Overview
ISO/TS 14441:2013 - "Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment" defines security and privacy requirements for electronic patient record systems used at the clinical point of care (point-of-service clinical systems) that interoperate with local, regional or national EHRs. The Technical Specification provides a set of 82 security and privacy requirements, a theoretical foundation, and best-practice guidance for designing and operating conformity assessment and certification programs. It is specifically aimed at software components (POS clinical systems); hardware, procedural/administrative and physical controls are out of scope.
Key topics and technical requirements
- Scope and target systems: POS clinical systems that receive, store, process, display and exchange clinical and administrative data and identity-related information.
- Security and privacy requirements: A comprehensive set addressing confidentiality, integrity, availability, access control, accountability, audit trails, anonymization and related protections for patient data.
- Common Criteria cross‑mapping: The 82 requirements are mapped against Common Criteria categories in ISO/IEC 15408 to support formal evaluation and alignment with established assurance frameworks.
- Theoretical foundation: Risk- and requirements-driven basis for technical controls appropriate to interoperable clinical systems.
- Conformity assessment guidance: Best practice and process guidance (Clause 6, Annex A) for designing, operating and maintaining certification and attestation programs, including concepts such as accreditation, audit, attestation and statements of conformity.
- Jurisdictional comparison: Annex B provides cross-jurisdictional analysis used to derive the requirements.
Applications and who uses it
ISO/TS 14441:2013 is practical for:
- Government agencies and regulators designing national or regional EHR certification schemes.
- Conformity assessment bodies and accreditation organizations seeking criteria and process guidance for health software certification.
- Health software vendors and developers that need to demonstrate compliance with security/privacy conformity requirements for interoperable electronic patient record systems.
- Healthcare providers and purchasers who want assurance that point‑of‑care systems meet recognized security and privacy standards.
- Auditors and security assessors performing evaluations mapped to Common Criteria or other assurance frameworks.
Practical uses include defining certification test criteria, creating conformity assessment programs, preparing vendor evidence for attestation, and aligning product security requirements with national privacy rules.
Related standards
- ISO/IEC 15408 (Common Criteria) - security evaluation categories
- ISO 27799 - information security management in health
- ISO/IEC 17000 series - conformity assessment principles
- ISO/TC 215 - health informatics standards development
Keywords: ISO/TS 14441:2013, EHR security, EHR privacy requirements, conformity assessment, Common Criteria, point-of-service clinical systems, health informatics, EHR certification.
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