UNIVERSAL ADVANCED Medical Device Firmware Security and Patch Registry Project Acronym: UAMDFSPR

PROBLEM: Connected health devices generate continuous data, yet the medical device firmware security and patch registry problem has no governed record: a reading, an alert, or a device fault can travel from sensor to clinician without any durable account of which device, which software version, and which consent applied. Patient safety depends on records that often do not exist.

SOLUTION: IBM Cloud Ideas would provide a governed medical device firmware security and patch registry record: every reading, device state, consent, and handoff logged with lineage, so care decisions are traceable to their source. It governs the record, not the clinical judgement.

EVIDENCE BASIS: DOCUMENTED — the U.S. Food and Drug Administration clears connected medical devices and has issued cybersecurity guidance for them; HIPAA governs protected health information; software-related device recalls are documented. Source: FDA device guidance; HIPAA.