Medical Device Metadata is a new ROOK Connect feature. It adds the device behind each blood glucose, blood pressure, SpO2, body temperature and ECG reading to the webhooks you already receive: its manufacturer, model and category. When a verified FDA or EU CE record exists for that model and measured function, it also includes that record. You enable it yourself in the ROOK Portal.
Field reference and payload examples: Medical Device Metadata documentation.
Why does the device behind a reading matter?
Before this release, every reading delivered by ROOK Connect looked the same, whether it came from an FDA-cleared blood pressure monitor or a consumer smartwatch. Teams building healthcare products had to find out on their own which device produced a measurement and whether a verified FDA or EU CE regulatory record exists for that measurement. Medical Device Metadata delivers that information in the event itself.
Which events and data sources are supported?
Medical Device Metadata covers 5 event types from 5 data sources:
- Blood glucose: Dexcom, Apple Health, Health Connect, Samsung Health.
- Blood pressure: Withings, Apple Health, Health Connect, Samsung Health.
- Oxygenation (SpO2): Withings, Apple Health, Health Connect, Samsung Health.
- Body temperature: Withings, Apple Health, Health Connect, Samsung Health.
- ECG: Withings, Apple Health.
What does the new field contain?
The
new device_source_data_array
field answers two questions for each device:- Which device captured this reading? manufacturer_string, model_stringanddevice_category_string. Example: Withings, BPM Core, Blood Pressure Monitor.
- Is there a verified regulatory record for this device and measurement? medical_device_boolandregulatory_info_array, with the regulatory system (FDAorEU_CE), the regulated function, the pathway (for example510korMDR), the authorization ID when it can be verified, and the access condition (otc, prescription or professional).
Why is regulatory status evaluated per function, not per device?
Medical Device Metadata evaluates each manufacturer, model and measured function separately, because one device can include both regulated functions and wellness features. An ECG event from an Apple Watch Series 9 returns
medical_device_bool: true
, backed by FDA 510(k) K201525. An SpO2 event from the same watch returns null
.Where does the regulatory information come from?
Medical Device Metadata uses regulatory records that ROOK verifies against primary sources, not marketing labels. The sources are the FDA 510(k) database, the European Database on Medical Devices (EUDAMED), certificates and declarations of conformity, and manufacturers' regulatory documentation. This release covers verified records for 26 device models from Apple, Dexcom and Withings, under the FDA (United States) and EU CE (European Union) systems.
What changes in my webhooks?
Your webhooks change only by adding
device_source_data_array
to the 5 supported events. No new endpoint or integration is needed, and all existing fields stay the same. While the feature is off, your payloads are unchanged.How do I enable Medical Device Metadata?
You enable Medical Device Metadata yourself, without contacting support. It is disabled by default.
- Sign in to the ROOK Portal and go to Products → ROOK Connect.
- Find Medical Device Metadata.
- Turn the toggle on. Your webhooks include the field from that moment on.
Medical Device Metadata FAQ
- What is Medical Device Metadata?Medical Device Metadata is a ROOK Connect feature. It adds the manufacturer, model and category of the device behind each supported reading to your webhooks. It also adds the device's FDA or EU CE regulatory record when one is verified for that model and function.
- What problem does Medical Device Metadata solve?Medical Device Metadata helps you identify when a reading comes from a device and function for which ROOK has verified an FDA or EU CE regulatory record. You get this without building and maintaining your own catalog of device models and regulatory records.
- Which events does Medical Device Metadata support?Medical Device Metadata supports 5 event types: blood glucose, blood pressure, oxygenation (SpO2), body temperature and ECG.
- Which data sources does Medical Device Metadata support?Medical Device Metadata supports Dexcom, Withings, Apple Health, Health Connect and Samsung Health. ECG is available from Withings and Apple Health.
- Is ECG available from Health Connect or Samsung Health?No. Samsung Health does not make ECG recordings available to third-party applications, so Medical Device Metadata does not include ECG from Health Connect or Samsung Health in this release.
