ISO/TR 18638:2017
(Main)Health informatics - Guidance on health information privacy education in healthcare organizations
Health informatics - Guidance on health information privacy education in healthcare organizations
ISO/TR 18638:2017 specifies the essential educational components recommended to establish and deliver a privacy education program to support information privacy protection in healthcare organizations. The primary users of this document are those responsible for planning, establishing and delivering healthcare information privacy education to a healthcare organization. ISO/TR 18638:2017 provides the components of privacy education within the context of roles and job responsibilities. It is the responsibility of the organization to define and apply privacy protection policies and procedures and, in turn, ensure that all staff in the healthcare organization understands their privacy protection responsibilities. The scope of ISO/TR 18638:2017 covers: a) the concept of information privacy in healthcare; b) the challenges of protecting information practices in the healthcare organization; c) the components of a healthcare information privacy education program; d) basic health information privacy educational content.
Informatique de santé — Composantes éducatives destinées à garantir la confidentialité des informations relatives à la santé
General Information
- Status
- Published
- Publication Date
- 31-May-2017
- Technical Committee
- ISO/TC 215 - Health informatics
- Drafting Committee
- ISO/TC 215/WG 4 - Security, Safety and Privacy
- Current Stage
- 6060 - International Standard published
- Start Date
- 01-Jun-2017
- Due Date
- 03-Jan-2017
- Completion Date
- 03-Jan-2017
Relations
- Consolidated By
ISO 16484-5:2017 - Building automation and control systems (BACS) - Part 5: Data communication protocol - Effective Date
- 06-Jun-2022
Overview
ISO/TR 18638:2017 - Health informatics: Guidance on health information privacy education in healthcare organizations provides recommended educational components for building and delivering a privacy education program that supports protection of personal health information (PHI) in healthcare settings. This technical report is intended for those who plan, establish or deliver privacy training and awareness in healthcare organizations and frames privacy education within roles and job responsibilities. The document addresses the concept of information privacy in healthcare, common protection challenges, program components and basic educational content.
Key topics and recommended components
- Concepts and definitions: information privacy, personal health information, confidentiality, access control, anonymization/pseudonymization and related terms used in health informatics.
- Privacy protection context: organizational privacy programs, policies and workforce roles in safeguarding PHI.
- Core components of a privacy education program: role‑based competencies, educational objectives and content mapped to job responsibilities.
- Content modules (examples):
- Introduction to information privacy, confidentiality and security in healthcare
- International guidelines and national legislation/policy
- Patient rights regarding personal health information
- Administrative policies and procedures for privacy protection
- Technical and physical safeguards
- Instructional design and delivery: orientation/on‑boarding, continuing education, patient education, instructors, delivery mechanisms and learning methods.
- Evaluation: suggested approaches for assessing learning outcomes (quizzes, competency checks, program evaluation).
- Supporting annexes: examples of learning objectives, levels by audience, educational methods and sample quiz questions; Annex A lists related ISO/TC 215 standards.
Note: ISO/TR 18638:2017 provides recommended (non‑normative) educational components - it guides design rather than imposing mandatory requirements.
Practical applications
- Develop role‑based privacy training programs for clinicians, administrative staff, IT personnel and managers.
- Create onboarding and continuing education modules to meet regulatory and organizational privacy obligations.
- Design patient‑facing privacy information and consent education.
- Align internal privacy policies and technical safeguards training with international best practices and local legislation.
- Evaluate training effectiveness and demonstrate organizational commitment to information privacy and PHI protection.
Who should use this standard
- Privacy officers, compliance managers and legal teams
- Learning & development and HR professionals in healthcare
- Clinical leaders and department managers responsible for workforce education
- Health IT and security teams implementing technical safeguards
- Policy makers and accreditation bodies developing privacy awareness requirements
Related standards
See Annex A of ISO/TR 18638:2017 for a curated list of ISO/TC 215 health informatics standards relevant to privacy protection and for guidance on integrating those standards into privacy education programs.
Keywords: ISO/TR 18638, health information privacy, privacy education, healthcare organizations, PHI, privacy training, health informatics standards.
