AAMI/IEC TIR80001-2-4:2012

This helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to establish a RISK MANAGEMENT framework, before the organization embarks on a detailed RISK ASSESSMENT of an individual instance of a MEDICAL IT-NETWORK. This Technical Report is addressed to all Healthcare Delivery Organizations. A Healthcare Delivery Organization includes hospitals, doctors— offices, community care homes and clinics. It identifies a series of decision points to steer the RESPONSIBLE ORGANIZATION through the process of understanding the MEDICAL IT-NETWORK context and identifying any organizational changes required before undertaking the RISK MANAGEMENT PROCESS identified in IEC 80001-1. Annex 3