Balancing the legal, ethical, and practical aspects of using digital health technologies in clinical research

Digital health technologies bring innovation to participants in clinical trials. They enable the collection, use, and sharing of large amounts of data for medical and scientific research purposes, which ultimately benefits patients. In the context of drug development, traditional clinical trials face significant privacy challenges due to a lack of harmonisation and diverging interpretations of privacy laws and authorities’ guidance. Given the use of digital health technologies, decentralised trials in particular have to manage an additional level of complexity. Involving technology providers increases concerns around the access, storage, and security of study data. Authorities, ethics committees, and healthcare institutions often ask for various additional or bespoke requirements that may diverge from or even conflict with each other, which can lead to unintended consequences for research initiatives and for individuals who are willing to participate in innovative clinical trials. This article outlines some legal, ethical, and practical issues as well as their consequences when using digital health technologies in the research sector.