Fig. 2.

Diagram illustrating the four approaches to publishing an open ICU database. Based on the four successful open ICU databases and rules ordained in the GDPR, we present four possible approaches for openly sharing sensitive healthcare data. These are not the only possible options for sharing healthcare data, but the approaches we believe to be most common or appropriate. The arrows indicate different choices to be made and what combinations of those are possible, each ending up in a different terminal node A, B, C, or D; the four approaches for publishing an open ICU database. The first node depicts whether the data can be processed locally or in the cloud, and the second node shows whether data was shared under the legal basis of explicit consent or if the data was shared on other GDPR grounds. The third node states which form of de-identification is used. The lower section shows four sets of bar charts: Security, Ease of use, Sustainability, and Implementability. For each set, all four options (A, B, C and D) are rated discretely for that topic from 1 to 5 by the authors. The ratings are relative, and the scale is explained in the legend at the bottom of the figure. Ratings are subjective; therefore, interpretations can differ. This figure shows that approach A allows the user to download pseudonymised data of patients who provided consent. Approach B also allows the user to download the data yet does not require consent, thus requiring another legal basis under the GDPR and pseudonymises the data. Approach C is identical to B, except it anonymises the data. Finally, approach D incorporates cloud computing, meaning that the users cannot download the data but must access it through an online portal containing pseudonymised patient data without the required consent. All four approaches are legally and practically valid but have different implications on data security, ease of use, sustainability, and implementability.