Application of risk management for IT-networks incorporating medical devices – Part 2-4: General implementation guidance for Healthcare Delivery Organizations

This technical report provides guidance to help a healthcare delivery organisation (HDO) fulfil its obligations in the application of IEC 80001-1. HDOs include hospitals, doctors' offices, community care homes and clinics.

This guide helps the HDO assess the impact of IEC 80001-1 on the organisation and establish a series of business-as-usual processes to manage risk in the creation, maintenance and upkeep of medical IT networks.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Responsible organisation

· Risk management implementation steps

· Responsibility agreements

· Annex A: Medical IT network configuration examples