This document provides an overview of security and privacy considerations for Electronic Health Records (EHR) in a cloud computing service that users can leverage when selecting a service provider.

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    • Technical report
      54 pages
      English language
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    • Draft
      58 pages
      English language

This document gives guidelines for certificate management issues involved in deploying digital certificates in healthcare. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements. This document also identifies the principles needed in a healthcare security policy for cross-border communication and defines the minimum levels of security required, concentrating on aspects unique to healthcare.

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    • Standard
      34 pages
      English language
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    • Draft
      34 pages
      English language

This document defines the basic concepts underlying the use of digital certificates in healthcare and provides a scheme of interoperability requirements to establish a digital certificate-enabled secure communication of health information. It also identifies the major stakeholders who are communicating health-related information, as well as the main security services required for health communication where digital certificates can be required. This document gives a brief introduction to public k...view more

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    • Standard
      41 pages
      English language
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    • Draft
      41 pages
      English language

This document gives a guideline for implementation of an ISMS by showing practical examples of risk analysis on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices or health information systems in order to protect both sides' information assets (primarily the information system itself and personal health data) in a safe and efficient (i.e. economical) manner. This document consists of: — application of ISMS to RMS; —...view more

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    • Technical report
      70 pages
      English language
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    • Draft
      68 pages
      English language

This document supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates. This document describes the common technical, operational, and policy requirements that need to be addressed to enable digital certificates to be used in protecting the exchange of healthcare information within a single domain, between domains, and acros...view more

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    • Standard
      27 pages
      English language
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    • Draft
      27 pages
      English language

The document gives guidance for managing healthcare service security using connectable personal health devices. This document considers unidirectional data uploading from the PHD to the gateway (manager device), however, there are many clinical use cases for bidirectional data exchange. This document is applicable to identification and authentication between the bidirectionally connected PHDs and gateway by providing possible use cases and the associated threats and vulnerabilities. Since some s...view more

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    • Technical report
      16 pages
      English language

This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both t...view more

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    • Technical specification
      16 pages
      English language

This document describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1. This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points at technical solutions a...view more

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    • Standard
      22 pages
      English language
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    • Standard
      23 pages
      French language

This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software. This document defines those data elements needed for identification of particular events including incidents, near-misses and unsafe conditions, as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software.

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    • Technical specification
      16 pages
      English language

ISO 17090-5:2017 defines the procedural requirements for validating an entity credential based on Healthcare PKI defined in the ISO 17090 series used in healthcare information systems including accessing remote systems. Authorization procedures and protocols are out of scope of this document. The data format of digital signatures is also out of scope of this document.

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    • Standard
      13 pages
      English language

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 re...view more

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    • Technical report
      32 pages
      English language

ISO 21298:2017 defines a model for expressing functional and structural roles and populates it with a basic set of roles for international use in health applications. Roles are generally assigned to entities that are actors. This will focus on roles of persons (e.g. the roles of health professionals) and their roles in the context of the provision of care (e.g. subject of care). Roles can be structural (e.g. licensed general practitioner, non-licensed transcriptionist, etc.) or functional (e.g. ...view more

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    • Standard
      33 pages
      English language
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    • Standard
      33 pages
      French language

ISO 25237:2017 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. This document is applicable to organizations who wish to undertake pseudonymization processes for themselves or to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. ISO 25237:2017 - defines one basic concept for pseudonymization (see Clause 5), - defines one basic methodology for pseudony...view more

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    • Standard
      62 pages
      English language
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    • Standard
      62 pages
      English language
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    • Standard
      68 pages
      French language
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    • Standard
      68 pages
      French language

ISO 21549-7:2016 applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-7:2016 specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices. The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-profe...view more

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    • Standard
      50 pages
      English language
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    • Standard
      50 pages
      French language

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 c...view more

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    • Standard
      99 pages
      English language
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    • Standard
      100 pages
      French language
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    • Standard
      100 pages
      French language

ISO 17090-2:2015 specifies the certificate profiles required to interchange healthcare information within a single organization, between different organizations and across jurisdictional boundaries. It details the use made of digital certificates in the health industry and focuses, in particular, on specific healthcare issues relating to certificate profiles.