Frequently Asked Questions
ISO/TR 18638:2017 is a technical report published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Guidance on health information privacy education in healthcare organizations". This standard covers: ISO/TR 18638:2017 specifies the essential educational components recommended to establish and deliver a privacy education program to support information privacy protection in healthcare organizations. The primary users of this document are those responsible for planning, establishing and delivering healthcare information privacy education to a healthcare organization. ISO/TR 18638:2017 provides the components of privacy education within the context of roles and job responsibilities. It is the responsibility of the organization to define and apply privacy protection policies and procedures and, in turn, ensure that all staff in the healthcare organization understands their privacy protection responsibilities. The scope of ISO/TR 18638:2017 covers: a) the concept of information privacy in healthcare; b) the challenges of protecting information practices in the healthcare organization; c) the components of a healthcare information privacy education program; d) basic health information privacy educational content.
ISO/TR 18638:2017 specifies the essential educational components recommended to establish and deliver a privacy education program to support information privacy protection in healthcare organizations. The primary users of this document are those responsible for planning, establishing and delivering healthcare information privacy education to a healthcare organization. ISO/TR 18638:2017 provides the components of privacy education within the context of roles and job responsibilities. It is the responsibility of the organization to define and apply privacy protection policies and procedures and, in turn, ensure that all staff in the healthcare organization understands their privacy protection responsibilities. The scope of ISO/TR 18638:2017 covers: a) the concept of information privacy in healthcare; b) the challenges of protecting information practices in the healthcare organization; c) the components of a healthcare information privacy education program; d) basic health information privacy educational content.
ISO/TR 18638:2017 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/TR 18638:2017 has the following relationships with other standards: It is inter standard links to ISO 16484-5:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO/TR 18638:2017 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 18638
First edition
2017-06
Health informatics — Guidance on
health information privacy education
in healthcare organizations
Informatique de santé — Composantes éducatives destinées à
garantir la confidentialité des informations relatives à la santé
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 7
5 Understanding information privacy in healthcare . 7
5.1 General concept . 7
5.2 Information privacy in healthcare. 8
5.2.1 Personal health information and privacy . 8
5.2.2 Patient’s rights on personal health information privacy . . 8
5.3 Privacy concerns . 9
5.4 Organization’s privacy protection program . 9
5.4.1 Policies and practices to protect health information . 9
5.4.2 Roles of workforce in protecting information privacy .10
5.4.3 Workforce education in protecting health information privacy .11
5.4.4 Patient’s education in protecting information privacy .11
6 Information privacy education in healthcare .11
6.1 General concepts .11
6.2 Target audience of the privacy education .12
6.3 Competencies, educational objectives and content.12
7 Examples of content modules .16
7.1 General .16
7.2 Introduction to information privacy, confidentiality and security in healthcare .16
7.3 International guidelines and principles for information privacy protection .16
7.4 National legislation, regulation and policies for information privacy protection .16
7.5 Patient’s rights on personal health information .17
7.6 Administrative policies for privacy protection .17
7.7 Technical and physical safeguards for protecting healthcare information privacy .18
8 Instructional methods, delivery mechanisms and evaluation .19
8.1 Instructors .19
8.2 Instructional methods and delivery mechanisms .19
8.3 Delivering training .19
8.3.1 Orientation and on-boarding training .19
8.3.2 Continuing education . .20
8.3.3 Education of patients .20
8.4 Evaluation methods .20
Annex A (informative) ISO/TC215 Health informatics: List of standards on privacy protection .21
e
Annex B (informative) Setting learning objectives (example) (Source: Triag Training
Group, HIPAA training playbook) .22
Annex C (informative) Level of Learning Objectives by Audience (Provided by South Korea) .24
Annex D (informative) Educational methods (examples) .26
Annex E (informative) Questions for quiz for privacy education (example) (Provided by
South Korea) .27
Bibliography .32
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2017 – All rights reserved
Introduction
Health information privacy concerns need to be addressed with the expanding adoption of health
information technology (HIT) including the use of electronic health record (EHR) systems. Both the
increasingly legislated environment around privacy and the increasing need for information sharing
between patients, providers, payers, researchers and administrators contribute to the growing need
for information privacy education in the healthcare sector. In spite of increasing awareness of and
sensitivity to patient privacy, there are no guidelines or standardization for education on privacy of the
healthcare information within healthcare organizations.
The purpose of this document is to describe the essential educational components recommended
to ensure health information privacy in a healthcare organization. This document describes the
concepts of health information privacy, the components of a privacy education program for healthcare
organizations and basic health information privacy educational content that can be applied to various
jurisdictions.
This document provides guidance for healthcare organizations for establishing and improving the
health information privacy education for their workforce.
