Overview
ISO/TR 80001-2-7:2015 provides practical guidance for Healthcare Delivery Organizations (HDOs) to self-assess conformance with IEC 80001-1 - the international framework for risk management of IT-networks that incorporate medical devices. The technical report presents an exemplar assessment method, supporting materials (a Process Reference Model - PRM and a Process Assessment Model - PAM) and aligns assessment practices with ISO/IEC 15504 process-assessment concepts.
Key topics and technical elements
- Purpose: Guidance for HDOs to evaluate their implementation of IEC 80001-1 processes and identify improvement opportunities.
- Assessment Method: A repeatable, seven-stage assessment lifecycle:
- Stage 1 - Define assessment scope
- Stage 2 - Stakeholder involvement
- Stage 3 - Information collection and evaluation
- Stage 4 - Findings report
- Stage 5 - Presentation of findings
- Stage 6 - Improvement plan (optional)
- Stage 7 - Follow-up assessment (optional)
- PRM & PAM: Included annexes define a Process Reference Model and an example Process Assessment Model that satisfy ISO/IEC 15504-2 requirements and provide standard process purposes, outcomes and indicators.
- Processes covered: The PAM groups 14 processes (examples include Medical IT Network Risk Management, Change/Release & Configuration Management, Monitoring, Event Management, Documentation & Planning, Responsibility Agreements).
- Assessment mechanics: Uses process attribute rating scales and capability levels (per ISO/IEC 15504) to evaluate how well risk-management processes are performed.
- Prerequisites: Recommends trained assessors (lead assessor where multiple assessors are used), stakeholder engagement, and access to relevant documentation and evidence.
- Tailoring: The exemplar method is intended to be tailored to the HDO context - enabling lightweight or more rigorous assessments as needed.
Practical applications and users
Who benefits:
- Healthcare Delivery Organizations (HDOs) seeking to validate or improve risk management for medical IT-networks.
- Clinical engineering, IT managers, risk managers and compliance teams conducting internal assessments.
- Assessors and auditors performing capability evaluations or preparing for external review.
- Vendors and medical device manufacturers collaborating in responsibility agreements or preparing evidence for HDO assessments.
Common uses:
- Self-assessment for IEC 80001-1 conformance.
- Baseline measurement of risk-management process capability and maturity.
- Identifying weaknesses and creating targeted improvement plans.
- Supporting change/release planning, go-live decisions, monitoring and event management practices.
Related standards
- IEC 80001-1:2010 - Roles, responsibilities and activities for risk management of medical IT-networks (normative reference).
- ISO/IEC 15504-1 / 15504-2 - Process assessment concepts and performing assessments (used for PRM/PAM alignment and capability rating).
Keywords: ISO TR 80001-2-7, IEC 80001-1, healthcare delivery organizations, HDO self-assessment, Medical IT-Network risk management, PRM, PAM, ISO/IEC 15504, process capability, assessment method.
Open preview (PDF)Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
