BRIDGE is a three-year flagship project of the Innovative Health Initiative, delivered by 28 organisations from 12 countries. These partners represent regulators, health technology assessment (HTA) bodies, research organisations, intergovernmental and multi-stakeholder associations at EU, Member State, and regional levels, as well as industry leaders.
The project aims to develop a framework for regulatory sandboxes, enabling the sustainable embedding of sandbox approaches into the European regulatory ecosystem. Through comprehensive recommendations, BRIDGE will guide the end-to-end implementation of regulatory sandboxes, supporting regulators, healthcare innovators, and decision-makers.
Regulatory sandboxes provide flexible, real-world environments where innovators and regulators can collaborate. Together, they explore how to regulate new technologies effectively ensuring end-user protection while removing unnecessary barriers that may hinder innovation. By fostering agile, evidence-based regulation, BRIDGE helps accelerate the safe and timely introduction of groundbreaking healthcare solutions, ultimately benefiting patients and health systems across Europe.
Key activities
Understanding the Landscape
BRIDGE examines how regulatory sandboxes are currently used across Europe and globally, while also identifying emerging health technologies that may challenge existing regulatory frameworks. The project will establish clear criteria for determining when a sandbox approach is most appropriate.
Designing the MOSAIC Architecture
MOSAIC stands for ‘Modular Operational Sandbox for Healthcare Innovation and Compliance’. The design and testing of the MOSAIC architecture lies at the heart of BRIDGE. This architecture will use configurable components, referred to as ‘bricks’ and ‘modules’, to provide a modular framework. This will allow regulators and innovators to create bespoke sandboxes. This flexible approach can accommodate a wide range of health technologies, from digital health and AI to advanced therapies.
Testing Through Real-World Cases
The project will conduct end-to-end simulations using selected case studies—such as AI-driven medical tools, advanced therapies, and hybrid technologies—to assess how a sandbox can support their evaluation and development. These simulations will help refine the model, as well as identify practical needs, gaps, and key regulatory considerations.
Ensuring Long-Term Uptake
BRIDGE will provide clear guidance on setting up, running, and maintaining regulatory sandboxes. To ensure broad acceptance and alignment with EU policies and regulations, the project collaborates closely with European regulators, health technology assessment (HTA) bodies, industry partners, clinicians, and patient groups.
Building a Community
The BRIDGE Knowledge and Community Hub will bring together experts from across Europe to share best practice, validate project outcomes and support the future implementation of regulatory sandboxes. Designed to serve as a lasting resource, it will support all stakeholders invested in regulatory innovation.
