[Smartphone-based fundus photography from the perspective of medical product regulation and IT security]. / Smartphone-basierte Fundusfotografie aus medizinprodukterechtlicher und IT-sicherheitsbezogener Sicht.

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).

[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?] / Abgrenzung und Klassifizierung von Medical Apps : Was ist zu beachten und welche Unterstützung bietet das BfArM?

Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.