HIMSS Europe 2026: How Synthetic Data Could Redesign Medical Device Regulation

At HIMSS Europe 2026, one of the world's leading events for digital health innovation, Stuart Harrison, Co-founder and CEO of ETHOS Ltd, INSAFEDARE Project Partner, shared how synthetic data is set to transform the future of medical device regulation in a featured interview highlighting the Horizon Europe-funded INSAFEDARE project.

As healthcare increasingly embraces artificial intelligence, ensuring that AI-enabled medical devices are safe, trustworthy, and compliant with regulatory requirements has become one of the sector's greatest challenges. The interview explored how INSAFEDARE is addressing this challenge by combining synthetic data, real-world evidence, and innovative assurance methodologies to support the next generation of digital health technologies.

Addressing One of Healthcare AI's Biggest Challenges

Developing and validating AI-powered medical devices requires access to high-quality, representative clinical data. However, privacy regulations, limited access to diverse patient populations, and lengthy validation processes often slow innovation.

Synthetic data offers a promising alternative. By generating privacy-preserving datasets that retain the statistical characteristics of real-world populations, developers can test, validate, and improve AI systems while protecting patient confidentiality.

Combined with real-world evidence, synthetic data has the potential to strengthen regulatory decision-making, accelerate innovation, and increase confidence in AI-enabled healthcare technologies.

INSAFEDARE's Vision

During the HIMSS Europe interview, Stuart Harrison highlighted how INSAFEDARE is developing a comprehensive assurance framework that supports regulators, manufacturers, and healthcare organisations throughout the lifecycle of AI-based medical devices.

The project is bringing together expertise from industry, academia, healthcare, and standards organisations to create practical tools that enable:

• Trustworthy AI assurance for digital health solutions

• Safe use of synthetic data and real-world evidence

• More transparent regulatory assessment processes

• Improved interoperability and compliance

• Faster and more efficient validation of innovative medical technologies

Rather than replacing traditional clinical evidence, these approaches complement existing regulatory pathways, helping organisations demonstrate safety, performance, and trustworthiness more effectively.

Sharing Innovation at HIMSS Europe 2026

HIMSS Europe 2026 provided an ideal platform to showcase INSAFEDARE's vision for the future of trustworthy digital health. The interview highlighted the growing importance of collaborative European research in addressing emerging regulatory challenges and supporting the safe adoption of AI across healthcare systems.

As digital health technologies continue to evolve, projects like INSAFEDARE are helping shape a future where innovation and regulatory assurance progress hand in hand—ensuring that patients, healthcare professionals, manufacturers, and regulators can all have greater confidence in AI-powered medical devices.

Watch the Interview

The full HIMSS Europe 2026 interview with Stuart Harrison is available to watch below and offers valuable insights into how synthetic data could help redesign medical device regulation while advancing trustworthy AI in healthcare.

Watch the interview here:https://himsstv.brightcovegallery.com/detail/videos/ai-ml/video/6396628313112/sponsored-how-synthetic-data-could-redesign-medical-device-regulation?autoStart=true