project European Data Protection Framework Legal Framework in Linked2Safety Conclusions.

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Legal and Ethical Framework

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  1. Legal and Ethical Framework Ass. iur. Fritz-Ulli Pieper Institute for Legal Informatics Leibniz University Hanover

  2. Table of Contents • Introduction • Legal Implications of the Project • European Data Protection Framework • Legal Framework in Linked2Safety • Conclusions

  3. II. Legal Implicationsofthe ProjectConsortium Partners andRoles

  4. II. Legal Implicationsofthe Project • Legal advisorsare not thekilljoys! • Youhave an idea? Great! • We will trytoshowyouthewaythroughthe legal implications

  5. II. Legal Implicationsofthe Project

  6. III. European Data Protection Framework • Medical/health research = information • Medical diagnosis, procedures, treatments = patient data • Applicable Data Protection Law? European Level! • Data Protection Directive 46/95/EC

  7. III. European Data Protection FrameworkDP Directive • Scope: Personal data, Art. 3 (1), Art. 2 (a) DPD • any information relating to an identified or identifiable natural person • account should be taken of all the means likely reasonably to be used to identify the said person • Health Data = Sensitive Data, Art. 8 (1) • Special datadeservespecialprotection • Special rulesfor sensitive data • Processing, Art. 2 (b), Section 7 (Criteriaforlegitimacy) • Principles, Art. 6; exemptions, datasubjectrights, …

  8. III. European Data Protection FrameworkDP Directive • Processing ofhealthdata, Art. 8 • Prohibited, Art. 8 (1) • Art. 8 (2) „Paragraph 1 shall not applywhere…“ • Explicit Consent, Art. 8 (2) (a) • Necessaryfor vital interests w/o legal capability, Art. 8 (2) (c) • Preventivemedicine, medicaldiagnosis, …, Art. 8 (3) • Art. 8 (4), Recital 34: Exemptionsforscientificresearchsubjecttosuitablesafeguards

  9. IV. Legal Framework for Linked2Safety • Threephases: Platformdevelopment, testing, exploitation • Different typesofdata: Healthdata vs. Linked2Safety data • includesgeneticdata – nowaytoanonymize! • Actual personal data vs. anonymizeddata • Anonymizeddatawon‘t fall underthe DP Directive • Data-cubeapproach!

  10. IV. Legal Framework for Linked2Safety • „Data Privacy Framework“ • InformedConsent (obtainedfrompatientsbyclinicalpartners), also coveringethicalbackground • Anonymization • Contractualagreements & organizationalstructure • Research exemption • Data Governance Framework, Data Governance Mediator • Consent Forms • Data Transfer Agreement, User Agreement • Platform Manager Agreement

  11. V. Conclusions • High-levelmedicalresearchhastotakeintoaccountcomplexdataprotectionimplications • Changeswithinnew DP Regulation?! • Data protectionprincinples must beobserved • Further safeguardsshouldbeimplemented • Sound collaborationbetweenmedical, technicaland legal stakeholders

  12. Who to Contact • Ass. iur. Fritz-Ulli Pieper • Institute for Legal Informatics, Leibniz University Hanover • Fon: +49 (0)511 762 8282Fax: +49 (0)511 762 8290 Email: pieper@iri.uni-hannover.de

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