Table 3.

The eHealth contexts considered essential for the validation of digital health systems.

eHealth strategy	Description
Telehealth	Digital support to well-established service workflows to enhance health care efficiencies. Typically, clinical evidence is not required. Not a medical device.
Integrated care	Digital support to enable innovative service workflows with a care continuum approach. Clinical evidence is required. Requires regulatory clearance or approval.
Digital therapeutics	Medical device software–driven therapeutic intervention for prevention, management, or treatment. Evidence and regulatory approval are required.