Healthcare Innovation and Artificial Intelligence in European Union

Aligning Goals with Societal Benefits Across Emerging Sectoral Frameworks
AI:Dental & Kempelen Institute of Intelligent Technologies

Small and medium-sized enterprises (SMEs) and startups are the backbone of the European Union's economy, fostering innovation and job creation. 

However, navigating the complex regulatory landscape of the EU, particularly regarding medical devices (MDR), Artificial Intelligence (AIA), and health data (EHDS), can be a significant challenge for these agile businesses operating in the area of healthcare. 

It is of particular essence to understand the complex nature of providing and deploying AI systems in the healthcare industry. On one hand, enhancing citizens' quality of life, including those with chronic and terminal illnesses, shall be stimulated by economic growth of market players through increased productivity and taxpayer contributions. On the other hand, easing the professional duties of medical staff by eliminating unnecessary bureaucratic burdens unrelated to their expertise, as well as reducing misdiagnoses and the wastage of resources on unnecessary tests and treatments.  

We provide a brief analysis of how these regulations, while essential for ensuring safety and health considerations, can create compliance burdens that hinder the development and commercialization of new technologies. The stance identifies specific challenges encountered by SMEs and startups, such as limited resources for compliance expertise, navigating complex legal frameworks, and adapting to evolving regulatory requirements. We also propose solutions to address these identified challenges. 

By fostering a regulatory environment that supports SMEs and startups, the EU can ensure that its businesses remain at the forefront of technological innovation while upholding the highest standards of safety and ethical considerations in the development and deployment of new technologies.