Overview
CEN ISO/TS 14441:2013 (ISO/TS 14441:2013) is a technical specification in health informatics that defines security and privacy requirements for electronic patient record systems at the point of care (POS clinical systems) that are interoperable with regional or national EHR infrastructures. The document is intended for use in conformity assessment (certification and conformance testing) and provides both a comprehensive requirements set and guidance for establishing and maintaining assessment programs.
Key topics and technical requirements
- Scope: Focuses on clinical point-of-care electronic patient record systems that receive, store, process, display and exchange clinical and administrative data. Hardware and organizational process controls are out of scope.
- Security & privacy requirements: The specification identifies a comprehensive set of 82 security and privacy requirements designed to protect patient information and mitigate principal categories of attack. These requirements are intended for use in conformity assessment.
- Common Criteria mapping: All 82 requirements are cross-mapped against the ISO/IEC 15408 (Common Criteria) categories to support formal security evaluation and target-of-evaluation (TOE) development.
- Theoretical foundation: Discusses the underlying security and privacy principles that justify the requirements and how they apply in interoperable clinical settings.
- Conformity assessment guidance: Best practice and operational guidance for designing, running and maintaining certification/conformance programs, including process models and illustrative examples.
- Supplementary material: Annex A provides design considerations and international examples of conformity programs; Annex B compares jurisdictional privacy and security requirements.
Practical applications and who uses it
This technical specification is practical for:
- Conformity assessment bodies and accreditation agencies designing or operating EHR certification programs.
- Health software vendors and developers producing POS clinical systems who need to demonstrate compliance with recognized security and privacy criteria.
- Purchasers and procurers (healthcare providers, hospitals, clinics) seeking assurance that products meet security and privacy requirements for interoperability with EHR infrastructures.
- Government bodies, standards organizations and health informatics professionals creating policy, procurement rules or national certification schemes.
- Auditors and security assessors performing evaluations referencing Common Criteria mappings.
Related standards
- ISO/IEC 15408 (Common Criteria) - cross-mapped to the 82 requirements
- ISO/IEC 27001 - referenced for information security management alignment
- ISO/IEC 17000 series (CASCO) - conformity assessment principles
- ISO/TC 215 work on EHR and health informatics
Keywords: ISO/TS 14441, EHR security, EHR privacy, conformity assessment, Common Criteria, point-of-care systems, health informatics, electronic patient record.
