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Interim results best practices and checklists regulatory requirements (German)
In the context of mobile health applications (mHealth apps for short), it is becoming increasingly important to meet regulatory requirements. On the one hand, the legislator, and on the other hand, international guidelines have made more and more requirements mandatory, which previously did not apply to mHealth apps, or it was not exactly clear whether they actually had to be met. In the context of pandemic apps - as the most recent representative of mHealth apps - regulatory requirements are therefore also an important aspect. Another complicating factor is that pandemic apps have to be developed in a comparatively short period of time, so meeting regulatory requirements in this context is particularly complex. The regulatory requirements studied are summarized in this document in the form of preliminary checklists (Deliverable 3.4 presents the final checklists). The checklists are intended to provide, in as compact a form as possible, the necessary insights into how pandemic apps can be developed in compliance with the regulations.
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