Types of security policies that further specify the ActClassPolicy value set.

Examples:

• obligation to encrypt
• refrain from redisclosure without consent

Authorisation policies are essentially security policies related to access-control and specify what activities a subject is permitted or forbidden to do, to a set of target objects. They are designed to protect target objects so are interpreted by access control agents or the run-time systems at the target system.

A positive authorisation policy defines the actions that a subject is permitted to perform on a target. A negative authorisation policy specifies the actions that a subject is forbidden to perform on a target. Positive authorisation policies may also include filters to transform the parameters associated with their actions. (Based on PONDERS)

An access control policy specific to the type of access control scheme, which is used to enforce one or more authorization policies.

Usage Note: Access control schemes are the type of access control policy, which is comprised of access control policy rules concerning the provision of the access control service.

There are two categories of access control policies, rule-based and identity-based, which are identified in CCITT Rec. X.800 aka ISO 7498-2. Rule-based access control policies are intended to apply to all access requests by any initiator on any target in a security domain. Identity-based access control policies are based on rules specific to an individual initiator, a group of initiators, entities acting on behalf of initiators, or originators acting in a specific role. Context can modify rule-based or identity-based access control policies. Context rules may define the entire policy in effect. Real systems will usually employ a combination of these policy types; if a rule-based policy is used, then an identity-based policy is usually in effect also.

An access control scheme may be based on access control lists, capabilities, labels, and context or a combination of these. An access control scheme is a component of an access control mechanism or "service") along with the supporting mechanisms required by that scheme to provide access control decision information (ADI) supplied by the scheme to the access decision facility (ADF also known as a PDP). (Based on ISO/IEC 10181-3:1996)

Examples:

• Attribute Based Access Control (ABAC)
• Discretionary Access Control (DAC)
• History Based Access Control (HBAC)
• Identity Based Access Control (IBAC)
• Mandatory Access Control (MAC)
• Organization Based Access Control (OrBAC)
• Relationship Based Access Control (RelBac)
• Responsibility Based Access Control (RespBAC)
• Risk Adaptable Access Control (RAdAC)

Delegation policies specify which actions subjects are allowed to delegate to others. A delegation policy thus specifies an authorisation to delegate. Subjects must already possess the access rights to be delegated.

Delegation policies are aimed at subjects delegating rights to servers or third parties to perform actions on their behalf and are not meant to be the means by which security administrators would assign rights to subjects. A negative delegation policy identifies what delegations are forbidden.

A Delegation policy specifies the authorisation policy from which delegated rights are derived, the grantors, which are the entities which can delegate these access rights, and the grantees, which are the entities to which the access rights can be delegated. There are two types of delegation policy, positive and negative. (Based on PONDERS)

Conveys the mandated workflow action that an information custodian, receiver, or user must perform.

Usage Notes: Per ISO 22600-2, ObligationPolicy instances 'are event-triggered and define actions to be performed by manager agent'. Per HL7 Composite Security and Privacy Domain Analysis Model: This value set refers to the action required to receive the permission specified in the privacy rule. Per OASIS XACML, an obligation is an operation specified in a policy or policy that is performed in conjunction with the enforcement of an access control decision.

Custodian system must remove any information that could result in identifying the information subject.

Custodian system must make available to an information subject upon request an accounting of certain disclosures of the individual's protected health information over a period of time. Policy may dictate that the accounting include information about the information disclosed, the date of disclosure, the identification of the receiver, the purpose of the disclosure, the time in which the disclosing entity must provide a response and the time period for which accountings of disclosure can be requested.

Custodian system must monitor systems to ensure that all users are authorized to operate on information objects.

Custodian system must monitor and maintain retrievable log for each user and operation on information.

Custodian security system must retrieve, evaluate, and comply with applicable policies associated with the target information.

Usage Note: CPLYPOL may be used as a security label code to inform senders and receivers of the tagged information to comply with applicable policy without specifying the specific policy type(s).

Custodian security system must retrieve, evaluate, and comply with the information handling directions of the Confidentiality Code associated with an information target.

Usage Note: CPLYCC may be used as a security label code to inform senders and receivers of information tagged with a Confidentiality Code to comply with applicable level of protection required by the assigned confidentiality code.

Custodian security system must retrieve, evaluate, and comply with applicable information subject consent directives.

Usage Note: CPLYCD may be used as a security label code to inform senders and receivers of information tagged with an ActCode_ActPolicyType_ActConsent code or an ActCode_ActPolicyType_ActPrivacyPolicy_ActConsentDirective code to comply with applicable consent directives.

Custodian security system must retrieve, evaluate, and comply with applicable Controlled Unclassified Information (CUI) policies associated with the target information.

Usage Note: In the US, CPLYCUI may be used as a security label code to inform recipients of information designated by a US Federal Agency as Controlled Unclassified Information (CUI) to comply with the applicable laws, regulations, executive orders, and other guidances, such as included in DURSAs, to persist, mark, and enforce required CUI controls

Background:

In accordance with US 32 CFR Part 2002 and US Executive Order 13556 Controlled Unclassified Information, US Federal Agencies and their contractors are charged with classifying and marking certain information they create as Controlled Unclassified Information (CUI).

The following definitions, which are provided for context, are based on terms defined by the CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html

• CUI is defined as "information in any form that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Government-wide policy requires or permits an agency to handle using safeguarding or dissemination controls."
• Designating CUI occurs when an authorized holder, consistent with 32 CFR Part 2002 and the CUI Registry, determines that a specific item of information falls into a CUI category or subcategory.
• The designating agency is the executive branch agency that designates or approves the designation of a specific item of information as CUI.
• The authorized holder who designates the CUI must make recipients aware of the information's CUI status when disseminating that information.
• • Disseminating occurs when authorized holders provide access, transmit, or transfer CUI to other authorized holders through any means, whether internal or external to the agency.

Once designated as CUI, US Federal Agencies and their contractors must assign CUI marks as prescribed by the National Archives and Records Administration (NARA) CUI Registry, and display marks as prescribed by the CUI Marking Handbook.

CUI markings must be displayed on hard copy, on containers, electronic media, and to end users for IT systems.

When HL7 content is designated as CUI, these computable markings can be interoperably conveyed using HL7 security label CUI tags, and may be included in HL7 text and narrative elements as human readable markings.

Impact of CUI markings:

CUI Custodians must enforce CUI security controls per applicable CUI policies. Federal agencies and their contractors must adhere to FISMA and NIST SP 800-53 security controls. Custodians, who are not Federal agencies or agency contractors, and are receivers of CUI, must adhere to NIST SP 800-171 security controls and those dictated by the Authorities indicated by the assigned CUI markings.

For most participants in US healthcare information exchange, including Federal Agencies and their contractors, additional controls are required by HIPAA Security standards for health information US 42 USC 1320d-2(d)(2) https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf

Federal Agencies and their contractors may be the CUI classifier of original CUI content; or a CUI derivative classifier, which reclassifies CUI content that has been aggregated with other CUI or Unclassified Uncontrolled Information (U) or dissembled from a larger CUI content; or declassifiers, depending on the designating agency's policies.

Applicable CUI policies include the following and any future applicable updates to policies or laws related to CUI:

• Executive Order 13556 https://www.federalregister.gov/articles/2010/11/09/2010-28360/controlled-unclassified-information
• US 32 CFR Part 2002 https://www.govinfo.gov/content/pkg/CFR-2017-title32-vol6/pdf/CFR-2017-title32-vol6-part2002.pdf
• NIST SP 800-171 https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r1.pdf
• NIST SP 800-171A https://doi.org/10.6028/NIST.SP.800-171A
• CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf
• CUI Registry - Health Information Category https://www.archives.gov/cui/registry/category-detail/health-info
• CUI Registry: Limited Dissemination Controls https://www.archives.gov/cui/registry/limited-dissemination
• CUI Policy and Guidance https://www.archives.gov/cui/registry/policy-guidance

Custodian security system must retrieve, evaluate, and comply with applicable jurisdictional privacy policies associated with the target information.

Usage Note: CPLYJPP may be used as a security label code to inform senders and receivers of information tagged with an ActCode_ActPolicyType_ActPrivacyPolicy_ActPrivacyLaw code or an ActCode_ActPolicyType_ActInformationPolicy.JurisIP code to comply with applicable jurisdictional privacy policy.

Custodian security system must retrieve, evaluate, and comply with applicable jurisdictional security policies associated with the target information.

Usage Note: CPLYJSP may be used as a security label code to inform senders and receivers of information tagged with an ActCode_ActPolicyType.SecurityPolicy code to comply with applicable jurisdictional security policy.

Custodian security system must retrieve, evaluate, and comply with applicable organizational privacy policies associated with the target information.

Usage Note: CPLYOPP may be used as a security label code to inform senders and receivers of information tagged with an ActCode_ActPolicyType_ActInformationPolicy.OrgIP code to comply with applicable organizational privacy policy.

Custodian security system must retrieve, evaluate, and comply with the organizational security policies associated with the target information.

Usage Note: CPLYOSP may be used as a security label code to inform senders and receivers of information tagged with an ActCode_ActPolicyType.SecurityPolicy code to comply with applicable organizational security policy.

Custodian security system must declassify information assigned security labels by instantiating a new version of the classified information so as to break the binding of the classifying security label when assigning a new security label that marks the information as unclassified in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the previous assignment and binding.

Custodian system must strip information of data that would allow the identification of the source of the information or the information subject.

Custodian system must remove target information from access after use.

Custodian security system must downgrade information assigned security labels by instantiating a new version of the classified information so as to break the binding of the classifying security label when assigning a new security label that marks the information as classified at a less protected level in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the previous assignment and binding.

Custodian security system must assign and bind security labels derived from compilations of information by aggregation or disaggregation in order to classify information compiled in the information systems under its control for collection, access, use and disclosure in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the previous assignment and binding.

Custodian system must render information unreadable by algorithmically transforming plaintext into ciphertext.

Usage Notes: A mathematical transposition of a file or data stream so that it cannot be deciphered at the receiving end without the proper key. Encryption is a security feature that assures that only the parties who are supposed to be participating in a videoconference or data transfer are able to do so. It can include a password, public and private keys, or a complex combination of all. (Per Infoway.)

Custodian system must render information unreadable and unusable by algorithmically transforming plaintext into ciphertext when "at rest" or in storage.

Custodian system must render information unreadable and unusable by algorithmically transforming plaintext into ciphertext while "in transit" or being transported by any means.

Custodian system must render information unreadable and unusable by algorithmically transforming plaintext into ciphertext while in use such that operations permitted on the target information are limited by the license granted to the end user.

Custodian system must require human review and approval for permission requested.

Custodian security system must assign and bind security labels in order to classify information created in the information systems under its control for collection, access, use and disclosure in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the assignment and binding.

Usage Note: In security systems, security policy label assignments do not change, they may supersede prior assignments, and such reassignments are always tracked for auditing and other purposes.

Custodian system must render information unreadable and unusable by algorithmically transforming plaintext into ciphertext. User may be provided a key to decrypt per license or "shared secret".

Custodian must limit access and disclosure to the minimum information required to support an authorized user's purpose of use.

Usage Note: Limiting the information available for access and disclosure to that an authorized user or receiver "needs to know" in order to perform permitted workflow or purpose of use.

Custodian security system must persist the binding of security labels to classify information received or imported by information systems under its control for collection, access, use and disclosure in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the assignment and binding.

Custodian must create and/or maintain human readable security label tags as required by policy.

Map: Aligns with ISO 22600-3 Section A.3.4.3 description of privacy mark: "If present, the privacy-mark is not used for access control. The content of the privacy-mark may be defined by the security policy in force (identified by the security-policy-identifier) which may define a list of values to be used. Alternately, the value may be determined by the originator of the security-label."

