1 Purpose of this document

NICE's assessment of KardiaMobile 6L recommends that further evidence is generated while it is being used in the NHS.

This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technology again in the future. It is not a study protocol.

The technology developer is responsible for ensuring that data collection and data analysis takes place. Support for evidence generation will be available through a competitive process facilitated by the Office for Life Sciences, pending business case approval. This will be in the form of funding for evidence generation consortia, bringing analytical partners and implementation sites together with developers for evidence generation.

Guidance on commissioning and procurement of the technology will be provided by NHS England, who is developing a digital health technology policy framework to further outline commissioning pathways.

NICE will withdraw the guidance if the technology developer does not meet the conditions in section 4 on monitoring.

After the evidence generation period (3 years), the developer should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technology can be routinely adopted in the NHS.