Which wearables give researchers raw sensor data?
Several do, but almost always behind a gate such as an approval or a contract. Garmin, Samsung Galaxy Watch, Apple Watch, Polar H10, Polar Verity Sense, Withings ScanWatch, and the ActiGraph devices document raw or near raw routes. Oura, WHOOP, and Fitbit Air do not. Through WeGuide, raw accelerometer and gyroscope data are available from supported Garmin models only.
Is an FDA cleared wearable cleared for everything it measures?
No. The FDA clears or authorises specific software features for specific indications, such as an ECG app that classifies atrial fibrillation in adults. Heart rate, HRV, sleep stages, and SpO2 on consumer wearables are usually wellness features. Check the feature and its 510(k) or De Novo number, which this tool links to the FDA database.
Can we pull Apple Watch data from Apple’s cloud?
No. Apple has no server or OAuth API for Apple Watch data. A study app reads HealthKit on each participant’s iPhone, with permission for each data type, and then uploads the data. Raw signals such as PPG and accelerometer data need SensorKit, which is only available to research studies that Apple has approved.
What does via Apple Health or Health Connect mean?
It means the maker’s phone app writes summary data into the phone’s health store, and WeGuide reads it from there. Only the data types that the maker writes can arrive, and they differ by maker. For example, WHOOP writes no HRV to either store, and Oura writes no HRV to Apple Health. It is not a direct integration with the maker.
Do participants need a paid subscription?
For Oura Ring Gen3 and later and for WHOOP, yes, because data access or collection stops without one. New Withings accounts created on or after 13 October 2026 need Withings+ to share data with other apps, including Apple Health and Health Connect. Garmin, Apple, Samsung, Polar, and Fitbit devices work without a subscription for core data.
If a device is validated, is my endpoint valid?
Not automatically. Validation applies to one metric, population, wear location, and firmware version. FDA guidance asks sponsors to show that a device is fit for purpose in the proposed population, and the V3 framework separates verification, analytical validation, and clinical validation. Use published studies to shortlist devices, then plan the evidence your endpoint needs.
Should we choose a ring, a wrist device, or a chest strap?
It depends on the measure and the wear schedule. Rings and screenless bands suit continuous overnight wear, wrist devices offer the broadest set of metrics, and chest straps such as the Polar H10 give beat to beat intervals but suit supervised sessions with a set start and end. Wear location also changes step counts, so do not mix placements without calibration.
What happens if firmware updates during my study?
Measurements can shift after an update. FDA guidance asks sponsors to keep a record of the timing and nature of updates for each device, so record the model, firmware, and app version for each participant and log the update dates. Where raw data are available, you can reprocess every participant with one fixed algorithm.
Can one device serve both iPhone and Android participants?
Yes, several can. Garmin, Fitbit Air, Fitbit Charge 6, Oura, WHOOP, Polar, and Withings devices work with both platforms. Apple Watch works only with iPhone, while Galaxy Watch and Pixel Watch work only with Android phones. Use the phone platform filter and choose Both to see the devices that suit a mixed cohort.
Can a new study still use the Fitbit Web API?
No. Google switches off the legacy Fitbit Web API on 30 October 2026, and new builds must use the Google Health API. Its health scopes are restricted and need a Google privacy and security review, and research use also needs an attestation with ethics approval. Every participant must also give consent again under the new API.