Health Software: How to Develop an eHealth Platform in Compliance with Legal Regulations

The advancing digitization of medical technology, in terms of medical devices but also health software, is bringing about several innovations in the healthcare sector. More and more medical practices and hospitals are using various software products and apps to analyze and evaluate diagnostic findings. For users and operators, it is important to know whether the product is considered as a medical device or as health software. If it is a medical device or health software, the laws and regulations that apply to medical devices must be observed. This bachelor thesis explains when software is considered as a medical device and the legal requirements that have to be fulfilled. The aim is to explain the most important laws, standards and directives and then give a ”harmonized approach” that covering all. The important aspects of the respective laws and standards have been summarized and described. Furthermore, the approach described in this thesis is exemplarily worked through with the eSano software. eSano is an eHealth platform that provides online support for therapeutic care. Online therapy is delivered through the use of internet and mobile-based interventions (IMIs) and patients are able to carry out these interventions.