Customer: Reset Health, a Safehand customer since August 2023 
Sector: Health IT Manufacturer and Chronic Care Delivery Service  
Services Safehand provided: Clinical Safety Consultancy underDCB 0129 and DCB 0160 

Background

Reset Health approached Safehand for support meeting the Clinical Safety requirements of the Digital Technology Assessment Criteria (DTAC). The Reset Health in-house clinicians manage patients with chronic conditions through their NICE recommended care delivery platform, Roczen.  

In the unusual position of being both the manufacturer of the digital health platform and a CQC registered healthcare service Reset Health valued compliance with the Standards to the highest standard and recognised Safehand’s expertise would bolster their process.  

Safehand were able to guide them through the structured clinical risk management process, from initial planning and hazard identification to the production of clinical safety documentation. 

Objectives 

  • Support the organisation to comply with DCB 0129 and DCB 0160 
  • Identify and mitigate clinical safety risks associated with the product and the risks associated with delivering healthcare services via the product  
  • Produce robust, auditable documentation including the Clinical Risk Management Plan, Hazard Log and Clinical Safety Case Report 
  • Align clinical risk management activities with local governance processes and produce and embed a Clinical Risk Management Process  

Our Approach

We began with an onboarding phase, providing Reset Health with a structured environment to upload system documentation and complete targeted questionnaires. Clinical Safety Officer (CSO) Lucy Birks was assigned to the project and led guided workshops involving the Clinical, Development and Product teams at Reset Health to understand the system’s functionality, patient safety impact, and operational context. Using a Structured What-If (SWIFT) based analysis and a risk matrix aligned with DCB 0129/0160, the CSO facilitated collaborative risk assessment sessions, ensuring clinical engagement throughout. 

Key project steps included: 

  • Gap analysis against DCB 0129/0160 requirements 
  • Hazard workshops 
  • Population of the Hazard Log using SafetyLogix 
  • Agreement on control measures and residual risk evaluation 
  • Production and approval of the CRM Plan, Hazard Log, Safety Case Report, and related artefacts 

Outcome  

Using the expertise and experience of the team at Safehand and retaining the ongoing CSO service, Reset Health can evidence ongoing compliance with both the DCB 0129 and the DCB 0160 Standards which has since made it possible to contract in the NHS.   

By taking the time to understand the systems and governance processes Reset Health already had in place, the CSO was able to seamlessly integrate with the team to develop and embed a documented Clinical Risk Management Process and Safety Incident Management Process assuring the platform and healthcare delivery throughout the products ongoing development. 

Customer feedback 

Dr Laura Falvey, the Executive Clinical Director and the Clinical Safety Sponsor commented, “Working with Safehand Consulting, and particularly our Clinical Safety Officer Lucy Birks, has been an outstanding experience. Lucy has been phenomenally helpful—pragmatic, calm, and highly skilled at rationalising and simplifying complex regulatory processes. She integrates into our ways of working, providing expert guidance without adding unnecessary burden. Safehand is a consulting firm that genuinely works with you, not just for you, ensuring clinical safety compliance is both achievable and embedded effectively within our organisation. We are grateful for their expertise and ongoing support”.