Legal and Regulatory Challenges for Digital Health Technologies with a Focus on the European Legal Situation
摘要
In the current healthcare context, medical applications, including apps, software solutions, smart devices, wearables, artificial intelligence (AI), digital decision support systems, telemedicine, remote monitoring, and patient training have revolutionized the provision and administration of healthcare services. Important regulatory and legal aspects need to be considered by programmers, manufacturers, and finally users of the digital health technologies in order to ensure patient and data safety. The article summarizes the most important facts on legal challenges for healthcare professionals who intend to use digital health technologies with and without artificial intelligence in their clinical practice.