Annex A provides the list of standards published by ISO/TC 215 that may be used to develop privacy
education in healthcare organizations as they convey specific content and approach health information
privacy protection.
TECHNICAL REPORT ISO/TR 18638:2017(E)
Health informatics — Guidance on health information
privacy education in healthcare organizations
1 Scope
This document specifies the essential educational components recommended to establish and deliver
a privacy education program to support information privacy protection in healthcare organizations.
The primary users of this document are those responsible for planning, establishing and delivering
healthcare information privacy education to a healthcare organization.
This document provides the components of privacy education within the context of roles and job
responsibilities. It is the responsibility of the organization to define and apply privacy protection
policies and procedures and, in turn, ensure that all staff in the healthcare organization understands
their privacy protection responsibilities.
The scope of this document covers:
a) the concept of information privacy in healthcare;
b) the challenges of protecting information practices in the healthcare organization;
c) the components of a healthcare information privacy education program;
d) basic health information privacy educational content.
2 Normative references
There are no normative references for this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
access
ability or means necessary to read, write, modify, or communicate data/information or otherwise make
use of any system resources
[SOURCE: ISO/TR 18307:2001, 3.1]
3.2
access control
means of ensuring that the resources of a data processing system can be accessed only by authorized
entities in authorized ways
[SOURCE: ISO 17090-1:2013, 3.2.1]
3.3
anonymization
process by which personal identifiable information (PII) (3.21) is irreversibly altered in such a way that
a PII principal (3.22) can no longer be identified directly or indirectly, either by the PII controller (3.23)
alone or in collaboration with any other party
Note 1 to entry: See pseudonymization (3.33).
[SOURCE: ISO/IEC 27038:2014, 2.1, modified]
3.4
asset
anything that has value to the organization
Note 1 to entry: There are many types of assets, including:
a) information;
b) software, such as a computer program;
c) physical, such as computer;
d) services;
e) people, and their qualifications, skills and experience, and
f) intangibles, such as reputation and image.
[SOURCE: ISO/IEC 27000: 2014, 3.6]
3.5
audit
systematic, independent, documented process for obtaining records, statements of fact or other relevant
information and assessing them objectively to determine the extent to which specified requirements
are fulfilled
[SOURCE: ISO/IEC 29110-2-1:2015, 4.7]
3.6
availability
property of data or of resources being accessible and usable on demand by an authorized entity
Note 1 to entry: This is the definition relevant to use in computer security.
[SOURCE: ISO/TS 27790:2009, 3.10]
3.7
confidentiality
property of data that indicates the extent to which these data have not been made available or disclosed
to unauthorized individuals, processes or other entities
[SOURCE: ISO/IEC 2382:2015, 2126249]
2 © ISO 2017 – All rights reserved
3.8
control
means of managing risk, including policies, procedures, guidelines, practices or organizational
structures, which can be administrative, technical, management or legal in nature
Note 1 to entry: Control is also used as a synonym for safeguard or countermeasure.
Note 2 to entry: Controls include any process, policy, device, practice, or other actions which modify risk.
Note 3 to entry: Controls may not always exert the intended or assumed modifying effect.
[SOURCE: ISO/IEC 27000:2016, 2.16]
3.9
education
knowledge, skill and understanding that you get from attending a school, college, university or
vocational teaching
Note 1 to entry: The action or process of teaching someone especially in a school, college, or university.
Note 2 to entry: A field of study that deals with the methods and problems of teaching.
Note 3 to entry: Synonyms are learning, knowledge, literacy, scholarship and enlightenment
Note 4 to entry: Education (which is concept based) is different than training (3.39) (which is skill based).
3.10
healthcare
type of services is provided by professionals or paraprofessionals with an impact on health status
[SOURCE: ISO 27799:2016, 3.3]
3.11
healthcare organization
organization involved in the direct or indirect provision of healthcare services to an individual or to a
population
[SOURCE: ISO 13606-1:2008, 3.33]
3.12
health professional
person who is authorized by a recognized body to be qualified to perform certain health duties
Note 1 to entry: The defined term is often “healthcare professional”.
