Koen Cobbaert
Koen Cobbaert is a Regulatory Science and Policy Expert at Philips, specialising in the application of tech law and standards for digital health products. He supports the advance of regulatory science through policy and regulatory initiatives at the European Commission, European Parliament, International Medical Device Regulators Forum, and the UK's National Commission on AI in Healthcare.
He represents Philips at the trade associations Digital Europe, MedTech Europe, and COCIR. He holds a master’s degree in electrical and safety engineering. Koen has over 20 years of hands-on experience developing regulatory and market authorisation strategies for medical device software across various jurisdictions and clinical domains.
Topics
Deploy First, Prove Later? The Rise of Real-World Testing in Healthcare
Medical AI is changing faster than traditional pre-market evidence can keep pace. Could carefully controlled real-world testing help close that gap—without asking patients to bear the risk? From the FDA’s TEMPO and the UK’s AI Airlock to emerging initiatives in China, Singapore and the EU, regulators are testing new approaches. This talk explores what makes these pathways useful, what safeguards they need, and when the evidence is strong enough for wider use. Join the discussion on how to test medical AI in care while protecting patients and building trust.