ISO/IEC-Standards on Quality and Safety of Telehealth Services and Mobile Medical Apps.

This paper investigates consistency of ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. Since mobile medical apps are 'software as a medical device', requirements for these apps are in software standards, in particular health software standards, as well as in medical device standards. These requirements were analyzed within an analysis model that has three domains: quality and safety management, core healthcare processes and resources. Telehealth services are healthcare processes and mobile medical apps are resources. There is good alignment of the standards that pertain to quality and safety management, the healthcare processes and medical devices. However, there is a lack of alignment, consistency and transparency of the ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. An international effort to address these issues is recommended.