Limitations of the new ISO standard for health and wellness apps

Abstract

Software apps for health and wellness are proliferating rapidly.1 Policy makers, health-care providers, and consumers can benefit from assessment and standardisation of these apps, to support decision making in a rapidly developing field. Recognising this unmet need, the International Organization for Standardization (ISO) published a standard in July, 2021, with the purpose of defining a framework for quality assessment and labelling of health apps.2 The framework defined by the standard comprises four subscales: healthy and safe, easy to use, secure data, and robust build, with corresponding questions and proposed evidence standards for those seeking to evaluate the apps in question. However, we fear that, in its current form, the standard could stigmatise some app users and worsen inequalities in access to digital health technologies.