[Future trend medical apps. From the apps store directly into medical practice?]. / Zukunftstrend "Medical Apps". Vom App-Store direkt in die medizinische Anwendung?

ABSTRACT

In day to day medical care, patients, nursing staff and doctors currently face a bewildering and rapidly growing number of health-related apps running on various "smart" devices and there are also uncountable possibilities for the use of such technology. Concerning regulation, a risk-based approach is applied for development and use (including safety and security considerations) of medical and health-related apps. Considering safety-related issues as well as organizational matters, this is a sensible approach but requires honest self-assessment as well as a high degree of responsibility, networking and good quality management by all those involved. This cannot be taken for granted. Apart from regulatory aspects it is important to not only consider what is reasonable, helpful or profitable. Quality aspects, safety matters, data protection and privacy as well as liability issues must also be considered but are often not adequately respected. If software quality is compromised, this endangers patient safety as well as data protection, privacy and data integrity. This can for example result in unwanted advertising or unauthorized access to the stored data by third parties; therefore, local, regional and international regulatory measures need to be applied in order to ensure safe use of medical apps in all possible areas, including the operating room (OR) with its highly specialized demands. Lawmakers need to include impulses from all stakeholders in their considerations and this should include input from existing private initiatives that already deal with the use and evaluation of apps in a medical context. Of course, this process needs to respect pre-existing national, European as well as international (harmonized) standards.