The General Data Protection Regulation (GDPR) enforcement date is looming, and will undoubtedly impact life science companies who handle vast amounts of personal data. In particular, the way in which pharmaceutical and medical device companies conduct clinical trials and research studies.
Whilst practices to protect participant data are already rigorous, companies will need to adapt their stringent procedures to ensure compliance to the new regulation. The GDPR introduces additional compliance obligations to those set out by the Directive, including: clearer and broader definitions; increased data subject rights; and significant penalties for non-compliance.
What are the key considerations for companies in the life sciences industry and what steps need to be taken before the GDPR enforcement date?
Read FRA’s Mark Scallon and Jenny McVey’s commentary here in the Life Science Compliance Update.
Authors: Mark Scallon, FRA partner & Jenny McVey, FRA Life Sciences manager
About FRA Life Sciences
FRA Life Sciences provides a broad set of services to help companies identify global compliance risk as well as develop practical, yet effective, solutions for operating under increasing scrutiny. Our expertise will help mitigate global compliance risk across multiple functional areas, including sales and marketing, medical affairs, research & development and instill any necessary change in a company’s compliance culture.