Transformations in twenty-first century-healthcare – When considering the transformation towards personalised healthcare, especially during the last five to six decades (1970–2020), three elements quickly catch the eye. The first transformation concerns the role of the patient in Western healthcare systems. This role has changed since Western medicine moved away from a doctor-knows best discipline and considered patient autonomy of great importance. Today patient empowerment is considered a credo. The patient is placed at the centre of the system. The second transformation relates to the impact of economic-societal challenges caused by changing demographics and rising costs confronting healthcare systems with the need to care for more people with fewer people. The third transformation in 21st-century healthcare systems is caused by ICT. Together these evolutions lefttheir mark on Western healthcare and the patient's position. Today, the rise of big data, machine learning and AI has a particular impact on the patient as a data subject.

The adoption of ICT gave rise to e-health and allows ‘datafication’, a concept adopted to illustrate one of the most important big data characteristics. Viktor Myer-Schönberger and Kenneth Cukier introduce the concept to describe the “ability to render into data many aspects of the world that have never been quantified before”. Mendelson and Mendelson adopt the concept to illustrate the creation of valuable information from processes and data sources previously invisible. “The collection and storage of data inherent in, or related to, objects, processes or people and the transformation of this data into new forms”, allow the creation of “value, related or unrelated, to the data's original context” they explain.

In the healthcare context, Thomas Eng observed more in general in 2004 that

Today, little over 15 years later, the ‘e-health’ industry is characterised by the vast amounts of sensitive data fed by users, professionals, and connections with other systems. Moreover, an even more considerable amount of meta-data accompanies those sensitive data: information about the data.