An originator must mark, persist, display, and convey computable and renderable Controlled Unclassified Information (CUI) marks as required by policy. A recipient must consume, persist, display, and reconvey CUI marks on information received based on agreements with the originator..

Examples:

• As CUI custodians, Federal Agencies and their contractors must mark, persist, display, and convey these marks.
• All CUI receivers must consume, persist, display, and reconvey CUI markings on information further disclosed

Usage Note:

In accordance with US 32 CFR Part 2002 and US Executive Order 13556 Controlled Unclassified Information, US Federal Agencies and their contractors are charged with classifying and marking certain information they create as Controlled Unclassified Information (CUI).

The following definitions, which are provided for context, are based on terms defined by the CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html

• CUI is defined as "information in any form that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Government-wide policy requires or permits an agency to handle using safeguarding or dissemination controls"
• Designating CUI occurs when an authorized holder, consistent with US 32 CFR Part 2002 and the CUI Registry, determines that a specific item of information falls into a CUI category or subcategory.
• The designating agency is the executive branch agency that designates or approves the designation of a specific item of information as CUI.
• The authorized holder who designates the CUI must make recipients aware of the information's CUI status when disseminating that information.
• Disseminating occurs when authorized holders provide access, transmit, or transfer CUI to other authorized holders through any means, whether internal or external to the agency.

Once designated as CUI, US Federal Agencies and their contractors must assign CUI marks as prescribed by the National Archives and Records Administration (NARA) CUI Registry, and display marks as prescribed by the CUI Marking Handbook.

CUI markings must be displayed on hard copy, on containers, electronic media, and to end users for IT systems.

When HL7 content is designated as CUI, these computable markings can be interoperably conveyed using HL7 security label CUI tags, and may be included in HL7 text and narrative elements as human readable markings.

Impact of CUI markings:

CUI Custodians must enforce CUI security controls per applicable CUI policies. Federal agencies and their contractors must adhere to FISMA and NIST SP 800-53 security controls. Custodians, who are not Federal agencies or agency contractors, and are receivers of CUI, must adhere to NIST SP 800-171 security controls and those dictated by the Authorities indicated by the assigned CUI markings.

For most participants in US healthcare information exchange, including Federal Agencies and their contractors, additional controls are required by HIPAA Security standards for health information US 42 USC 1320d-2(d)(2) https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf

Federal Agencies and their contractors may be the CUI classifier of original CUI content; or a CUI derivative classifier, which reclassifies CUI content that has been aggregated with other CUI or Unclassified Uncontrolled Information (U) or dissembled from a larger CUI content; or declassifiers, depending on the designating agency's policies.

Applicable CUI policies include the following and any future applicable updates to policies or laws related to CUI:

• Executive Order 13556 https://www.federalregister.gov/articles/2010/11/09/2010-28360/controlled-unclassified-information
• US 32 CFR Part 2002 https://www.govinfo.gov/content/pkg/CFR-2017-title32-vol6/pdf/CFR-2017-title32-vol6-part2002.pdf
• NIST SP 800-171 https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r1.pdf
• NIST SP 800-171A https://doi.org/10.6028/NIST.SP.800-171A
• CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf
• CUI Registry - Health Information Category https://www.archives.gov/cui/registry/category-detail/health-info
• CUI Registry: Limited Dissemination Controls https://www.archives.gov/cui/registry/limited-dissemination
• CUI Policy and Guidance https://www.archives.gov/cui/registry/policy-guidance

Custodian system must strip information of data that would allow the identification of the source of the information or the information subject. Custodian may retain a key to relink data necessary to reidentify the information subject.

Custodian system must remove information, which is not authorized to be access, used, or disclosed from records made available to otherwise authorized users.

Custodian security system must declassify information assigned security labels by instantiating a new version of the classified information so as to break the binding of the classifying security label when assigning a new security label that marks the information as classified at a more protected level in accordance with applicable jurisdictional privacy policies associated with the target information. The system must retain an immutable record of the previous assignment and binding.

Custodian security system must take note that the data object contains inline security labels and process them.

An abstract code for human readable marks indicating, e.g., the level of confidentiality protection, an authorized compartment, the integrity, or the handling instruction required by applicable policy. Such markings must be displayed as directed by applicable policy on electronically rendered information content and any electronic transmittal envelope or container; or on hardcopy information and any physical transmittal envelope or container.

Examples of protocols for marking displays on electronic or hardcopy rendered content: Across the top or "banner" of each page ; as a watermark placed diagonally cross each page; at the bottom or "footer" of each page; and may be displayed at the beginning of any portion within the content that required markings different than other portions of the content. The banner or top of page marking typically acts as a "high watermark" by including all of the markings made on any marked portions within the entirety of the information content.

Usage Note: A "Privacy Mark" is a Security Control Observation (SECCONOBS) named tag set as specified by the HL7 Privacy and Security Classification System (HCS). A Privacy Mark Named Tag Set is valued with a Privacy Mark leaf code "tag", which is a member of the Security Control Observation Value (_SecurityObservationValue) tag set. Related Security Control Observation named tag sets are Purpose of Use, Obligation Policy, and Refrain Policy, each with their own Security Control Observation Value tag sets.

Foundational standard definitions: ISO 22600-3 Section A.3.4.3 - If present, the privacy-mark is not used for access control. The content of the privacy-mark may be defined by the security policy in force (identified by the security-policy-identifier) which may define a list of values to be used. Alternately, the value may be determined by the originator of the security-label. IEEE Security Glossary Compendium 93- CESG Memorandum No.1 Issue 1.2 Oct 1992 - Human readable word or phrase acting as an indicator of all or part of the security constraints that apply to a document so marked. NOTE: A machine readable representation of a marking.

Comment: While policies requiring creators, processors, custodians, senders or recipients apply, enforce, and persist applicable Privacy Marks may be dictated by a jurisdiction, organization or personal privacy, security, or integrity policy, those required to comply may be governed under different policies, so compliance may need to be enforced through trust contracts. For example, information content marked with GDPR related policies may require adherence by processors or recipients outside of the European Union. For this reason, this code system is likely to evolve with the inclusion of multiple policy domains needing to communicate encoded policies in a standard, interoperable manner.

Information the US Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Government-wide policy requires or permits an agency to handle using safeguarding or dissemination controls. However, CUI does not include classified information (see definition above) or information a non-executive branch entity possesses and maintains in its own systems that did not come from, or was not created or possessed by or for, an executive branch agency or an entity acting for an agency. Law, regulation, or Government-wide policy may require or permit safeguarding or dissemination controls in three ways: Requiring or permitting agencies to control or protect the information but providing no specific controls, which makes the information CUI Basic; requiring or permitting agencies to control or protect the information and providing specific controls for doing so, which makes the information CUI Specified; or requiring or permitting agencies to control the information and specifying only some of those controls, which makes the information CUI Specified, but with CUI Basic controls where the authority does not specify. Based on CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html .

Usage Note: Mandatory control marking, which must be displayed on the top portion of each rendered or printed page containing controlled information. Should be displayed at the bottom of each rendered or printed page containing controlled information. Must be displayed on each portion of controlled information at the portion level if portions are uncontrolled unclassified information. Based on CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf. For definitions of key terms see CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

A displayed mark, required to be rendered as "CONTROLLED", indicating that the electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Mandatory control marking, which must be displayed on the top portion of each rendered or printed page containing controlled information. Should be displayed at the bottom of each rendered or printed page containing controlled information. Must be displayed on each portion of controlled information at the portion level if portions are uncontrolled unclassified information. Based on CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf.

A displayed mark, required to be rendered as "CUI", indicating that the electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Mandatory control marking, which must be displayed on the top portion of each rendered or printed page containing controlled information. Should be displayed at the bottom of each rendered or printed page containing controlled information. Must be displayed on each portion of controlled information at the portion level if portions are uncontrolled unclassified information. Based on CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf.

A displayed mark, required to be rendered as "CUI//HLTH", indicating that the electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of healthcare regulation governing CUI Basic marking include HIPAA Unique Identifier provisions 42 USC 1320d-2 note(b) https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf; Title 38 Section 7332 https://www.govinfo.gov/content/pkg/USCODE-2016-title38/pdf/USCODE-2016-title38-partV-chap73-subchapIII-sec7332.pdf; and several sections of 42 CFR Part 2.related to consent and confidentiality, e.g., https://www.govinfo.gov/content/pkg/CFR-2017-title42-vol1/pdf/CFR-2017-title42-vol1-sec2-12.pdf

A displayed mark, required to be rendered as "(CUI//HLTH)", indicating that a portion of an electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of healthcare regulation governing CUI Basic marking include HIPAA Unique Identifier provisions 42 USC 1320d-2 note(b) https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf; Title 38 Section 7332 https://www.govinfo.gov/content/pkg/USCODE-2016-title38/pdf/USCODE-2016-title38-partV-chap73-subchapIII-sec7332.pdf; and several sections of 42 CFR Part 2.related to consent and confidentiality, e.g., https://www.govinfo.gov/content/pkg/CFR-2017-title42-vol1/pdf/CFR-2017-title42-vol1-sec2-12.pdf

A displayed mark, required to be rendered as "(CUI)", indicating that a portion of an electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of healthcare regulation governing CUI Basic marking include HIPAA Unique Identifier provisions 42 USC 1320d-2 note(b) https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf; Title 38 Section 7332 https://www.govinfo.gov/content/pkg/USCODE-2016-title38/pdf/USCODE-2016-title38-partV-chap73-subchapIII-sec7332.pdf; and several sections of 42 CFR Part 2.related to consent and confidentiality, e.g., https://www.govinfo.gov/content/pkg/CFR-2017-title42-vol1/pdf/CFR-2017-title42-vol1-sec2-12.pdf

A displayed mark, required to be rendered as "CUI//PRVCY", indicating that the electronic or hardcopy controlled unclassified basic privacy information is private and must be protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of privacy regulation governing CUI Basic marking include 20 CFR 401.100 related to SSA disclosure of personal, program, and non-program information. https://www.govinfo.gov/content/pkg/CFR-2017-title20-vol2/pdf/CFR-2017-title20-vol2-sec401-100.pdf.

A displayed mark, required to be rendered as "(CUI//PRVCY)", indicating that a portion of an electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of privacy regulation governing CUI Basic marking include 20 CFR 401.100 related to SSA disclosure of personal, program, and non-program information. https://www.govinfo.gov/content/pkg/CFR-2017-title20-vol2/pdf/CFR-2017-title20-vol2-sec401-100.pdf.

A displayed mark, required to be rendered as "CUI//SP-HLTH", indicating that the electronic or hardcopy information is protected at the level of the subset of CUI in which the authorizing law, regulation, or Government-wide policy contains specific handling controls that it requires or permits agencies to use that differ from those for CUI Basic. The CUI Registry indicates which laws, regulations, and Government-wide policies include such specific requirements. CUI Specified controls may be more stringent than, or may simply differ from, those required by CUI Basic; the distinction is that the underlying authority spells out the controls for CUI Specified information and does not for CUI Basic information. CUI Basic controls apply to those aspects of CUI Specified where the authorizing laws, regulations, and Government-wide policies do not provide specific guidance. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of healthcare regulation governing CUI Specified marking include HIPAA Transaction and Code Sets and references the Congressional requirement that HHS promulgate Privacy, and Security rules https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf.

