Table 2.

Abridged contextual questions to help identify higher-risk digital health technologies (DHTs), abridged from [10].

Question	Risk adjustment
1. Are the intended users of the DHT considered to be in a potentially vulnerable group such as children or at-risk adults?	The National Health Service (NHS) England defines an at-risk adult as an adult “who may be in need of community care services by reason of mental or other disability, age or illness; and who is or may be unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation.” If the DHT is intended to be used by people considered to be in a potentially vulnerable group, then a higher level of evidence may be needed, or relevant expert opinion on whether the needs of the users are being appropriately addressed.
2. How serious could the consequences be to the user if the DHT failed to perform as described?	A higher level of potential harm may indicate that the best-practice evidence standards should be used.
3. Is the DHT intended to be used with regular support from a suitably qualified and experienced health or social care professional?	DHTs that are intended to be used with support (ie, with regular support or guidance from a suitably qualified and experienced health or social care professional) could be considered to have lower risk than DHTs that are intended to be used by the patients on their own. This contextual question may require careful interpretation depending on the individual DHT as the involvement of a clinician may in itself indicate that the DHT presents a specific risk.
4. Does the DHT include machine learning algorithms or artificial intelligence?	Refer to the code of conduct for data-driven health and care technology for additional considerations when assessing DHTs that use artificial intelligence or machine learning.
5. Is the financial or organizational risk of the DHT expected to be very high?	DHTs with very high financial risk should be assessed using the best-practice standards to provide surety that the DHT represents good value. High organizational risks may include situations in which implementing the DHT would need complex changes in working practice or care pathways.