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GDPR Impact on Data Collection Practices New project kick off in Optimizing the Use of Data Standards working group Sara Pauwels 29NOV2017 GDPR Impact on Data Collection Practices Changing regulatory environment in EU with the


  1. GDPR Impact on Data Collection Practices New project kick off in ‘Optimizing the Use of Data Standards’ working group Sara Pauwels 29NOV2017

  2. GDPR Impact on Data Collection Practices • Changing regulatory environment in EU with the release of the General Data Protection Regulation (GDPR)​ ( Approved 14Apr16, enforcement date 25May18).​ • More strict on personal data​ collection • Increased territorial scope • Data portability • Principle of minimization • Subjects have right to have personal data erased • … Countries within the EU May 2016: EU general data start “translating” this May 2018: EU GDPR protection regulation GDPR into their local requirement (GDPR) released legislation and guidances

  3. GDPR Impact on Data Collection Practices More strict on personal data collection Example: DOB May 2016: EU general data protection regulation (GDPR) Example: France CNIL updated ref. methodology for the released processing of pers. data used in biomed. research (MR- 001): Trials with FPI after 14Aug17​ should not collect day of Countries within the EU birth (only month/year allowed) for subjects > 2 yrs. start “translating” this GDPR into their local legislation and guidances How to deal with current EU landscape on DOB collection and quickly react on May 2018: EU GDPR requirement further evolutions ? STANDARD approach needed in company ?

  4. GDPR Impact on Data Collection Practices Goal: • Share experiences and approaches for collecting date of birth and other personal information in compliance with regulations. • For example, the project will explore the impact of collecting minimal expected information on Date of Birth Deliverable: • A best practices white paper to summarize experiences and recommendations. As the project progresses, it may also explore other general EU regulations and aspects of the GDPR and/or local implications.

  5. Interested in joining the team ? Wendy Dobson (wendy@phuse.eu) Sara Pauwels (spauwel2@its.jnj.com)

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