ISO/TS 14441:2013 PDF

Name: ISO/TS 14441:2013 — Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment
SKU: ISO/TS 14441:2013
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Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment

Название (английский):

ISO/TS 14441:2013

Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 112
Дата публикации:: 3 декабря 2013 г.
Издание:: ISO TS 14441 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

ISO/TS 14441:2013 examines electronic patient record systems at the clinical point of care that are also interoperable with EHRs. ISO/TS 14441:2013 addresses their security and privacy protections by providing a set of security and privacy requirements, along with guidelines and best practice for conformity assessment. ISO/TS 14441:2013 includes a cross-mapping of 82 security and privacy requirements against the Common Criteria categories in ISO/IEC 15408 (all parts).

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO/TS 14441:2013 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

SIST EN ISO/IEC 19896-3:2026

Information security, cybersecurity and privacy protection - Requirements for the competence of IT security c…

SIST EN ISO 27799:2026

Health informatics - Information security controls in health based on ISO/IEC 27002 (ISO 27799:2025)

SIST EN ISO/IEC 17000:2020

Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020, Corrected version 2020-12)