Table 2.

The domains considered essential for the validation of digital health systems [20].

Domain and component		Description
Technical
	Robustness	Testing of performance when compared to a technical gold standard
	Privacy and security	Testing of privacy and security requirements
	Interoperability	Testing of interoperability requirements
	Transferability	Potential to adapt to other services and implementation scenarios
	Smartness	Testing of innovative features powered by artificial intelligence
Clinical
	Safety	Critical appraisal of technology impact on patient safety outcomes
	Medical benefit	Evidence of positive health care effects
Usability
	Ease of use	Whether digital health systems can be used as intended by users
	Feasibility	Whether digital health systems work as intended in each context
Cost
	Value generation	Anticipated cost impact on the clinical outcome of interest
	Affordability	If the costs of digital health systems can be made affordable