RDF Graph - https://81001.org/

SubjectPredicateObject
ufti:isPartOf rdf:type rdf:Property
rdfs:comment Expresses a partitive relationship between two concepts.
rdfs:subPropertyOf skos:broader
owl:inverseOf ufti:hasPart
ufti:hasPart rdf:type rdf:Property
rdfs:comment Expresses a partitive relationship between two concepts.
rdfs:subPropertyOf skos:narrower
owl:inverseOf ufti:isPartOf
https://81001.org/ rdf:type skos:ConceptScheme
dc:title Safe, effective and secure health software and health IT systems
skos:hasTopConcept https://81001.org/concept/cloud_computing
https://81001.org/concept/event
https://81001.org/concept/exploit
https://81001.org/concept/exposure
https://81001.org/concept/harm
https://81001.org/concept/hazard
https://81001.org/concept/hazardous_situation
https://81001.org/concept/health_IT_infrastructure
https://81001.org/concept/intended_use
https://81001.org/concept/Concept_75
https://81001.org/concept/key_property
https://81001.org/concept/life_cycle
https://81001.org/concept/organization
https://81001.org/concept/privacy
https://81001.org/concept/process
https://81001.org/concept/quality
https://81001.org/concept/residual_risk
https://81001.org/concept/responsibility_agreement
https://81001.org/concept/risk
https://81001.org/concept/risk_management_file
https://81001.org/concept/risk_tolerance
https://81001.org/concept/role
https://81001.org/concept/root_cause
https://81001.org/concept/security_capability
https://81001.org/concept/severity
https://81001.org/concept/threat
https://81001.org/concept/usability
https://81001.org/concept/verification
https://81001.org/concept/weakness
https://81001.org/concept/accompanying_information rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition information accompanying or marked on a health IT product or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use @en
skos:prefLabel accompanying information@en
skos:altLabel accompanying document@en
accompanying documentation@en
skos:broader https://81001.org/concept/asset
https://81001.org/concept/administrator rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition role responsible for the ongoing operation of the implemented health IT system and ensuring it is safeguarded and maintained on an ongoing basis @en
skos:prefLabel administrator@en
skos:broader https://81001.org/concept/role
https://81001.org/concept/asset rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition physical or digital entity that has value to an individual, an organization or a government @en
skos:prefLabel asset@en
skos:narrower https://81001.org/concept/health_information_technology
https://81001.org/concept/IT-network
https://81001.org/concept/personal_health_information
https://81001.org/concept/product
https://81001.org/concept/system
https://81001.org/concept/accompanying_information
ufti:hasPart https://81001.org/concept/component
skos:related https://81001.org/concept/harm
https://81001.org/concept/security_capability
https://81001.org/concept/health_IT_infrastructure
https://81001.org/concept/assurance_case rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition reasoned, auditable artefact created that supports the contention that its top-level claim (or set of claims), is satisfied, including systematic argumentation and its underlying evidence and explicit assumptions that support the claim(s) @en
skos:prefLabel assurance case@en
skos:note Note 1 to entry: An assurance case contains the following and their relationships: — one or more claims about properties; — arguments that logically link the evidence and any assumptions to the claim(s); — a body of evidence and possibly assumptions supporting these arguments for the claim(s); and — justification of the choice of top-level claim and the method of reasoning. @en
skos:broader https://81001.org/concept/product
skos:related https://81001.org/concept/product
https://81001.org/concept/risk_management_file
https://81001.org/concept/change_management rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition process for recording, coordination, approval and monitoring of all changes @en
skos:prefLabel change management@en
skos:broader https://81001.org/concept/process
skos:narrower https://81001.org/concept/clinical_change_management
https://81001.org/concept/change-release%20management rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition process that ensures that all changes to the health IT infrastructure (and its components) are assessed, approved, implemented and reviewed in a controlled manner and that changes are delivered, distributed, and tracked, leading to release of the change in a controlled manner with appropriate input and output with configuration management @en
skos:prefLabel change-release management@en
skos:broader https://81001.org/concept/process
skos:related https://81001.org/concept/health_IT_infrastructure
https://81001.org/concept/clinical_change_management rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition strategic and systematic approach that supports people and their organizations in the successful transition and adoption of electronic health solutions, with a focus on outcomes including solution adoption by users and the realization of benefits @en
skos:prefLabel clinical change management@en
skos:broader https://81001.org/concept/change_management
https://81001.org/concept/cloud_computing rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition paradigm for enabling network access to a scalable and elastic pool of shareable physical or virtual resources with self-service provisioning and administration on-demand @en
skos:prefLabel cloud computing@en
skos:related https://81001.org/concept/cloud_service
https://81001.org/concept/cloud_service rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition one or more capabilities offered via cloud computing invoked using a defined interface @en
