harm specification

IRI: https://spec.industrialontologies.org/ontology/construct/HarmSpecification

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/

SubClass Of: information content entity

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › harm specification

Definition

information content entity that describes an adverse condition, consequence, or loss

Explanatory Notes

1) In the current model, many harms can be represented through harmed states, especially when the harm involves damage to, degradation of, or loss of required qualities in a material entity, product, process output, equipment item, organism, person, population, or environment. For these cases, an information content entity that describes a harmed state is sufficient for classification as a harm specification. 2) The class is intentionally left open because not all relevant harms are expected to be adequately represented as material harmed states. In cybersecurity, information governance, software, and digital infrastructure contexts, harms may involve loss of confidentiality, loss of data integrity, loss of system availability, unauthorized access, loss of control over an automated process, or compromise of decision-relevant information. Some of these may require future modeling patterns that are not reducible to harmed states in the material domain. 3) A harm specification should not be confused with the harm itself. The harm specification is the information content entity used to represent, communicate, evaluate, or reason about the harm. The harm itself is the adverse condition, consequence, or loss being specified.

Examples

• Harm specification that describes a patient being in a bloodstream infection state after receiving a contaminated injectable biologic; Harm specification that describes a patient being in an anaphylactic state after administration of a product containing an unintended immunogenic contaminant; Harm specification that describes an operator being in a hypoxic injury state after remaining in an oxygen-deficient room following helium discharge; Harm specification that describes loss of batch sterility as a harm to be prevented during aseptic processing; Harm specification that describes unauthorized disclosure of batch genealogy data as a cybersecurity-related harm;

Adapted From

• https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-2_en.pdf and https://nvlpubs.nist.gov/nistpubs/legacy/sp/nistspecialpublication800-30r1.pdf and ISO 31000

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

InformationContentEntity(x) ∧ ∃h (HarmedState(h) ∧ describes(x, h)) → HarmSpecification(x)

Semi-Formal Natural Language Axioms

if x is an ‘information content entity’ that ‘describes’ some ‘harmed state’, then x is a ‘harm specification’

Description Logic

constr:HarmSpecification ⊑ constr:InformationContentEntity

constr:InformationContentEntity ⊓ ∃ constr:describes .constr:HarmedState ⊑ constr:HarmSpecification

SubClassOf: constr:InformationContentEntity

constr:InformationContentEntity and constr:describes some constr:HarmedState SubClassOf: constr:HarmSpecification