This page is part of the FHIR Data Segmentation for Privacy (v0.2.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions
This IG provides guidance for applying security labels in FHIR. Security labels are used in access control systems governing the collection, access, use, and disclosure of the target information, such as FHIR resource(s), as required by applicable organizational, jurisdictional, or personal policies related to privacy, security, and trust.
Using security labels is an essential part of the Share with Protection paradigm by enabling information to be shared after assigning the security labels specifying how the information can be used and the restrictions to which it may be subject. Regardless of the content syntax, “Security Labels enable more data to flow as they enable policy fragments to accompany the resource data.” [FHIR Security Label Module].
While stated with respect to FHIR content, this holds for other labeled content as well, “The intent of a security label is that the recipient of resources or bundles with security tags is obligated to enforce the handling caveats of the tags and carry the security labels forward as appropriate.”
This IG describes how to structure FHIR security labels (in Resource.meta.security
or inline as defined by this IG) to meet the syntactic and semantic rules of the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 (HCS), and to convey computable and interoperable privacy, security, and trust policies within a policy domain, which are typically based on trust contracts with binding capability statements including recipient obligations.
HL7 has also developed standards for segmenting sensitive data for HL7 v2 and CDA using Security Labels in accordance with the normative HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 (HCS).
Unlike HCS-based security labeling guidance provided by HL7 Version 2.9 and the HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 and the HL7 CDA® R2 Implementation Guide: Data Provenance, Release 1 - US Realm, there is a need for more detailed implementation guidance for FHIR implementers, which is reasonable given that the FHIR core is agnostic to the HCS syntax requirements.
That said, the FHIR Security Label Module does specify several Core Security Labels, such as purpose of use and confidentiality tags. which all conformant FHIR Applications SHOULD use where appropriate. There are explanations about high water mark requirements, “break the glass”, and references to the HCS and its security label terminology.
Importantly, the Module points out that security labels are intended to convey a policy to which participants in an exchange ecosystem are bound by a trust contract:
“Security labels are only a device to connect specific resources, bundles, or operations to a wider security framework; a full set of policy and consent statements and their consequent obligations is needed to give the labels meaning. Because of this, security labels are most effective in fully trusted environments - that is, where all trading partners have agreed to abide by them in a Mutual Trust Framework. Note also that security labels support policy, and specific tagging of individual resources is not always required to implement policy correctly.”
However, the FHIR Security Label module provides only minimal detail about how to construct a label to convey a specific policy per the HCS or guidance on which security label values should be included to convey any particular privacy, security, or trust policy, particularly, because it does not provide an approach for:
Differentiating which set of Resource.meta.security
elements belongs to which policy in the (not uncommon) case where more than one policy applies to a resource, and
Granular data segmentation at the sub-resource level known as inline labeling.
An implementer relying on the general documentation of Resource.meta.security
would not have the tools for labeling a resource which is, for example, governed under both US 42 CFR Part 2 for substance use disorder confidentiality and under CFR 32 Part 2002 for Control Unclassified Information (CUI), because there are no built-in security label “set” delimiters. To address this need, the FHIR DS4P IG specifies the sec-label-basis
extension which enables an implementer to group relevant security label tags in Resource.meta.security
into an HCS-conformant security label to represent each applicable policy as a separate security label.
This provides guidance in the following areas:
The main sections of this IG are:
The following sections are informative: