IT Security and Data Privacy in Global Trials from an EU Perspective
Marc E Brooks,
Chief Executive Officer,
Elderbrook Solutions GmbH
The EU showed to be very clear on their expectations regarding data privacy when the European High Court invalidated the Safe Harbour agreement with the United States. Since then the awareness to data privacy has risen even to the point that companies require servers to be hosted in Europe, so they can ensure to comply with EU privacy laws. However, the EU offers a standard clause template for data privacy agreements to provide means for transfering and processing privacy relevant data in non-EU countries. This standard clause requires a minimum of technical and organizational measures, meaning that IT security needs to be implemented. Typically, in clinical trials privacy relevant data is sent around the globe – not only patient data such as adverse or serious adverse events, but also investigators and nurses CVs. IT security awareness will not only grow due to increasing data integrity requirements but also with respect to data privacy requirements. The presentation will cover necessary security and privacy requirements in some typical clinical processes.
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