🛫 Overview of requirements for NHS pilot studies

Summary

• This guide offers a quick but essential overview of what's required when running different types of pilot studies in the NHS—helping HealthTech companies avoid costly compliance mistakes.
• It distinguishes between user testing, simulation studies, and full clinical studies, clarifying that regulatory obligations vary significantly depending on the study type.
• The content serves as a checklist for those conducting clinical pilots involving real patients, outlining necessary approvals and data governance frameworks.

What this carousel covers

• The three main categories of pilot studies: user testing, simulation, and clinical studies
• Key NHS and UK compliance requirements for clinical studies:
  • Ethics approval
  • MHRA notification
  • Information governance (Caldicott)
  • Data Protection Impact Assessment (DPIA)
  • Data Security Protection Toolkit (DSPT)
• Links to relevant regulatory tools and official NHS guidance

Key takeaways

• If your pilot doesn’t use real patient data, you likely don’t need formal approvals—but once patient data is involved, regulations apply
• Clinical pilots require careful planning and must be aligned with NHS data protection and ethics standards
• Each requirement—from DPIA to DSPT—is mandatory for patient-facing studies and must be completed before initiation
• Using the right resources and decision tools early in the process can save time and ensure smoother NHS integration

‍