[Smartphone-based fundus photography from the perspective of medical product regulation and IT security].

Abstract

Digital applications on mobile devices are also becoming more widespread in medicine and increasingly support the diagnostics and treatment. Smartphone-based fundus photography (SBF) is a mobile and cost-effective form of ocular fundus imaging and offers many new applications in healthcare. For its practical implementation there are various adapters that are connected to commercially available smartphones, so that the adapter can be used as an ophthalmoscope with the integration of the smartphone. The use of corresponding software applications and adapters for smartphones poses challenges in terms of both medical product law and IT security, which are discussed in this article from the perspective of the German Federal Institute for Drugs and Medical Devices (BfArM) and the German Federal Office for Information Security (BSI).