What is ISO 81001‑1 about?
ISO 81001‑1 provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning.
ISO 81001‑1 identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. ISO 81001‑1 establishes a coherent concept and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
Who is ISO 81001‑1 for?
ISO 81001‑1 on health software and health IT systems is useful for:
- Organizations of health informatics professionals
- Healthcare service delivery organizations
- Health IT systems
- Medical device manufacturers
- Health monitoring agencies
Why should you use ISO 81001‑1?
In ISO 81001‑1 benefits of digital health are widely explained. The potential for inadvertent and adverse impacts on safety, effectiveness, and security caused by health software and health IT systems is also becoming more apparent.
ISO 81001‑1 guideline helps all parties involved in the health software and health IT systems life cycle. ISO 81001‑1 defines terms and definitions being used and their relationship to other standards addressing various aspects of health software and health IT systems safety, effectiveness and security.
ISO 81001‑1 provides advanced levels of decision support and integrates patient data between systems, across organizational lines, and across the continuum of care to sophisticated health software and health IT systems.