A displayed mark, required to be rendered as "(CUI//SP-HLTH)", indicating that a portion of an electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of healthcare regulation governing CUI Specified marking include HIPAA Transaction and Code Sets and references the Congressional requirement that HHS promulgate Privacy, and Security rules https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap7-subchapXI-partC-sec1320d-2.pdf

A displayed mark, required to be rendered as "CUI//SP-PRVCY", indicating that the electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of privacy regulation governing CUI Specified marking is OMB M-17-12� This Memorandum sets forth the policy for Federal agencies to prepare for and respond to a breach of personally identifiable information (PII). It includes a framework for assessing and mitigating the risk of harm to individuals potentially affected by a breach, as well as guidance on whether and how to provide notification and services to those individuals. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/m-17-12_0.pdf.

A displayed mark, required to be rendered as "(CUI//SP-PRVCY)", indicating that a portion of an electronic or hardcopy information is protected at the level of the subset of CUI for which the authorizing law, regulation, or Government-wide policy does not set out specific handling or dissemination controls. Agencies handle CUI Basic according to the uniform set of controls set forth in this part and the CUI Registry. CUI Basic differs from CUI Specified (see definition for CUI Specified), and CUI Basic controls apply whenever CUI Specified ones do not cover the involved CUI. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html.

Usage Note: Examples of privacy regulation governing CUI Specified marking is OMB M-17-12� This Memorandum sets forth the policy for Federal agencies to prepare for and respond to a breach of personally identifiable information (PII). It includes a framework for assessing and mitigating the risk of harm to individuals potentially affected by a breach, as well as guidance on whether and how to provide notification and services to those individuals. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/m-17-12_0.pdf.

A displayed mark, required to be rendered as "(U)", indicating that a portion of an electronic or hardcopy information is neither Executive Order 13556 nor classified information authorities cover as protected. Although this information is not controlled or classified, agencies must still handle it in accordance with Federal Information Security Modernization Act (FISMA) requirements. From CUI Glossary https://www.archives.gov/cui/registry/cui-glossary.html

Usage Note: Regulatory Source: 32 CFR § 2002.20 Marking. Federal Register Page 63344 63344 (ii) Authorized holders permitted to designate CUI must portion mark both CUI and uncontrolled unclassified portions.

CUI Marking Handbook https://www.archives.gov/files/cui/20161206-cui-marking-handbook-v1-1.pdf

CUI Portion Marking: Portion marking of CUI is optional in a fully unclassified document, but is permitted and encouraged to facilitate information sharing and proper handling of the information. Agency heads may approve the required use of CUI Portion marking on all CUI generated within their agency. As such, users should consult their agency CUI policy when creating CUI documents. When CUI Portion Markings are used and a portion does not contain CUI a "U" is placed in parentheses to indicate that the portion contains Uncontrolled Unclassified Information. (Page 14)

CUI Portion Markings are placed at the beginning of the portion to which they apply and must be used throughout the entire document. They are presented in all capital letters and separated as indicated in this handbook and the CUI Registry. The presence of EVEN ONE item of CUI in a document requires CUI marking of that document. Because of this, CUI Portion Markings can be of great assistance in determining if a document contains CUI and therefore must be marked as such. Remember: When portion markings are used and any portion does not contain CUI, a "(U)" is placed in front of that portion to indicate that it contains Uncontrolled - or non-CUI - Unclassified Information. (Page 15)

An abstract code for displayed Security Label tags.

Usage Note: These marks may be based on any of the HL7 Security Labeling related codes from various code systems and values sets, which are organized according to the HL7 Privacy and Security Classification System into HL7 Security Observation Type Named Tag Sets and valued with codes associated with the HL7 Security Observation Value Tag Set Names.

A displayed mark rendered as "Confidential", which indicates to end users that the electronic or hardcopy information they are viewing must be protected at a level of protection as dictated by applicable policy.

May be used to indicate proprietary or classified information that is, for example, business, intelligence, or project related, e.g., secret ingredients in a therapeutic substance; location of disaster health facilities and providers, or the name of a manufacturer or project contractor. Example use cases include a display to alert authorized business system users that they are viewing additionally protected proprietary and business confidential information deemed proprietary under an applicable jurisdictional or organizational policy.

Usage Note:

The ConfidentialMark (confidential mark) description is based on the HL7 Confidentiality Concept Domain: Types of privacy metadata classifying an IT resource (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.

Usage Note: Confidentiality codes may be used in security labels and privacy markings to classify IT resources based on sensitivity to indicate the obligation of a custodian or receiver to ensure that the protected resource is not made available or disclosed to individuals, entities, or processes (security principals) unless authorized per applicable policies. Confidentiality codes may also be used in the clearances of initiators requesting access to protected resources.

Map: Definition aligns with ISO 7498-2:1989 - Confidentiality is the property that information is not made available or disclosed to unauthorized individuals, entities, or processes.

A displayed mark indicating that the electronic or hardcopy information is a copy of an authoritative source for the information. The copy is not considered authoritative but is a duplicate of the authoritative content.

Usage Note: Applicable policy will dictate how the COPY mark will be displayed. Typical renderings include the marking appearing at the top or "banner" of electronic or hardcopy pages, or as watermarks set diagonally across each page.

A displayed mark on an electronic transmission or physical container such as an electronic transmittal wrapper, batch file, message header, or a physical envelop or package indicating that the contents, whether electronic or hardcopy information, must only be delivered to the authorized recipient(s) named in the address.

Usage Note: Required by US 32 CRF Part 2002 for container storing or transmitting CUI.

A displayed mark rendered to end users as a prescribed text warning that the electronic or hardcopy information shall not be further disclosed without consent of the subject of the information. For example, in order to warn a recipient of 42 CFR Part 2 information of the redisclosure restrictions, the rule mandates that end users receive a written prohibition against redisclosure unless authorized by patient consent or otherwise permitted by Part 2. See 42 CFR § 2.32 Prohibition on re-disclosure. (a)Notice to accompany disclosure. Each disclosure made with the patient's written consent must be accompanied by one of the following written statements: (1) This information has been disclosed to you from records protected by federal confidentiality rules ( 42 CFR part 2). The federal rules prohibit you from making any further disclosure of information in this record that identifies a patient as having or having had a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person unless further disclosure is expressly permitted by the written consent of the individual whose information is being disclosed or as otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose (see § 2.31). The federal rules restrict any use of the information to investigate or prosecute with regard to a crime any patient with a substance use disorder, except as provided at § § 2.12(c)(5) and 2.65; or (2) 42 CFR part 2 prohibits unauthorized disclosure of these records. https://www.law.cornell.edu/cfr/text/42/2.32

Usage Note: Example of marking requirement from SAMHSA FAQ Response to question 13:

Would a logon or splash page notification on an HIO's portal that contains the Part 2 notice prohibiting redisclosure be sufficient to meet Part 2's requirement that disclosures made with patient consent be accompanied by such a statement?

No. Part 2 requires each disclosure made with written patient consent to be accompanied by a written statement that the information disclosed is protected by federal law and that the recipient cannot make any further disclosure of it unless permitted by the regulations (42 CFR § 2.32). A logon page is the page where a user logs onto a computer system; a splash page is an introductory page to a web site. A logon or splash page notification on a HIO's portal including the statement as required by § 2.32 would not be sufficient notification regarding prohibitions on redisclosure since it would not accompany a specific disclosure. The notification must be tied to the Part 2 information being disclosed in order to ensure that the recipient of that information knows that specific information is protected by Part 2 and cannot be redisclosed except as authorized by the express written consent of the person to whom it pertains or as otherwise permitted by Part 2. https://www.samhsa.gov/about-us/who-we-are/laws-regulations/confidentiality-regulations-faqs

A displayed mark rendered to end users as "Restricted Confidentiality", which indicates that the electronic or hardcopy information they are viewing, must be protected at a restricted level of confidentiality protection as defined by HL7 Confidentiality code "R" (restricted). Examples: Includes information that is additionally protected such as sensitive conditions mental health, HIV, substance abuse, domestic violence, child abuse, genetic disease, and reproductive health; or sensitive demographic information such as a patient's standing as an employee or a celebrity. Use cases include a display to alert authorized EHR users that they are viewing additionally protected health information deemed sensitive by an applicable jurisdictional, organizational, or personal privacy policy.

Usage Note: The definition is based on HL7 Confidentiality code "R" (restricted), which is described as:

Privacy metadata indicating highly sensitive, potentially stigmatizing information, which presents a high risk to the information subject if disclosed without authorization. May be pre-empted by jurisdictional law, e.g., for public health reporting or emergency treatment. Foundational definitions of Confidentiality: From HL7 Confidentiality Concept Domain: Types of privacy metadata classifying an IT resource (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.

Usage Note from HL7 Confidentiality code "R": Confidentiality codes may be used in security labels and privacy markings to classify IT resources based on sensitivity to indicate the obligation of a custodian or receiver to ensure that the protected resource is not made available or disclosed to individuals, entities, or processes (security principals) unless authorized per applicable policies. Confidentiality codes may also be used in the clearances of initiators requesting access to protected resources.

This metadata indicates that the receiver may be obligated to comply with applicable, prevailing (default) jurisdictional privacy law or disclosure authorization.

Map: Definition aligns with ISO 7498-2:1989 - Confidentiality is the property that information is not made available or disclosed to unauthorized individuals, entities, or processes. Map: Partial Map to ISO 13606-4 Sensitivity Level (3) Clinical Care: Default for normal clinical care access (i.e. most clinical staff directly caring for the patient should be able to access nearly all of the EHR). Maps to normal confidentiality for treatment information but not to ancillary care, payment and operations.

A displayed mark indicating that the electronic or hard-copy information is still under development and is not yet considered to be ready for normal use.

Conveys prohibited actions which an information custodian, receiver, or user is not permitted to perform unless otherwise authorized or permitted under specified circumstances.

Usage Notes: ISO 22600-2 species that a Refrain Policy "defines actions the subjects must refrain from performing". Per HL7 Composite Security and Privacy Domain Analysis Model: May be used to indicate that a specific action is prohibited based on specific access control attributes e.g., purpose of use, information type, user role, etc.

Prohibition on disclosure without information subject's authorization.

Prohibition on collection or storage of the information.

Prohibition on disclosure without organizational approved patient restriction.

Prohibition on disclosure without a consent directive from the information subject.

Prohibition on Integration into other records.

Prohibition on disclosure except to entities on specific access list.

Prohibition on disclosure without an interagency service agreement or memorandum of understanding (MOU).

Prohibition on disclosure without organizational authorization.

Prohibition on disclosing information to patient, family or caregivers without attending provider's authorization.

Usage Note: The information may be labeled with the ActInformationSensitivity TBOO code, triggering application of this RefrainPolicy code as a handling caveat controlling access.

Maps to FHIR NOPAT: Typically, this is used on an Alert resource, when the alert records information on patient abuse or non-compliance.

FHIR print name is "keep information from patient". Maps to the French realm - code: INVISIBLE_PATIENT.

• displayName: Document non visible par le patient
• codingScheme: 1.2.250.1.213.1.1.4.13

French use case: A label for documents that the author chose to hide from the patient until the content can be disclose to the patient in a face to face meeting between a healthcare professional and the patient (in French law some results like cancer diagnosis or AIDS diagnosis must be announced to the patient by a healthcare professional and should not be find out by the patient alone).

Prohibition on collection of the information beyond time necessary to accomplish authorized purpose of use is prohibited.

Prohibition on redisclosure without patient consent directive.

Prohibition on redisclosure without patient consent directive.

Prohibition on redisclosure without a consent directive from the information subject.

Prohibition on disclosure without authorization under jurisdictional law.

Prohibition on associating de-identified or pseudonymized information with other information in a manner that could or does result in disclosing information intended to be masked.

