APRIL 20248In My OpinionARTIFICIAL INTELLIGENCE REGULATIONS AND ITS IMPACT ON MEDICAL DEVICESLeo Hovestadt, Director Governmental Affairs EU, ElektaByIntroductionArtificial intelligence (AI) has huge potential improving healthcare using the vast amounts of clinical data. AI software algorithms can use real-world data to support better health care decisions or improve performance and safety of medical devices. Manufacturers have embedded AI technology into various applications such as imaging, laboratory testing, patient monitoring, personalised apps and robotics.AI also presents unique challenges due to its complexity and the iterative and data-driven nature of its development. This triggered the development of the European Union AI Act and the development in the US, Canada and the UK of the Good Machine Learning Practices. European Union AI ActThe European Union AI Act (EU-AIA) is aimed at covering AI in general. The structure of the Medical Device Regulation (MDR) was used as blue print for the EU-AIA. This is very pleasant, since it makes the EU-AIA easy to understand. The MDR includes requirements on risk management, conformity assessment by notified bodies, post-market surveillance and a vigilance system. Those elements can also be found in the EU-AIA.The EU-AIA however has substantial changes when compared to MDR. The MDR focusses on treating individual patients with safe and performing medical devices. The EU-AIA focusses on protecting the population from AI solutions. The goals are incompatible and maybe even conflicting, so the substantial changes are logical.The incompatible requirements are a significant barrier for high quality AI-based medical devices being placed on the EU market. The EU-AIA changed concepts for risk management and did not define risk. EU-AIA risks for fundamental rights conflict with MDR patient safety risks, potentially making medical devices unsafe. The EU-AIA also defined provider, user, importer and putting into service differently than the MDR. Medical device manufacturers also often lack direct access to training data because of patients rights, but authorities in the EU-AIA need to be granted direct access to patient training data. In addition datasets for the EU-AIA need to be error free and complete, however for medical devices testing data is used to check the quality of AI clinical data.The list of inconsistencies and duplications is very long, creating legal uncertainty, increasing costs and potentially blocking market access. Most software medical devices are within the scope of the EU-AIA, not only the AI-based medical devices. The EU-AIA will have an adverse effect on the availability of (AI-based) software medical devices, which cannot be the purpose of the act. Availability in 2022 of medical devices is already endangered since less then 20% of the devices have been transferred from the AIMDD and MDD to the MDR. The administrative burden and unclarity of requirements of the Leo Hovestadt is involved with developing and implementing medical device regulations and guidance, starting with the Active Implantable Medical Device Directive 30 years ago. Leo is the author of the recent MDR Guide for Medical Device Software, and is a regular key note speaker on topics like medical device clinical evidence, artificial intelligence and digital health. He is the Director EU Governmental Affairs of Elekta, a radiation therapy medical device company.Leo Hovestadt
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