A mandate, regulation, obligation, principle, requirement, rule, or expectation of how an entity is to conduct itself or execute an activity, which may be dictated and enforced by an authority of competent jurisdiction.

Specifies the type or actual definition of a contractually binding agreement or a non-binding representation of that agreement between a grantor and a grantee as to the exchange of the grantee's considerations in return for the grantor's control of certain assets. The type of assets exchanged include rights, license, terms of service, valued items, information and real property assets and control over such assets such as physical and locatable property; intellectual property; biospecimen; genomic and genetic information related to an individual including that disclosed by genetically related individuals with or without the individual's consent; personal identifiable, pseudonymized, anonymized, de-identified per some rubric, and relinkable variants.

Usage Note: Types or actual definitions of a contractually binding agreement or a non-binding representation of that agreement include:

• _ActDecision (formally ActConsentDirective), which specifies the type of decision made by the grantor. The decision types are mapped to ISO/TS 17975 Health informatics - Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information;
• _ActPrivacyConsentDirective, which is the parent of types of registry participation consent directives, and of realm specific privacy consent directive policies such as _USPrivacyConsentDirective and _GDPRPrivacyConsentDirective.

Specifies the type of agreement between one or more grantor and grantee in which rights and obligations related to one or more shared items of interest are allocated.

Usage Note: Such agreements may be considered "consent directives" or "contracts" depending on the context, and are considered closely related or synonymous from a legal perspective.

Examples:

• Healthcare Privacy Consent Directive permitting or restricting in whole or part the collection, access, use, and disclosure of health information, and any associated handling caveats.
• Healthcare Medical Consent Directive to receive medical procedures after being informed of risks and benefits, thereby reducing the grantee's liability.
• Research Informed Consent for participation in clinical trials and disclosure of health information after being informed of risks and benefits, thereby reducing the grantee's liability.
• Substitute decision maker delegation in which the grantee assumes responsibility to act on behalf of the grantor.
• Contracts in which the agreement requires assent/dissent by the grantor of terms offered by a grantee, a consumer opts out of an "award" system for use of a retailer's marketing or credit card vendor's point collection cards in exchange for allowing purchase tracking and profiling.
• A mobile device or App privacy policy and terms of service to which a user must agree in whole or in part in order to utilize the service.
• Agreements between a client and an authorization server or between an authorization server and a resource operator and/or resource owner permitting or restricting e.g., collection, access, use, and disclosure of information, and any associated handling caveats.

A grantor's terms of agreement to which a grantee may assent or dissent, and which may include an opportunity for a grantee to request restrictions or extensions.

Comment: A grantor typically is able to stipulate preferred terms of agreement when the grantor has control over the topic of the agreement, which a grantee must accept in full or may be offered an opportunity to extend or restrict certain terms.

Usage Note: If the grantor's term of agreement must be accepted in full, then this is considered "basic consent". If a grantee is offered an opportunity to extend or restrict certain terms, then the agreement is considered "granular consent".

Examples:

• Healthcare: A PHR account holder [grantor] may require any PHR user [grantee] to accept the terms of agreement in full, or may permit a PHR user to extend or restrict terms selected by the account holder or requested by the PHR user.
• Non-healthcare: The owner of a resource server [grantor] may require any authorization server [grantee] to meet authorization requirements stipulated in the grantor's terms of agreement.

A grantor's presumed assent to the grantee's terms of agreement is based on the grantor's behavior, which may result from not expressly assenting to the consent directive offered, or from having no right to assent or dissent offered by the grantee.

Comment: Implied or "implicit" consent occurs when the behavior of the grantor is understood by a reasonable person to signal agreement to the grantee's terms.

Usage Note: Implied consent with no opportunity to assent or dissent to certain terms is considered "basic consent".

Examples:

• Healthcare: A patient schedules an appointment with a provider, and either does not take the opportunity to expressly assent or dissent to the provider's consent directive, does not have an opportunity to do so, as in the case where emergency care is required, or simply behaves as though the patient [grantor] agrees to the rights granted to the provider [grantee] in an implicit consent directive.
• An injured and unconscious patient is deemed to have assented to emergency treatment by those permitted to do so under jurisdictional laws, e.g., Good Samaritan laws.
• Non-healthcare: Upon receiving a driver's license, the driver is deemed to have assented without explicitly consenting to undergoing field sobriety tests.
• A corporation that does business in a foreign nation is deemed to have deemed to have assented without explicitly consenting to abide by that nation's laws.

A grantor's presumed assent to the grantee's terms of agreement, which is based on the grantor's behavior, and includes a right to dissent to certain terms.

Comment: A grantor assenting to the grantee's terms of agreement may or may not exercise a right to dissent to grantor selected terms or to grantee's selected terms to which a grantor may dissent.

