The VASCUNET Manifesto on Data Privacy Compliant Real World Evidence

Between 1997 and today, the history of the VASCUNET collaboration 1 has been accompanied by various milestones of the digital revolution. In 1998, when only 1% of European inhabitants used the internet, a company known for the most popular search engine was founded in a garage in California, USA. Subsequently, the increasing data exchange between the European Union (EU) and the US led to the “Safe Harbour” agreement in 2000. While in 1993 only 3% of the world's information was stored digitally, this proportion increased to 96% in 2007. 2 Shortly afterwards, in 2008, the catchphrase “big data” was introduced to the biomedical community, 3 and only four years later, it wasn't surgeon but data scientist that was voted “the sexiest job of the 21st century”. 4 These rapid developments led to both opportunities and challenges for real world research using clinical and administrative registries. Research groups proved that the concept of data privacy is a complex and fragile construct. 5 Recently, the “EU–US Privacy Shield” agreement, a continuation of the “Safe Harbour”, agreement allowing transatlantic data transfer, collapsed over a decision of the European Court of Justice, creating a legislative vacuum in this field.