What is PD IEC/TR 80001-2-4- Risk management guidance for Healthcare Delivery Organizations about?
PD IEC/TR 80001-2-4 is the second subpart of the fourth part of the multiple series document that 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. The steps are supported by PD IEC/TR 80001-2-4 of decision points to steer the RESPONSIBLE ORGANIZATION through the PROCESS of understanding the MEDICAL IT-NETWORK context and identifying any organizational changes required to execute the responsibilities of TOP MANAGEMENT as defined in Figure 1 of IEC 80001-1:2010.
Who is PD IEC/TR 80001-2-4 - Risk management guidance for Healthcare Delivery Organizations for?
PD IEC/TR 80001-2-4 on IT networks incorporating medical devices is useful for:
- Health care delivery organizations 
- Medical device manufacturers
- Biomedical and clinical engineering departments
- Risk managers
- Software developers/IT engineers 
- Manufacturers and suppliers of alarm systems devices 
- Hospitals 
Why should you use PD IEC/TR 80001-2-4 - Risk management guidance for Healthcare Delivery Organizations?
IT-NETWORK (INFORMATION TECHNOLOGY NETWORK) is a system made up of communicative nodes and transmission links that enable physically linked or wireless transmission between two or more communication nodes.
PD IEC/TR 80001-2-4 refers to the duties which are placed by IEC 80001-1 on the organization’s TOP MANAGEMENT and cover the need for explicit policies setting out IEC 80001-1 compliance. PD IEC/TR 80001-2-4 provides three steps proposed to implement IEC 80001-1, which are:
- Determine the clinical context within which the healthcare provision is made
- Establish an underlying risk management framework
- Determine and understand existing medical it-network(s)
Overall, PD IEC/TR 80001-2-4 oversees the effective operation of RISK MANAGEMENT practices in the organization.
