Brief · Use case · Innovation
Digital Therapeutic Evidence Assessment.
LiveAssessmentJudge whether the evidence for a prescription digital therapeutic is enough for payer coverage, how strong each support is and where it is thin.
Digital Therapeutic Evidence Assessment is a ready-made use case for Innovation. It ships under the Assessment template.
For digital health and market access leads. You get a position with its confidence, the evidence graded, the strongest payer objection answered and the weaknesses ranked by effect. Claims are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
How well supported is the position that the evidence base for a prescription digital therapeutic is sufficient to support payer coverage?
What the assessment examines
Payers in different countries ask for different evidence. The assessment grades the evidence base against the standards of three systems, and says which of them it meets.
| Part of the position | What the assessment examines | Where it looks |
|---|---|---|
| Germany | Evidence that the application improves a patient’s health or ability to cope with the disease, examined together with data protection, interoperability and usability. Provisional listing is available while final evidence is generated.1 | The BfArM’s DiGA fast track. |
| France | Evidence of clinical benefit assessed by the health technology agency, with interoperability and security checked separately, for one year of early coverage while benefit is finished.2 | The early-access route for digital medical devices (PECAN). |
| England | Evidence standards that rise with the risk of the product’s function, with a technology that treats or manages a condition in the highest tier.3,4 | The NICE Evidence Standards Framework. |
What the assessment does
Sufficient for whom? Sufficiency is relative to a payer’s standard. The assessment says which system the evidence is graded against and shows where the evidence would be enough under one standard and not under another.1,2,3
Evidence tiers. The English framework sorts digital health technologies by function into tiers, and the evidence required rises with risk. The assessment places the product in a tier and grades the evidence for that tier.3,4
Provisional is not permanent. The German fast track allows provisional listing while final evidence is generated, and the French route gives one year of early coverage. The assessment says what has to be shown to move from the early status to a lasting one.1,2
The strongest objection. The objection is that effects in a trial of a digital product may not last in practice, because use falls away. The assessment restates it fairly and answers it from engagement and outcome data, if the evidence base has them.
Recommended length
Comprehensive
The position will be challenged by people who hold another view. Comprehensive adds the alternatives considered and the reasoning behind the support, which is what a challenger asks for.
You can pick another length on the form. The other two stay available.
Assumptions the assessment checks
The assessment states the assumptions the position rests on and says which one would hurt most if it failed. Examples for this position:
- The product’s intended function places it in the tier the assessment assigns.
- The pivotal evidence applies to the patients the payer would cover.
- Usage in practice resembles usage in the trial.
Standards, guidance and sources
Payer standards
- BfArM, Digital Health Applications (DiGA): the fast-track process and its evidence of positive healthcare effects.1
- The French early-access route for digital medical devices (PECAN), described by the national digital health agency.2
- NICE Evidence Standards Framework for digital health technologies, and its account in the peer-reviewed literature.3,4
The decision practice behind the memo itself is on the template page.
What gets flagged
Any payer standard the evidence does not meet, any gap between trial use and real-world use, and any tier assignment the assessment could not confirm.
What arrives
- The position
- The basis
- Why the evidence supports it
- The strongest objection, answered
- Other views considered
- Where it is weak
What it will not do
It does not recommend an action. A Decision Memo takes the assessment as its starting point.
It does not predict a coverage decision, and it does not replace advice from the payer or the health technology agency.
It does not recommend an action. An assessment says how well a position is supported; a Decision Memo recommends what to do.
Certainty ratings are analyst judgment from an AI specialist, not measurements, and the reason for each is on the page so you can disagree with it.
It does not settle a question the evidence leaves open. Where the evidence is thin, the assessment says so and says what would settle it.
References
- [1] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025. Read on 9 October 2026.
- [2] Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices. Read on 9 October 2026.
- [3] National Institute for Health and Care Excellence. Evidence standards framework for digital health technologies (ECD7). NICE’s page could not be opened from our tools; content is taken from reference 4 and from NICE’s search listing. Check the current version.
- [4] Unsworth, H. et al. The NICE Evidence Standards Framework for digital health and care technologies. Digital Health, 2021;7. DOI 10.1177/20552076211018617. Describes the 2021 version of the framework; NICE has revised it since.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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