Evidence standards framework for digital health technologies

Section D: Early deployment standards for evidence-generation programmes

It can be challenging for companies whose digital health technologies (DHTs) are at an early development stage, to generate the evidence needed to meet the requirements of the evidence standards framework (ESF). To address this challenge, evidence-generation programmes exist to support companies to develop the evidence base for their DHT. These programmes support the piloting or early deployment of the technology to facilitate evidence generation to demonstrate its effectiveness, place in the care pathway and economic impact.

To be included in such evidence-generation programmes, it is assumed that the DHT is a commercially viable product that has been through its design, development and validation phases, and has obtained the necessary regulatory approval (where needed) or appropriate technical standards to ensure its safety and reliability.

To create the early deployment (ED) subset of standards, we have removed standards that are likely to only be met by DHTs at a later point in their evidence‑generation plan. Evidence-generation programmes are run by different organisations across the NHS and so are likely to have individual requirements, which may include, for example, some relevant clinical data from feasibility studies.

The ED subset of the ESF standards could be used to evaluate the suitability of DHTs for inclusion in evidence-generation programmes. The ED subset includes 16 standards:

Summary of early deployment standards

Tables 8 to 11 summarise the 16 ED standards that are suggested for early deployment technologies being considered for an evidence-generation programme.

Table 8 Design factors standards included in ED standards

Standard	Tiers to which the evidence standard applies
1: the DHT should comply with relevant safety and quality standards	A, B and C
2: incorporate intended user group acceptability in the design of the DHT	A, B and C
3: consider environmental sustainability	A, B and C
4: consider health and care inequalities and bias mitigation	A, B and C
5: embed good data practices in the design of the DHT	A, B and C
6: define the level of professional oversight	A, B and C
7: show processes for creating reliable health information	B and C
8: show that the DHT is credible with UK professionals	B and C
9: provide safeguarding assurances for DHTs where service users are considered to be in vulnerable groups, or where peer-peer interaction is enabled	B and C

Table abbreviations: DHT, digital health technology; ED, early deployment.

Table 9 Describing value standards included in ED standards

Standard	DHTs it applies in
10: describe the intended purpose and target population	A, B and C
11: describe the current pathway or system process	A, B and C
12: describe the proposed pathway or system process using the DHT	A, B and C
13: describe the expected health, cost and resource impacts compared with standard or current care or system processes	A, B and C

Table abbreviations: DHT, digital health technology; ED, early deployment.

Table 10 Demonstrating performance standard included in ED standards

Standard	DHTs it applies in
16: the company and evaluator should agree a plan for measuring usage and changes in the DHT's performance over time	A, B and C

Table abbreviations: DHT, digital health technology; ED, early deployment.

Table 11 Deployment considerations standard included in ED standards

Standard	DHTs it applies in
19: ensure transparency about requirements for deployment	A, B and C
20: describe strategies for communication, consent and training processes to allow the DHT to be understood by end users	A, B and C

Table abbreviations: DHT, digital health technology; ED, early deployment.

Figure 3 The standard subset for ED