[SOURCE: ISO 27799:2016, 3.5]
3.13
identifiable person
one who can be identified, directly or indirectly, in particular by reference to an identification number
or one or more factors specific to his/her physical, physiological, mental, economic, cultural or social
identity
[SOURCE: ISO 22857:2013, 3.7]
3.14
information privacy
rights and obligations of individuals and organizations with respect to the collection, use, retention,
disclosure and disposal of personal information
[SOURCE: ISO/TS 14441:2013, 3.26]
3.15
information security
protection of information from (accidental or intentional) unauthorized access, use, disclosure,
disruption, modification or destruction
[SOURCE: ISO/TS 21547:2010, 3.2.24]
3.16
media
means by which information is perceived, expressed, stored or transmitted
EXAMPLE Audio, video, (animated) graphics, images, text.
Note 1 to entry: Medium (plural media).
[SOURCE: ISO/IEC 14478-1:1998, 3.2.2]
3.17
patient
subject of care consisting of one person
[SOURCE: ISO 13606-2:2008, 4.13]
3.18
personal information
information about an individual which can be used to identify that individual
Note 1 to entry: The specific information used for this identification will be that defined by national legislation.
Note 2 to entry: See personal identifiable information (PII) (3.21).
[SOURCE: ISO/IEC 27011:2008, 3.1.5]
3.19
personal health information
information about an identifiable person that relates to the physical or mental health of the individual
[SOURCE: ISO 27799:2016, 3.8]
3.20
personal health record
PHR
representation of information regarding or relevant to the health, including wellness, development, and
welfare of a subject of care, which may be stand-alone or integrating health information from multiple
sources, and for which the individual, or their authorized representative, manages and controls the PHR
content and grants permissions for access by and/or sharing with other parties
[SOURCE: ISO/TR 14639-2:2014, 2.60]
3.21
personal identifiable information
PII
information about a person that can be used to identify that individual
Note 1 to entry: The specific information used for this identification will be that defined by national legislation.
Note 2 to entry: See personal health information (3.19) and pseudonymization (3.33).
[SOURCE: ISO/IEC 27011:2008, 3.1.5]
4 © ISO 2017 – All rights reserved
3.22
personal identifiable information principal
PII principal
person who granted/entrusted an organization with the ability to manage his/her PII
Note 1 to entry: See pseudonymization (3.33).
3.23
personal identifiable information controller
PII controller
person designated by an organization to control access to PII
Note 1 to entry: See pseudonymization (3.33).
3.24
policy
set of rules such as legal, political, organizational which can be expressed as obligations, permissions or
prohibitions
Note 1 to entry: Adapted from ISO/TS 22600-1:2014, 3.13.
[SOURCE: ISO/TR 14639-1:2012]
3.25
privacy
freedom from intrusion into the private life or affairs of an individual when that intrusion results from
undue or illegal gathering and use of data about that individual
[SOURCE: ISO/TS 27790:2009, 3.56]
3.26
privacy in healthcare
right of an individual to keep oneself and one`s health information concealed or hidden from
unauthorized access and view by others that rests on the principle of confidentiality between healthcare
providers and patients
3.27
privacy breach
situation where personal information (3.18) is collected, accessed, used or disclosed in an unlawful
manner or in violation of one or more relevant privacy policies
[SOURCE: ISO/TS 17975:2015, 3.26]
3.28
privacy manager
individual designated as a privacy official, who manages personal information directly or via another
person as part of his/her duties, who is responsible for developing and implementing its privacy policies
and procedures or a contact person or contact office responsible for receiving complaints and providing
individuals with information on the healthcare organization’s privacy practice
3.29
privacy protection
capacity to control when, how and to what degree information about oneself is communicated to others
3.30
privacy stakeholders
individuals involved in privacy protection (3.29) including PII principal (3.22), PII controller (3.23),
privacy manager (3.28) and other defined by the national regulation
3.31
procedure
specified way to carry out an activity or a process
[SOURCE: ISO 30000:2009, 3.12]
3.32
provider
person or organization that is involved in or associated with delivery of health care to a subject of care,
or caring for the well-being of a subject of care
Note 1 to entry: A provider in this context includes not only healthcare providers, but also those directly involved
in the provision of services to patients.
Note 2 to entry: The defined term is often “healthcare professional”. A convention has been adopted in this
document whereby the term “healthcare” is abbreviated to “health” when used in an adjectival form. When used
in a noun form, the word “care” is retained but as a separate word (e.g. delivery of health care).
[SOURCE: ISO/TS 27527:2010, 3.6]
3.33
pseudonymization
process applied to personal identifiable information (PII) (3.21) which replaces identifying information
with an alias
Note 1 to entry: Synonym is reduction, masking.
