General Data Protection Regulation (EU GDPR) New Data Privacy Laws & their impact on life sciences
- Obligation to inform in the event of data protection violations: If data protection is breached, the GDPR demands that such breach be reported to the supervisory authorities and the persons concerned, and stipulates tight deadlines for doing so. This innovation particularly affects the life sciences, since health data is considered a high risk.
- Data protection—impact assessment: If there is a “presumably high risk to the rights and freedoms of natural persons,” the responsible party must perform asses in advance of the impact data processing would have. This investigation demonstrates how sensitive data is collected, processed and protected in accordance with statutory specifications.
- Substantial new sanctions: Non-compliance with this regulation might incur a massive fine from two to four percent of the company’s annual worldwide revenue, or 10 or 20 million euros, depending on the severity of the violation.