29WP Guidelines on Consent under the GDPR
Recently, on the 10th April 2018, the 29 WP has published a Guidance tool on consent under GDPR. It’s no new that the concept of consent as used in the Data Protection Directive has evolved. The GDPR provides additional requirements for obtaining and demonstrating a valid consent and these Guidelines are considered a practical guidance […]
Healthcare data breaches and cybersecurity – why health data and how to protect it?
Healthcare data breaches are increasing year over year. According to the Ponemon Institute’s Fifth Annual Study, cyberattacks in healthcare have increased by a factor of 125% since 2010. But why Healthcare data is so desired? It is valuable on the black market because it often contains all of an individual’s personally identifiable information, as opposed […]
Differences between EU Privacy Directive and GDPR regarding the Data Protection Representative
According to the Directive 95/46/EC, when controllers are not established on the territory of the EU and for the purposes of processing personal data make use of equipment, automated or otherwise, situated on the territory of the said Member State, they must designate a representative established in the territory of that Member State, without prejudice […]
FDA Guidance on data retention when subjects withdraw from clinical trials and how this could be different with the GDPR
According to FDA Guidance , when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed, additionally, no new data shall be collected unless patient consents to that. So if a subject withdraws from a study and does not consent […]
