Practical templates for digital health ethics applications in Sweden: lessons from a sensor-based monitoring study.

Obtaining ethical approval for digital health research involving vulnerable populations presents significant challenges for researchers, particularly when navigating complex regulatory frameworks like Sweden's ethical review system. Despite official guidelines, researchers often struggle to translate general principles into concrete application documents that satisfy review authorities. This paper presents practical, reusable templates developed through the successful preparation of an ethics application for a radar-based monitoring study of older adults in Sweden. The application, involving cross-border data handling and vulnerable populations, received first-submission approval from the Swedish Ethical Review Authority (Etikprövningsmyndigheten) without reviewer comments. We provide structured templates for key application sections, identify common pitfalls, and offer evidence-based guidance for researchers preparing similar applications. These resources are practice-grounded (one approved applications plus practice-based reflections) and are intended to reduce administrative burden and improve application quality; they should be adapted to local institutional requirements.