The relevance of data protection and consent has never been more topical in healthcare as it is today. The shift towards ‘big data’ and ‘real-world evidence’ is creating opportunities for health research but this also raises important challenges (e.g. anonymity, role of consent) in terms of patient confidence and trust in how patient data (and biomaterial) is used for research purposes.
Meanwhile, data compliance and the impending EU Data Protection legislation is a major issue for the collection, use and sharing of patient data, and in particular the need for greater transparency around explicit consent.
The ‘dynamic consent’ model, which is more flexible over time, and more personalised, is an example of how information technology could be used to satisfy the legal and regulatory requirements for research consent, while simultaneously providing a communication interface for interacting with patients, participants and citizens.