This page is part of the FHIR Data Segmentation for Privacy (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Detailed Specifications

Extensions Summary

The following extensions are defined by this IG:

• The display extension to require the consumer to display a specific mark when rendering the resource content in print or electronic user interfaces.
• The sec-label-basis extension which enables specifying the policy or regulation based on which a label has been assigned.
• The sec-label-related-artifact extension which enables recording a pointer to an artifact related to the label, particularly, a consent directive based on which the label has been assigned, or a provenance resource which further backs up the integrity label.
• The sec-label-classifier extension which enables recording the entity that has assigned or updated the label.

Furthermore, the following extension is defined to enable fine-grained labeling at the sub-resource level using inline security labels.

• the inline-sec-label extension enables specifying a security label inline on any element in a resource where an extension is allowed to appear.

This extension is used in tandem with the PROCESSINLINELABEL code (from the ObligationPolicy value set in v3-ActCode) that enables specifying whether a resource contains inline security labels and assists consumers in deciding whether they should invoke a deep inspection of the resource content to look for inline security labels.

The concept of inline security labels and the corresponding extension are defined and discussed further in a separate page.

display Extension

The display extension is based on the Annotation Data Type to record information about who made the statement and when. (Note that the author and time attributes in this data structure refer to the author and time for the display marking and should not be confused with the author of the Resource itself.)

This extension SHOULD be used in the context of Resource.meta when codes from the SecurityLabelMark value set (e.g., COPYMark and ConfidentialMark) are used on the resource to indicate that a prompt is to be rendered to end users. The SecurityLabelMark code definitions include the information to be displayed.

Policies SHALL describe the details and conditions for where and in what context these markings must or must not be displayed; for example, whether and how the markings should be rendered in summary forms or condensed displays.

The ability to convey renderable SecurityLabelMark security labels, including the author and the markdown role may be required by classification policies within a domain.

sec-label-basis Extension

The sec-label-basis extension MAY be used on a security label (i.e., in the context of Resource.meta.security) if there is only one policy being conveyed by the all of the security label elements in meta. When more than one policy is conveyed by the security label elements in meta, this extension SHALL be used with each security label element used to convey a specific policy.

For example, in the US, if a federal agency labels a Resource as 42 CFR Part 2 information, then the Resource would have both 42 CFR Part 2 and Controlled Unclassified Information (CUI) security labels in the meta. Security labels on the resource would leverage the sec-label-basis extension to indicate whether the basis for the label is 42 CFR Part 2 or 32 CFR Part 2002 (the law behind CUI).

This extension specifies the policy using a code from the privacy policy value set. Note that the strength of this binding is currently set to example. Use-case-specific profiles of this IG are encouraged to narrow down the values with a more strict binding to ensure a consistent understanding of codes across different providers and consumers. Further information about the policy can be conveyed via the sec-label-related-artifact extension that allows more metadata including references and URLs.

The need: In HCS, the key/value pairs in a Security Label are called Named Tag Sets/Tag Sets and the values are Tags. A Security Label instance represents applicable policy as a specified set of Named Tag Sets/Tag Sets with applicable Tag values. This pattern is followed explicitly in HL7 V2.9 and DS4P CDA IG. In FHIR, there’s no differentiation between Named Tag Sets/Tag Sets, so there is no built-in way to delineate the <security> elements belonging to a specific policy. In order to address this in the FHIR DS4P IG, we propose the use of extension-sec-label-basis on each <security> within a group of <security> elements belonging to a specific policy.

sec-label-classifier Extension

The sec-label-classifier extension is a reference to the classifying entity (e.g., individual or organization).

The ability to convey the authority, organization, or agent name, contact, and classification role may be required by classification policies within a domain.

This extension SHOULD be used on a security label (i.e., in the context of Resource.meta.security) so that the entity that has assigned the security label can be identified and retrieved.

For example, the security label codes may originally be assigned by a classifier authority or agent, then later, the security label code may be reclassified with a different code when the governing policy of a Resource changes. Use cases for changing security labels include:

• Permitting more or less restrictive confidentiality level protection, e.g., in the US, from normal under HIPAA to moderate once released via an Individual Right of Access Directive. For example, if a patient discloses a HIPAA governed Resource to a non-HIPAA covered entity, that Resource is no longer protected at the level of HIPAA, which is the “norm” for protection in the US. The patient disclosed information would be protected under laws that are different from the norm, and are typically less protective. So, the confidentiality label would be downgraded from normal to moderate. The entity downgrading the patient disclosed information may or may not be the patient. It could be done by the disclosing Covered Entity or a third party App based on the patient’s Right of Access Directive.

• Different, broader, or narrower sensitivity, e.g., access may be to all substance use disorder information rather than limited to opioid use disorder information.

• Different, broader, or narrower purposes of use, e.g., from all types of research purposes to disease specific purposes.

• When information is aggregated or disaggregated, there may be a need to change classification of the resulting content Declassified, i.e., removing a security label code, e.g., when information is made public with no restrictions on access.

sec-label-related-artifact Extension

The sec-label-related-artifact extension is based on the Related Artifact MetaData Type. The RelatedArtifact structure defines resources related to a module such as previous and next versions of documents, documentation, citations, etc. Note that the name resource here is being used in a more general sense than the FHIR-specific Resource. The related resource may be a FHIR resource, or it may be another type of resource, represented using the Attachment data type.