Usage Note: Implied or "implicit" consent with an "opportunity to dissent" occurs when the grantor's behavior is understood by a reasonable person to signal assent to the grantee's terms of agreement whether the grantor requests or the grantee approves further restrictions, is considered "granular consent".

Examples:

• Healthcare Examples: A healthcare provider deems a patient's assent to disclosure of health information to family members and friends, but offers an opportunity or permits the patient to dissent to such disclosures.
• A health information exchanges deems a patient to have assented to disclosure of health information for treatment purposes, but offers the patient an opportunity to dissents to disclosure to particular provider organizations.
• Non-healthcare Examples: A bank deems a banking customer's assent to specified collection, access, use, or disclosure of financial information as a requirement of holding a bank account, but provides the user an opportunity to limit third-party collection, access, use or disclosure of that information for marketing purposes.

No notification or opportunity is provided for a grantor to assent or dissent to a grantee's terms of agreement.

Comment: A "No Consent" policy scheme provides no opportunity for accommodation of an individual's preferences, and may not comply with Fair Information Practice Principles [FIPP] by enabling the data subject to object, access collected information, correct errors, or have accounting of disclosures.

Usage Note: The grantee's terms of agreement, may be available to the grantor by reviewing the grantee's privacy policies, but there is no notice by which a grantor is apprised of the policy directly or able to acknowledge.

Examples:

• Healthcare: Without notification or an opportunity to assent or dissent, a patient's health information is automatically included in and available (often according to certain rules) through a health information exchange. Note that this differs from implied consent, where the patient is assumed to have consented.
• Without notification or an opportunity to assent or dissent, a patient's health information is collected, accessed, used, or disclosed for research, public health, security, fraud prevention, court order, or law enforcement.
• Non-healthcare: Without notification or an opportunity to assent or dissent, a consumer's healthcare or non-healthcare internet searches are aggregated for secondary uses such as behavioral tracking and profiling.
• Without notification or an opportunity to assent or dissent, a consumer's location and activities in a shopping mall are tracked by RFID tags on purchased items.

A grantor's assent to the terms of an agreement offered by a grantee without an opportunity for to dissent to any terms.

Comment: Acceptance of a grantee's terms pertaining, for example, to permissible activities, purposes of use, handling caveats, expiry date, and revocation policies.

Usage Note: Opt-in with no opportunity for a grantor to restrict certain permissions sought by the grantee is considered "basic consent".

Examples:

• Healthcare: A patient [grantor] signs a provider's [grantee's] consent directive form, which lists permissible collection, access, use, or disclosure activities, purposes of use, handling caveats, and revocation policies.
• Non-healthcare: An employee [grantor] signs an employer's [grantee's] non-disclosure and non-compete agreement.

A grantor's assent to the grantee's terms of an agreement with an opportunity for to dissent to certain grantor or grantee selected terms.

Comment: A grantor dissenting to the grantee's terms of agreement may or may not exercise a right to assent to grantor's pre-approved restrictions or to grantee's selected terms to which a grantor may dissent.

Usage Note: Opt-in with restrictions is considered "granular consent" because the grantor has an opportunity to narrow the permissions sought by the grantee.

Examples:

• Healthcare: A patient assent to grantee's consent directive terms for collection, access, use, or disclosure of health information, and dissents to disclosure to certain recipients as allowed by the provider's pre-approved restriction list.
• Non-Healthcare: A cell phone user assents to the cell phone's privacy practices and terms of use, but dissents from location tracking by turning off the cell phone's tracking capability.

A grantor's dissent to the terms of agreement offered by a grantee without an opportunity for to assent to any terms.

Comment: Rejection of a grantee's terms of agreement pertaining, for example, to permissible activities, purposes of use, handling caveats, expiry date, and revocation policies.

Usage Note: Opt-out with no opportunity for a grantor to permit certain permissions sought by the grantee is considered "basic consent".

Examples:

• Healthcare: A patient [grantor] declines to sign a provider's [grantee's] consent directive form, which lists permissible collection, access, use, or disclosure activities, purposes of use, handling caveats, revocation policies, and consequences of not assenting.
• Non-healthcare: An employee [grantor] refuses to sign an employer's [grantee's] agreement not to join unions or participate in a strike where state law protects employee's collective bargaining rights.
• A citizen [grantor] refuses to enroll in mandatory government [grantee] health insurance based on religious beliefs, which is an exemption.

A grantor's dissent to the grantee's terms of agreement except for certain grantor or grantee selected terms.

Comment: A rejection of a grantee's terms of agreement while assenting to certain permissions sought by the grantee or requesting approval of additional grantor terms.

Usage Note: Opt-out with exceptions is considered a "granular consent" because the grantor has an opportunity to accept certain permissions sought by the grantee or request additional grantor terms, while rejecting other grantee terms.

