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ISO 27799:2016

Current
Current

The latest, up-to-date edition.

Health informatics Information security management in health using ISO/IEC 27002
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

01-07-2016

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s).

It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard.

ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care.

It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected.

ISO 27799:2016 and ISO/IEC 27002 taken together define what is required in terms of information security in healthcare, they do not define how these requirements are to be met. That is to say, to the fullest extent possible, ISO 27799:2016 is technology-neutral. Neutrality with respect to implementing technologies is an important feature. Security technology is still undergoing rapid development and the pace of that change is now measured in months rather than years. By contrast, while subject to periodic review, International Standards are expected on the whole to remain valid for years. Just as importantly, technological neutrality leaves vendors and service providers free to suggest new or developing technologies that meet the necessary requirements that ISO 27799:2016 describes.

As noted in the introduction, familiarity with ISO/IEC 27002 is indispensable to an understanding of ISO 27799:2016.

The following areas of information security are outside the scope of ISO 27799:2016:

a) methodologies and statistical tests for effective anonymization of personal health information;

b) methodologies for pseudonymization of personal health information (see Bibliography for a brief description of a Technical Specification that deals specifically with this topic);

c) network quality of service and methods for measuring availability of networks used for health informatics;

d) data quality (as distinct from data integrity).

DevelopmentNote
Supersedes ISO/DIS 27799. (07/2016)
DocumentType
Standard
Pages
100
PublisherName
International Organization for Standardization
Status
Current
Supersedes

