Foley Special Counsel Kyle Faget will be a speaker at the NE Clinical Operations Executive Breakfast on April 24, 2018. Her presentation will focus on upcoming changes for companies involved in clinical trials.
The new General Data Protection Regulation 2016/679/EU (GDPR) will become effective throughout EU on May, 25th 2018. All organizations managing EU citizens’ data, regardless of geography, will be subject to GDPR and will need to act proactively to ensure compliance. While GDPR is believed to be an aggressive piece of regulation, it is set to improve the patient experience by introducing the Right to be Forgotten, reducing the Subject Access Request time frame and changing the Explicit Consent. GDPR aims to advance and increase the scope of the existing Data Protection Directive (DPD) but also adds new compliance requirements and raises some important questions regarding clinical trials. The healthcare industry already faces multiple challenges when it comes to protecting sensitive data and now, GDPR, adds the principle of accountability and strengthens the principles of transparency, data confidentiality and integrity.