Examples:

• Healthcare: A patient [grantor] dissents to a health information exchange consent directive with the exception of disclosure based on a limited "time to live" shared secret [e.g., a token or password], which the patient can give to a provider when seeking care.
• Non-healthcare: A social media user [grantor] dissents from public access to their account, but assents to access to a circle of friends.

Specifies types of consent directives governing the collection, access, use, or disclosure of personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual.

European Union General Data Protection Regulation (GDPR) consent directives.

A consent directive compliant with the European Union General Data Protection Regulation (GDPR) definition: Consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.

Where processing is based on consent, the controller shall be able to demonstrate that the data subject has consented to processing of his or her personal data. If the data subject's consent is given in the context of a written declaration which also concerns other matters, the request for consent shall be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. Any part of such a declaration which constitutes an infringement of this Regulation shall not be binding. The data subject shall have the right to withdraw his or her consent at any time. The withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal. Prior to giving consent, the data subject shall be informed thereof. It shall be as easy to withdraw as to give consent. When assessing whether consent is freely given, utmost account shall be taken of whether, inter alia, the performance of a contract, including the provision of a service, is conditional on consent to the processing of personal data that is not necessary for the performance of that contract. Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject's acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided.

Usage Note: Article 4.11 GDPR Definitions https://gdpr-info.eu/art-4-gdpr/ 11) 'Consent' of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her. Article 7 GDPR Conditions for consent https://gdpr-info.eu/art-7-gdpr Recital 32 Conditions for consent* https://gdpr-info.eu/recitals/no-32 Recital 42 Burden of proof and requirements for consent* https://gdpr-info.eu/recitals/no-42/> Recital 43 Freely given consent* https://gdpr-info.eu/recitals/no-43 GDPR Consent Brief https://gdpr-info.eu/issues/consent/ Art. 4 GDPR Definitions Art. 6 GDPR Lawfulness of processing Art. 7 GDPR Conditions for consent Art. 8 GDPR Conditions applicable to child's consent in relation to information society services Art. 9 GDPR Processing of special categories of personal data Art. 22 GDPR Automated individual decision-making, including profiling Art. 49 GDPR Derogations for specific situations

Relevant GDPR Recitals: (32) Conditions for consent (33) Consent to certain areas of scientific research (38) Special protection of children's personal data (40) Lawfulness of data processing (42) Burden of proof and requirements for consent (43) Freely given consent (50) Further processing of personal data (51) Protecting sensitive personal data (54) Processing of sensitive data in public health sector (71) Profiling (111) Exceptions for certain cases of international transfers (155) Processing in the employment context (161) Consenting to the participation in clinical trials (171) Repeal of Directive 95/46/EC and transitional provisions

A consent directive that complies with regulatory requirements for a consent directive compliant with the European Union General Data Protection Regulation (GDPR) definition: Consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.

GDPR research consent directive has the additional caveat that it is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognized ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.

Usage Note: HL7 Purpose of Use codes include specialize research purposes of use, which could be used to convey a data subject's purpose of use restrictions related to areas of research or parts of research projects. See citations for GDPRResearchCD and below: Recital 33 Consent to certain areas of scientific research https://gdpr-info.eu/recitals/no-33/> Recital 157 Information from registries and scientific research https://gdpr-info.eu/recitals/no-157 Recital 159 Processing for scientific research purposes* https://gdpr-info.eu/recitals/no-159/

Specifies types of consent directives authorizing a registry or repository to collect and, under certain terms, manage the access, use, and disclosure of personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual.

Registries governed by registry consent directives are data management systems, which use metadata to support the collection, access, use, and disclosure of personal information or effects as well as observational or analytic information generated about personal information or effects stored in federated repositories. Such registries are used for a variety of purposes by federated health information exchanges, health information systems, personal record systems, and research organizations to locate and retrieve personal information or effects as well as observational or analytic information generated about personal information stored externally to their systems.

Repositories governed by registry consent directives are data stores used to collect, access, use, and disclose personal information or effects as well as observational or analytic information generated about personal information or effects and metadata used to manage the repository contents. Such repositories are used for a variety of purposes by centralized health information exchanges, health information systems used by providers and payers, personal record systems, and research organizations. A repository typically includes a registry component that provides the data store with content management capabilities for internal purposes. A repository may also interface with one or more external registries, which provide federated content management.

An expressed privacy consent directive permitting the collection of a some or all personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual in a registry or repository for purposes such as treatment, payment, operations, research, information exchange, public health, data analytics, marketing, and profiling.

Usage Note: Useful when a more specific jurisdictional or organizational consent directive policy or form is not specified, available, or known, for example, where an individual wishes to opt-in to collection of some or all of the individual's information by multiple registries and repositories.

