17 1 Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know BACKGROUND The use of mobile applications (‘apps’) has gained solid ground in healthcare. Currently there are over 400.000 health apps available on app stores worldwide.1 Health and wellness apps can be defined as apps operating on smartphones that process health-related data or information, as medical apps are considered to be used for medical or clinical purposes.2 Medical apps may thus facilitate not only patients, but also healthcare professionals (HCPs), their institutions, and society as a whole. Medical apps can aid in access to, distribution, exchange, management and maintenance of information and even facilitate clinical decision making.3 An important benefit of using an app on a personal mobile device is the possibility of (inter-)connectivity. The use of apps on mobile devices enables the use of integrated sensors like the gyroscope, accelerometer, camera or microphone.4 Although the use of apps in healthcare and medical research can be convenient and may improve quality of care, there are associated risks. Before using or developing an app, it is important to decide what objective needs to be met and to investigate if the app is truly the best and a reliable solution. Wrongful use of an app, or rightful use in the wrong context, is potentially harmful.5 This is especially applicable to medical apps that fail to provide any evidence of its effectiveness or safety.6 How to critically appraise an app or how to use an app responsibly, is not a standard part of the medical curriculum. As a result, HCPs including medical researchers, often lack knowledge of the safe use of medical apps. This is an unwanted scenario, as HCPs can be held accountable for the wrongful use of nonconfirmative medical apps. Although this problem has existed for longer, the social-cultural discussion has been accelerated by both the covid-19 pandemic as well as the implementation of the Medical Device Regulation (MDR).7 MDR safeguards stringent requirements for technical development, validation, quality surveillance, and manufacturing. This study serves three purposes. First, to provide an overview of current and relevant European legislation applicable to medical apps and the institutes responsible for legal enforcement. Second, this study gives an overview of responsibilities and liabilities relevant to the medical professional who use medical apps. Finally, to provide the reader with a framework to critically appraise existing medical apps including a comprehensive checklist for those building and/or using medical apps. Several studies on the safe use of medical apps have been published, however most of them focus on the framework provided by the FDA.8,9 To our knowledge, this is the first study to focus on the contemporary European regulations.
RkJQdWJsaXNoZXIy MTk4NDMw