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    Are there any additional implementation factors that need to be considered?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

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1 Purpose of this document

NICE's early value assessment of digital technologies for managing low back pain (that is, ACT for PAIN, getUBetter, Hinge Health Digital MSK Clinic, Kaia App, Pathway through Pain, selfBACK and SupportBack) recommends that further evidence is generated while they are being used in the NHS. Ascenti Reach and Phio Engage can only be used in research and are not covered in this plan.

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.

The technology developers 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 developers for evidence generation.

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

NICE will withdraw the guidance if the technology developers do not meet the conditions about monitoring evidence generation in section 4 on monitoring.

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