ABSTRACT
AIMS: In three days at the beginning of the COVID-19 pandemic, the Copenhagen Emergency Medical Services developed a digital diagnostic device. The purpose was to assess and triage potential COVID-19 symptoms and to reduce the number of calls to public health-care helplines. The device was used almost 150,000 times in a few weeks and was described by politicians and administrators as a solution and success. However, high usage cannot serve as the sole criterion of success. What might be adequate criteria? And should digital triage for citizens by default be considered low risk? METHODS: This paper reflects on the uncertain aspects of the performance, risks and issues of accountability pertaining to the digital diagnostic device in order to draw lessons for future improvements. The analysis is based on the principles of evidence-based medicine (EBM), the EU and US regulations of medical devices and the taxonomy of uncertainty in health care by Han et al. RESULTS: Lessons for future digital devices are (a) the need for clear criteria of success, (b) the importance of awareness of other severe diseases when triaging, (c) the priority of designing the device to collect data for evaluation and (d) clear allocation of responsibilities. CONCLUSIONS: A device meant to substitute triage for citizens according to its own criteria of success should not by default be considered as low risk. In a pandemic age dependent on digitalisation, it is therefore important not to abandon the ethos of EBM, but instead to prepare the ground for new ways of building evidence of effect.