Clinical trial app regulations

Abstract Clinical trial apps must follow the highest possible standards in development in all relevant areas (data acquisition and management, data protection). It is also important to provide a transparent and detailed standardized description of the functionality of the app and to specify the rationale for the trial. Regulatory oversight is highly likely as clinical trial apps are a medical product. The General Data Protection Regulation (GDPR) massively affects the clinical trial app approach: while it makes provisions for risk-based acquisition and processing of data, research may still be hampered as specific modalities for research may be adapted (Article 89) by individual member states of the EU. There are also concerns that, due to its complexity, the GDPR is often overinterpreted by those without appropriate GDPR training.