12/30236518 DC : 0 BS ISO/IEC 27000 - INFORMATION SECURITY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
PD CEN/TS 16850:2015 Societal and Citizen Security. Guidance for managing security in healthcare facilities
DD ISO/TS 21547:2010 Health informatics. Security requirements for archiving of electronic health records. Principles
DIN EN ISO 27789:2013-06 Health informatics - Audit trails for electronic health records (ISO 27789:2013)
15/30319488 DC : 0 BS ISO/IEC 27000 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
DD ISO/TS 29585:2010 Health informatics. Deployment of a clinical data warehouse
BS ISO/IEC 27000 : 2016 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
11/30192880 DC : 0 BS ISO 22857 - HEALTH INFORMATICS - GUIDELINES ON DATA PROTECTION TO FACILITATE TRANS-BORDER FLOWS OF PERSONAL HEALTH INFORMATION
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS ISO 17090-4:2014 Health informatics. Public key infrastructure Digital Signatures for healthcare documents
14/30266753 DC : 0 BS ISO 17090-4 - HEALTH INFORMATICS - PUBLIC KEY INFRASTRUCTURE - PART 4: DIGITAL SIGNATURES FOR HEALTHCARE DOCUMENTS
BS EN ISO 27789:2013 Health informatics. Audit trails for electronic health records
PD ISO/TR 11636:2009 Health informatics. Dynamic on-demand virtual private network for health information infrastructure
10/30156465 DC : DRAFT DEC 2010 BS EN ISO 27789 - HEALTH INFORMATICS - AUDIT TRAILS FOR ELECTRONIC HEALTH RECORDS
BS ISO 22857:2013 Health informatics. Guidelines on data protection to facilitate transborder flows of personal health data
CSA TELECOM ORGANIZATIONS PACKAGE : 2018 CONSISTS OF CAN/CSA-ISO/IEC 27000:18 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY; CAN/CSA-ISO/IEC 27001:14, INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS; CAN/CSA-ISO/IEC 27002:15 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - CODE OF PRACTICE FOR
S.R. CEN ISO/TS 14441:2013 HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF EHR SYSTEMS FOR USE IN CONFORMITY ASSESSMENT (ISO/TS 14441:2013)
ISO/TS 21089:2018 Health informatics Trusted end-to-end information flows
NF EN ISO 27789 : 2013 HEALTH INFORMATICS - AUDIT TRAILS FOR ELECTRONIC HEALTH RECORDS
ISO 22857:2013 Health informatics — Guidelines on data protection to facilitate trans-border flows of personal health data
ISO 17090-5:2017 Health informatics — Public key infrastructure — Part 5: Authentication using Healthcare PKI credentials
CEN/TS 17159:2018 Societal and citizen security - Guidance for the security of hazardous materials (CBRNE) in healthcare facilities
ISO/IEC 27000:2018 Information technology — Security techniques — Information security management systems — Overview and vocabulary
ISO/TR 14639-2:2014 Health informatics Capacity-based eHealth architecture roadmap Part 2: Architectural components and maturity model
I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
CEN ISO/TS 14265:2013 Health Informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2011)
CEN/TS 16850:2015 Societal and Citizen Security - Guidance for managing security in healthcare facilities
ISO/TR 21548:2010 Health informatics Security requirements for archiving of electronic health records Guidelines
BS EN ISO 21091:2013 Health informatics. Directory services for healthcare providers, subjects of care and other entities
BS ISO 17090-5:2017 Health informatics. Public key infrastructure Authentication using Healthcare PKI credentials
AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
DIN ISO/IEC 27000:2015-12 (Draft) INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
PD ISO/TR 21548:2010 Health informatics. Security requirements for archiving of electronic health records. Guidelines
17/30349163 DC : 0 BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING
13/30284691 DC : 0 BS ISO/IEC 27000 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
DD ISO/TS 25237:2008 Health informatics. Pseudonymization
ISO/TR 22221:2006 Health informatics - Good principles and practices for a clinical data warehouse
UNI CEN ISO/TS 14441 : 2014 HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF HER SYSTEMS FOR USE IN CONFORMITY ASSESSMENT
IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
NEMA CPSP 1 : 2015 SUPPLY CHAIN BEST PRACTICES
PD CEN ISO/TS 14265:2013 Health Informatics. Classification of purposes for processing personal health information
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BIP 0139 : 2013 AN INTRODUCTION TO ISO/IEC 27001:2013
15/30285708 DC : 0 BS EN ISO 25237 - HEALTH INFORMATICS - PSEUDONYMISATION
DD ISO/TS 14265 : 2011 HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION
ISO/TS 29585:2010 Health informatics — Deployment of a clinical data warehouse
UNE-EN 16372:2015 Aesthetic surgery services
16/30327465 DC : 0 BS ISO 17090-5 - HEALTH INFORMATICS - PUBLIC KEY INFRASTRUCTURE - PART 5: AUTHENTICATION USING HEALTHCARE PKI CREDENTIALS
12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
I.S. EN ISO 25237:2017 HEALTH INFORMATICS - PSEUDONYMIZATION (ISO 25237:2017)
S.R. CEN ISO/TS 14265:2013 HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION (ISO/TS 14265:2011)
I.S. EN ISO/IEC 27000:2017 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY (ISO/IEC 27000:2016)
AAMI/IEC TIR80001-2-8:2016 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC 80001-2-2
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
UNI CEN ISO/TS 14265 : 2013 HEALTH INFORMATICS - CLASSIFICATION OF PURPOSES FOR PROCESSING PERSONAL HEALTH INFORMATION
UNI EN ISO 27789 : 2013 HEALTH INFORMATICS - AUDIT TRAILS FOR ELECTRONIC HEALTH RECORDS
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
EN ISO 21091:2013 Health informatics - Directory services for healthcare providers, subjects of care and other entities (ISO 21091:2013)
UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
PD IEC/TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
I.S. EN ISO 21091:2013 HEALTH INFORMATICS - DIRECTORY SERVICES FOR HEALTHCARE PROVIDERS, SUBJECTS OF CARE AND OTHER ENTITIES (ISO 21091:2013)
CSA INFORMATION SECURITY PACKAGE : 2018 CONSISTS OF CAN/CSA-ISO/IEC 27000:18 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY; CAN/CSA-ISO/IEC 27001:14, INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS; CAN/CSA-ISO/IEC 27002:15 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - CODE OF PRACTICE FOR INFORMATION
PD IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
PD IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
BS ISO 17090-2:2015 Health informatics. Public key infrastructure Certificate profile
PD ISO/TR 22221:2006 Health informatics. Good principles and practices for a clinical data warehouse
ANSI/AAMI/IEC TIR80001-2-1:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
DIN EN ISO 25237:2015-10 (Draft) HEALTH INFORMATICS - PSEUDONYMIZATION (ISO 25237:2017)
PD ISO/TS 17975:2015 Health informatics. Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information
UNE-ISO/IEC 27000:2014 Information technology -- Security techniques -- Information security management systems -- Overview and vocabulary
BS EN ISO/IEC 27000:2017 Information technology. Security techniques. Information security management systems. Overview and vocabulary
ISO/TS 25237:2008 Health informatics Pseudonymization
ISO/TS 13606-4:2009 Health informatics Electronic health record communication Part 4: Security
ISO 17090-4:2014 Health informatics Public key infrastructure Part 4: Digital Signatures for healthcare documents
ISO/TS 14265:2011 Health Informatics - Classification of purposes for processing personal health information
ISO 25237:2017 Health informatics — Pseudonymization
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
EN ISO/IEC 27000:2017 Information technology - Security techniques - Information security management systems - Overview and vocabulary (ISO/IEC 27000:2016)
EN 16372:2014 Aesthetic surgery services
EN ISO 25237:2017 Health informatics - Pseudonymization (ISO 25237:2017)
UNI EN ISO 21091 : 2013 HEALTH INFORMATICS - DIRECTORY SERVICES FOR HEALTHCARE PROVIDERS, SUBJECTS OF CARE AND OTHER ENTITIES
BS EN 16372:2014 Aesthetic surgery services
I.S. EN ISO 27789:2013 HEALTH INFORMATICS - AUDIT TRAILS FOR ELECTRONIC HEALTH RECORDS (ISO 27789:2013)
BS EN ISO 25237:2017 Health informatics. Pseudonymization
CSA ISO/IEC 27000 : 2018 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - OVERVIEW AND VOCABULARY
PD ISO/TR 14639-2:2014 Health informatics. Capacity-based eHealth architecture roadmap Architectural components and maturity model
PD CEN ISO/TS 14441:2013 Health informatics. Security and privacy requirements of EHR systems for use in conformity assessment
ISO/TS 21547:2010 Health informatics Security requirements for archiving of electronic health records Principles
S.R. CEN/TS 16850:2015 SOCIETAL AND CITIZEN SECURITY - GUIDANCE FOR MANAGING SECURITY IN HEALTHCARE FACILITIES
S.R. CEN/TS 17159:2018 SOCIETAL AND CITIZEN SECURITY - GUIDANCE FOR THE SECURITY OF HAZARDOUS MATERIALS (CBRNE) IN HEALTHCARE FACILITIES
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
ISO/TS 17975:2015 Health informatics — Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information
ISO 17090-2:2015 Health informatics Public key infrastructure Part 2: Certificate profile
ISO/TR 11636:2009 Health Informatics Dynamic on-demand virtual private network for health information infrastructure
EN ISO 27789:2013 Health informatics - Audit trails for electronic health records (ISO 27789:2013)
ONORM EN ISO 27789 : 2013 HEALTH INFORMATICS - AUDIT TRAILS FOR ELECTRONIC HEALTH RECORDS (ISO 27789:2013)

AS ISO 20387:2020 Biotechnology - Biobanking - General requirements for biobanking
AS 2828.2:2019 Health records Digitized health records

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