Map: An "expressed" consent directive maps to ISO/TS 17975:2015(E) definitions for "Express or Expressed: Consent to Collect, Use and Disclose personal health information is expressly given by the subject of care" and "Opt-in".

An expressed privacy consent directive permitting access, use, or disclosure of a some or all personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual in a registry or repository for purposes such as treatment, payment, operations, research, information exchange, public health, data analytics, marketing, and profiling.

Usage Note: Useful when a more specific jurisdictional or organizational consent directive policy or form is not specified, available, or known, for example, where an individual wishes to opt-in to access, use, or disclosure of some or all of the individual's information by multiple registries and repositories.

Map: An "expressed" consent directive maps to ISO/TS 17975:2015(E) Express or Expressed: Consent to Collect, Use and Disclose personal health information is expressly given by the subject of care and "Opt-in".

An expressed privacy consent directive restricting or prohibiting collection of personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual in a registry or repository for purposes such as treatment, payment, operations, research, information exchange, public health, data analytics, marketing, and profiling.

Usage Note: Useful when a more specific jurisdictional or organizational consent directive policy or form is not specified, available, or known, for example, where an individual wishes to opt-out of access, use, or disclosure of some or all of the individual's information by multiple registries and repositories.

Map: An "expressed" opt-out to collection consent directive maps to ISO/TS 17975:2015(E) definitions for "Express or Expressed: Consent to Collect, Use and Disclose personal health information is expressly given by the subject of care" and "Express or Expressed (and Informed) Denial".

An expressed privacy consent directive restricting or prohibiting access, use, or disclosure of personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual in a registry or repository for purposes such as treatment, payment, operations, research, information exchange, public health, data analytics, marketing, and profiling.

Usage Note: Useful when a more specific jurisdictional or organizational consent directive policy or form is not specified, available, or known, for example, where an individual wishes to opt-out of access, use, or disclosure of some or all of the individual's information by multiple registries and repositories.

Map: An "expressed" opt-out to sharing consent directive maps to ISO/TS 17975:2015(E) definitions for "Express or Expressed: Consent to Collect, Use and Disclose personal health information is expressly given by the subject of care" and "Express or Expressed (and Informed) Denial".

Specific US privacy consent directives in accordance with US federal, state, regional, organizational, or personal privacy policies.

A code representing an individual's privacy consent directive that complies with 42 CFR Part 2.31 Consent requirements https://www.gpo.gov/fdsys/pkg/CFR-2017-title42-vol1/pdf/CFR-2017-title42-vol1-sec2-31.pdf, which is a US Federal law stipulating the policy elements of a written consent to a disclosure under the regulations in Part 2.

(1) The name of the patient. (2) The specific name(s) or general designation(s) of the part 2 program(s), entity(ies), or individual(s) permitted to make the disclosure. (3) How much and what kind of information is to be disclosed, including an explicit description of the substance use disorder information that may be disclosed. (4) (i) The name(s) of the individual(s) to whom a disclosure is to be made; or (ii)Entities with a treating provider relationship with the patient. If the recipient entity has a treating provider relationship with the patient whose information is being disclosed, such as a hospital, a health care clinic, or a private practice, the name of that entity; or (iii)Entities without a treating provider relationship with the patient. (A) If the recipient entity does not have a treating provider relationship with the patient whose information is being disclosed and is a third-party payer, the name of the entity; or (B) If the recipient entity does not have a treating provider relationship with the patient whose information is being disclosed and is not covered by paragraph (a)(4)(iii)(A) of this section, such as an entity that facilitates the exchange of health information or a research institution, the name(s) of the entity(-ies); and (1) The name(s) of an individual participant(s); or (2) The name(s) of an entity participant(s) that has a treating provider relationship with the patient whose information is being disclosed; or (3) A general designation of an individual or entity participant(s) or class of participants that must be limited to a participant(s) who has a treating provider relationship with the patient whose information is being disclosed. (i) When using a general designation, a statement must be included on the consent form that the patient (or other individual authorized to sign in lieu of the patient), confirms their understanding that, upon their request and consistent with this part, they must be provided a list of entities to which their information has been disclosed pursuant to the general designation (see Section 2.13(d)). (ii) [Reserved] (5) The purpose of the disclosure. In accordance with Section 2.13(a), the disclosure must be limited to that information which is necessary to carry out the stated purpose. (6) A statement that the consent is subject to revocation at any time except to the extent that the part 2 program or other lawful holder of patient identifying information that is permitted to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third-party payer (7) The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must ensure that the consent will last no longer than reasonably necessary to serve the purpose for which it is provided. (8) The signature of the patient and, when required for a patient who is a minor, the signature of an individual authorized to give consent under Section 2.14; or, when required for a patient who is incompetent or deceased, the signature of an individual authorized to sign under Section 2.15. Electronic signatures are permitted to the extent that they are not prohibited by any applicable law. (9) The date on which the consent is signed.