Note 2 to entry: Pseudonymization can be performed either by PII principals (3.22) themselves or by PII controllers
(3.23). See PII, PII principal and PII controller.
Note 3 to entry: Pseudonymization can be employed by PII principal to consistently use a resource or service
without disclosing his/her identity to this resource or service (or between services), while still being held
accountable for that use.
Note 4 to entry: Pseudonymization does not rule out the possibility that there might be (a restricted set
of) privacy stakeholders other than the PII principle controller of the pseudonymized data which are able to
determine the PII principal’s identity based on the alias and data linked to it.
[SOURCE: ISO/IEC 29100:2011, 2.24]
3.34
review
verification of the suitability, adequacy and effectiveness of selection and determination activities, and
the results of these activities, with regard to the fulfilment of specified requirements by an object of
conformity assessment
[SOURCE: ISO/TS 14441:2013, 3.44]
3.35
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 10377:2013, 2.16]
3.36
risk management
coordinated activities to direct and control an organization with regard to risk (3.35)
[SOURCE: ISO/TS 16901:2015, 3.32]
6 © ISO 2017 – All rights reserved
3.37
subject of care
one or more persons scheduled to receive, receiving, or having received a health service
[SOURCE: ISO/TS 18308:2011, 3.47]
3.38
threat
potential cause of an unwanted incident that may result in harm to a system or organization
3.39
training
process by which someone is taught the skills that are needed for an art, profession or job
Note 1 to entry: The action of teaching a person or animal a particular skill or type of behaviour.
Note 2 to entry: The action of undertaking a course of exercise and diet in preparation for a sporting event.
Note 3 to entry: Exercise, exercises, working out, conditioning.
Note 4 to entry: See education (3.9).
3.40
workforce
people who provide a service or labor to contribute to business or organizational outcomes
[SOURCE: ISO 30409:2016, 10.1]
4 Abbreviations
EHR electronic health record
EN European Norm (Standard)
EU European Union
HIT health information technology
ID identification
ICT information and communication technology
OECD Organization for Economic Cooperation and Development
PHI personal health information
5 Understanding information privacy in healthcare
5.1 General concept
The internet and emerging health information and communication technologies are changing the way
that health professionals and the public gain access to health information, resulting in an expectation for
the increased use of such information. Although personal health information is personally private data,
such information may be used for public health, clinical research, medical education, policy making,
legislation enforcement, accreditation and other purposes for the betterment of society. Healthcare
organizations should develop a comprehensive approach to enable adequate protection of health
information privacy for their patients. Workforce education regarding health information privacy
should be an integral part of this approach including guidance on when and how health information
should be protected with regards to the specific workforce roles.
Privacy education in a healthcare organization is a set of educational resources tailored to the roles of
the workforce involved in the creation, management, sharing, use and re-use of health information. The
education should be built upon agreed international concepts and standards on the topic of information
privacy, in general, and health information privacy, specifically. Jurisdictional legislation should be
considered in the design and implementation of organizational policies and the procedures of the
privacy protection program as well as being an educational component of such a program. Educational
requirements need to be inclusive of local settings and legislation. Furthermore, these requirements
should consider information privacy and healthcare goals in the context of clinical care and other
information use.
5.2 Information privacy in healthcare
5.2.1 Personal health information and privacy
Health information contains unique sensitivity characteristics in terms of privacy. Personal health
information includes wide range of patient demographics including name, identification numbers,
address, phone number, education, marital status, socio-economic status and other individually
identifiable data points. Personal health information also includes data about physical and mental
health status, provision of healthcare services to a subject of care or payment for healthcare services
provided to a subject of care. It is collected or created in the context of scheduling delivery or payment
for a healthcare service including:
a) registration and identity verification of the individual for the provision of healthcare services;
b) information about the individual that is collected or created during the provision of healthcare
services to the individual;
c) information about the workforce involved in the provision of healthcare services to the individual;
d) results derived during the provision of healthcare services to the individual including test or
examination results, medications prescribed and other.
Such information may be considered sensitive by the person to whom it relates.
Personal health information may be shared with multiple providers involved in the provision of
healthcare services to the individual. In addition, this information can be re-used for a wide array of
purposes, such as clinical research, public health, training and other health related activities.
Personal health information that is collected during the delivery of healthcare services is recorded
in health records. It can reside in various media including paper records, electronic records, mobile
applications, films, specimens, etc. This information is collected, maintained, transmitted, stored,
used and re-used by workforce involved in the healthcare delivery. Therefore, it is the responsibility
of the healthcare organization as well as its workforce to protect privacy of health information for the
patients.
