Direct-to-patient digital diagnostics in primary care: Opportunities, challenges, and conditions necessary for responsible digital diagnostics.

Background: Diagnostics are increasingly shifting to patients' home environment, facilitated by new digital technologies. Digital diagnostics (diagnostic services enabled by digital technologies) can be a tool to better respond to the challenges faced by primary care systems while aligning with patients' and healthcare professionals' needs. However, it needs to be clarified how to determine the success of these interventions.

Objectives: We aim to provide practical guidance to facilitate the adequate development and implementation of digital diagnostics.

Strategy: Here, we propose the quadruple aim (better patient experiences, health outcomes and professional satisfaction at lower costs) as a framework to determine the contribution of digital diagnostics in primary care. Using this framework, we critically analyse the advantages and challenges of digital diagnostics in primary care using scientific literature and relevant casuistry.

Results: Two use cases address the development process and implementation in the Netherlands: a patient portal for reporting laboratory results and digital diagnostics as part of hybrid care, respectively. The third use case addresses digital diagnostics for sexually transmitted diseases from an international perspective.

Conclusions: We conclude that although evidence is gathering, the often-expected value of digital diagnostics needs adequate scientific evidence. We propose striving for evidence-based 'responsible digital diagnostics' (sustainable, ethically acceptable, and socially desirable digital diagnostics). Finally, we provide a set of conditions necessary to achieve it. The analysis and actionable guidance provided can improve the chance of success of digital diagnostics interventions and overall, the positive impact of this rapidly developing field.