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Surgeons at the arms of a surgical robot in an operating room
Kemberly Groue, U.S. Air Force · Wikimedia Commons · Public domain

Policy ideaseedpublic

Risk-based regulation for service robots in healthcare settings

A proportional regulatory path so logistics robots are not certified as clinical devices.

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Proposal: classify service robots by clinical proximity and autonomy, with proportional certification. Logistics-only robots in non-clinical corridors get a light-touch class.

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Structure

Jurisdiction
Brazil (federal, ANVISA)
Policy instrument
RDC amendment creating a logistics-robot class
Stakeholders
ANVISA, hospital associations, robot operators, nursing councils
Expected impact
Certification cost −60% for logistics-only robots.

Claims in this investigation

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Evidence1