skos:prefLabel cloud service@en
ufti:isPart https://81001.org/concept/system
skos:related https://81001.org/concept/cloud_computing
https://81001.org/concept/component rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition collection of system resources that (a) forms a physical or logical part of the system, (b) has specified functions and interfaces, and (c) is treated (e.g., by policies or specifications) as existing independently of other parts of the system. @en
skos:prefLabel component@en
skos:broader https://81001.org/concept/product
ufti:isPart https://81001.org/concept/asset
skos:related https://81001.org/concept/interoperability
https://81001.org/concept/customer rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition person or organization that could or does receive a product or a service that is intended for or required by this person or organization @en
skos:prefLabel customer@en
skos:note Note 1 to entry: A customer can be internal or external to the organization. [SOURCE: ISO 9000:2015, 3.2.4, modified — Example deleted.] @en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/healthcare_delivery_organization
https://81001.org/concept/Concept_70 rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition role responsible for execution of the design and development phase (from concept to release and maintenance) of a health software or health IT system @en
skos:prefLabel developer@en
skos:example Part of a manufacturing organization, a supplier of services, or a healthcare delivery organization. @en
skos:broader https://81001.org/concept/role
https://81001.org/concept/effectiveness rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition ability to produce the intended result @en
skos:prefLabel effectiveness@en
skos:broader https://81001.org/concept/key_properties
skos:related https://81001.org/concept/usability
https://81001.org/concept/intended_use
https://81001.org/concept/event rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition occurrence or change of a particular set of circumstances @en
skos:prefLabel event@en
skos:note Note 1 to entry: An event can be one or more occurrences and can have several causes. Note 2 to entry: An event can consist of something not happening. Note 3 to entry: An event can sometimes be referred to as an “incident” or “accident”. @en
skos:related https://81001.org/concept/root_cause
https://81001.org/concept/hazardous_situation
https://81001.org/concept/exposure
https://81001.org/concept/harm
https://81001.org/concept/risk_control
https://81001.org/concept/exploit rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition defined way to breach the security of information systems through vulnerability @en
skos:prefLabel exploit@en
skos:related https://81001.org/concept/vulnerability
https://81001.org/concept/exposure rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition extent to which an organization and/or stakeholder is subject to an event @en
skos:prefLabel exposure@en
skos:related https://81001.org/concept/organization
https://81001.org/concept/event
https://81001.org/concept/harm rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition injury or damage to the health of people, or damage to property or the environment @en
skos:prefLabel harm@en
skos:related https://81001.org/concept/asset
https://81001.org/concept/hazard
https://81001.org/concept/threat
https://81001.org/concept/event
https://81001.org/concept/severity
https://81001.org/concept/risk_control
https://81001.org/concept/hazard rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition potential source of harm @en
skos:prefLabel hazard@en
skos:related https://81001.org/concept/hazardous_situation
https://81001.org/concept/harm
https://81001.org/concept/risk_analysis
https://81001.org/concept/severity
https://81001.org/concept/hazardous_situation rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition circumstance in which people, property or the environment is/are exposed to one or more hazards @en
skos:prefLabel hazardous situation@en
skos:related https://81001.org/concept/hazard
https://81001.org/concept/vulnerability
https://81001.org/concept/event
https://81001.org/concept/health_information_technology rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition documented and intended application of information technology that is intended to be applied for the collection, storage, processing, retrieval, and communication of information relevant to health, patient care, and well-being @en
skos:prefLabel health information technology@en
skos:altLabel health IT@en
skos:broader https://81001.org/concept/asset
https://81001.org/concept/health_IT_infrastructure rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition combined set of IT assets available to the individual or organization for developing, configuring, integrating, maintaining, and using IT services and supporting health, patient care and other organizational objectives @en
skos:prefLabel health IT infrastructure@en
skos:example As per the definition for asset this can include the following: a) data and information; b) health software; c) medical devices; d) externally provided resources such as data centres, networks, and software-as-a-service and cloud solutions; e) people, and their qualifications, skills and experience; f) technical procedures and documentation to manage and support the health IT infrastructure; g) health IT systems that are configured and implemented to address organizational objectives by leveraging the above assets; h) intangibles, such as reputation and image. i) services, including security, software development, IT operations and externally provided services such as data centres, internet and software-as-a-service and cloud computing; @en
skos:related https://81001.org/concept/asset