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by an individual's 42 CFR Part 2.31 consent directive, "42CFRPart2CD" as the security label policy code.

Since information governed by an individual's 42 CFR Part 2.31 consent directive has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR § 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

A code representing an individual's consent directive that complies with HIPAA Privacy rule 45 CFR Section 164.508 Uses and disclosures for which an authorization is required https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is a US Federal law stipulating the policy elements of a valid authorization under this Section specific to disclosures for purposes of research when combined with a Common Rule or Federal Drug Administration consent to participate in research also known as a compound authorization.

Usage Note: The Agency for Healthcare Research and Quality (AHRQ) has developed the Informed Consent and Authorization Toolkit for Minimal Risk Research to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research subjects. This toolkit contains information for people responsible for ensuring that potential research subjects are informed in a manner that is consistent with medical ethics and regulatory guidelines. From https://www.ahrq.gov/sites/default/files/publications/files/ictoolkit.pdf.

Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by an individual's right of access directive under 45 CFR Section 164.508 use "CompoundResearchCD" as the security label policy code.

Information or biospecimen disclosed under the Common Rule are not protected by the HIPAA Privacy Rule. If protected under other laws such as confidentiality provisions under the Common Rule, assign the HL7 Confidentiality code "M" (moderate).

See ActCode._ActPolicyType._ActPrivacyPolicy._ActPrivacyLaw._ActUSPrivacyLaw.HIPAAAuth (HIPAA Authorization for Disclosure). See: HIPAAAuth and NIH Sample Authorization Language for Research Uses and Disclosures of Individually Identifiable Health Information by a Covered Health Care Provider https://privacyruleandresearch.nih.gov/authorization.asp

A code representing an individual's consent directive that complies with HIPAA Privacy rule 45 CFR Section 164.508 Uses and disclosures for which an authorization is required https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is a US Federal law stipulating the policy elements of a valid authorization under this Section.

An "authorization" is required by the Privacy Rule for uses and disclosures of protected health information not otherwise allowed by the Rule. Where the Privacy Rule requires patient authorization, voluntary consent is not sufficient to permit a use or disclosure of protected health information unless it also satisfies the requirements of a valid authorization. An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.

An authorization must specify a number of elements, including a description of the protected health information to be used and disclosed, the person authorized to make the use or disclosure, the person to whom the covered entity may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed. With limited exceptions, covered entities may not condition treatment or coverage on the individual providing an authorization. https://www.hhs.gov/hipaa/for-professionals/faq/264/what-is-the-difference-between-consent-and-authorization/index.html

A HIPAA Authorization must comply with 45 CFR Section164.508(c) Implementation specifications: Core elements and requirements - (1) Core elements. A valid authorization under this Section must contain at least the following elements: (i) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion. (ii) The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure. (iii) The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure. (iv) A description of each purpose of the requested use or disclosure. The statement "at the request of the individual" is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose. (v) An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. The statement "end of the research study," "none," or similar language is sufficient if the authorization is for a use or disclosure of protected health information for research, including for the creation and maintenance of a research database or research repository. (vi) Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided. (2)Required statements. In addition to the core elements, the authorization must contain statements adequate to place the individual on notice of all of the following: (i) The individual's right to revoke the authorization in writing, and either: (A) The exceptions to the right to revoke and a description of how the individual may revoke the authorization; or (B) To the extent that the information in paragraph (c)(2)(i)(A) of this section is included in the notice required by Section 164.520, a reference to the covered entity's notice. https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf

Usage Note: Used to indicate the legal authority for assigning security labels to HIPAA governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by a an individual's HIPAA Authorization for Disclosure, use "HIPAAAuthCD" as the security label policy code.

Information governed under a HIPAA Authorization for Disclosure has the level of confidentiality protection afforded under the 45 CFR Section 164.506 - Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, which is considered the "norm", assign the HL7 Confidentiality code "N" (normal).

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR Section 164.522 Rights to request privacy protection for protected health information https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-522.pdf, which stipulates the process by which a covered entity seeks agreement from an individual regarding how it will use and disclose the individual's protected health information for treatment, payment, and health care operations is termed a "consent."

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by an individual's consent directive under 45 CFR Section 164.522 use "HIPAAConsentCD" as the security label policy code.

Since information governed by a 45 CFR Section 164.522 has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

A code representing an individual's consent directive that complies with HIPAA Privacy rule 45 CFR Section 164.508 Uses and disclosures for which an authorization is required https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is a US Federal law stipulating the policy elements of a valid authorization under this Section specific to disclosures for purposes of research.

