1 Purpose of this document

NICE's assessment of digital health technologies to help manage symptoms of psychosis and prevent relapse recommends that more evidence is generated while the technologies (AVATAR Therapy, SlowMo and CareLoop) are being used for adults in the NHS. The technologies can only be used once they have appropriate regulatory approval including NHS England's Digital Technology Assessment Criteria (DTAC) approval.

This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence if these are able to address the research gap.

The companies are responsible for ensuring that data collection and 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 companies for evidence generation.

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

NICE will withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (3 years, or less if evidence is available), the companies 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 technologies can be routinely adopted in the NHS.