New European regulation set to enhance health data access in Iceland

A new European regulation is set to enhance patients’ access to health information collected during their treatment. Currently awaiting formal approval from the European Union, this regulation is expected to be applicable within the European Economic Area (EEA), including Iceland. It would allow for the sharing of encrypted data across borders for research purposes.

Hrefna Dögg Gunnarsdóttir, a lecturer at the University of Iceland’s Faculty of Law, highlighted that historically, individuals have not had rights to access data about themselves collected in scientific research. The new regulation proposes that individuals should have the ability to access significant health information derived from research studies. The presumption will be that individuals wish to receive this information, as opposed to the current framework which requires them to actively seek it.

However, the regulation does not guarantee access to all health data but focuses on relevant and significant information. The definition of what constitutes important health information will be determined by each state, meaning it will be up to Iceland to decide what is considered essential. Furthermore, there is a debate regarding the provision of potentially life-threatening disease information that is untreatable, which raises ethical questions in both health law and medical ethics.