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UNI CEN ISO/TS 14441 : 2014

Current
Current

The latest, up-to-date edition.

HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF HER SYSTEMS FOR USE IN CONFORMITY ASSESSMENT
Published date

02-06-2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Security and privacy requirements
6 Best practice and guidance for establishing and
  maintaining conformity assessment programs
Annex A (informative) - Conformity assessment
        programs - Design considerations and
        illustrative examples from member countries
        as of 2010
Annex B (informative) - Comparison of jurisdictional
        requirements
Bibliography

This Technical Specification examines electronic patient record systems at the clinical point of care that are also interoperable with EHRs.

Committee
CT 500
DocumentType
Technical Specification
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current

Standards Relationship
ISO/TS 14441:2013 Identical

ISO/IEC 17065:2012 Conformity assessment — Requirements for bodies certifying products, processes and services
ISO/IEC 17000:2004 Conformity assessment Vocabulary and general principles
ISO/TS 25237:2008 Health informatics Pseudonymization
ISO/TS 22600-1:2006 Health informatics Privilege management and access control Part 1: Overview and policy management
ISO 18308:2011 Health informatics — Requirements for an electronic health record architecture
ISO/IEC 15408-2:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 2: Security functional components
ISO/TS 14265:2011 Health Informatics - Classification of purposes for processing personal health information
ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
ISO/IEC 17021:2011 Conformity assessment Requirements for bodies providing audit and certification of management systems
CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
ISO/IEC 15408-3:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 3: Security assurance components
ISO/IEC 27006:2015 Information technology — Security techniques — Requirements for bodies providing audit and certification of information security management systems
ISO/TS 21547:2010 Health informatics Security requirements for archiving of electronic health records Principles
ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
ISO/TS 22600-2:2006 Health informatics Privilege management and access control Part 2: Formal models
ISO/TS 13606-4:2009 Health informatics Electronic health record communication Part 4: Security
ISO/TS 22600-3:2009 Health informatics Privilege management and access control Part 3: Implementations
ISO/IEC 15408-1:2009 Information technology — Security techniques — Evaluation criteria for IT security — Part 1: Introduction and general model
ISO/HL7 10781:2015 Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)
ISO/TR 21548:2010 Health informatics Security requirements for archiving of electronic health records Guidelines
ISO/IEC 27000:2016 Information technology Security techniques Information security management systems Overview and vocabulary
ISO/TS 21298:2008 Health informatics Functional and structural roles
ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002

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