Prohibition on use of the information beyond the purpose of use initially authorized.

Prohibition on disclosure except to principals with access permission to specific VIP information.

Prohibition on disclosure except as permitted by the information originator.

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.

Usage Notes: The rationale or purpose for an act relating to the management of personal health information, such as collecting personal health information for research or public health purposes.

To perform one or more operations on information for marketing services and products related to health care.

To perform one or more operations on information used for conducting administrative and contractual activities related to the provision of health care.

To perform analytics, evaluation and other secondary uses of treatment and healthcare related information to manage the quality, efficacy, patient safety, population health, and cost effectiveness of healthcare delivery. Explicitly excludes the use of information to organize the delivery of health care for care coordination and case management, or to provide healthcare treatment.

Usage Note: The concept of care management is narrower than the list of activities related to more general organizational objectives such as provider profiling, education of healthcare and non-healthcare professionals; insurance underwriting, premium rating, reinsurance; organizational legal, medical review, auditing, compliance and fraud and abuse detection; business planning, development, and restructuring; fund-raising; and customer service.

Map: Maps to ISO 14265 Classification Term "Health service management and quality assurance" described as "To inform persons or processes responsible for determining the availability, quality, safety, equity and cost-effectiveness of health care services."

There is a semantic gap in concepts. This classification term is described as activities, i.e., "to inform persons" or "to inform processes" rather than the rationale for performing actions/operations on information related to the activity.

To perform one or more operations on information used for cadaveric organ, eye or tissue donation.

To perform one or more operations on information used for fraud detection and prevention processes.

To perform one or more operations on information used within government processes.

To perform one or more operations on information for conducting activities related to meeting accreditation criteria.

To perform one or more operations on information used for conducting activities required to meet a mandate.

To perform one or more operations on information used for handling deceased patient matters.

To perform one or more operation operations on information used to manage a patient directory.

Examples:

• facility
• enterprise
• payer
• health information exchange patient directory

To perform one or more actions on information used for conducting administrative and contractual activities by or on behalf of organizational entities responsible for delivery of an individual's benefits in a healthcare program, health plan or insurance. Explicitly excludes the use of information to organize the delivery of health care for care coordination and case management, or to provide healthcare treatment.

Usage Note: Examples of activities conducted under this purpose of use: provider profiling, risk adjustment, underwriting, fraud and abuse, quality improvement population health and care management. Aligns with HIPAA Operation POU minus coordination of care or other treatment related activities. Similar to the description in SAMHSA Confidentiality of Substance Use Disorder Patient Records Supplemental notice of proposed rulemaking.

Map: Maps to ISO 14265 Classification Term "Administration of care for an individual subject of care" described as "To inform persons or processes responsible for enabling the availability of resources or funding or permissions for providing health care services to the subject of care."

However, this classification term is described as activities, i.e., "to inform persons" or "to inform processes" rather than the rationale for performing actions/operations on information related to the activity.

To perform one or more operations on information for conducting activities required by legal proceeding.

To perform one or more operations on information used for assessing results and comparative effectiveness achieved by health care practices and interventions.

To perform one or more operations on information used for conducting activities to meet program accounting requirements.

To perform one or more operations on information used for conducting administrative activities to improve health care quality.

To perform one or more operations on information to administer the electronic systems used for the delivery of health care.

To perform one or more operations on information to assign, persist, and manage labels to healthcare data to characterize various aspects, such as its security classification, sensitivity, compartment, integrity, and provenance; applicable privacy, consent, security, provenance, and trust policies; and handling caveats such as purpose of use, obligations, and refrain policies.

Label management includes classification of target data by constructing and binding of a label set per applicable policies, security policy information file semantics, and classification guides. Label management also includes process and procedures for subsequent revision of a label for, e.g., reclassification, downgrading classification, and declassification.

Label revisions may be triggered by, e.g., expiry of classification period; changes in applicable policy, e.g., revocation of a consent directive; or changes in the governing policy domain in which the data is relocated or a copy of the data is sent. If a label is revised, an audit log should be kept and the provenance of the label changes should be tracked.

To perform one or more operations on information to assign, persist, and manage metadata to healthcare data to characterize various aspects used for its indexing, discovery, retrieval, and processing by systems, applications, and end users. For example, master index identifier, media type, and location.

To perform one or more operations on information to administer health care coverage to an enrollee under a policy or program.

To perform one or more operations on information for conducting activities required by military processes, procedures, policies, or law.

To perform one or more operations on information used for operational activities conducted to administer the delivery of health care to a patient.

To perform one or more operations on information in processes related to ensuring the safety of health care.

To perform one or more operations on information used for monitoring performance of recommended health care practices and interventions.

To perform one or more operations on information used within the health records management process.

To perform one or more operations on information to design, develop, implement, test, or deploy a healthcare system or application.

To perform one or more operations on information that is simulated or synthetic health data used for testing system capabilities outside of a production or operational system environment.

Usage Note: Data marked with a HTEST security label enables an access control system to permit interfacing systems or end users provisioned with a clearance, which includes a HTEST purpose of use attribute, to test, verify, or validate that a system or application will operate in production as intended based on design specifications.

To perform one or more operations on information used in training and education.

To perform one or more operations on information used in training a machine learning (AI) model.

To perform one or more operations on information for conducting financial or contractual activities related to payment for provision of health care.

To perform one or more operations on information for provision of additional clinical evidence in support of a request for coverage or payment for health services.

To perform one or more operations on information for conducting prior authorization or predetermination of coverage for services.

To perform one or more operations on information for conducting activities related to coverage under a program or policy.

To perform one or more operations on information used for conducting eligibility determination for coverage in a program or policy. May entail review of financial status or disability assessment.

To perform one or more operations on information used for conducting eligibility verification of coverage in a program or policy. May entail provider contacting coverage source (e.g., government health program such as workers compensation or health plan) for confirmation of enrollment, eligibility for specific services, and any applicable copays.

To perform one or more operations on information used for enrolling a covered party in a program or policy. May entail recording of covered party's and any dependent's demographic information and benefit choices.

To perform one or more operations on information for the process of releasing military personnel from their service obligations, which may include determining service merit, discharge benefits, and disability assessment.

To perform one or more operations on information about the amount remitted for a health care claim.

To apply algorithms (e.g. AI, CDS) to perform one or more operations on information to arrive at decision used in payment for provision of health care.

To perform one or more operations on information for conducting scientific investigations to obtain health care knowledge. Use of the data iincludes basic and applied research such as biomedical, population origin or ancestry, translational research, and disease, discipline, specialty specific healthcare research and clinical trial research.

To perform one or more operations on information for conducting scientific investigations to obtain health care knowledge. Use of the data must be related to specified biomedical basic or applied research. For example, research on rare plants to determine whether biologic properties may be useful for pharmaceutical development. May be used in combination with clinical trial and other healthcare research purposes of use.

To perform one or more operations on information for conducting scientific investigations in accordance with clinical trial protocols to obtain health care knowledge.

To perform one or more operations on information for conducting scientific investigations in accordance with clinical trial protocols to obtain health care knowledge without provision of patient care. May be post-coordinated or used with other purposes of use such as disease, discipline, specialty, population origins or ancestry, translational healthcare research. For example, a clinical trial conducted on laboratory specimens collected from a specified patient population.

To perform one or more operations on information for conducting scientific investigations with patient care in accordance with clinical trial protocols to obtain health care knowledge. May be post-coordinated or used with other purposes of use such as disease, discipline, specialty, population origins or ancestry, translational healthcare research. For example, an "off-label" drug used for cancer therapy administer to a specified patient population.

To perform one or more operations on information in preparation for conducting scientific investigation to obtain health care knowledge, such as research on animals or review of patient health records, to determine the feasibility of a clinical trial study; assist with protocol design; or in preparation for institutional review board or ethics committee approval process. May be post-coordinated or used with other purposes of use such as disease, discipline, specialty, population origins or ancestry, translational healthcare research.

To perform one or more operations on information for conducting scientific investigations to obtain health care knowledge. Use of the data must be related to specified conditions, diagnosis, or disease healthcare research. For example, conducting cancer research by testing reaction of tumor cells to certain biologics. May be used in combination with clinical trial and other healthcare research purposes of use.

To perform one or more operations on information, including genealogical pedigrees, historical records, surveys, family health data, health records, and genetic information, for conducting scientific investigations to obtain health care knowledge. Use of the data must be related to population origins and/or ancestry healthcare research. For example, gathering genetic specimens from a specific population in order to determine the ancestry and population origins of that group. May be used in combination with clinical trial and other healthcare research purposes of use.

To perform one or more operations on information for conducting scientific investigations to obtain health care knowledge related to evidence based medicine during the course of providing healthcare treatment. Sometimes referred to as "bench to bedside", which is the iterative feedback loop between healthcare research and clinical trials with input from information collected in the course of routine provision of healthcare. For example, by extending a patient encounter to conduct a survey related to a research topic such as attitudes about use of a wellness device that a patient agreed to use. May be used in combination with clinical trial and other healthcare research purposes of use.

To perform one or more operations on information in response to a patient's request.

To perform one or more operations on information in response to a request by a family member authorized by the patient.

To perform one or more operations on information in response to a request by a person appointed as the patient's legal representative.

To perform one or more operations on information in response to a request by a person authorized by the patient.

To perform one or more operations on information for conducting public health activities, such as the reporting of notifiable conditions.

To perform one or more operations on information used for provision of immediately needed health care to a population of living subjects located in a disaster zone.

To perform one or more operations on information used to prevent injury or disease to living subjects who may be the target of violence.

To perform one or more operations on information for provision of health care.

To perform health care as part of the clinical trial protocol.

To perform one or more actions on information in order to organize the provision and case management of an individual's healthcare, including: Monitoring a person's goals, needs, and preferences; acting as the communication link between two or more participants concerned with a person's health and wellness; organizing and facilitating care activities and promoting self-management by advocating for, empowering, and educating a person; and ensuring safe, appropriate, non-duplicative, and effective integrated care.

Usage Note: Use when describing these functions: 1. Monitoring a person's goals, needs, and preferences. 2. Acting as the communication link between two or more participants concerned with a person's health and wellness. 3. Organizing and facilitating care activities and promoting self-management by advocating for, empowering, and educating a person. 4. Ensuring safe, appropriate, non-duplicative, and effective integrated care.

The goal is to clearly differentiate this type of coordination of care from HIPAA Operations by specifying that these actions on information are undertaken in the provision of healthcare treatment.

For similar uses of this concept, see SAMHSA Confidentiality of Substance Use Disorder Patient Records Supplemental notice of proposed rulemaking, which differentiates concepts of care coordination and case management for the provision of treatment as specifically distinct from activities related to health care delivery management and the operations of organizational entities involved in the delivery of healthcare.

Map: Maps to ISO 14265 Classification Terms: "Support of care activities within the provider organisation for an individual subject of care" described as "To inform persons or processes enabling others to provide health care services to the subject of care." "Subject of Care Uses" described as "To inform the subject of care in support of his or her own interests."

To perform one or more operations on information for provision of immediately needed health care for an emergent condition.

To perform policy override operations on information for provision of immediately needed health care for an emergent condition affecting potential harm, death or patient safety by end users who are not provisioned for this purpose of use. Includes override of organizational provisioning policies and may include override of subject of care consent directive restricting access.

