User actions lost on bad networks or devices
Submissions, messages or orders disappear or duplicate.
Severity: trust. Attached to 4 of 46 published product types, backed by 6 evidence records.
Product types that carry it
| Product type | Grade | Note for this type | Evidence |
|---|---|---|---|
| patient portal | secondary | A secure message to the care team shows as sent in the portal but never reaches the clinician's inbox or the chart, so the symptom it reports goes unanswered. | |
| software as a medical device | primary | A low-glucose or sensor-failed alarm raised by the device never sounds because the phone's focus mode or a new OS version silences the app. | |
| smart home or IoT app | primary | With the home internet down, tapping "unlock" in the app does nothing and shows no message, although the phone and the lock share the same Wi-Fi. | |
| fleet and logistics tracking | primary | The cab tablet loses its link to the engine module, and hours driven during the gap never reach the driver's log or raise a malfunction flag. |
Tests that address it
- release smoke tests: mandatory for this risk on 3 product types.
- end-to-end functional tests: mandatory for this risk on 1 product types.
- integration tests: mandatory for this risk on 2 product types.
- device and browser compatibility: mandatory for this risk on 3 product types.
- resilience and failure testing: mandatory for this risk on 1 product types.
- offline and poor-network testing: mandatory for this risk on 2 product types.
Evidence
ev-0127regulatorsecondary
Healthcare Inspection - Poor Follow-Up Care and Incomplete Assessment of Disability, VA San Diego Healthcare System San Diego, California, U.S. Department of Veterans Affairs, Office of Inspector General
Government inspection report: a patient's secure messages to his primary care provider through the VA patient portal were mostly not reflected in the health record, and OIG recommended guidance on what portal messages must be documented. Supports lost-actions for patient portals whose messages do not land in the chart.
published 2016-01-05 · verified 2026-10-07
ev-0128regulatorsecondary
Care Coordination Deficiencies after the New Electronic Health Record Go-Live at the Mann-Grandstaff VA Medical Center in Spokane, Washington, U.S. Department of Veterans Affairs, Office of Inspector General
Patient portal and secure messaging being inaccessible
Government inspection report listing an inaccessible patient portal and secure messaging among the care coordination problems after an EHR go-live. Supports lost-actions for patient portals that depend on the record system behind them, and for EHR systems whose go-live cuts the portal off.
published 2022-03-17 · verified 2026-10-07
ev-0165regulatorprimary
Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure, U.S. Food and Drug Administration
FDA correction notice: when the sensor transmitter failed, the glucose monitor app ended the session and stopped reporting values without the Sensor Failed alert, so users missed readings and alarms. Supports user-harm and lost-actions for SaMD that relays sensor data and alarms through a phone.
published undated · verified 2026-10-07
ev-0166regulatorprimary
FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices, U.S. Food and Drug Administration
FDA safety communication: phone settings and operating system updates not supported by the device app can stop critical alerts from reaching the user. Supports lost-actions and user-harm for SaMD that depends on a consumer phone to deliver alarms.
published 2025-02-05 · verified 2026-10-07
ev-0241regulatorprimary
49 CFR Part 395 Subpart B: Electronic Logging Devices (ELDs), U.S. Federal Motor Carrier Safety Administration (eCFR)
Edits requested by any system or by any person other than the driver must require the driver's electronic confirmation or rejection.
Applies where the fleet platform provides electronic logging of drivers' hours: the rule requires accurate records, annotated edits confirmed by the driver, and recorded malfunctions and data diagnostic events.
published undated · verified 2026-10-07
ev-0257standardprimary
ETSI EN 303 645 V3.1.3: Cyber Security for Consumer Internet of Things: Baseline Requirements, ETSI
Consumer IoT devices should remain operating and locally functional in the case of a loss of network access and should recover cleanly in the case of restoration of a loss of power.
The consumer IoT baseline standard asks for resilience to network and power outages, unique per-device passwords and a secure update mechanism, which the phone app controlling the device has to respect.
published undated · verified 2026-10-07