The main goal of the regulation making its way through the European Parliament, known as the General Data Protection Regulation, is to strengthen the digital privacy rights of Europeans. But the professors claim that a few amendments to the regulation would “make most epidemiological and health research impossible,” according to an editorial in the British Medical Journal.
Last December, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs “called for amendments that would put insurmountable obstacles in the way of research that uses sensitive data, such as health data, especially retrospective studies,” the professors of health law and social medicine write.
The amendments make few exceptions for processing “personal data concerning health which is necessary for historical, statistical or scientific research purposes,” such as when that research serves “an ‘exceptionally high public interest,’” or if “that research cannot possibly be carried out otherwise. The data in question shall be anonymised, or if that is not possible for the research purposes, pseudonymised.”
But the professors wonder which research will fall under this category of “exceptionally high public interest” and “who would decide that.”
“The potential of a research project to yield exceptionally important findings is hard to predict because scientific progress is incremental,” the professors write. “This amendment would prohibit most epidemiological and health research, including research that used data from dead or untraceable patients, retrospective studies, and large scale cohort studies where obtaining informed consent might not be completely impossible but would require disproportionate effort by researchers.”
In addition, a committee amendment “proposed to take away the European Commission’s competence to adopt ‘delegated acts’ to further specify criteria and requirements on research using personal data. We think that the commission should remain in the position to make use of its powers and should remove, as urgently as possible, existing obstacles for research across borders.”
The professors, however, do agree that review by an independent body should be part of the legal framework when non-pseudonymised or directly identifying data are collected and used without explicit consent of the patients involved. “This should also be the case when the research gives rise to specific privacy concerns, such as the collection of genetic data, or when the research has stigmatising consequences for the participants,” they write.
But the professors call on the committee to use the expertise of ethical review committees, rather than competent supervisory authorities to make the decisions on which research can be accessed “because of their expertise in reviewing research protocols.”