https://81001.org/concept/change-release_management
https://81001.org/concept/health_IT_system rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition combination of interacting health IT elements that is configured and implemented to support and enable an individual or organization’s specific health objectives @en
skos:prefLabel health IT system@en
skos:example Such elements include health software, medical devices, IT hardware, interfaces, data, procedures and documentation @en
skos:broader https://81001.org/concept/system
skos:related https://81001.org/concept/integrator
https://81001.org/concept/implementer
https://81001.org/concept/key_properties
https://81001.org/concept/health_software rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition software intended to be used specifically for managing, maintaining, or improving health of individual persons, or the delivery of care, or which has been developed for the purpose of being incorporated into a medical device @en
skos:prefLabel health software@en
skos:note Note 1 to entry: ”Health Software” fully includes what is considered software as a medical device @en
ufti:isPart https://81001.org/concept/health_software_product
https://81001.org/concept/health_software_product rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition @en
skos:prefLabel health software product@en
skos:broader https://81001.org/concept/product
ufti:hasPart https://81001.org/concept/health_software
https://81001.org/concept/healthcare_delivery_organization rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition facility or enterprise such as a clinic or hospital that provides healthcare services @en
skos:prefLabel healthcare delivery organization@en
skos:altLabel HDO@en
skos:broader https://81001.org/concept/role
https://81001.org/concept/organization
skos:related https://81001.org/concept/customer
https://81001.org/concept/product
https://81001.org/concept/integrator
https://81001.org/concept/implementation rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition life cycle phase at the end of which the hardware, software and procedures of the system considered become operational @en
skos:prefLabel implementation@en
skos:broader https://81001.org/concept/process
skos:related https://81001.org/concept/system
https://81001.org/concept/implementer rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition role responsible for the clinical installation, workflow optimization, and training of health software and health IT systems in the clinical setting @en
skos:prefLabel implementer@en
skos:note Note 1 to entry: an implementer may be the manufacturer, the healthcare delivery organization, or a third party @en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/user
https://81001.org/concept/health_IT_system
https://81001.org/concept/manufacturer
https://81001.org/concept/integrator rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition role responsible for the incorporation of components into the health IT infrastructure used by the healthcare delivery organization, including technical installation, configuration, and data migration @en
skos:prefLabel integrator@en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/health_IT_system
https://81001.org/concept/medical_device
https://81001.org/concept/healthcare_delivery_organization
https://81001.org/concept/intended_use rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer @en
skos:prefLabel intended use@en
skos:altLabel intended purpose@en
skos:note Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use. @en
skos:related https://81001.org/concept/manufacturer
https://81001.org/concept/product
https://81001.org/concept/quality
https://81001.org/concept/effectiveness
https://81001.org/concept/Concept_75 rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition ability of two or more systems or components to exchange information and to use the information that has been exchanged @en
skos:prefLabel interoperability@en
skos:related https://81001.org/concept/component
https://81001.org/concept/system
https://81001.org/concept/IT-network rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition a system or systems composed of communicating nodes and transmission links to provide physically linked or wireless transmission between two or more specified communication nodes @en
skos:prefLabel IT-network@en
skos:broader https://81001.org/concept/asset
https://81001.org/concept/key_property rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition three risk management characteristics of safety, effectiveness, and security @en
skos:prefLabel key properties@en
skos:narrower https://81001.org/concept/security
https://81001.org/concept/safety
https://81001.org/concept/effectiveness
skos:related https://81001.org/concept/health_IT_system
https://81001.org/concept/quality
https://81001.org/concept/life_cycle rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition series of all phases in the life of a product or system, from the initial conception to final decommissioning and disposal @en
skos:prefLabel life cycle@en
skos:related https://81001.org/concept/product
https://81001.org/concept/system
https://81001.org/concept/manufacturer rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition organization with responsibility for design or manufacture of a product @en
skos:prefLabel manufacturer@en
skos:broader https://81001.org/concept/role
https://81001.org/concept/organization
skos:related https://81001.org/concept/intended_use
https://81001.org/concept/responsibility_agreement
https://81001.org/concept/product
https://81001.org/concept/implementer
https://81001.org/concept/reasonably_foreseeable_misuse