Map: Partially Maps to ISO 14265 Classification Term "Emergency care provision to an individual subject of care" described as "To inform persons needing to provide health care services to the subject of care urgently, possibly needing to over-ride the policies and consents pertaining to Purpose 1 above." Purpose 1 is equivalent to HL7 treatment purpose of use: "Clinical care provision to an individual subject of care" described as "To inform persons or processes responsible for providing health care services to the subject of care." The ISO description conflates both of the proposed specializations of HL7 ETREAT: break the glass and the typically broader access to health information normally available to providers who are provisioned for emergency workflows on a regular basis, e.g., Emergency Room providers. Examples of greater access than is normally accessible by providers based on the need to know are access to sensitive information for which access typically requires a patient's consent. This is not an override of a patient's dissent to disclose sensitive information in cases where the applicable policy waives the need for that consent to access this information. In US, Title 38 Section 7332 and 42 CFR Part 2 both permit emergency access without the need to override a patient's consent directive; rather, this access is a limitation to the patient's right to dissent from disclosure.

To perform one or more operations on information for provision of immediately needed health care for an emergent condition in an emergency room or similar emergent care context by end users provisioned for this purpose, which does not constitute as policy override such as in a "Break the Glass" purpose of use.

Map:Partially Maps to ISO 14265 Classification Term "Emergency care provision to an individual subject of care" described as "To inform persons needing to provide health care services to the subject of care urgently, possibly needing to over-ride the policies and consents pertaining to Purpose 1 above." Purpose 1 is equivalent to HL7 treatment purpose of use: "Clinical care provision to an individual subject of care" described as "To inform persons or processes responsible for providing health care services to the subject of care."

The ISO description conflates both of the proposed specializations of HL7 ETREAT: break the glass and the typically broader access to health information normally available to providers who are provisioned for emergency workflows on a regular basis, e.g., Emergency Room providers. Examples of greater access than is normally accessible by providers based on the need to know are access to sensitive information for which access typically requires a patient's consent. This is not an override of a patient's dissent to disclose sensitive information in cases where the applicable policy waives the need for that consent to access this information. In US, Title 38 Section 7332 and 42 CFR Part 2 both permit emergency access without the need to override a patient's consent directive; rather, this access is a limitation to the patient's right to dissent from disclosure.

There is a semantic gap in concepts. This classification term is described as activities "to inform persons" rather than the rationale for performing actions/operations on information related to the activity.

To perform one or more operations on information for provision of health care to a population of living subjects, e.g., needle exchange program.

To apply algorithms (e.g. AI, CDS) to perform one or more operations on information to arrive at decision used in health care treatment.

Codes specify the category of observation, evidence, or document used to assess for services, e.g., discharge planning, or to establish eligibility for coverage under a policy or program. The type of evidence is coded as observation values.

Code specifying financial indicators used to assess or establish eligibility for coverage under a policy or program; e.g., pay stub; tax or income document; asset document; living expenses.

Codes specifying asset indicators used to assess or establish eligibility for coverage under a policy or program.

Indicator of annuity ownership or status as beneficiary.

Indicator of real property ownership, e.g., deed or real estate contract.

Indicator of retirement investment account ownership.

Indicator of status as trust beneficiary.

Code specifying income indicators used to assess or establish eligibility for coverage under a policy or program; e.g., pay or pension check, child support payments received or provided, and taxes paid.

Indicator of child support payments received or provided.

Indicator of disability income replacement payment.

Indicator of investment income, e.g., dividend check, annuity payment; real estate rent, investment divestiture proceeds; trust or endowment check.

Indicator of paid employment, e.g., letter of hire, contract, employer letter; copy of pay check or pay stub.

Indicator of retirement payment, e.g., pension check.

Indicator of spousal or partner support payments received or provided; e.g., alimony payment; support stipulations in a divorce settlement.

Indicator of income supplement, e.g., gifting, parental income support; stipend, or grant.

Indicator of tax obligation or payment, e.g., statement of taxable income.

Codes specifying living expense indicators used to assess or establish eligibility for coverage under a policy or program.

Indicator of clothing expenses.

Indicator of transportation expenses.

Indicator of health expenses; including medication costs, health service costs, financial participations, and health coverage premiums.

Indicator of housing expense, e.g., household appliances, fixtures, furnishings, and maintenance and repairs.

Indicator of legal expenses.

Indicator of mortgage amount, interest, and payments.

Indicator of rental or lease payments.

Indicator of transportation expenses.

Indicator of transportation expenses, e.g., vehicle payments, vehicle insurance, vehicle fuel, and vehicle maintenance and repairs.

Indicator of transportation expenses.

Code specifying eligibility indicators used to assess or establish eligibility for coverage under a policy or program eligibility status, e.g., certificates of creditable coverage; student enrollment; adoption, marriage or birth certificate.

Indicator of adoption.

Indicator of birth.

Indicator of creditable coverage.

Indicator of driving status.

Indicator of foster child status.

Indicator of status as covered member under a policy or program, e.g., member id card or coverage document.

Indicator of military status.

Indicator of marriage status.

Indicator of citizenship.

Indicator of student status.

Code specifying non-clinical indicators related to health status used to assess or establish eligibility for coverage under a policy or program, e.g., pregnancy, disability, drug use, mental health issues.

Indication of disability.

Indication of drug use.

Indication of IV drug use .

Non-clinical report of pregnancy.

Code specifying observations related to living dependency, such as dependent upon spouse for activities of daily living.

Continued living in private residence requires functional and health care assistance from one or more relatives.

Continued living in private residence requires functional and health care assistance from spouse or life partner.

Continued living in private residence requires functional and health care assistance from one or more unrelated persons.

Code specifying observations related to living situation for a person in a private residence.

Living alone. Maps to PD1-2 Living arrangement (IS) 00742 [A]

Living with one or more dependent children requiring moderate supervision.

Living with disabled spouse requiring functional and health care assistance

Living with one or more dependent children requiring intensive supervision

Living with family. Maps to PD1-2 Living arrangement (IS) 00742 [F]

Living with one or more relatives. Maps to PD1-2 Living arrangement (IS) 00742 [R]

Living only with spouse or life partner. Maps to PD1-2 Living arrangement (IS) 00742 [S]

Living with one or more unrelated persons.

Code specifying observations or indicators related to socio-economic status used to assess to assess for services, e.g., discharge planning, or to establish eligibility for coverage under a policy or program.

Indication of abuse victim.

Indication of status as homeless.

Indication of status as illegal immigrant.

Indication of status as incarcerated.

Indication of probation status.

Indication of refugee status.

Indication of unemployed status.

Indicates the result of a particular allergy test. E.g. Negative, Mild, Moderate, Severe

**Description:**Patient exhibits no reaction to the challenge agent.

**Description:**Patient exhibits a minimal reaction to the challenge agent.

**Description:**Patient exhibits a mild reaction to the challenge agent.

**Description:**Patient exhibits moderate reaction to the challenge agent.

**Description:**Patient exhibits a severe reaction to the challenge agent.

Observation values that communicate the method used in a quality measure to combine the component measure results included in an composite measure.

Code specifying that the measure uses all-or-nothing scoring. All-or-nothing scoring places an individual in the numerator of the composite measure if and only if they are in the numerator of all component measures in which they are in the denominator.

Code specifying that the measure uses linear scoring. Linear scoring computes the fraction of component measures in which the individual appears in the numerator, giving equal weight to each component measure.

Code specifying that the measure uses opportunity-based scoring. In opportunity-based scoring the measure score is determined by combining the denominator and numerator of each component measure to determine an overall composite score.

Code specifying that the measure uses weighted scoring. Weighted scoring assigns a factor to each component measure to weight that measure's contribution to the overall score.

**Description:**Coded observation values for coverage limitations, for e.g., types of claims or types of parties covered under a policy or program.

**Description:**Coded observation values for types of covered parties under a policy or program based on their personal relationships or employment status.

**Description:**Child over an age as specified by coverage policy or program, e.g., student, differently abled, and income dependent.

**Description:**Dependent biological, adopted, foster child as specified by coverage policy or program.

**Description:**Person requiring functional and/or financial assistance from another person as specified by coverage policy or program.

**Description:**Persons registered as a family unit in a domestic partner registry as specified by law and by coverage policy or program.

**Description:**An individual employed by an employer who receive remuneration in wages, salary, commission, tips, piece-rates, or pay-in-kind through the employeraTMs payment system (i.e., not a contractor) as specified by coverage policy or program.

**Description:**As specified by coverage policy or program.

**Description:**Person as specified by coverage policy or program.

**Description:**A pair of people of the same gender who live together as a family as specified by coverage policy or program, e.g., Naomi and Ruth from the Book of Ruth; Socrates and Alcibiades

**Description:**Coded observation values for types or instances of items for which coverage is provided under a policy or program, e.g., a type of vehicle or a named work of art.

**Description:**Coded observation values for types or instances of locations for which coverage is provided under a policy or program, e.g., in the covered party home, in state or in the country.

A clinical judgment as to the worst case result of a future exposure (including substance administration). When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.

Worst case result of a future exposure is assessed to be life-threatening or having high potential for organ system failure.

Worst case result of a future exposure is not assessed to be life-threatening or having high potential for organ system failure.

Unable to assess the worst case result of a future exposure.

Concepts representing whether a person does or does not currently have a job or is not currently in the labor pool seeking employment.

Individuals who, during the last week: a) did any work for at least 1 hour as paid or unpaid employees of a business or government organization; worked in their own businesses, professions, or on their own farms; or b) were not working, but who have a job or business from which the individual was temporarily absent because of vacation, illness, bad weather, childcare problems, maternity or paternity leave, labor-management dispute, job training, or other family or personal reasons, regardless of whether or not they were paid for the time off or were seeking other jobs.

Persons not classified as employed or unemployed, meaning those who have no job and are not looking for one.

Persons who currently have no employment, but are available for work and have made specific efforts to find employment.

Description: The domain contains genetic analysis specific observation values, e.g. Homozygote, Heterozygote, etc.

Description: An individual having different alleles at one or more loci regarding a specific character

Observation values that indicate what change in a measurement value or score is indicative of an improvement in the measured item or scored issue.

Improvement is indicated as a decrease in the score or measurement (e.g. Lower score indicates better quality)

Improvement is indicated as an increase in the score or measurement (e.g. Higher score indicates better quality)

Observation values used to indicate the type of scoring (e.g. proportion, ratio) used by a health quality measure.

A measure in which either short-term cross-section or long-term longitudinal analysis is performed over a group of subjects defined by a set of common properties or defining characteristics (e.g., Male smokers between the ages of 40 and 50 years, exposure to treatment, exposure duration).

A measure score in which each individual value for the measure can fall anywhere along a continuous scale (e.g., mean time to thrombolytics which aggregates the time in minutes from a case presenting with chest pain to the time of administration of thrombolytics).

A score derived by dividing the number of cases that meet a criterion for quality (the numerator) by the number of eligible cases within a given time frame (the denominator) where the numerator cases are a subset of the denominator cases (e.g., percentage of eligible women with a mammogram performed in the last year).

A score that may have a value of zero or greater that is derived by dividing a count of one type of data by a count of another type of data (e.g., the number of patients with central lines who develop infection divided by the number of central line days).

Observation values used to indicate what kind of health quality measure is used.

A measure that is composed from one or more other measures and indicates an overall summary of those measures.

A measure related to the efficiency of medical treatment.

A measure related to the level of patient engagement or patient experience of care.

A measure that indicates the result of the performance (or non-performance) of a function or process.

A measure that evaluates the change over time of a physiologic state observable that is associated with a specific long-term health outcome.

A measure that is a comparison of patient reported outcomes for a single or multiple patients collected via an instrument specifically designed to obtain input directly from patients.

A measure which focuses on a process which leads to a certain outcome, meaning that a scientific basis exists for believing that the process, when executed well, will increase the probability of achieving a desired outcome.

