How can we trust artificial intelligence? On the opportunities and risks for the medical technology industry.

The medical technology industry is currently undergoing a transformation through the integration of artificial intelligence (AI) into the software of medical devices. This technological innovation opens up countless possibilities for improving diagnostics, therapy and patient care. Dr. Andreas Schwab, leading expert for artificial intelligence in medical software at TÜV Rheinland, sheds light on the developments and challenges of integrating AI into medical software. 

A key area of application for AI is diagnostic support. Artificial intelligence can recognize patterns - for example in medical images but also (text-based) patient records - and create precise and fast diagnoses based on this data. One example of this is imaging procedures in which AI algorithms evaluate X-ray images or CT or MRI scans and identify potential abnormalities. This early detection capability can make a decisive contribution to timely treatment and thus to improving patient prognoses.

 AI also plays a crucial role in personalized medicine. By analyzing individual patient data, AI can create customized treatment plans that are tailored to a patient's specific needs. The hope is that this could lead to more effective treatments and fewer side effects.

 But for all its benefits, the integration of AI into medical devices also comes with risks. Regulatory requirements, not least the EU AI Act and the MDR, pose key challenges. It is essential that the AI models used comply with the legal requirements in order to gain the trust of users. Compliance with international norms and standards is essential.

 "The future of the medical device industry lies in the safe and secure use of artificial intelligence," says Andreas Schwab, emphasizing the importance of a binding legal framework as well as continuous further development and training in the field of AI technologies.

 It is essential for companies in the medical technology industry to address the possibilities and requirements of AI in medical software at an early stage and to build up the relevant expertise. Only in this way can they meet the increasing demands and develop innovative solutions that sustainably improve healthcare. With its broad service portfolio, TÜV Rheinland offers attractive market access services in the field of AI.

 Further information can be found here.