24 Chapter 1 PART III: WHERE TO START AND WHAT TO DO WHEN USING OR DEVELOPING AN APP AS A MEDICAL DEVICE In this part of this article, theoretical knowledge from the previous sections is translated into a practical checklist for using or developing an app as a medical device. Critical appraisal of medical apps Within the overwhelming amount of apps, it is challenging to find the apps with peer reviewed content and in compliance with the GDPR and MDR. Medical apps should be assessed on several aspects. A frequently used framework to assess medical apps are the Health on the Net (HON)-criteria.22 The HON foundation was founded in May 1996 and promoted the effective and reliable use of the new technologies for telemedicine in healthcare worldwide. Unfortunately, this non-profit organisation was not able to maintain their foundation and has discontinued their services as of December 15, 2022. The mHealthHUB, supported by the European Union’s Horizon 2020 research and innovation programme, has published a knowledge tool reviewing available frameworks in 2021.23 In August 2021 a new standard was published regarding the quality requirements for health and wellness apps, the ISO/TS 82304-2. The standard covers the entire life cycle of a medical app (post market surveillance and quality control). Apps are scored on four different domains, as shown in Figure 1. An overall quality score is also provided.24 Building custom medical apps When there is a healthcare scenario that cannot be addressed using an existing medical app meeting the necessary requirements, one can decide to build a new app. In order to do so the right way, the following aspects must be considered (see also Figure 2). Conditions Any medical app must meet specific healthcare-oriented privacy, design, and functionality criteria. To ensure that the app meets these conditions, content experts are needed, next to functional and graphical design specialists. If an app is designed to be used by patients, it is recommended that they be involved early in the development process. “Human factor engineering” or “patient included innovation” will improve the community support amongst intended users and decreases the risk of (wrong) usage of medical devices. An appropriate and well-functioning “User Interface” (UI) and “User Experience” (UX) of the app, designed together with the intended users, will help in presenting information effectively. Usability tests within the intended user group are important because only 30 to 60% of people can be considered health literate.25 To validate the quality and safety of the app, user trials or tests must also be incorporated in the development process, which is also specifically stated in the MDR.
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