A measure that assesses the use of one or more processes where the expected health benefit exceeds the expected negative consequences.

A measure related to the extent of use of clinical resources or cost of care.

A measure related to the structure of patient care.

Observation values used to assert various populations that a subject falls into.

Patients who should be removed from the eMeasure population and denominator before determining if numerator criteria are met. Denominator exclusions are used in proportion and ratio measures to help narrow the denominator.

Denominator exceptions are those conditions that should remove a patient, procedure or unit of measurement from the denominator only if the numerator criteria are not met. Denominator exceptions allow for adjustment of the calculated score for those providers with higher risk populations. Denominator exceptions are used only in proportion eMeasures. They are not appropriate for ratio or continuous variable eMeasures. Denominator exceptions allow for the exercise of clinical judgment and should be specifically defined where capturing the information in a structured manner fits the clinical workflow. Generic denominator exception reasons used in proportion eMeasures fall into three general categories:

• Medical reasons
• Patient reasons
• System reasons

It can be the same as the initial patient population or a subset of the initial patient population to further constrain the population for the purpose of the eMeasure. Different measures within an eMeasure set may have different Denominators. Continuous Variable eMeasures do not have a Denominator, but instead define a Measure Population.

The initial population refers to all entities to be evaluated by a specific quality measure who share a common set of specified characteristics within a specific measurement set to which a given measure belongs.

The initial patient population refers to all patients to be evaluated by a specific quality measure who share a common set of specified characteristics within a specific measurement set to which a given measure belongs. Details often include information based upon specific age groups, diagnoses, diagnostic and procedure codes, and enrollment periods.

Measure population is used only in continuous variable eMeasures. It is a narrative description of the eMeasure population. (e.g., all patients seen in the Emergency Department during the measurement period).

Numerators are used in proportion and ratio eMeasures. In proportion measures the numerator criteria are the processes or outcomes expected for each patient, procedure, or other unit of measurement defined in the denominator. In ratio measures the numerator is related, but not directly derived from the denominator (e.g., a numerator listing the number of central line blood stream infections and a denominator indicating the days per thousand of central line usage in a specific time period).

Numerator Exclusions are used only in ratio eMeasures to define instances that should not be included in the numerator data. (e.g., if the number of central line blood stream infections per 1000 catheter days were to exclude infections with a specific bacterium, that bacterium would be listed as a numerator exclusion.)

Value for Act.partialCompletionCode attribute that implies 81-99% completion

Value for Act.partialCompletionCode attribute that implies 61-80% completion

Value for Act.partialCompletionCode attribute that implies 41-60% completion

Value for Act.partialCompletionCode attribute that implies 1-20% completion

Value for Act.partialCompletionCode attribute that implies 0% completion

Value for Act.partialCompletionCode attribute that implies 21-40% completion

Observation values used to indicate security observation metadata.

Abstract security observation values used to indicate security category metadata.

Examples: Codes conveying:

• privacy law
• information sensitivity
• consent directive types

Abstract security observation values used to indicate security classification metadata.

Examples: Confidentiality Codes

Abstract security observation values used to indicate security control metadata.

Examples: Codes conveying dissemination controls, information handling caveats, purpose of use, refrain policies, and obligations to which custodians and information receivers must comply.

Abstract security observation values used to indicate security integrity metadata.

Examples: Codes conveying integrity status, integrity confidence, and provenance.

Abstract security metadata observation values used to indicate mechanism used for authorized alteration of an IT resource (data, information object, service, or system capability)

Security metadata observation values used to indicate the use of a more abstract version of the content, e.g., replacing exact value of an age or date field with a range, or remove the left digits of a credit card number or SSN.

Security metadata observation values used to indicate the use of an algorithmic combination of actual values with the result of an aggregate function, e.g., average, sum, or count in order to limit disclosure of an IT resource (data, information object, service, or system capability) to the minimum necessary.

Security metadata observation value conveying the alteration integrity of an IT resource (data, information object, service, or system capability) by used to indicate the mechanism by which software systems can strip portions of the resource that could allow the identification of the source of the information or the information subject. No key to relink the data is retained.

Security metadata observation value used to indicate that the IT resource semantic content has been transformed from one encoding to another.

Usage Note: "MAP" code does not indicate the semantic fidelity of the transformed content.

To indicate semantic fidelity for maps of HL7 to other code systems, this security alteration integrity observation may be further specified using an Act valued with Value Set: MapRelationship (2.16.840.1.113883.1.11.11052).

Semantic fidelity of the mapped IT Resource may also be indicated using a SecurityIntegrityConfidenceObservation.

Security metadata observation value conveying the alteration integrity of an IT resource (data, information object, service, or system capability) by indicating the mechanism by which software systems can make data unintelligible (that is, as unreadable and unusable by algorithmically transforming plaintext into ciphertext) such that it can only be accessed or used by authorized users. An authorized user may be provided a key to decrypt per license or "shared secret".

Usage Note: "MASKED" may be used, per applicable policy, as a flag to indicate to a user or receiver that some portion of an IT resource has been further encrypted, and may be accessed only by an authorized user or receiver to which a decryption key is provided.

Security metadata observation value conveying the alteration integrity of an IT resource (data, information object, service, or system capability), by indicating the mechanism by which software systems can strip portions of the resource that could allow the identification of the source of the information or the information subject. Custodian may retain a key to relink data necessary to reidentify the information subject.

Rationale: Personal data which has been processed to make it impossible to know whose data it is. Used particularly for secondary use of health data. In some cases, it may be possible for authorized individuals to restore the identity of the individual, e.g.,for public health case management. Based on ISO/TS 25237:2008 Health informatics-Pseudonymization

Security metadata observation value used to indicate the mechanism by which software systems can filter an IT resource (data, information object, service, or system capability) to remove any portion of the resource that is not authorized to be access, used, or disclosed.

Usage Note: "REDACTED" may be used, per applicable policy, as a flag to indicate to a user or receiver that some portion of an IT resource has filtered and not included in the content accessed or received.

Metadata observation used to indicate that some information has been removed from the source object when the view this object contains was constructed because of configuration options when the view was created. The content may not be suitable for use as the basis of a record update

Usage Note: This is not suitable to be used when information is removed for security reasons - see the code REDACTED for this use.

Security metadata observation value used to indicate that the IT resource syntax has been transformed from one syntactical representation to another.

Usage Note: "SYNTAC" code does not indicate the syntactical correctness of the syntactically transformed IT resource.

Security metadata observation value used to indicate that the IT resource has been translated from one human language to another.

Usage Note: "TRSLT" does not indicate the fidelity of the translation or the languages translated.

The fidelity of the IT Resource translation may be indicated using a SecurityIntegrityConfidenceObservation.

To indicate languages, use the Value Set:HumanLanguage (2.16.840.1.113883.1.11.11526)

Security metadata observation value conveying the alteration integrity of an IT resource (data, information object, service, or system capability) which indicates that the resource only retains versions of an IT resource for access and use per applicable policy

Usage Note: When this code is used, expectation is that the system has removed historical versions of the data that falls outside the time period deemed to be the effective time of the applicable version.

Abstract security observation values used to indicate data integrity metadata.

Examples: Codes conveying the mechanism used to preserve the accuracy and consistency of an IT resource such as a digital signature and a cryptographic hash function.

Security metadata observation value used to indicate the mechanism by which software systems can establish that data was not modified in transit.

Rationale: This definition is intended to align with the ISO 22600-2 3.3.19 definition of cryptographic checkvalue: Information which is derived by performing a cryptographic transformation (see cryptography) on the data unit. The derivation of the checkvalue may be performed in one or more steps and is a result of a mathematical function of the key and a data unit. It is usually used to check the integrity of a data unit.

Examples:

• SHA-1
• SHA-2 (Secure Hash Algorithm)

Security metadata observation value used to indicate the mechanism by which software systems use digital signature to establish that data has not been modified.

Rationale: This definition is intended to align with the ISO 22600-2 3.3.26 definition of digital signature: Data appended to, or a cryptographic transformation (see cryptography) of, a data unit that allows a recipient of the data unit to prove the source and integrity of the data unit and protect against forgery e.g., by the recipient.

Abstract security observation value used to indicate integrity confidence metadata.

Examples: Codes conveying the level of reliability and trustworthiness of an IT resource.

Security metadata observation value used to indicate that the veracity or trustworthiness of an IT resource (data, information object, service, or system capability) for a specified purpose of use is perceived to be or deemed by policy to be very high.

Security metadata observation value used to indicate that the veracity or trustworthiness of an IT resource (data, information object, service, or system capability) for a specified purpose of use is perceived to be or deemed by policy to be adequate.

Security metadata observation value used to indicate that the veracity or trustworthiness of an IT resource (data, information object, service, or system capability) for a specified purpose of use is perceived to be or deemed by policy to be uncertain.

Security metadata observation value used to indicate that the veracity or trustworthiness of an IT resource (data, information object, service, or system capability) for a specified purpose of use is perceived to be or deemed by policy to be inadequate.

Abstract security metadata observation value used to indicate the provenance of an IT resource (data, information object, service, or system capability).

Examples: Codes conveying the provenance metadata about the entity reporting an IT resource.

Abstract security provenance metadata observation value used to indicate the entity that asserted an IT resource (data, information object, service, or system capability).

Examples: Codes conveying the provenance metadata about the entity asserting the resource.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a clinician.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a device.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a healthcare professional.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a patient acquaintance.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a patient.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a payer.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a professional.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was asserted by a substitute decision maker.

Security provenance metadata observation value used to indicate that an IT resource (data, or information object) was asserted by a Artificial Intelligence (e.g. Clinical Decision Support, Machine Learning, Algorithm).

Security provenance metadata observation value used to indicate that an IT resource (data, or information object) was asserted by a Dictation algorithm transforming human communications (e.g. speech).

Abstract security provenance metadata observation value used to indicate the entity that reported the resource (data, information object, service, or system capability).

Examples: Codes conveying the provenance metadata about the entity reporting an IT resource.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a clinician.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a device.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a healthcare professional.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a patient acquaintance.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a patient.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a payer.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a professional.

Security provenance metadata observation value used to indicate that an IT resource (data, information object, service, or system capability) was reported by a substitute decision maker.

Abstract security observation values used to indicate integrity status metadata.

Examples: Codes, such as those in the HL7 DocumentClassification code system conveying the workflow status of resource as authenticated, legally authenticated, and in progress.

Observation value used to indicate aspects of trust applicable to an IT resource (data, information object, service, or system capability).

Values for security trust accreditation metadata observation made about the formal declaration by an authority or neutral third party that validates the technical, security, trust, and business practice conformance of Trust Agents to facilitate security, interoperability, and trust among participants within a security domain or trust framework.

Values for security trust agreement metadata observation made about privacy and security requirements with which a security domain must comply. [ISO IEC 10181-1] [ISO IEC 10181-1]

Values for security trust certificate metadata observation made about a set of security-relevant data issued by a security authority or trusted third party, together with security information which is used to provide the integrity and data origin authentication services for an IT resource (data, information object, service, or system capability). [Based on ISO IEC 10181-1]

For example, a Certificate Policy (CP), which is a named set of rules that indicates the applicability of a certificate to a particular community and/or class of application with common security requirements. A particular Certificate Policy might indicate the applicability of a type of certificate to the authentication of electronic data interchange transactions for the trading of goods within a given price range. Another example is Cross Certification with Federal Bridge.

Values for security trust framework metadata observation made about a complete set of contracts, regulations or commitments that enable participating actors to rely on certain assertions by other actors to fulfill their information security requirements. [Kantara Initiative]

Values for security trust assurance metadata observation made about the digital quality or reliability of a trust assertion, activity, capability, information exchange, mechanism, process, or protocol.

