Breakthrough Regulatory Innovation and Development throuGh sandbox Environments

Objective

BRIDGE aims to enhance healthcare innovation in Europe by developing a comprehensive framework for designing and operationalizing regulatory sandboxes. By addressing current regulatory limitations and engaging all stakeholders while ensuring compliance, the project seeks to create adaptable, fit-for-purpose methodologies that strengthen the regulatory ecosystem's capacity to promote healthcare innovation. The project’s objectives include identifying and analysing existing regulatory sandboxes across various domains and maturity levels, to determine how their modules can complement current healthcare regulations. BRIDGE will develop a horizon scanning methodology to continuously identify emerging technologies that challenge existing regulatory systems, analyzing their requirements for potential inclusion in regulatory sandboxes to ensure adaptability within an evolving innovation ecosystem. Through multi-stakeholder consultations, BRIDGE will elaborate and assess case studies, as well as develop operational checklists for module design and evidence packages to guide tailored sandbox launches. The project will also develop the Modular Operational Sandbox for Healthcare Innovation and Compliance (MOSAIC), an architectural model with interconnected modules featuring detailed functional specifications and mapped information flows aligned with specific case studies. Additionally, BRIDGE will engage key stakeholders—including regulatory bodies, industry consortia, HTA bodies, payers, healthcare providers, and patients—in an in-depth analysis, consultation, and consensus-building process to ensure the sandbox approach is comprehensive, functional, and adaptable to future advancements. Finally, the project will deliver comprehensive recommendations for the sandbox methodology’s end-to-end operations, encompassing legal, compliance, policy, and regulatory outputs to provide a robust implementation framework.