Medtech Connect Episode 8: Exploring Regulatory Differences Between The EU And US
In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.
You may also be interested in...
Consistency and coherence with other relevant regulations should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence in the drug lifecycle, pharmaceutical industry representatives have said.
Companies that use AI technologies will be responsible for demonstrating that regulatory standards are met and that the data they provide “has not been synthetically generated or completely made up,” an EU workshop heard this week.
Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.