Security Tags for Sensitive Information

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	HL7® Healthcare Privacy and Security Classification System (HCS), Release 1	Final	Production		No	Free	No
Standard	HL7 v2.9	Final	Production		No	Free
Standard	HL7 FHIR® R4 - Security Labels	Final	Production		No	Free
Implementation Specification	HL7 Version 3 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1	Final	Production		No	Free	Yes
Implementation Specification	IHE IT Infrastructure Technical Framework Volume 4 - National Extensions – Section 3.1 Data Segmentation for Privacy (DS4P)	Final	Pilot		No	Free	No
Implementation Specification	HL7 FHIR Data Segmentation for Privacy	In Development	Pilot		No	Free	No
Standard	HL7 Version 3 Standard: Privacy, Access and Security Services (PASS); Access Control, Release 1	Final	Feedback requested	Feedback Requested	No	Free

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
The 2015 Edition Cures Update Health IT Certification Criteria includes two optional criteria for Security Tags - Summary of Care (§ 170.315(b)(7) and § 170.315(b)(8)). Health IT certified to these criteria use the HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1. HL7 FHIR v3 Implementation Guide for DS4P provides CDA® templates to enable privacy and segmentation markings at the document, section and entry (data element) levels: CDA Privacy Markings Section - specifies how a document, section, or entry may be constrained to specify privacy and security markings. CDA Privacy Segmented Section - may apply to any section of a C-CDA document if that section's metadata (sensitivity, confidentiality) is different than the metadata of the overall document. Privacy Metadata Templates - support the exchange of protected information by annotating specific entries with several observations, policies and constraints. Examples include: CDA Privacy Annotation - a set of security observations that allow for specific privacy metadata for an entry that overrides that of a document or section. CDA Protected Problem - combines a mandatory provenance and privacy annotations with the default constraints applied to a ProblemObservation. CDA Security Observation - a class of abstract templates to indicate a security classification, control, category, or integrity criterion. Subclasses include Obligation, Confidentiality, Refrain Policy, and Purpose-of-Use Security Observations. US Realm CDA documents are required to include a Confidentiality code in the document header, taken from the HL7 BasicConfidentialityKind value set defined by the DS4P standard. Therefore, adoption levels may be higher for document-level tagging (vs. section level). HL7 v2.9 adopted HL7 Healthcare Privacy and Security Classification System syntax for assigning security labels in the ARV (Access Restrictions), BHS (Batch Header), FHS (File Header), and MSH (Message Header) segments.	Feedback requested. Additional information about security patterns can be found in Appendix 1. ISO/IEC 27000 - Information security management systems NIST SP 800-53 Rev. 5 - Security and Privacy Controls for Information Systems and Organizations

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

The 2015 Edition Cures Update Health IT Certification Criteria includes two optional criteria for Security Tags - Summary of Care (§ 170.315(b)(7) and § 170.315(b)(8)). Health IT certified to these criteria use the HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1.
HL7 FHIR v3 Implementation Guide for DS4P provides CDA® templates to enable privacy and segmentation markings at the document, section and entry (data element) levels:
- CDA Privacy Markings Section - specifies how a document, section, or entry may be constrained to specify privacy and security markings.
- CDA Privacy Segmented Section - may apply to any section of a C-CDA document if that section's metadata (sensitivity, confidentiality) is different than the metadata of the overall document.
- Privacy Metadata Templates - support the exchange of protected information by annotating specific entries with several observations, policies and constraints. Examples include:
  - CDA Privacy Annotation - a set of security observations that allow for specific privacy metadata for an entry that overrides that of a document or section.
  - CDA Protected Problem - combines a mandatory provenance and privacy annotations with the default constraints applied to a ProblemObservation.
  - CDA Security Observation - a class of abstract templates to indicate a security classification, control, category, or integrity criterion. Subclasses include Obligation, Confidentiality, Refrain Policy, and Purpose-of-Use Security Observations.
US Realm CDA documents are required to include a Confidentiality code in the document header, taken from the HL7 BasicConfidentialityKind value set defined by the DS4P standard. Therefore, adoption levels may be higher for document-level tagging (vs. section level).
HL7 v2.9 adopted HL7 Healthcare Privacy and Security Classification System syntax for assigning security labels in the ARV (Access Restrictions), BHS (Batch Header), FHS (File Header), and MSH (Message Header) segments.

Feedback requested.
Additional information about security patterns can be found in Appendix 1.
ISO/IEC 27000 - Information security management systems
NIST SP 800-53 Rev. 5 - Security and Privacy Controls for Information Systems and Organizations

Comment

Submitted by kathleen_conno… on 2020-09-20

HL7® v2.8 - ARV Access Restrictions Segment

HL7® v2.8 - ARV Access Restrictions Segment is incorrect. The ARV Access Restrictions Segment, as well as the BHS, FHS, and MSH segments adopted HL7 Healthcare Privacy and Security Classification System syntax for assigning security labels in HL7 v2.9. Noteworthy for ISA is that these updated segments to support security labeling may be pre-adopted by any implementer of a preceding HL7 V2 message version. Please correct.

Submitted by shellyspiro on 2018-10-01

Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

The Pharmacy HIT Collaborative supports the use of Consolidated HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1; HL7 Clinical Document Architecture (CDA), Release 2.0, Final Edition and IHE IT Infrastructure Technical Framework Volume 4 – National Extensions – Section 3.1 Data Segmentation for Privacy (DS4P). The Collaborative also supports Consent2Share FHIR Consent Profile Design, which is in development.

Submitted by gdixon on 2018-09-12

Is Federally required accurate?

Federally required, MU2015 this was an optional certification criteria at the document level for DS4P, is Federally required accurate if optional or does that apply to use of this IG?

CDA DS4P segmentation applied to section level. CDA Privacy Segmented Section-may apply to any section of a C-CDA document if that section metadata (sensitivity, confidentiality) is different than the document's overall

This IG needs further development. The concept that a section is more private then the document is pointless. The Document privacy should be inherited from the most private section. Esp. when the MU2015 optional certification was limited to document level privacy.