In this episode, we are joined by Adrian Stavert-Dobson, where we delve into the complexities of Clinical Risk Management and regulatory compliance in digital health. Our conversation covers a range of crucial topics, including:
- Governance – National and Local: We explore NHSE responsibilities and the ongoing discussions around the regulation of DCB0129/0160, even touching on the inclusion of MHRA and CQC.
- The Role of the CSO: How the role is evolving with expanding regulatory compliance pathways, such as DTAC, InfoSec, MDR (national/international), ISO standards, and AI.
- NHS Safety Standards: A look ahead at how NHS safety standards could change (or should change!) over the next five years, especially with upcoming consultations to improve the current compliance framework.
- Manufacturer vs Health Organisation: We discuss the ongoing challenge of raising CRM awareness, the need for better communication, and the power dynamics between manufacturers and healthcare organisations that often hinder safe and effective digital health project delivery.
- Safehand: Adrian shares insights into Safehand, his business challenges, and what keeps him motivated.
- SafetyLogix: Learn about this digital platform and its role in clinical risk management. We also discuss the platform’s risk assessment under DCB0129 and Adrian's first-time experience as an exhibitor at HETT 2024.
This episode is packed with valuable insights into the future of digital health governance and the evolving roles within this sector. Don’t miss it!