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by an individual's HIPAA Authorization for Disclosure for Research under 45 CFR Section 164.508 use "HIPAAResearchAuthCD" as the security label policy code.

Information disclosed under an individual's HIPAA Authorization for Disclosure for Research are not protected by the HIPAA Privacy Rule. If protected under other laws such as confidentiality provisions under the Common Rule, assign the HL7 Confidentiality code "M" (moderate).

See ActCode._ActPolicyType._ActPrivacyPolicy._ActPrivacyLaw._ActUSPrivacyLaw.HIPAAAuth (HIPAA Authorization for Disclosure). See: HIPAAAuth and NIH Sample Authorization Language for Research Uses and Disclosures of Individually Identifiable Health Information by a Covered Health Care Provider https://privacyruleandresearch.nih.gov/authorization.asp

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR Section 164.524 Access of individuals to protected health information https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-524.pdf, stipulating the policy elements of an individual's written and signed right of access directive requesting that a covered entity send the individual's protected health information (PHI) to a third party.

See 45 CFR 164.524(c)(3)(ii) If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information. https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-524.pdf

This right applies to PHI in a designated record set, which is defined as "Designated record set means: (1) A group of records maintained by or for a covered entity that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider; (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals. [https://www.law.cornell.edu/cfr/text/45/164.501]. Also see HHS Individuals' Right under HIPAA to Access their Health Information 45 CFR Section 164.524 [https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html#maximumflatfee].

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by an individual's right of access directive under 45 CFR Section 164.524 use "HIPAAROAD" as the security label policy code.

Information disclosed under a HIPAA 42 CFR Section 164.524 no longer has the level of confidentiality protection afforded under the 45 CFR Section 164.506 - Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is considered the "norm", assign the HL7 Confidentiality code "M" (moderate), which may be protected under other laws such as the Federal Trade Commission privacy and security regulations.

The State of Michigan standard privacy consent form for sharing of health information specific to behavioral health and substance use treatment in accordance with Public Act 129 of 2014. In Michigan, while providers are not required to use this new standard form (MDHHS-5515), they are required to accept it.

Usage Note: For legislative background, current MDHHS-5515 consent directive form, and provider and patient FAQs see http://www.michigan.gov/mdhhs/0,5885,7-339-71550_2941_58005-343686--,00.html

The State of Michigan standard privacy consent form for sharing of health information specific to behavioral health governed by the Michigan Mental Health Code Act 258 of 1974, which require patient authorization for purposes other than treatment, payment, and coordination of care, in accordance with Public Act 129 of 2014.

Usage Note: For legislative background, current MDHHS-5515 consent directive form, and provider and patient FAQs see http://www.michigan.gov/mdhhs/0,5885,7-339-71550_2941_58005-343686--,00.html

The State of Michigan standard privacy consent form for sharing of health information specific to substance use information governed under US 42 CFR Part 2 in accordance with Public Act 129 of 2014.

Usage Note: For legislative background, current MDHHS-5515 consent directive form, and provider and patient FAQs see http://www.michigan.gov/mdhhs/0,5885,7-339-71550_2941_58005-343686--,00.html

An informed assertion by a minor who is a candidate research subject, of the individual's willingness to participate in research. Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent. The minor's assent must be accompanied by parental or guardian consent that the minor participate in a specified research. The assent is not legally binding, however, the accompanying consent is legally binding. Background: In the US, informed assent is governed under 21 CFR Part 50, Subpart D - Additional Safeguards for Children in Clinical Investigations. Available at https://www.law.cornell.edu/cfr/text/21/part-50/subpart-D

An informed assertion by an adult, or the parent/guardian of a minor who is a candidate research subject, of the individual's willingness to participate in a specified research study. The consent is legally binding. Background: In the US, informed assent is governed under 49 CFR § 11.116 - General Requirements for Informed Consent. Available at https://www.law.cornell.edu/cfr/text/49/11.116

An informed assertion by an adult, or the parent/guardian of a minor who is a candidate research subject, of the individual's willingness to participate in unspecified research studies, including storage, maintenance, and secondary research use of identifiable biospecimens and data. If broad consent is obtained, any subsequent storage, maintenance, and secondary research uses of the individual’s identifiable biospecimens and data consistent with the broad consent would not require additional consent, so long as additional conditions are met, including limited review by an IRB. The consent is legally binding. Background: In the US, informed assent is governed under 49 CFR § 11.116 - General Requirements for Informed Consent. Available at https://www.law.cornell.edu/cfr/text/49/11.116

The type of action permitted on information by jurisdictional, organizational, or personal policy.

Authorization to obtain information with no further permission to collect and store it.

Authorization to gather and store information.

