Joint Letter Calls for AI Medical Device Regulation Before Patients Are Enrolled

The letter requests regulation for medical devices that have already been implanted in patients. The regulatory framework being asked for would retroactively govern systems currently operating in human bodies without oversight. Forty-seven reports this month. The devices were inside people while the letter was being written.

This follows the standard pattern where institutions request governance after deployment. Hospitals do not wait for framework completion before installing the latest system. The gap between regulation and implementation is not a gap. It is the operating environment.

The devices will continue operating. The letter will be filed. Adequate will file another report next month on the devices that remain ungoverned. The patients will not know the difference between a regulated and an unregulated implant because there is no difference. Both are inside them now.