5.2.2 Patient’s rights on personal health information privacy
According to the 2002 guidelines on the protection of privacy and trans-border flows of personal data
from the Organization of Economic Cooperation and Development (OECD), privacy is the right of an
individual to keep oneself and one’s information concealed or hidden from unauthorized access and
view by others. Patients’ rights for privacy of health information include:
a) right to access and obtain personal health information in a readable form and format;
b) right to permit access or disclosure before personal health information can be used and shared for
specified purposes (except where otherwise permitted by legislation);
c) right to correct or amend personal health information if an individual believes the information is
incorrect, incomplete or inaccurate;
8 © ISO 2017 – All rights reserved
d) right to receive confidential communication;
e) right to file a complaint if an individual believes rights are being denied or health information is not
being protected properly;
f) right to delegate personal health information access and/or retrieval to a third party.
5.3 Privacy concerns
Privacy concerns regarding personal health information, whilst not new, are a major issue for healthcare
organizations. As organizations have been increasingly sharing information electronically, the risk of
patient health information being accessed by unauthorized persons or being used for unauthorized
purposes by those with legitimate access raises concerns that information privacy breaches might
lead to information misuse or abuse with consequences ranging from embarrassment, financial loss,
discrimination and legal consequences.
5.4 Organization’s privacy protection program
Privacy protection refers to the capacity to control when, how and to what degree information about
oneself is communicated to others. An organization’s privacy protection policies and practices are aimed
to guard patient’s health information. These policies and practices form the basis of organization’s
privacy protection program.
An organization’s privacy protection program should be designed to protect patient rights with respect
to information privacy and should be developed and implemented within the framework of the relevant
jurisdictional laws. The program should specify:
a) policies and practices to protecting patient’s privacy within an organization;
b) specific roles of the workforce involved in collection, management, sharing, use and reuse of patient
health information;
c) education of workforce regarding privacy protection policies and practices;
d) education of patients regarding their right in health information privacy.
5.4.1 Policies and practices to protect health information
Information protection policies and practices performed by the workforce of a healthcare organization
ensure that:
a) all uses of information are known and appropriate in accordance with jurisdictional laws;
b) health information is protected from inadvertent or deliberate misuse or disclosure;
c) health information collection, sharing and storing are legally permitted and justified;
d) patients are informed about their rights regarding health information;
e) patients are informed why, when and how their health information is collected, shared and stored
prior to the beginning of collection of their information;
f) patients can expect that their data is protected by information privacy protection program;
g) patients are informed about their right to access their healthcare information.
As a part of the privacy protection program, the organization should maintain reasonable and
appropriate administrative, technical and physical safeguards to prevent intentional or accidental use
or disclosure of personal health information which may violate jurisdictional privacy legislation. This
includes limiting incidental use and disclosure pursuant to otherwise, permitted or required use or
disclosure of the information; as well as appropriate use of patient consents and directives regarding
information capture, management, sharing, use and re-use. Education of workforce is critical part of
the organization’s privacy protection program.
5.4.2 Roles of workforce in protecting information privacy
An organization’s privacy protection program’s policies and practices are carried out by workforce
involved in managing patient health information in various roles. The roles of the workforce fall into
the following groups:
a) health professionals;
b) healthcare information managers;
c) administrative staff;
d) researchers;
e) IT, security and privacy workforce;
f) other workforce involved in patient’s care;
g) other workforce that support operation of healthcare organization.
Table 1 presents the roles of workforce in protecting health information privacy by group.
Table 1 — Roles of workforce in protecting health information privacy in healthcare
organization
Group Roles
Health professionals Individuals who provide healthcare services, such as physicians, nurses, allied
health professionals, medical technicians and other directly involved in the gener-
ation, sharing and use of information within the episode of care to support care de-
livery. They are also involved in establishing organizational policies and procedures
related to care delivery using clinical guidelines and best practices.
Health information Individuals such as medical record staff and others who maintain health records
managers created during the care delivery. They are involved in the collection, access, valida-
tion, verification, codification, audit, protection, retention, storage and disposition
of information, i.e. support of the information lifecycle within an organization.
