Regulatory and Standardization Challenges for Connected and Intelligent Medical Devices (REG-MEDTECH)

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The REG-MEDTECH project investigates the critical cybersecurity, software, algorithmic decision-making challenges posed by connected, intelligent medical devices.

This project investigates a pressing, yet underexplored area, at the intersection of cybersecurity in IoT ecosystems (especially medical devices at the edge and software as medical device), law and regulation, and digital healthcare. In recent years, several policy and regulatory initiatives have been established to address the security, safety, and trust implications of connected, intelligent devices. However, a critical gap remains pertaining to the development of standards that underpin regulatory guidelines and requirements, updating design, risk management, and mitigation practices for key stakeholders: software developers, manufacturers, healthcare providers and regulators.

The project offers a unique and established partnership between UCL and BSI (UK national standards body), with a high-value network of collaborators across academia, industry, regulators, specialist agencies, and international organisations.