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Connected Health Device Feature Spec Template
Free connected health device spec template for health tech PMs. Define device integration, data flows, clinical thresholds, patient-facing features,...
Updated 2026-03-05
Connected Health Device Feature Spec
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Frequently Asked Questions
How do I handle patients who have multiple connected devices?+
Design a unified dashboard that aggregates data from all connected devices into a single patient view. Use consistent color coding and threshold logic across device types. Prioritize the most clinically relevant reading on the home screen and let patients drill into individual device data. On the provider side, correlate multi-device data (e.g., blood pressure trends alongside weight trends) to surface insights that single-device data misses.
What happens when the device firmware needs an update?+
Define a firmware update strategy that minimizes patient disruption. Over-the-air (OTA) updates via the companion app are standard. Require user consent before updating, schedule updates during low-use periods (e.g., overnight charging), and ensure the device stores pending readings during the update process. Never force an update that blocks the patient from taking a measurement.
How do I spec data accuracy validation?+
For FDA-cleared devices, the manufacturer's 510(k) submission includes accuracy validation data. Your responsibility is ensuring data fidelity from device to app to cloud to provider dashboard. Test the full pipeline: take a reading, verify the value matches at every stage (device screen, app display, cloud database, provider dashboard). Document acceptable rounding rules if any.
Should the provider dashboard integrate into the EHR or be a standalone app?+
Both. Start with a standalone web dashboard for faster iteration and broader provider access. In parallel, build FHIR-based integrations to push readings and alerts into the EHR as Observations. Most providers will not check a separate dashboard daily, but they will see an alert in their EHR inbox. The standalone dashboard serves care managers who do population-level monitoring.
How do I handle time zone differences between device and app?+
Store all timestamps in UTC. Convert to the patient's local time zone for display in the app and to the provider's local time zone for the dashboard. Document the time zone handling in the data model spec. This matters for clinical interpretation: a reading taken at 6 AM in Pacific time is different context than a reading at 6 AM Eastern. ---
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