Authorization to alter or remove identifying characteristics of an entity or individual that is a subject of the information.

Authorization to make information known to another party.

Authorization to alter information in order to conceal it from unauthorized recipients.

Authorization to access information within a specific context for communication purposes only. Storing, manipulating, and further disclosure are prohibited and may be technically disabled.

Authorization to remove information that a recipient is not authorized to access.

Authorization to make disclosed information known to another party.

Authorization to alter or relink deidentified information so that an entity or individual that is the subject of that information identifiable.

Authorization to employ or alter information.

Information management directives related to privacy, security, integrity, and control concerns, which may be governed by specific laws; based on private sector self-governance; adopted "best practices" recognized by a community of interest; or terms of license, participation, or service as implemented in jurisdictional, organizational, or personal policies.

Jurisdictional policy on collection, access, use, or disclosure of information as defined by applicable jurisdictional law.

Jurisdictional policy on collection, access, use, or disclosure of controlled unclassified information as defined by applicable jurisdictional law.

Jurisdictional policy on collection, access, use, or disclosure of de-identified information as defined by applicable jurisdictional law.

Jurisdictional policy on collection, access, use, or disclosure of information in a limited data set as defined by applicable jurisdictional law.

Jurisdictional policy on collection, access, use, or disclosure of information deemed non-sensitive by applicable jurisdiction law.

Jurisdictional policy on collection, access, use, or disclosure of information deemed public by applicable jurisdiction law.

Jurisdictional policy on collection, access, use, or disclosure of specified controlled unclassified information as defined by applicable jurisdictional policy.

Jurisdictional policy on collection, access, use, or disclosure of uncontrolled unclassified information as defined by applicable jurisdictional policy.

Organizational policy on collection, access, use, or disclosure of information, which does not conflict with jurisdictional law.

Organizational policy on collection, access, use, or disclosure of basic controlled unclassified information as defined by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of de-identified information as defined by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of information in a limited data set as defined by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of information deemed non-sensitive by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of public information as defined by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of specified controlled unclassified information as defined by the organization or by applicable jurisdictional law.

Organizational policy on collection, access, use, or disclosure of uncontrolled unclassified information as defined by the organization or governing jurisdiction.

Personal policy on collection, access, use, or disclosure of information.

Personal policy on collection, access, use, or disclosure of de-identified information as defined by the information subject or by applicable jurisdictional law.

Personal policy personal policy on collection, access, use, or disclosure of information in a limited data set by the information subject.

Personal policy on collection, access, use, or disclosure of information deemed non-sensitive by the information subject.

Personal policy on collection, access, use, or disclosure of information deemed public by the information subject.

A policy deeming certain information to be private to an individual or organization.

Definition: A mandate, obligation, requirement, rule, or expectation relating to privacy.

Discussion: ActPrivacyPolicyType codes support the designation of the 1..* policies that are applicable to an Act such as a Consent Directive, a Role such as a VIP Patient, or an Entity such as a patient who is a minor. 1..* ActPrivacyPolicyType values may be associated with an Act or Role to indicate the policies that govern the assignment of an Act or Role confidentialityCode. Use of multiple ActPrivacyPolicyType values enables fine grain specification of applicable policies, but must be carefully assigned to ensure cogency and avoid creation of conflicting policy mandates.

Usage Note: Statutory title may be named in the ActClassPolicy Act Act.title to specify which privacy policy is being referenced.

Specifies the type of agreement between one or more grantor and grantee in which rights and obligations related to one or more shared items of interest are allocated.

Usage Note: Such agreements may be considered "consent directives" or "contracts" depending on the context, and are considered closely related or synonymous from a legal perspective.

Examples:

• Healthcare Privacy Consent Directive permitting or restricting in whole or part the collection, access, use, and disclosure of health information, and any associated handling caveats.
• Healthcare Medical Consent Directive to receive medical procedures after being informed of risks and benefits, thereby reducing the grantee's liability.
• Research Informed Consent for participation in clinical trials and disclosure of health information after being informed of risks and benefits, thereby reducing the grantee's liability.
• Substitute decision maker delegation in which the grantee assumes responsibility to act on behalf of the grantor.
• Contracts in which the agreement requires assent/dissent by the grantor of terms offered by a grantee, a consumer opts out of an "award" system for use of a retailer's marketing or credit card vendor's point collection cards in exchange for allowing purchase tracking and profiling.
• A mobile device or App privacy policy and terms of service to which a user must agree in whole or in part in order to utilize the service.
• Agreements between a client and an authorization server or between an authorization server and a resource operator and/or resource owner permitting or restricting e.g., collection, access, use, and disclosure of information, and any associated handling caveats.