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    • Standard
      32 pages
      English language

ISO/TS 17975:2015 defines the set of frameworks of consent for the Collection, Use and/or Disclosure of personal information by health care practitioners or organizations that are frequently used to obtain agreement to process the personal health information of subjects of care. This is in order to provide an Informational Consent framework which can be specified and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdictions, countries) as an aid...view more

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    • Technical specification
      34 pages
      English language

ISO 21549-5:2015 describes and defines the basic structure of the identification data objects held on healthcare data cards, but does not specify particular data sets for storage on devices. The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21549 (although its structures can accommodate suitable data objects elsewhere specified): - security functions and related services that are likely to be specified by users for data cards depending o...view more

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    • Standard
      8 pages
      English language
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    • Standard
      8 pages
      French language

ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situatio...view more

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    • Standard
      67 pages
      English language
    • sale 15% off
    • Standard
      75 pages
      French language

ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situatio...view more

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    • Standard
      26 pages
      English language
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    • Standard
      27 pages
      French language

ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situatio...view more

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    • Standard
      27 pages
      English language
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    • Standard
      29 pages
      French language

ISO 20302:2014 is designed to confirm, via a numbering system and registration procedure, the identities of both the healthcare application provider and the health card holder in order that information may be exchanged by using cards issued for healthcare services. ISO 20302:2014 focuses on the machine-readable cards of ID-1 type defined in ISO/IEC 7810 that are issued for healthcare services provided in a service area that crosses the national borders of two or more countries/areas. ISO 20302:2...view more

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    • Standard
      7 pages
      English language

ISO 21549-4:2014 is applicable to situations in which clinical data additional to the limited clinical data defined in ISO 21549‑3 is recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-4:2014 specifies the basic structure of the data contained within the data object extended clinical data, but does not specify or mandate particular data sets for storage on devices.

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    • Standard
      17 pages
      English language
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    • Standard
      18 pages
      French language

ISO 21549-2:2014 establishes a common framework for the content and the structure of common objects used to construct data held on patient healthcare data cards. It is also applicable to common objects referenced by other data objects. ISO 21549-2:2014 is applicable to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-2:2014 specifies the basic structure of the data, but does ...view more

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    • Standard
      15 pages
      English language
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    • Standard
      17 pages
      French language

ISO 21549-3:2014 is applicable to situations in which limited clinical data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-3:2014 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1). ISO 21549-3:2014 specifies the basic structure of the data contained within the data object limited clinical data,...view more

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    • Standard
      11 pages
      English language
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    • Standard
      13 pages
      French language

ISO 20301:2014 describes general characteristics of machine-readable cards used in the field of healthcare. This International Standard is designed to confirm the identities of both the healthcare application provider and the healthcare cardholder in order that information can be exchanged by using cards issued for healthcare service. This International Standard focuses on the machine-readable cards of ID-1 type defined in ISO/IEC 7810 that are issued for healthcare services provided in a servic...view more

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    • Standard
      12 pages
      English language

ISO 22857:2013 provides guidance on data protection requirements to facilitate the transfer of personal health data across national or jurisdictional borders. It is normative only in respect of international or trans-jurisdictional exchange of personal health data. However it can be informative with respect to the protection of health information within national/jurisdictional boundaries and provide assistance to national or jurisdictional bodies involved in the development and implementation of...view more

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    • Standard
      56 pages
      English language

ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:201...view more

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    • Technical report
      47 pages
      English language

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).

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    • Technical specification
      112 pages
      English language

ISO 21549-1:2013 defines a general structure for the different types of data to be defined in other parts of ISO 21549 using UML notation. ISO 21549 defines data structures held on patient healthcards compliant with the physical dimensions of ID-1 cards, as defined by ISO/IEC 7810.

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    • Standard
      4 pages
      English language
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    • Standard
      5 pages
      French language

ISO 17090-1:2013 defines the basic concepts underlying the use of digital certificates in healthcare and provides a scheme of interoperability requirements to establish a digital certificate-enabled secure communication of health information. It also identifies the major stakeholders who are communicating health-related information, as well as the main security services required for health communication where digital certificates may be required. ISO 17090-1:2013 gives a brief introduction to pu...view more

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    • Standard
      39 pages
      English language

ISO 27789:2013 specifies a common framework for audit trails for electronic health records (EHR), in terms of audit trigger events and audit data, to keep the complete set of personal health information auditable across information systems and domains. It is applicable to systems processing personal health information which, complying with ISO 27799, create a secure audit record each time a user accesses, creates, updates or archives personal health information via the system. ISO 27789:2013 cov...view more

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    • Standard
      45 pages
      English language
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    • Standard
      46 pages
      French language

ISO 21091:2013 defines minimal specifications for directory services for healthcare. It can be used to enable communications between organizations, devices, servers, application components, systems, technical actors, and devices. ISO 21091:2013 provides the common directory information and services needed to support the secure exchange of healthcare information over public networks where directory information and services are used for these purposes. It addresses the health directory from a comm...view more

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    • Standard
      46 pages
      English language
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    • Standard
      49 pages
      French language

ISO/TS 14265:2011 defines a set of high-level categories of purposes for which personal health information can be processed. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdictions, countries) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health rec...view more

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    • Technical specification
      13 pages
      English language

ISO 21549‑8:2010 defines a way to facilitate access to distributed patient records and/or administrative information using healthcards. It defines the structure and elements of “links” typically stored in healthcards and representing references to individual patients' records as well as to subcomponents of them. Access control mechanisms, data protection mechanisms, access methods and other security services are outside the scope of ISO 21549‑8:2010.