This extension SHOULD be used on a security label code for which justification or documentation can be found in an attached or discoverable information instance. Examples include a policy security label code, which is justified based on a law, patient consent directive, or organizational policy; a provenance security label, which is documented by a Provenance Resource; a trust security label code, which is documented by a trust accreditation certificate, trust mark, or a trust agreement, such as a Data Use and Reciprocal Support Agreement (DURSA).

Value Sets Summary

Value-sets used and defined by this IG are discussed below.

Security Classification

Type of security metadata observation made about the classification of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security classification is defined by ISO/IEC 2382-8:1998(E/F)/ T-REC-X.812-1995 as: The determination of which specific degree of protection against access the data or information requires, together with a designation of that degree of protection.

Security classification metadata is based on an analysis of applicable policies and the risk of financial, reputational, or other harm that could result from unauthorized disclosure.

Security Classification label is mandatory and can take only a single value ([1..1]) since this label is used to determine whether a requester meets the minimum bar for accessing information and also to ensure that the recipient can understand without ambiguity the level of protection that must be applied to the resource. Note that this does not mean that a resource is globally and permanently assigned a single confidentiality label regardless of context. Unlike some other labels that are tied to the clinical content of a resource (such as Sensitivity labels discussed below), the confidentiality label for a resource is context- and policy-dependent and therefore must often be determined dynamically and should be assigned based on the context (e.g., a jurisdiction, organization, or transaction). So, it is possible for a resource to have one confidentiality label in one context and a different confidentiality label in another context.

Tag Set	Card.	Description	Example Tags
Confidentiality	1..1	Security label metadata classifying an IT resource (clinical fact, data, information object, service, or system capability) according to its level of sensitivity, which is based on an analysis of applicable privacy policies and the risk of financial, reputational, or other harm to an individual or entity that could result if made available or disclosed to unauthorized individuals, entities, or processes.	Unrestricted, Normal, Very Restricted

Security Category

Type of security metadata observation made about the category of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security category metadata is defined by ISO/IEC 2382-8:1998(E/F)/ T-REC-X.812-1995 as: A nonhierarchical grouping of sensitive information used to control access to data more finely than with hierarchical security classification alone.

Tag Set	Card.	Description	Example Tags
Policy	0..1	Security label metadata that segments an IT resource by conveying a mandate, obligation, requirement, rule, or expectation relating to its privacy.
Sensitivity	0..*	Security label metadata that segments an IT resource by categorizing the value, importance, and vulnerability of an IT resource perceived as undesirable to share.	STD, HIV, SUD
Compartment	0..*	Security label metadata that segments an IT resource by indicating that access and use is restricted to members of a defined community or project.	Care Team, Research Project
Integrity	0..*	Security label metadata that segments an IT resource by conveying the completeness, veracity, reliability, trustworthiness, and provenance of an IT resource.	Anonymized, Digitally signed
Provenance	0..*	Security label metadata that segments an IT resource by conveying the provenance of the IT resource’s asserted or reported source.	Patient reported, Clinician asserted
Trust	0..*	Security label metadata that segments an IT resource by conveying the basis for trusting the source. Note that the Provenance resource can be leveraged for a more elaborate recording of trust including chaining of the trust levels between different entities involved in the data lifecycle.	Trust Accreditation, Trust Agreement

(*) Value-sets defined by this IG.

Security Control

Type of security metadata observation made about the control of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security control metadata conveys instructions for secure distribution, transmission, storage or use.

Tag Set	Card.	Description	Example Tags
Purpose of Use	0..*	Security label metadata that segments an IT resource by conveying the reason for performing one or more operations on information, which may be permitted by source system’s security policy in accordance with one or more privacy policies and consent directives.	Treatment, Payment, Operation, Research
General Purpose of Use	0..*	Security label metadata that segments an IT resource by conveying the reason for performing one or more operations on information of purpose of use at a general level.	Coverage, Patient Requested, Emergency Treatment
Obligation	0..*	Security label metadata that segments an IT resource by conveying the mandated workflow action that an information custodian, receiver, or user must perform. Enforcement of obligations is predicated on a binding mutual trust agreements between the sender and receiver.	Encrypt, mask, comply with policy
Refrain	0..*	Security label metadata that segments an IT resource by conveying actions which an information custodian, receiver, or user is not permitted to perform unless otherwise authorized or permitted under specified circumstances. Enforcement of refrains is predicated on a binding mutual trust agreements between the sender and receiver.	Do not disclose without consent, no reuse
Security Label Mark *	0..*	Security label metadata that segments an IT resource by conveying a displayed mark rendered as specified.	Draft, Confidential
Security Authorization Policy *	0..*	Security label metadata that segments an IT resource by conveying specific permissions used for access control.	Authorization policy, Delegation policy

(*) Value-sets defined by this IG. (**) Privacy-revealing Obligation or Refrain tags (e.g., the Obligation Policy MASK (mask) or the Refrain Policy NODSCLCD (no disclosure without consent directive)) shall not be included in the High Water Mark labels of a Bundle, DocumentReference, or Message Resources.

(*) Value-sets defined by this IG.