The V3 framework and ATS-1 evidence tiers
Two ways of describing evidence for digital measures: one for whether a measure is fit for a clinical purpose, one for how strong each wellness claim is.
V3 in plain terms
V3 stands for verification, analytical validation and clinical validation. The Digital Medicine Society describes it as a modular, three-component framework for judging whether a digital measure is fit for purpose (DiMe, the V3 framework); the framework was set out in Goldsack et al., 2020, npj Digital Medicine.
The three components
| Component | The question it asks |
|---|---|
| Verification | Does the sensor capture and store the signal correctly? |
| Analytical validation | Does the algorithm turn the signal into the intended measure accurately? |
| Clinical validation | Does the measure reflect a meaningful state in a defined population and context of use? |
How ATS-1 evidence tiers relate
ATS-1 evidence tiers grade claims, not devices: Established, Model, Hypothesis or Inspiration. They are ANTRL's own framework and are not equivalent to V3. V3 questions still matter: ATS-1 asks for device provenance (a verification question) and algorithm versions (an analytical question) on every record.
Wellness use and the evidence burden
For general wellness products, the FDA's 2026 policy says validation may come from the manufacturer's own testing or peer-reviewed publication, and encourages making results public (FDA, General Wellness: Policy for Low Risk Devices, reissued 6 January 2026). ATS-1 has not undergone clinical validation and is not used for clinical purposes. See wellness versus medical device.
What this means for buyers
- Ask your device supplier for verification and analytical evidence for each measure you use
- Use ATS-1 tiers to label every claim you make to customers
- Keep out of scope what ATS-1 excludes: what ATS-1 will not do
Questions
Is ATS-1 validated under V3?
No. ATS-1 never uses that word. It is a research and general-wellness specification, and its accuracy is currently being studied.
Sources
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Verification, analytical validation and clinical validation (V3) in plain terms, and how ATS-1 evidence tiers relate to them for wellness use.