UK Digital Health market access can be difficult. Managing multiple quality assurance and compliance requirements across the subjects of Information Security, Information Governance, Cyber Security, Medical Device Regulatory is time consuming and costly. The UK NHS places additional requirements of Digital Technology Assessment (DTAC) and Clinical Safety on manufacturers. ETHOS will demonstrate how to manage the problem of multiple competing regulatory challenges through a strategized approach including agile processes.

ETHOS will share insights on the critical friend service provided, evidenced by success stories.

Speaker: Stuart Harrison, Co-founder & CEO, ETHOS

Stuart led the Clinical Safety movement in the UK NHS alongside some of the most prominent Clinical leaders for over 15 years. Stuart has authored UK NHS Clinical Safety & Risk Management Systems, re-authored NHS safety standard, and worked at the highest level to ensure core safety engineering principles are embedded in the UK NHS code of practice. These are the foundational principles on which health informatics will be led throughout the coming decades and he is passionate about driving at scale improvement across the sector, both in the UK and internationally. He leads the development of ISO standards for health software (including medical devices) and continues to lead the emergence of standards aligned to innovative digital health interventions. His PhD studies at the Institute of Digital Healthcare, University of Warwick are focused on clinical decision supporting systems including safety concepts for emerging technology & complementary regulatory frameworks and also the inclusion of mobile health data into safer decision making, exploring the lifecycle models of clinical decision support systems.

Location: UK Presentation Theatre: Hall 16, J48