Data Privacy is becoming more important. Especially there have been a lot of legislative focus on protecting personal data in the European Union. While these efforts have been done with the best intentions they have created a patchwork of regional and local laws and other requirements that often are ambiguous and sometimes contradictory.
For drug safety and clinical development it creates particular problems as collection and processing of personal health data is essential to develop new medicines and to ensure that these new medicines are safe to use.
The collection and use of personal data in the European Union is currently governed by the EU data protection directive of 1995.
Personal Data is here defined as any information that relates to an identified individual. The definition included any information that permits the identification of an individual based on this information alone, or in combination with other available information.