Legal regulation of digital public health interventions—hindrance or stimulus?

Abstract

The potential benefits of digital health technologies in population-based health research depend mainly on whether and to what extent these technologies can be based on the processing of personal health data. However, there needs to be more certainty in the application and interpretation of the relevant legal regulations on the processing of research data using digital health technologies. Research practice primarily uses consent as a legitimation basis for data processing, although the information model of the German and European legislator, with its ambitious requirements for voluntary and informed consent, is unrealistic and needs to be revised. Even the concepts of broad consent, dynamic consent, and meta consent, which represent alternatives to the classic consent solution, cannot remedy all the deficits of the consent model. In order to guarantee the informational self-determination of the persons concerned and, at the same time, keep an eye on the interests of research in the public health sector, data protection for research purposes must be further developed. Solutions should not only be tailored to consent behavior but must also consider the legitimization of research data processing without consent or aim to remove the personal reference of the data irretrievably. To date, the law has only fulfilled its task of striking an appropriate balance between the interests of all stakeholders to a limited extent. However, improvement is in sight, especially given current regulatory initiatives and new legal solutions. This discussion article illustrates the ambivalent role of law: on the one hand, health data protection law is often perceived as an obstacle to innovation, but on the other hand, law can pave the way for digital health technologies if further developed.