The value assigned as the indicator of the digital quality or reliability of the verification and validation process used to verify the claimed identity of an entity by securely associating an identifier and its authenticator. [Based on ISO 7498-2]

For example, the degree of confidence in the vetting process used to establish the identity of the individual to whom the credential was issued, and 2) the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued. [OMB M-04-04 E-Authentication Guidance for Federal Agencies]

Indicator of low digital quality or reliability of the digital reliability of the verification and validation process used to verify the claimed identity of an entity by securely associating an identifier and its authenticator. [Based on ISO 7498-2]

The degree of confidence in the vetting process used to establish the identity of the individual to whom the credential was issued, and 2) the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued. [OMB M-04-04 E-Authentication Guidance for Federal Agencies]

Low authentication level of assurance indicates that the relying party may have little or no confidence in the asserted identity's validity. Level 1 requires little or no confidence in the asserted identity. No identity proofing is required at this level, but the authentication mechanism should provide some assurance that the same claimant is accessing the protected transaction or data. A wide range of available authentication technologies can be employed and any of the token methods of Levels 2, 3, or 4, including Personal Identification Numbers (PINs), may be used. To be authenticated, the claimant must prove control of the token through a secure authentication protocol. At Level 1, long-term shared authentication secrets may be revealed to verifiers. Assertions issued about claimants as a result of a successful authentication are either cryptographically authenticated by relying parties (using approved methods) or are obtained directly from a trusted party via a secure authentication protocol. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of basic digital quality or reliability of the digital reliability of the verification and validation process used to verify the claimed identity of an entity by securely associating an identifier and its authenticator. [Based on ISO 7498-2]

The degree of confidence in the vetting process used to establish the identity of the individual to whom the credential was issued, and 2) the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued. [OMB M-04-04 E-Authentication Guidance for Federal Agencies]

Basic authentication level of assurance indicates that the relying party may have some confidence in the asserted identity's validity. Level 2 requires confidence that the asserted identity is accurate. Level 2 provides for single-factor remote network authentication, including identity-proofing requirements for presentation of identifying materials or information. A wide range of available authentication technologies can be employed, including any of the token methods of Levels 3 or 4, as well as passwords. Successful authentication requires that the claimant prove through a secure authentication protocol that the claimant controls the token. Eavesdropper, replay, and online guessing attacks are prevented. Long-term shared authentication secrets, if used, are never revealed to any party except the claimant and verifiers operated by the CSP; however, session (temporary) shared secrets may be provided to independent verifiers by the CSP. Approved cryptographic techniques are required. Assertions issued about claimants as a result of a successful authentication are either cryptographically authenticated by relying parties (using approved methods) or are obtained directly from a trusted party via a secure authentication protocol. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of medium digital quality or reliability of the digital reliability of verification and validation of the process used to verify the claimed identity of an entity by securely associating an identifier and its authenticator. [Based on ISO 7498-2]

The degree of confidence in the vetting process used to establish the identity of the individual to whom the credential was issued, and 2) the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued. [OMB M-04-04 E-Authentication Guidance for Federal Agencies]

Medium authentication level of assurance indicates that the relying party may have high confidence in the asserted identity's validity. Level 3 is appropriate for transactions that need high confidence in the accuracy of the asserted identity. Level 3 provides multifactor remote network authentication. At this level, identity-proofing procedures require verification of identifying materials and information. Authentication is based on proof of possession of a key or password through a cryptographic protocol. Cryptographic strength mechanisms should protect the primary authentication token (a cryptographic key) against compromise by the protocol threats, including eavesdropper, replay, online guessing, verifier impersonation, and man-in-the-middle attacks. A minimum of two authentication factors is required. Three kinds of tokens may be used:

• "soft" cryptographic token, which has the key stored on a general-purpose computer,
• "hard" cryptographic token, which has the key stored on a special hardware device, and
• "one-time password" device token, which has symmetric key stored on a personal hardware device that is a cryptographic module validated at FIPS 140-2 Level 1 or higher. Validation testing of cryptographic modules and algorithms for conformance to Federal Information Processing Standard (FIPS) 140-2, Security Requirements for Cryptographic Modules, is managed by NIST.

Authentication requires that the claimant prove control of the token through a secure authentication protocol. The token must be unlocked with a password or biometric representation, or a password must be used in a secure authentication protocol, to establish two-factor authentication. Long-term shared authentication secrets, if used, are never revealed to any party except the claimant and verifiers operated directly by the CSP; however, session (temporary) shared secrets may be provided to independent verifiers by the CSP. Approved cryptographic techniques are used for all operations. Assertions issued about claimants as a result of a successful authentication are either cryptographically authenticated by relying parties (using approved methods) or are obtained directly from a trusted party via a secure authentication protocol. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of high digital quality or reliability of the digital reliability of the verification and validation process used to verify the claimed identity of an entity by securely associating an identifier and its authenticator. [Based on ISO 7498-2]

The degree of confidence in the vetting process used to establish the identity of the individual to whom the credential was issued, and 2) the degree of confidence that the individual who uses the credential is the individual to whom the credential was issued. [OMB M-04-04 E-Authentication Guidance for Federal Agencies]

High authentication level of assurance indicates that the relying party may have very high confidence in the asserted identity's validity. Level 4 is for transactions that need very high confidence in the accuracy of the asserted identity. Level 4 provides the highest practical assurance of remote network authentication. Authentication is based on proof of possession of a key through a cryptographic protocol. This level is similar to Level 3 except that only “hard� cryptographic tokens are allowed, cryptographic module validation requirements are strengthened, and subsequent critical data transfers must be authenticated via a key that is bound to the authentication process. The token should be a hardware cryptographic module validated at FIPS 140-2 Level 2 or higher overall with at least FIPS 140-2 Level 3 physical security. This level requires a physical token, which cannot readily be copied, and operator authentication at Level 2 and higher, and ensures good, two-factor remote authentication.

Level 4 requires strong cryptographic authentication of all parties and all sensitive data transfers between the parties. Either public key or symmetric key technology may be used. Authentication requires that the claimant prove through a secure authentication protocol that the claimant controls the token. Eavesdropper, replay, online guessing, verifier impersonation, and man-in-the-middle attacks are prevented. Long-term shared authentication secrets, if used, are never revealed to any party except the claimant and verifiers operated directly by the CSP; however, session (temporary) shared secrets may be provided to independent verifiers by the CSP. Strong approved cryptographic techniques are used for all operations. All sensitive data transfers are cryptographically authenticated using keys bound to the authentication process. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

The value assigned as the indicator of the digital quality or reliability of a defined sequence of messages between a Claimant and a Verifier that demonstrates that the Claimant has possession and control of a valid token to establish his/her identity, and optionally, demonstrates to the Claimant that he or she is communicating with the intended Verifier. [Based on NIST SP 800-63-2]

Indicator of the low digital quality or reliability of a defined sequence of messages between a Claimant and a Verifier that demonstrates that the Claimant has possession and control of a valid token to establish his/her identity, and optionally, demonstrates to the Claimant that he or she is communicating with the intended Verifier. [Based on NIST SP 800-63-2]

Low authentication process level of assurance indicates that (1) long-term shared authentication secrets may be revealed to verifiers; and (2) assertions and assertion references require protection from manufacture/modification and reuse attacks. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the basic digital quality or reliability of a defined sequence of messages between a Claimant and a Verifier that demonstrates that the Claimant has possession and control of a valid token to establish his/her identity, and optionally, demonstrates to the Claimant that he or she is communicating with the intended Verifier. [Based on NIST SP 800-63-2]

Basic authentication process level of assurance indicates that long-term shared authentication secrets are never revealed to any other party except Credential Service Provider (CSP). Sessions (temporary) shared secrets may be provided to independent verifiers by CSP. Long-term shared authentication secrets, if used, are never revealed to any other party except Verifiers operated by the Credential Service Provider (CSP); however, session (temporary) shared secrets may be provided to independent Verifiers by the CSP. In addition to Level 1 requirements, assertions are resistant to disclosure, redirection, capture and substitution attacks. Approved cryptographic techniques are required. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the medium digital quality or reliability of a defined sequence of messages between a Claimant and a Verifier that demonstrates that the Claimant has possession and control of a valid token to establish his/her identity, and optionally, demonstrates to the Claimant that he or she is communicating with the intended Verifier. [Based on NIST SP 800-63-2]

Medium authentication process level of assurance indicates that the token can be unlocked with password, biometric, or uses a secure multi-token authentication protocol to establish two-factor authentication. Long-term shared authentication secrets are never revealed to any party except the Claimant and Credential Service Provider (CSP).

Authentication requires that the Claimant prove, through a secure authentication protocol, that he or she controls the token. The Claimant unlocks the token with a password or biometric, or uses a secure multi-token authentication protocol to establish two-factor authentication (through proof of possession of a physical or software token in combination with some memorized secret knowledge). Long-term shared authentication secrets, if used, are never revealed to any party except the Claimant and Verifiers operated directly by the CSP; however, session (temporary) shared secrets may be provided to independent Verifiers by the CSP. In addition to Level 2 requirements, assertions are protected against repudiation by the Verifier.

Indicator of the high digital quality or reliability of a defined sequence of messages between a Claimant and a Verifier that demonstrates that the Claimant has possession and control of a valid token to establish his/her identity, and optionally, demonstrates to the Claimant that he or she is communicating with the intended Verifier. [Based on NIST SP 800-63-2]

High authentication process level of assurance indicates all sensitive data transfer are cryptographically authenticated using keys bound to the authentication process. Level 4 requires strong cryptographic authentication of all communicating parties and all sensitive data transfers between the parties. Either public key or symmetric key technology may be used. Authentication requires that the Claimant prove through a secure authentication protocol that he or she controls the token. All protocol threats at Level 3 are required to be prevented at Level 4. Protocols shall also be strongly resistant to man-in-the-middle attacks. Long-term shared authentication secrets, if used, are never revealed to any party except the Claimant and Verifiers operated directly by the CSP; however, session (temporary) shared secrets may be provided to independent Verifiers by the CSP. Approved cryptographic techniques are used for all operations. All sensitive data transfers are cryptographically authenticated using keys bound to the authentication process. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

The value assigned as the indicator of the high quality or reliability of the statement from a Verifier to a Relying Party (RP) that contains identity information about a Subscriber. Assertions may also contain verified attributes.

Indicator of the low quality or reliability of the statement from a Verifier to a Relying Party (RP) that contains identity information about a Subscriber. Assertions may also contain verified attributes.

Assertions and assertion references require protection from modification and reuse attacks. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the basic quality or reliability of the statement from a Verifier to a Relying Party (RP) that contains identity information about a Subscriber. Assertions may also contain verified attributes.

Assertions are resistant to disclosure, redirection, capture and substitution attacks. Approved cryptographic techniques are required for all assertion protocols. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the medium quality or reliability of the statement from a Verifier to a Relying Party (RP) that contains identity information about a Subscriber. Assertions may also contain verified attributes.

Assertions are protected against repudiation by the verifier. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the high quality or reliability of the statement from a Verifier to a Relying Party (RP) that contains identity information about a Subscriber. Assertions may also contain verified attributes.

Strongly resistant to man-in-the-middle attacks. "Bearer" assertions are not used. "Holder-of-key" assertions may be used. RP maintains records of the assertions. [Summary of the technical requirements specified in NIST SP 800-63 for the four levels of assurance defined by the December 2003, the Office of Management and Budget (OMB) issued Memorandum M-04-04, E-Authentication Guidance for Federal Agencies.]

