On May 21, 2024, the EU Council finally adopted the AI Act. For manufacturers of medical software with AI, transition periods for implementation now apply, depending on the risk class defined in the AI Act.
Approaches to implementing AI in medical devices are already becoming more and more common. Potential is seen especially in the field of psychotherapy, according to the Handelsblatt digital health newsletter: researchers at Stanford University observed that 10 percent of ChatGPT users with mental health problems turn to the AI for advice. Yet this use case is not intended at all.
The AI often provides surprisingly good answers in other areas too, for example on the treatment of breast cancer. This suggests the possibility of training a chatbot on specific data such as a medical guideline. Such a chatbot could potentially answer questions faster than any medical professional and so possibly free up time for doctors. What currently often deters manufacturers from developing specialised products is the strict regulation of medical devices (the MDR, for example).
Handelsblatt reported on the adoption of the AI Act: https://www.handelsblatt.com/inside/digital-health/ai-act-welche-fristen-gelten-/29812950.html