Healthcare Innovation Cycle for "Digital Medicine" Solutions

Digital Medicine is a broad term for the subset of the Digital Health field that related to promoting wellness or providing medical care (see Digital Therapeutics Alliance Definition). Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description and curated resources.

Note:To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest.

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MaturityDisplay

Requirement

Preliminary Indications for Use

A description of the way the solution is intended to be used and indications for when it is to be used.
The way a solution is intended to be used will have a major impact on the regulatory pathway. For example, if you are intending a solution to diagnose a medical condition, it will require much more proof than if it reports a value which clinicians use in making a diagnosis.
“Indications for use” describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. To be determined substantially equivalent, the device's indications for use must fall within the intended use of the predicate device.

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Regions/Markets