Indicator of the digital quality or reliability of the activities performed by the Credential Service Provider (CSP) subsequent to electronic authentication registration, identity proofing and issuance activities to manage and safeguard the integrity of an issued credential and its binding to an identity. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the low digital quality or reliability of the activities performed by the Credential Service Provider (CSP) subsequent to electronic authentication registration, identity proofing and issuance activities to manage and safeguard the integrity of an issued credential and its binding to an identity. Little or no confidence that an individual has maintained control over a token that has been entrusted to him or her and that that token has not been compromised. Characteristics include weak identity binding to tokens and plaintext passwords or secrets not transmitted across a network. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the basic digital quality or reliability of the activities performed by the Credential Service Provider (CSP) subsequent to electronic authentication registration, identity proofing and issuance activities to manage and safeguard the integrity of an issued credential and its binding to an identity. Some confidence that an individual has maintained control over a token that has been entrusted to him or her and that that token has not been compromised. Characteristics include: Verification must prove claimant controls the token; token resists online guessing, replay, session hijacking, and eavesdropping attacks; and token is at least weakly resistant to man-in-the middle attacks. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the medium digital quality or reliability of the activities performed by the Credential Service Provider (CSP) subsequent to electronic authentication registration, identity proofing and issuance activities to manage and safeguard the integrity of an issued credential and it's binding to an identity. High confidence that an individual has maintained control over a token that has been entrusted to him or her and that that token has not been compromised. Characteristics include: Ownership of token verifiable through security authentication protocol and credential management protects against verifier impersonation attacks. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the high digital quality or reliability of the activities performed by the Credential Service Provider (CSP) subsequent to electronic authentication registration, identity proofing and issuance activities to manage and safeguard the integrity of an issued credential and it's binding to an identity. Very high confidence that an individual has maintained control over a token that has been entrusted to him or her and that that token has not been compromised. Characteristics include: Verifier can prove control of token through a secure protocol; credential management supports strong cryptographic authentication of all communication parties. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the quality or reliability in the process of ascertaining that an individual is who he or she claims to be.

Indicator of low digital quality or reliability in the process of ascertaining that an individual is who he or she claims to be. Requires that a continuity of identity be maintained but does not require identity proofing. [Based on Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of some digital quality or reliability in the process of ascertaining that that an individual is who he or she claims to be. Requires identity proofing via presentation of identifying material or information. [Based on Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of high digital quality or reliability in the process of ascertaining that an individual is who he or she claims to be. Requires identity proofing procedures for verification of identifying materials and information. [Based on Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of high digital quality or reliability in the process of ascertaining that an individual is who he or she claims to be. Requires identity proofing procedures for verification of identifying materials and information. [Based on Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the digital quality or reliability in the process of establishing proof of delivery and proof of origin. [Based on ISO 7498-2]

Indicator of low digital quality or reliability in the process of establishing proof of delivery and proof of origin. [Based on ISO 7498-2]

Indicator of basic digital quality or reliability in the process of establishing proof of delivery and proof of origin. [Based on ISO 7498-2]

Indicator of medium digital quality or reliability in the process of establishing proof of delivery and proof of origin. [Based on ISO 7498-2]

Indicator of high digital quality or reliability in the process of establishing proof of delivery and proof of origin. [Based on ISO 7498-2]

Indicator of the digital quality or reliability of the information exchange between network-connected devices where the information cannot be reliably protected end-to-end by a single organization's security controls. [Based on NIST SP 800-63-2]

Indicator of low digital quality or reliability of the information exchange between network-connected devices where the information cannot be reliably protected end-to-end by a single organization's security controls. [Based on NIST SP 800-63-2]

Indicator of basic digital quality or reliability of the information exchange between network-connected devices where the information cannot be reliably protected end-to-end by a single organization's security controls. [Based on NIST SP 800-63-2]

Indicator of medium digital quality or reliability of the information exchange between network-connected devices where the information cannot be reliably protected end-to-end by a single organization's security controls. [Based on NIST SP 800-63-2]

Indicator of high digital quality or reliability of the information exchange between network-connected devices where the information cannot be reliably protected end-to-end by a single organization's security controls. [Based on NIST SP 800-63-2]

Indicator of the digital quality or reliability of single and multi-token authentication. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the low digital quality or reliability of single and multi-token authentication. Permits the use of any of the token methods of Levels 2, 3, or 4. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the basic digital quality or reliability of single and multi-token authentication. Requires single factor authentication using memorized secret tokens, pre-registered knowledge tokens, look-up secret tokens, out of band tokens, or single factor one-time password devices. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the medium digital quality or reliability of single and multi-token authentication. Requires two authentication factors. Provides multi-factor remote network authentication. Permits multi-factor software cryptographic token. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Indicator of the high digital quality or reliability of single and multi-token authentication. Requires token that is a hardware cryptographic module validated at validated at Federal Information Processing Standard (FIPS) 140-2 Level 2 or higher overall with at least FIPS 140-2 Level 3 physical security. Level 4 token requirements can be met by using the PIV authentication key of a FIPS 201 compliant Personal Identity Verification (PIV) Card. [Electronic Authentication Guideline - Recommendations of the National Institute of Standards and Technology, NIST Special Publication 800-63-1, Dec 2011]

Values for security trust mechanism metadata observation made about a security architecture system component that supports enforcement of security policies.

Potential values for observations of severity.

Indicates the condition may be life-threatening or has the potential to cause permanent injury.

Indicates the condition may result in some adverse consequences but is unlikely to substantially affect the situation of the subject.

Indicates the condition may result in noticable adverse adverse consequences but is unlikely to be life-threatening or cause permanent injury.

Contains codes for defining the observed, physical position of a subject, such as during an observation, assessment, collection of a specimen, etc. ECG waveforms and vital signs, such as blood pressure, are two examples where a general, observed position typically needs to be noted.

Lying on the left side.

Lying with the front or ventral surface downward; lying face down.

Lying on the right side.

A semi-sitting position in bed with the head of the bed elevated approximately 45 degrees.

Resting the body on the buttocks, typically with upper torso erect or semi erect.

To be stationary, upright, vertical, on one's legs.

Lying on the back, on an inclined plane, typically about 30-45 degrees with head raised and feet lowered.

Lying on the back, on an inclined plane, typically about 30-45 degrees, with head lowered and feet raised.

Values for observations of verification act results

Examples: Verified, not verified, verified with warning.

Definition: Coverage is in effect for healthcare service(s) and/or product(s).

Definition: Coverage is in effect for healthcare service(s) and/or product(s) - Pending Investigation

Definition: Coverage is in effect for healthcare service(s) and/or product(s).

Definition: Coverage is not in effect for healthcare service(s) and/or product(s).

Definition: Coverage is not in effect for healthcare service(s) and/or product(s) - Pending Investigation.

Definition: Coverage is not in effect for healthcare service(s) and/or product(s) - Pending Eligibility Update.

Definition: Coverage is not in effect for healthcare service(s) and/or product(s). May optionally include reasons for the ineligibility.

Concepts that describe an individual's typical arrangement of working hours for an occupation.

A person who is scheduled for work during daytime hours (for example between 6am and 6pm) on a regular basis.

Consistent Early morning schedule of 13 hours or less per shift (between 2 am and 2 pm)

A person who is scheduled for work during evening hours (for example between 2pm and midnight) on a regular basis.

Scheduled for work during nighttime hours (for example between 9pm and 8am) on a regular basis.

Scheduled for work times that change periodically between days, and/or evenings, and includes some night shifts.

Scheduled for work days/times that change periodically between days, but does not include night or evening work.

Shift consisting of two distinct work periods each day that are separated by a break of a few hours (for example 2 to 4 hours)

Shifts of 17 or more hours.

Irregular, unpredictable hours scheduled on a short notice (for example, less than 2 day notice): inconsistent schedule, on-call, as needed, as available.

**Description:**Used in a patient care message to value simple clinical (non-lab) observations.

Definition: The non-laboratory, non-DI (diagnostic imaging) coded observation if no value is also required to convey the full meaning of the observation. This may be a single concept code or a complex expression.

Definition: The non-laboratory, non-diagnostic imaging coded result of the coded observable or "question" represented by the paired concept from the the NonLabDICodedObservationType domain.

]

**Examples:**An APGAR result, a functional assessment, etc. The value must not require a specific unit of measure.

Definition: The category of addiction used for coverage purposes that may refer to a substance, the consumption of which may result in physical or emotional harm.

This domain is established as a parent to a variety of value domains being defined to support the communication of Individual Case Safety Reports to regulatory bodies. Arguably, this aggregation is not taxonomically pure, but the grouping will facilitate the management of these domains.

A code that provides information on the overall effect or outcome of the adverse reaction/adverse event reported in the ICSR. Note the criterion applies to the case as a whole and not to an individual reaction.

Example concepts are: death, disability, hospitalization, congenital anomaly/ birth defect, and other medically important condition.

A code set that includes codes that are used to characterize the outcome of the device evaluation process. The code defines the manufacturer's conclusions following the evaluation.

Examples include: inadequate alarms, device maintenance contributed to event, device failed just prior to use, user error caused event

Code assigned to indicate a relevant fact within the context of the evaluation of a reported product. There are a number of concept types including the status of the evaluation, the type of evaluation findings, and the type of activity carried out as part of the evaluation process.

Examples include: Actual device involved in incident was evaluated, electrical tests performed, visual examination.

Code assigned to indicate an outcome of the manufacturer's investigation of a product for which a defect has been reported.

Examples include:.component/subassembly failure: air cleaner, computer-, imaging system-, microprocessor-controlled device problem: cache memory, design -- not fail safe.

A code to capture the reporter's assessment of the extent to which the reaction is related to the suspect product reported in the ICSR.

Example concepts include: related, not related, possibly related and unlikely related.

A code that characterizes the role that the primary reporter felt that the suspect intervention -- either a substance administration or a device related procedure - played in the incident being reported. This code will capture the primary reporter's assessment of the role that the suspect product played in the incident reported in the ICSR.

Examples include: Suspect, Concomitant, Interacting, Re-challenge.

Code used to indicate the action taken by practitioner in response to the problem (whether drug or device related) that is reported in the ICSR.

Examples include: failing device replaced, medication stopped, medication dose adjusted.

A code to capture the kind of reaction that was suffered by the investigated subject, and that is being reported in the ICSR. At this point, SNOMED or MedDRA have been suggested as code systems to be used for providing this information.

Example concepts include hives, swelling, rash, anaphylactic shock.

Code that captures the emphasis that the reporter placed on this reaction.

Examples include: highlighted by the reporter, NOT serious, Not highlighted by the reporter, NOT serious, Highlighted by the reporter, SERIOUS, Not highlighted by the reporter, SERIOUS.

Code that captures the type of outcome from an individual outcome of a reaction to the suspect product reported in the ICSR.

Examples include: Recovered/resolved. Recovering/resolving, Not recovered/not resolved, Recovered/resolved with sequelae, Fatal.

Values for observations of injuries.

Codes identifying pariticular groupings of allergens and other agents which cause allergies and intolerances. E.g. the drug, allergen group, food or environmental agent which triggers the intolerance

The combined domain for different types of coded observation issue triggers, such as diagnoses, allergies, etc.

Indicates an observed reason for a medical action other than an indication or symptom. E.g. Need for a contrast agent prior to a diagnostic image, need for anesthesia prior to surgery, etc.

Indicates the specific observation result which is the reason for the action (prescription, lab test, etc.). E.g. Headache, Ear infection, planned diagnostic image (requiring contrast agent), etc.

Diagnosis Value

Indicates an observed abnormality in the patientaTMs condition, but does not assert causation. E.g. Runny nose, swelling, flaky skin, etc.