They support information management for the provision of direct care, as well as
information exchange/sharing including the release of information (disclosure) to
the authorized users. In addition, they participate in planning, implementation and
operation of information systems including EHR and ancillary systems that contain
health information. They are also involved in establishing healthcare information
management (HIM) policies and procedures for the health information lifecycle,
including policies and procedures for protecting information privacy.
Administrative staff Individuals who use healthcare information for non-clinical administrative duties
including an organization’s operation and financial management, business deci-
sion-making to support tasks related to operational policy development and
evaluation. They may be employees of the healthcare organization as well as busi-
ness associates, e.g. contractors that perform operational, non-clinical services.
Researchers Individuals who use healthcare information for research purposes, e.g. clinical
research, population health surveillance, monitoring of health risks, health services
utilization research and others. They may be involved in the development of educa-
tional materials for care delivery and disease prevention for health care provider
and patients as well as the development and delivery of health education to health
professionals including health information managers.
10 © ISO 2017 – All rights reserved
Table 1 (continued)
Group Roles
IT, security and privacy Individuals who implement and support the operation of health information sys-
workforce tems and applications to enable electronic collection, management, sharing and use
of healthcare information. Such individuals may include those who have specific
roles in information security and information privacy.
Other workforce in- Outsourcing agents, contractors, pastoral care workers, counselors, volunteers,
volved in patient care social workers, students and others who may be involved in healthcare delivery and
information management services.
Other workforce that Sanitation workers, guards, maintenance technicians and others who provide daily
support organization’s operational support to the healthcare organization. They are not directly involved in
operation patient care and are not allowed to access patient records. However, as employees of
healthcare organization they need to be aware about general organizational policies
regarding information privacy protection of patients.
To ensure the protection of patient rights for information privacy, an organization may establish a
committee of representatives from these workforce groups to define and implement organizational
policies and procedures as well as specific responsibilities of each group in privacy protection. This
committee, in turn, may define specific educational content, training formats and periodicity for each
of these groups of workforce as described in 5.4.3 and 5.4.4.
5.4.3 Workforce education in protecting health information privacy
Organization’s privacy protection program’s policies and practices contribute to a privacy culture
and help form the basis of privacy education for the workforce involved in information creation,
management, use and re-use. Education should help workforce to ensure the protection of patient rights
for information privacy. Clause 6 provides guidance regarding workforce’s education in protecting
health information privacy in a healthcare organization.
5.4.4 Patient’s education in protecting information privacy
Prior to collection of health information, the patient and/or his/her legal representative should be
informed about why, when, with whom and how their personal health information is shared, used and
re-used. The patient and/or his/her legal representative have to express via consent directives, why,
when, with whom and how personal health information may be shared, used and re-used. Therefore,
an organization’s privacy protection program should include an educational component for patients
and/or their legal representatives on how patient information privacy is protected by the organization.
This includes execution of consent directives. Clause 6 provides guidance for privacy education.
6 Information privacy education in healthcare
6.1 General concepts
Healthcare organizations have an obligation to educate their workforce, business partners and
stakeholders as well as patients and/or their legal representatives themselves regarding health
information privacy protection. Health information privacy education should be an integral part
of the overall healthcare organization workforce training. It should be based on international and
jurisdictionally-relevant educational standards, ethics and core competencies on privacy protection
tailored to the applicable legislation and organizational policies and procedures. Privacy education can be
delivered through existing organizational educational programs or as a specialized program of its own.
The healthcare organization should maintain and update the privacy education curriculum as needed
according with the changes in privacy protection technology and standards. It is important to keep
educational materials up to date and ensure that workforce renew their training periodically according
to the organizational policy for the workforce continuing education. The organization should also
document evidence of workforce compliance with the privacy protection policies and practices as well
as retain proof of such compliance.
6.2 Target audience of the privacy education
The target audience for health information privacy education includes the seven groups of organization’s
workforce as described in Table 1. These consist of six groups (groups 1 to 6) who are involved in
managing patient healthcare information and group 7 who are involved in the general support of the
organization’s operation.
In addition, health information privacy education should be delivered to patients or their legal
representatives.
6.3 Competencies, educational objectives and content
According to the Global Academic Curricula Competencies for Health Information Professionals (2015),
privacy education should be aimed at the overall information protection including data privacy,
confidentiality and security. The central theme of these competencies is that information is viewed as
a strategic organizational asset that requires high level oversight in order to be able to effectively use
it for safe care delivery, organizational decision-making, performance improvement, cost management
and risk mitigation. From these perspectives, workforce of the organization as well as its customers
(patients) carries out specific roles and responsibilities in protecting health information privacy.
