European Cancer Organisation and Artificial Intelligence Regulation: Reply to Commission Consultation August 2021

During the summer of 2021 the European Commission conducted a public consultation with stakeholders on the regulation of Artificial Intelligence.

The European Cancer Organisation replied to express the importance of creating trustworthy AI systems, which indicates a need for a strong pan European regulatory framework. Other key points expressed in its response to the consultation included:

•  Fundamental to the success of AI, and its regulation, including ensuring its safety, reliability and trustworthiness are the crucial requirements of data quality, transparency and human oversight. This should be embedded in the EU’s approach to AI regulation.

• The European Cancer Organisation welcomes efforts made to ensure that regulation is proportionate to risk, including for AI. Most applications of AI in clinical settings will be classified as high risk under this new regulation, meaning that a conformity assessment process will be required to permit the use of the AI function. It is of great importance that the conformity assessment process includes the possibility for healthcare professional views and perspectives to be taken into consideration during this decision-making. Healthcare professionals are not only a key end user, but also have high consciousness of the practical safety risks and ethical considerations.

• Specific consideration is required on the integration of this new regulation with existing EU regulations in the field of health. An example in this regard is the Medical Devices Regulation which already regulates “AI with an intended medical purpose”. As the healthcare environment is already highly regulated, it is important that the AI Regulation does not overlap with other conformity assessment schemes and surveillance systems. Conflicting regulations should be avoided not to overcomplicate decisions in clinical settings.

See full response here.