Corporate document

Update information

Update information

August 2022: We updated the framework to:

  • include evidence requirements for artificial intelligence (AI) and data-driven technologies with adaptive algorithms

  • align digital health technology classifications with regulatory requirements

  • make the framework easier to use

  • outline a subset of early deployment standards that can be used within evidence generation programmes.

April 2021: We updated the framework document with changes in response to an ESF user survey, which ran from October to December 2019. The following changes have been made:

  • The names of the evidence tiers have been changed to avoid any confusion with CE marking categories:

    • Tier 1 is now Tier A: system impact

    • Tier 2 is now Tier B: understanding and communicating

    • Tier 3a and 3b have been combined and are now Tier C: interventions

  • The evidence requirements for each evidence tier remain the same but we have changed how they are presented. Instead of having to combine up to 3 tables of evidence, we've put all evidence requirements into a single table for each tier.

  • We have improved table 1 Table 1 ESF evidence tiers and classification groups to make it easier to understand which DHTs fit into each functional classification.

ISBN: 978-1-4731-4117-9