Annex B provides detailed description and examples of setting learning objectives under the four levels
of comprehension as follows:
a) awareness;
b) understanding;
c) practice;
d) habit.
In general, the academic educational objectives are to assure that trainees
— understand applicable healthcare law, regulation and standards related to information protection
from the perspectives of various stakeholders;
— be able to develop and implement related privacy, security and confidentiality organizational
policies;
— be able to develop and maintain an organizational infrastructure on information protection
including privacy protection;
— be able to educate stakeholders on health information protection methods and their responsibilities.
Though the Global Competencies were developed for the academic education, they may be applicable
to vocational (on-the-job) training at the healthcare organizations as well. Thus, overall educational
objectives of the privacy education in a healthcare organization are aimed to enable workforce to:
a) understand the concepts of patient’s information privacy, confidentiality and the recommended
safeguards to protect that information;
b) understand the importance of patient’s privacy protection;
c) understand the relationship between information privacy and information security in a continually
changing healthcare environment;
d) recognize potential threats to patient privacy;
e) acquire knowledge of legal, administrative, technical and physical safeguards for privacy
protection;
f) learn effective approaches for protecting patient privacy in relation to patient information;
12 © ISO 2017 – All rights reserved
g) understand the actions required to safeguard personal health information;
h) understand the roles of workforce in protecting patients’ privacy when managing patient
information;
i) apply knowledge obtained in item a-h above in protecting information privacy on the job.
The specific types of training modules, the depth and the degree of comprehension upon training
completion for each workforce’s group depend on
...
記事のタイトル:ISO/TR 18638:2017 - ヘルスインフォマティクス - 医療機関における情報プライバシー教育に関する指針 記事の内容:ISO/TR 18638:2017は、医療機関における情報プライバシー保護をサポートするためのプライバシー教育プログラムの確立と提供に必要な教育の要素を具体化したガイドラインです。この文書の主な利用者は、医療機関における情報プライバシー教育の計画、確立、提供に責任を持つ人々です。ISO/TR 18638:2017では、役割と職務のコンテキストでプライバシー教育の要素を提供しています。組織はプライバシー保護ポリシーと手順を定義し適用する責任があり、医療機関の全てのスタッフが自身のプライバシー保護の責任を理解することを確保する必要があります。ISO/TR 18638:2017の対象範囲は次の通りです:a)医療分野における情報プライバシーの概念、b)医療機関における情報保護の課題、c)医療情報プライバシー教育プログラムの要素、d)基本的な健康情報プライバシー教育内容。
기사 제목: ISO/TR 18638:2017 - 건강정보학 - 의료기관에서의 건강정보 보호 교육에 대한 안내 기사 내용: ISO/TR 18638:2017은 건강정보 보호를 지원하기 위해 건강관리 기관에서 개인정보 보호 교육 프로그램을 수립하고 전달하기 위해 권장되는 필수 교육 요소를 명시합니다. 이 문서의 주 사용자는 건강관리 기관에 건강정보 보호 교육을 기획, 수립, 전달하는 역할을 담당하는 사람들입니다. ISO/TR 18638:2017은 역할과 직무 책임의 문맥에서 개인정보 보호 교육의 구성 요소를 제공합니다. 기관은 개인정보 보호 정책 및 절차를 정의하고 적용하는 책임이 있으며, 이에 따라 건강관리 기관의 모든 직원이 개인정보 보호 책임을 이해할 수 있도록 해야 합니다. ISO/TR 18638:2017의 범위는 다음과 같습니다: a) 의료 분야에서의 개인정보 보호 개념; b) 의료기관에서 정보 보호 실천의 어려움; c) 의료 정보 보호 교육 프로그램의 구성 요소; d) 기본적인 건강정보 보호 교육 콘텐츠.
ISO/TR 18638:2017 is a guidance document that outlines the necessary educational components for implementing a privacy education program in healthcare organizations. The document is aimed at individuals responsible for planning, establishing, and delivering healthcare information privacy education. It emphasizes the importance of defining and implementing privacy protection policies and procedures within the organization and ensuring that all staff understand their privacy protection responsibilities. The scope of the document covers the concept of information privacy in healthcare, challenges related to protecting information practices, components of a healthcare information privacy education program, and basic educational content on health information privacy.










Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...