IEC/CD TS 81001-2-2

Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls

Scope

This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the entire life cycle of HEALTH SOFTWARE (including MEDICAL DEVICE software) and for the information exchange between the MEDICAL DEVICE MANUFACTURERS (MDMs), health software manufacturers, HEALTH DELIVERY ORGANIZATIONS (HDOs) and/or other stakeholders.