- Does medical_device_bool: true mean every metric from that device is medical-grade?No.medical_device_boolapplies only to the function measured in that event. A device can have a regulated function, such as ECG, and wellness features, such as SpO2 or skin temperature. Checkregulated_function_stringinregulatory_info_arrayto see which function the record covers.
- Why is medical_device_bool null for my device?medical_device_boolisnullwhen ROOK has no verified FDA or EU CE record for that model and function. The model may not be evaluated yet, may not be identified precisely by the data source, or may be presented by its manufacturer as a wellness feature.nulldoes not mean the device is not a medical device.
- Does Medical Device Metadata return false?Not in this time. false is reserved for functions explicitly evaluated as non-medical. Today medical_device_bool returns eithertrueornull.
- Which device models have verified regulatory records? Medical Device Metadata currently has verified FDA or EU CE records for 26 device models:
- Blood glucose: Dexcom G6, G7, ONE, ONE+, Stelo.
- Blood pressure: Withings BPM Connect, BPM Connect Pro, BPM Core, BPM Pro 2, BPM Vision.
- ECG: Apple Watch Series 4, 5, 6, 7, 8, 9, 10, 11, Ultra, Ultra 2, Ultra 3; Withings BeamO, Move ECG, ScanWatch, ScanWatch 2.
- SpO2: Withings BeamO, ScanWatch.
- Body temperature: Withings BeamO, Thermo.
A model may have an FDA record, an EU CE record, or both. Check regulatory_info_array for the exact records. ROOK reviews and expands this list over time.
- Which regulatory systems does Medical Device Metadata cover?Medical Device Metadata covers the FDA (US Food and Drug Administration) and EU CE marking (European Union). Other regulatory authorities are not included in this release.
- Why can one device have several regulatory records?A device model can be authorized in more than one jurisdiction, or hold more than one authorization for the same function. Medical Device Metadata returns each verified record as a separate item inregulatory_info_array.
- Why are authorization_id_string or regulatory_pathway_string sometimes null?Medical Device Metadata includes a regulatory identifier or pathway only when the evidence confirms it for that exact model. When the public record does not allow an exact match, the field isnullinstead of an inferred value. ROOK never copies a record from a similar model.
- Does ROOK use the device information sent by the data source?The device identity fields (manufacturer, model and category) come from the data source. The regulatory fields, medical_device_bool and regulatory_info_array, are always calculated by ROOK against its verified records. Regulatory values sent by a data source are never used.
- Why are most device fields null in some events? Readings entered manually in a companion app, such as the Withings app, are not captured by a connected device. In those events, manufacturer_string,model_stringand the regulatory fields are usuallynull.
- Can one event include more than one device?No.device_source_data_arraycurrently returns at most one device per event. When the same measurement is reported by more than one source (for example, Withings and Apple Health), ROOK applies source-priority rules to determine which device's information is kept.
- Will I receive Medical Device Metadata for past events?No. Medical Device Metadata is available only for events that ROOK Connect ingested after the feature was released. Events ingested earlier are not reprocessed.
- Does enabling Medical Device Metadata change my existing payloads?Only by addingdevice_source_data_arrayto the 5 supported events. All existing fields stay the same, and payloads are unchanged while the feature is off.
- Do I need a new endpoint or integration?No. Medical Device Metadata is delivered inside the ROOK Connect webhooks you already receive for the supported events.
- How do I enable or disable Medical Device Metadata?In the ROOK Portal, go to Products → ROOK Connect → Medical Device Metadata and use the toggle. It is disabled by default.
- Does Medical Device Metadata transfer a device's authorization to my application?No. A device's FDA or EU CE status applies only to that device and function. It does not extend to or imply regulatory approval, clearance, or certification of your application, product, or service. You remain responsible for determining the regulatory status of your own product.
- Is Medical Device Metadata legal, medical or regulatory advice?No. Regulatory information in Medical Device Metadata is provided for informational and reference purposes only. It is based on public regulatory sources consulted at the time of verification, may change or differ in scope between jurisdictions, and does not replace validation with the relevant authority, the manufacturer or a qualified specialist.