AI in Healthtech: Regulatory Challenges Highlighted at TechTour Health 2024
At the TechTour Health event on September 10, 2024, Dietmar Schaffarczyk from the ETH Technology Platform dTIP, led a crucial session on AI in healthtech.
The discussion revealed a critical regulatory challenge: global market entry for AI health solutions must navigate 43 different AI regulations. While most are vertical extensions of national health laws, the EU AI Act stands out as a horizontal regulation impacting all sectors, including healthcare.
For European manufacturers, this means complying with two distinct conformity assessments: MDR/IVDR for medical tech, and the EU AI Act. The lack of harmonization complicates market entry, adding regulatory hurdles that delay innovation. Schaffarczyk stressed the importance of understanding these frameworks early to avoid costly delays.
As the sector advances, the need for regulatory alignment becomes increasingly urgent. TechTour Health continues to connect innovators with key insights, driving solutions forward despite these legal complexities.
TechTour Health 2024 took place from September 9 to 11, 2024, in Lausanne, Switzerland. It was the 15th edition of this prominent healthtech event, gathering startups, investors, and industry experts from across Europe. Around 40 healthtech companies were selected to present their innovative projects to over 40 investors, creating significant opportunities for networking and investment in the health sector.
More information on external page TechTour