This episode features a conversation with Jeanette Kusel- Director for Scientific advice at NICE the national institute of health and care excellence, and addresses the role that NICE  has to play with regards to digital health technologies

Discussion topics include:

• The difference between the evaluation required for regulatory approval (CE/UKCA marking) and NICE approval
• Innovative new approaches to assessing healthtech innovations including:
  • The NICE META tool
  • Early value assessments
  • The AI and digital regulations service
  • NICE Evidence Standards Framework
• What is involved in a NICE approval process for digital health technologies 
• Common mistakes that companies make when evaluating their products and how these can be avoided

Links:

META tool: https://meta.nice.org.uk/

Early value assessments: https://www.nice.org.uk/about/what-we-do/eva-for-medtech

AI and digital regulations service: https://transform.england.nhs.uk/ai-lab/ai-lab-programmes/regulating-the-ai-ecosystem/the-ai-and-digital-regulations-service/

NICE evidence standards framework: https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies

NICE Real World Evidence framework: https://www.nice.org.uk/corporate/ecd9/chapter/overview