Overview
ISO/TR 21332:2021 - Health informatics - Cloud computing considerations for the security and privacy of health information systems provides an authoritative overview of security and privacy considerations when Electronic Health Records (EHR) and other health information systems operate in cloud environments. The technical report helps health organizations and cloud service customers evaluate cloud providers, manage migration and contractual arrangements, and address legal/regulatory needs for protecting patient data (PII/PHI).
Key topics and technical coverage
The document organizes practical guidance across cloud computing concepts and specific security/privacy controls:
- Cloud fundamentals: cloud computing roles, cloud capabilities types (application, infrastructure, platform), and service categories such as Compute-as-a-Service, Data Storage-as-a-Service (DSaaS), Communications-as-a-Service (CaaS) and Infrastructure-as-a-Service (IaaS).
- Deployment models: community, hybrid, private and public cloud considerations and their implications for control and data residency.
- Security and privacy controls: information security policies, protection of PII/PHI, access control and multi-tenant segmentation, cryptography and obfuscation, audit trails and logging.
- Operational resilience: retention, backup, deletion, disaster recovery, change management, testing and evaluation.
- Workforce and endpoint: teleworking policies, portable device management and secure remote access.
- Governance and provider selection: guidance for selecting and risk-managing public cloud providers, contractual arrangements, and handling of data off-shoring.
- Annexes and practical guidance: informative annexes include example national guidance (UK), detailed advice, and service classification recommendations.
Applications and who should use it
ISO/TR 21332:2021 is intended for organizations and professionals involved in deploying or procuring cloud-based health IT:
- Healthcare providers and CIOs evaluating cloud EHR platforms and cloud migration strategies.
- Health IT vendors and system integrators designing cloud-capable EHRs and complying with privacy-by-design principles.
- Health information security officers and compliance teams establishing policies for PII/PHI protection, logging, retention and incident response.
- Cloud service customers and procurement teams assessing provider controls, SLAs and contractual obligations.
- Regulators, auditors and risk managers seeking a structured reference for cloud-related security/privacy considerations in health informatics.
Related guidance and implementation
ISO/TR 21332:2021 complements other ISO/IEC cloud and security standards (e.g., ISO/IEC 17788 cloud concepts) and can be used alongside national legal/regulatory requirements. It is a practical resource for risk assessment, provider selection, contractual clauses and designing secure cloud-native EHR deployments.