Table 3.

Overview of the impediment clusters.

	Ineffective stakeholder collaboration	Lack of ethical awareness among digital health innovators	Lack of relevant regulation
Description & context: What it is	•Digital health occurs in complex, inter-dependent stakeholder ecosystems •Core stakeholders lack incentives to jointly pursue digital health innovation	•Innovators’ early-stage design choices have long-lasting impact	•Digital health disrupts regulators’ modus operandi •Regulators do not react adequately to innovation
Transmission mechanism: How it impedes responsible digital health	•Stakeholder complexity distracts from user centricity •Ineffective stakeholder collaboration slows data-sharing	•Some innovators do not address ethical concerns due to lack of awareness and resources	•Regulatory uncertainty and complexity hinder innovators •Regulatory uncertainty drives out compliance focused innovators •Regulators should build up capabilities and adopt a new operating mode
Lead stakeholders: Who is responsible	All stakeholders	Innovators	Regulators

For each impediment cluster, the “Description & context” layer describes “what” an impediment is and in what context it occurs; the “transmission mechanism” details “how” the impediment cluster ultimately impacts responsible digital health. Lead stakeholders are those with the highest impact and responsibility for the obstacle.