https://81001.org/concept/medical_device rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one of more of the specific medical purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury, — investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — cleaning, disinfection, or sterilization of medical devices, — providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means @en
skos:prefLabel medical device@en
skos:note Note 1 to entry: Products which could be considered to be medical devices in some jurisdictions but not in others include: — disinfection substances, — aids for persons with disabilities, — devices incorporating animal and/or human tissues, — devices for in-vitro fertilization or assisted reproductive technologies. @en
skos:broader https://81001.org/concept/product
skos:related https://81001.org/concept/integrator
https://81001.org/concept/organization rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives @en
skos:prefLabel organization@en
skos:note Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm, enterprise, authority, partnership, association, charity or institution, or part or combination thereof, whether incorporated or not, public or private @en
skos:narrower https://81001.org/concept/healthcare_delivery_organization
https://81001.org/concept/manufacturer
skos:related https://81001.org/concept/exposure
https://81001.org/concept/role
https://81001.org/concept/top_management
https://81001.org/concept/personal_health_information rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition information about an identifiable person that relates to the physical or mental health of the individual @en
skos:prefLabel personal health information@en
skos:note Note 1 to entry: To provision of health services to the individual and that may include: a) information about the registration of the individual for the provision of health services; b) information about payments or eligibility for health care in respect to the individual; c) a number, symbol, or particular assigned to an individual to uniquely identify the individual for health purposes; d) any information about the individual that is collected in the course of the provision of health services to the individual; e) information derived from the testing or examination of a body part or bodily substance; and f) identification of a person (e.g. a health professional) as provider of healthcare to the individual. Note 2 to entry: Personal health information does not include information that, either by itself or when combined with other information available to the holder, is anonymized, the identity of the individual who is the subject of the information cannot be ascertained from the information. @en
skos:broader https://81001.org/concept/asset
https://81001.org/concept/privacy rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition 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 @en
skos:prefLabel privacy@en
skos:related https://81001.org/concept/security
https://81001.org/concept/process rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition set of interrelated or interacting activities that use inputs to deliver an intended result @en
skos:prefLabel process@en
skos:narrower https://81001.org/concept/change_management
https://81001.org/concept/implementation
https://81001.org/concept/risk_management
https://81001.org/concept/change-release_management
skos:related https://81001.org/concept/quality
https://81001.org/concept/product rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition output of an organization that can be produced without any transaction taking place between the organization and the customer @en
skos:prefLabel product@en
skos:note Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider and customer, but can often involve this service element upon its delivery to the customer. Note 2 to entry: The dominant element of a product is that it is generally tangible. @en
skos:broader https://81001.org/concept/asset
skos:narrower https://81001.org/concept/assurance_case
https://81001.org/concept/component
https://81001.org/concept/health_software_product
https://81001.org/concept/medical_device
skos:related https://81001.org/concept/assurance_case
https://81001.org/concept/healthcare_delivery_organization
https://81001.org/concept/manufacturer
https://81001.org/concept/intended_use
https://81001.org/concept/life_cycle
https://81001.org/concept/responsibility_agreement
https://81001.org/concept/quality
https://81001.org/concept/reasonably_foreseeable_misuse
https://81001.org/concept/quality rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition degree to which all the properties and characteristics of a product, process, or service satisfy the requirements which ensue from the purpose for which that product, process, or service is to be used @en
skos:prefLabel quality@en
skos:related https://81001.org/concept/intended_use
https://81001.org/concept/product
https://81001.org/concept/verification
https://81001.org/concept/key_properties
https://81001.org/concept/process
https://81001.org/concept/usability
https://81001.org/concept/reasonably_foreseeable_misuse rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour @en
skos:prefLabel reasonably foreseeable misuse@en
skos:note Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g., lay and professional users. Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional. @en
skos:broader https://81001.org/concept/weakness
skos:related https://81001.org/concept/manufacturer
https://81001.org/concept/system
https://81001.org/concept/product
https://81001.org/concept/user
https://81001.org/concept/residual_risk rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition risk remaining after risk control measures have been implemented @en
skos:prefLabel residual risk@en
skos:related https://81001.org/concept/risk_tolerance
https://81001.org/concept/responsibility_agreement rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition document that fully defines the responsibilities of all relevant stakeholders @en
