ГОСТ Р 57301-2016/ISO/TS 14441:2013 Информатизация здоровья. Требования защиты и конфиденциальности систем EHR, используемые при оценке соответствия

[1]

ANSI/HL7 EHR R1-2007, The HL7 EHR System Functional Model Release 1 Chapter One Overview, February 12 2007

[2]

Brazil Manual Certicacao, SBIS CFM 2009 v3 Conformity Requirements

[3]

Canada Health Infoway, Electronic Health Record (EHR) Privacy and Security Requirements, Release 1.1 Montreal November 30, 2004 revised February 7, 2005

[4]

Certification Commission for Healthcare Information Technology (CCHIT), Ambulatory Certification Criteria - 2008 Final Criteria Security - Privacy, May 13, 2008

[5]

NHS Connecting for Health, Information Governance Requirements for ESP and GPSoC Systems, version 5.0, 17 March 2009

[6]

NHS National Programme for Information Technology, Information Governance version 3 - Baseline Index Foundation Module, version 1.0, 30 march 2009

[7]

NHS Connecting for Health, CAP Common Assurance Process

[8]

EU HITCH project. Healthcare interoperability Testing and Conformance Harmonisation. Available at: http://www. hitch-project.eu/

[9]

Central Secretariat ISO Building trust: The Conformity Assessment Toolbox, February 2010

[10]

ISO/HL7 10781:2009, Health informatics - Electronic Health Record - System Functional Model R 1.1

[11]

ISO/TS 13606-4:2009, Health informatics - Electronic health record communication - Part 4: Security

[12]

ISO/TS 14265, Health Informatics - Classification of purposes for processing personal health information

[13]

ISO/IEC 15408-1, Information technology - Security techniques - Evaluation criteria for IT security - Part 1: Introduction and general model

[14]

ISO/IEC 15408-2, Information technology - Security techniques - Evaluation criteria for IT security - Part 2: Security functional components

[15]

ISO/IEC 15408-3, Information technology - Security techniques - Evaluation criteria for IT security - Part 3: Security assurance components

[16]

ISO/IEC 17021:2011, Conformity assessment - Requirements for bodies providing audit and certification of management systems

[17]

ISO 18308, Health informatics - Requirements for an electronic health record architecture

[18]

ISO/TS 21298, Health informatics - Functional and structural roles

[19]

ISO/TS 21547:2010, Health informatics - Security requirements for archiving of electronic health records - Principles

[20]

ISO/TR 21548:2010, Health informatics - Security requirements for archiving of electronic health records - Guidelines

[21]

ISO/TS 25237, Health informatics - Pseudonymization

[22]

ISO 22600-1, Health informatics - Privilege management and access control - Part 1: Overview and policy management

[23]

ISO 22600-2, Health informatics - Privilege management and access control - Part 2: Formal models

[24]

ISO 22600-3, Health informatics - Privilege management and access control - Part 3: Implementations

[25]

ISO/IEC 27000, Information technology - Security techniques - Information security management systems - Overview and vocabulary

[26]

ISO/IEC 27001, Information technology - Security techniques - Information security management systems - Requirements

[27]

ISO/IEC 27002, Information technology - Security techniques - Code of practice for information security controls

[28]

ISO/IEC 27005, Information technology - Security techniques - Information security risk management

[29]

ISO/IEC 27006, Information technology - Security techniques - Requirements for bodies providing audit and certification of information security management systems

[30]

ISO/CD 27789, Health informatics - Audit trails for electronic health records

[31]

Suarez, Walter MD, Overview of Health IT Initiatives in the US: Privacy and Security Standards and Certification Criteria, MPH Director Health IT Strategy, Kaiser Permanente, February 7, 2010

[32]

US Government, Federal Register Part III Department of Health and Human Services 45 cfr Part 170 - Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule, July 28, 2010

[33]

ISO/IEC 17065, Conformity assessment - Requirements for bodies certifying products, processes and services

УДК 004:61:006.354

ОКС 35.240.80

Ключевые слова: здравоохранение, информатизация здоровья, электронный учет здоровья, требования защиты и конфиденциальности, оценка соответствия