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

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

The development of connected, intelligent medical devices offers significant benefits in healthcare, especially in improving patient care, and increases the efficiency of the healthcare system and patient outcomes. However, these devices also create new risks and challenges. Connected, intelligent medical devices disrupt established standards and regulatory frameworks, creating new questions around cybersecurity, the integrity and reliability of algorithmic decision-making, patient safety, and the resilience of broader healthcare infrastructures, as well as consumer awareness and transparency.

Medical devices are highly regulated and standardized across the world, with notable regulatory frameworks established in the UK, EU, US and South-East Asia. These regulatory frameworks are also harmonised in organizations such as the International Medical Device Regulators Forum (IMDRF).

Embedding connectivity and intelligence in medical devices disrupts these established frameworks. Several critical challenges have already been identified, but require further research, especially in relation to their implications for existing standards and regulations:

• Connected medical devices have poor cybersecurity and can be easily compromised;
• Compromised devices generate security spillovers across the healthcare infrastructure, with critical consequences for confidentiality, integrity and availability;
• Software as Medical Device (SaMD), connected and intelligent implantables, and the growth of Internet-connected wellbeing devices blur the lines between existing medical device classifications, which address product quality and safety.

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