skos:prefLabel responsibility agreement@en
skos:note Note 1 to entry: This agreement can be a legal document, for example, a contract. @en
skos:related https://81001.org/concept/manufacturer
https://81001.org/concept/product
https://81001.org/concept/top_management
https://81001.org/concept/risk rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition combination of the probability of occurrence of harm and the severity of that harm @en
skos:prefLabel risk@en
skos:note Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation and the possibility to avoid or limit the harm @en
skos:related https://81001.org/concept/risk_analysis
https://81001.org/concept/risk_management
https://81001.org/concept/risk_tolerance
https://81001.org/concept/safety
https://81001.org/concept/risk_control
https://81001.org/concept/risk_analysis rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition systematic use of available information to identify hazards and to estimate the risk @en
skos:prefLabel risk analysis@en
skos:broader https://81001.org/concept/risk_management
skos:related https://81001.org/concept/risk
https://81001.org/concept/hazard
ufti:isPart https://81001.org/concept/risk_assessment
https://81001.org/concept/risk_assessment rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition overall process comprising a risk analysis and a risk evaluation @en
skos:prefLabel risk assessment@en
ufti:hasPart https://81001.org/concept/risk_analysis
https://81001.org/concept/risk_control rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels @en
skos:prefLabel risk control@en
skos:broader https://81001.org/concept/risk_management
skos:related https://81001.org/concept/risk
https://81001.org/concept/event
https://81001.org/concept/harm
https://81001.org/concept/risk_tolerance
https://81001.org/concept/risk_estimation rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition process used to assign values to the probability of occurrence of harm and the severity of that harm @en
skos:prefLabel risk estimation@en
skos:broader https://81001.org/concept/risk_management
https://81001.org/concept/risk_evaluation rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk @en
skos:prefLabel risk evaluation@en
skos:broader https://81001.org/concept/risk_management
https://81001.org/concept/risk_management rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk @en
skos:prefLabel risk management@en
skos:broader https://81001.org/concept/process
skos:narrower https://81001.org/concept/risk_estimation
https://81001.org/concept/risk_evaluation
https://81001.org/concept/risk_analysis
https://81001.org/concept/risk_control
skos:related https://81001.org/concept/risk
https://81001.org/concept/risk_management_file
https://81001.org/concept/risk_management_file rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition set of records and other documents that are produced by risk management @en
skos:prefLabel risk management file@en
skos:related https://81001.org/concept/risk_management
https://81001.org/concept/assurance_case
https://81001.org/concept/risk_tolerance rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition organization's or stakeholder's readiness to bear the risk after risk control in order to achieve its objectives @en
skos:prefLabel risk tolerance@en
skos:note Note 1 to entry: Risk tolerance can be influenced by legal or regulatory requirements. @en
skos:related https://81001.org/concept/residual_risk
https://81001.org/concept/risk
https://81001.org/concept/risk_control
https://81001.org/concept/role rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition function or position @en
skos:prefLabel role@en
skos:narrower https://81001.org/concept/customer
https://81001.org/concept/healthcare_delivery_organization
https://81001.org/concept/manufacturer
https://81001.org/concept/top_management
https://81001.org/concept/user
https://81001.org/concept/integrator
https://81001.org/concept/administrator
https://81001.org/concept/implementer
https://81001.org/concept/system_owner
https://81001.org/concept/subject_of_care
https://81001.org/concept/developer
skos:related https://81001.org/concept/organization
https://81001.org/concept/root_cause rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition set of conditions or actions that occur at the beginning of a sequence of events that result in the initiation of a failure mode @en
skos:prefLabel root cause@en
skos:related https://81001.org/concept/event
https://81001.org/concept/safety rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition freedom from unacceptable risk @en
skos:prefLabel safety@en
skos:broader https://81001.org/concept/key_properties
skos:related https://81001.org/concept/risk
https://81001.org/concept/usability
https://81001.org/concept/security rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition state where information and systems are protected from unauthorized activities, such as access, use, disclosure, disruption, modification, or destruction to a degree that the related risks to confidentiality, integrity, and availability are maintained at an acceptable level throughout the lifecycle @en
skos:prefLabel security@en
skos:altLabel cybersecurity@en
skos:example ` @en
skos:broader https://81001.org/concept/key_properties
skos:related https://81001.org/concept/privacy
https://81001.org/concept/security_capability
https://81001.org/concept/usability
https://81001.org/concept/security_capability rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition broad category of technical, administrative or organizational controls to manage risks to confidentiality, integrity, availability and accountability of data and systems @en
skos:prefLabel security capability@en
skos:related https://81001.org/concept/asset
