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Medical Devices & Data Reuse

Pieter Kalis & Helena Ursic| Amsterdam 20-11-2015

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Agenda1. Why Medical Devices and why data

reuse?2. Briefly on EU legal framework3. Privacy

• Current legal framework• The GDPR’s challenge

4. Security5. Questions?

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Why medical devices & why data reuse? 1878 2015

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Briefly on Legal framework

• 3 Directives• Proposed Regulation • Policy

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PrivacyProtecting Privacy of medical Data

- Fairness- Purpose limitation- Openness

• GDPR- Research exception- Data portability

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SecurityProtecting Security of Medical Data Transmissions

• Threats

• Current legislation - Telecoms package

• Future legislation- NIS Directive

6

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Questions?