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    • Standard
      9 pages
      English language
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    • Standard
      9 pages
      French language

The purpose of ISO/TS 21547:2010 is to define the basic principles needed to securely preserve health records in any format for the long term. It concentrates on previously documented healthcare specific archiving problems. It also gives a brief introduction to the general archiving principles. Unlike the traditional approach to standardization work, where the perspective is that of modelling, code sets and messages, this Technical Specification looks at archiving from the angle of document mana...view more

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    • Technical specification
      77 pages
      English language

ISO/TR 21548:2010 is an implementation guide for ISO/TS 21547. ISO/TR 21548:2010 will provide a methodology that will facilitate the implementation of ISO/TS 21547 in all organizations that have the responsibility to securely archive electronic health records for the long term. ISO/TR 21548:2010 gives an overview of processes and factors to consider in organizations wishing to fulfil requirements set by ISO/TS 21547.

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    • Technical report
      30 pages
      English language

ISO/TR 11636:2009 explains the network requirements in the healthcare field, the network security of an open network for the healthcare field, and the minimum guidelines for security management of health information exchange, including personal data, between external institutions. These requirements will assist in understanding the operation of security and evaluation of security issues in the healthcare field, and the usefulness of a managed VPN, like a dynamic on-demand VPN. ISO/TR 11636:2009 ...view more

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    • Technical report
      70 pages
      English language

ISO/TR 11633‑2:2009 provides an example of selected and applied "controls" for RMS security based on the definition in the ISMS, on the basis of the risk analysis result mentioned in ISO/TR 11633‑1. ISO/TR 11633‑2:2009 excludes the handling of the communication problems and the use of encryption method. ISO/TR 11633‑2:2009 consists of: a catalogue of types of security environment in health care facilities and RMS providers; an example of combinations of threats and vulnerabilities identified und...view more

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    • Technical report
      66 pages
      English language

ISO 21549-6:2008 is applicable to situations in which administrative data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-6:2008 specifies the basic structure of the data contained within the data object administrative data, but does not specify or mandate particular data sets for storage on devices. The detailed functions and mechanisms of the following services are not within the scope of this ISO 215...view more

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    • Standard
      6 pages
      English language
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    • Standard
      6 pages
      French language

ISO 17090-3:2008 gives guidelines for certificate management issues involved in deploying digital certificates in healthcare. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements. ISO 17090-3:2008 also identifies the principles needed in a healthcare security policy for cross-border communication and defines the minimum levels of security required, concentrating on aspects unique to healthcare.

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    • Standard
      36 pages
      English language

ISO/TR 27809:2007 considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is: necessary for the proper application of a medical device or an accessory to a medical device or a medical device in its own right. ISO/TR 27809:2007 is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be regulated or controlled in some other formal or informal or v...view more

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    • Technical report
      38 pages
      English language

ISO/TS 25238:2007 is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health software products, in order to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks, such as financial or organizational risks, are outside the scope of ISO/TS 25238:2007 unless they have the potential to harm a patient. ISO/TS 25238:2007 applies to an...view more

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    • Technical specification
      24 pages
      English language

ISO 17090-4:2014 supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates. Furthermore, it defines the provable compliance with a PKI policy necessary in the domain of healthcare. This part of ISO 17090 adopts long-term signature formats to ensure integrity and non-repudiation in long-term electronic preservation of healthca...view more

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    • Standard
      24 pages
      English language

ISO/TS 22600-3:2009 instantiates requirements for repositories for access control policies and requirements for privilege management infrastructures for health informatics. It provides implementation examples of the formal models specified in ISO/TS 22600-2:2006.

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    • Technical specification
      70 pages
      English language

ISO/TR 11633-1:2009 focuses on remote maintenance services (RMS) for information systems in health care facilities as provided by vendors of medical devices or health information systems (RMS providers) and shows an example of carrying out a risk analysis in order to protect both sides' information assets (primarily the information system itself and personal health data) in a safe and efficient (i.e. economical) manner. ISO/TR 11633-1:2009 consists of: a catalogue of use cases for RMS; a catalog...view more

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    • Technical report
      17 pages
      English language

ISO/TS 13606-4:2009 describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606‑1. ISO/TS 13606-4:2009 seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points at technical...view more

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    • Technical specification
      30 pages
      English language

ISO/TS 25237:2008 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. ISO/TS 25237:2008 is applicable to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. ISO/TS 25237:2008: defines one basic concept for pseudonymization; gives an overview of different use cases for pseudonymization that can be both reversible and irreversible; defines one basic methodol...view more

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    • Technical specification
      57 pages
      English language

ISO 27799:2008 defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that standard. ISO 27799:2008 specifies a set of detailed controls for managing health information security and provides health information security best practice guidelines. By implementing this International Standard, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is...view more

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    • Standard
      58 pages
      English language
    • sale 15% off
    • Standard
      63 pages
      French language