https://81001.org/concept/security
https://81001.org/concept/severity rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition measure of the possible consequences of a hazard @en
skos:prefLabel severity@en
skos:related https://81001.org/concept/hazard
https://81001.org/concept/harm
https://81001.org/concept/sociotechnical_ecosystem rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition complex ‘ecosystem’ or ‘sociotechnical system’ environment where the software is tightly integrated with other systems, technologies, infrastructure, and domains (people, organizations and external environments) and where it is configured to support local clinical and business processes @en
skos:prefLabel sociotechnical ecosystem@en
skos:broader https://81001.org/concept/system
ufti:isPart https://81001.org/concept/system
https://contsys.org/concept/subject_of_care rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition person who seeks to receive, is receiving, or has received healthcare @en
skos:prefLabel subject of care@en
skos:altLabel subject of healthcare@en
service user@en
patient@en
client@en
skos:note NOTE A fœtus may be considered as a subject of care when receiving healthcare. @en
skos:example EXAMPLES A treated patient, a client of a physiotherapist, each particular member of a target population for screening, each particular member of a group of diabetic people attending a session of medical education, a person seeking health advice. @en
skos:broader https://81001.org/concept/role
https://81001.org/concept/system rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition combination of interacting elements organized to achieve one or more stated purposes @en
skos:prefLabel system@en
skos:broader https://81001.org/concept/asset
skos:narrower https://81001.org/concept/sociotechnical_ecosystem
https://81001.org/concept/health_IT_system
skos:related https://81001.org/concept/implementation
https://81001.org/concept/system_owner
https://81001.org/concept/user
https://81001.org/concept/life_cycle
https://81001.org/concept/interoperability
https://81001.org/concept/reasonably_foreseeable_misuse
ufti:hasPart https://81001.org/concept/sociotechnical_ecosystem
https://81001.org/concept/cloud_service
https://81001.org/concept/system_owner rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition senior executive accountable for ensuring the health IT system being acquired and implemented will meet their organization’s healthcare delivery services needs for its intended use @en
skos:prefLabel system owner@en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/system
https://81001.org/concept/threat rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition potential for violation of security, which exists when there is a circumstance, capability, action, or event that could breach security and cause harm @en
skos:prefLabel threat@en
skos:related https://81001.org/concept/harm
https://81001.org/concept/vulnerability
https://81001.org/concept/top_management rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition Group of people who direct and control an organization and have overall accountability in an organization. @en
skos:prefLabel top management@en
skos:note Note 1 to entry: Adapted from ISO 9000:2015, definition 3.1.1. @en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/responsibility_agreement
https://81001.org/concept/organization
https://81001.org/concept/usability rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment @en
skos:prefLabel usability@en
skos:note Note 1 to entry: all aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety @en
skos:related https://81001.org/concept/effectiveness
https://81001.org/concept/safety
https://81001.org/concept/security
https://81001.org/concept/quality
https://81001.org/concept/user rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition person using the system for a health-related purpose @en
skos:prefLabel user@en
skos:example The user may be the subject of care directly, or an individual assisting (as proxy for) the subject of care. @en
skos:broader https://81001.org/concept/role
skos:related https://81001.org/concept/implementer
https://81001.org/concept/system
https://81001.org/concept/reasonably_foreseeable_misuse
https://81001.org/concept/verification rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition confirmation, through the provision of objective evidence, that specified requirements have been fulfilled @en
skos:prefLabel verification@en
skos:note Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The activities carried out for verification are sometimes called a qualification process. Note 3 to entry: The word “verified” is used to designate the corresponding status. @en
skos:related https://81001.org/concept/quality
https://81001.org/concept/vulnerability rdf:type skos:Concept
skos:inScheme https://81001.org/
skos:definition flaw or weakness in a system’s design, implementation, or operation and management that could be exploited to violate the system’s security policy @en
skos:prefLabel vulnerability@en
skos:note Note 1 to entry: This definition of “vulnerability” differs from the definition of “vulnerability” used in the context of general risk management, where it encompasses the notion of possibility of exposition to a risk. @en
skos:broader https://81001.org/concept/weakness
skos:related https://81001.org/concept/exploit
https://81001.org/concept/threat
https://81001.org/concept/hazardous_situation
https://81001.org/concept/weakness rdf:type skos:Concept
skos:topConceptOf https://81001.org/
skos:definition kind of deficiency. @en
skos:prefLabel weakness@en
skos:note Note 1 to entry: Weakness may result in security and/or privacy risks. @en
skos:narrower https://81001.org/concept/vulnerability
https://81001.org/concept/reasonably_foreseeable_misuse