Privacy consent directive restricting or prohibiting access, use, or disclosure of personal information, including de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, which may be used to identify an individual in a registry or repository for all purposes except for emergency treatment generally, which may include treatment during a disaster, a threat, in an emergency department and for break the glass purposes of use as specified by applicable domain policy.

Usage Note: To specify the scope of an "EMRGONLY" consent directive within a policy domain, use one or more of the following Purpose of Use codes in the ActReason code system OID: 2.16.840.1.113883.5.8.

• ETREAT (Emergency Treatment): To perform one or more operations on information for provision of immediately needed health care for an emergent condition.
• BTG (break the glass): 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.
• ERTREAT (emergency room treatment): 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.
• THREAT (threat): To perform one or more operations on information used to prevent injury or disease to living subjects who may be the target of violence.
• DISASTER (disaster): 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.

Map: An "emergency only" consent directive maps to ISO/TS 17975:2015(E) 5.13 Exceptional access

An implied privacy consent directive or notification, which the data subject may or may not acknowledge. The notification specifies permitted actions, which may include access, use, or disclosure of any and all personal information. The notification specifies the scope of personal information, which may include de-identified information, and personal effects, such as biometrics, biospecimen or genetic material, that may be used to identify an individual in a registry or repository. The notification specifies the purposes for which personal information may be used such as treatment, payment, operations, research, information exchange, public health, disaster, quality and safety reporting; as required by law including court order, law enforcement, national security, military authorities; and for data analytics, marketing, and profiling.

Usage Notes: Map: An "implied" consent directive maps to ISO/TS 17975:2015(E) definition forImplied: Consent to Collect, Use and Disclose personal health information is implied by the actions or inactions of the individual and the circumstances under which it was implied".

A jurisdictional mandate, regulation, obligation, requirement, rule, or expectation deeming certain information to be private to an individual or organization, which is imposed on:

• The activity of a governed party
• The behavior of a governed party
• The manner in which an act is executed by a governed party

GDPR is a regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive). Promulgated by the European Parliament and Council of the European Union. Regulation available at L119, 4 May 2016, p. 1-88.

GDPR privacy policies specifying types of lawful personal data processing based on a controller meeting one or more processing condition such as specified by law, compliance with data controller legal obligations, protection of data subject's vital interests, perform tasks in the public interest, related to legal claims, research and statistics, management of health or social care systems, legitimate interests of controller or third party. Processing sensitive personal data, including genetic, biometric and health data, as well as personal data from which racial and ethnic origin, political opinions, religious or ideological convictions or membership in a union can be attributed to a person, requires meeting at least one sensitive personal processing condition.

GDPR 'processing' means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. Article 4 https://gdpr-info.eu/art-4-gdpr/

Usage Note:

• Confidentiality: e.g., U (unrestricted) for anonymized personal information; L (low) for pseudonymized U (unrestricted) for anonymized personal information; M (moderate) for indirectly identifiable information such as test scores and work times; N (normal) for personal information; and R (restricted) for sensitive personal information
• DPR sensitivity [personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation, some of which are defined at Article 4 https://gdpr-info.eu/art-4-gdpr/
• GDPR processing policies and GDPR ConsentDirectiveTypes, such as data subject consent and research consent.
• Other security category codes, such as compartment codes for legitimate relationship,
• Handling instructions including
• Purpose of use stipulated in a GDPR consent or contract restricting processing or related to the scope of the processing policy such as public health, research, and legal obligations
• Obligation policies such as GDPR Information Obligations https://gdpr-info.eu/issues/information-obligations, data minimization and deleting when processing is complete
• Refrain policies such as no relinking

See Intersoft GDPR at https://gdpr-info.eu/issues/personal-data/ Art. 4 GDPR Definitions https://gdpr-info.eu/art-4-gdpr/ Art. 9 GDPR Processing of special categories of personal data https://gdpr-info.eu/art-9-gdpr/ Relevant Recitals (26) Not applicable to anonymous data (30) Online identifiers for profiling and identification (34) Genetic data (35) Health data (51) Protecting sensitive personal data at Intersoft GDPR briefing papers and navigating tool https://gdpr-info.eu/

Authorities

• European Data Protection Supervisor - Security Measures for Personal Data Processing (Link)
• Data Protection Authority Isle of Man - Know your data - Mapping the 5 W's (Link)
• Data Protection Authority UK - Key definitions (Link)
• European Commission - What is personal data? (Link)
• European Commission - What personal data is considered sensitive? (Link)
• EU publications - Handbook on European data protection law - Personal data, page 83 (Link)

Expert contribution A&L Goodbody - The GDPR: A Guide for Businesses - Definition of Personal & Sensitive Data, Page 8 (Link) Bird & Bird - Sensitive data and lawful processing (Link) https://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en General Data Protection Regulation https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1528874672298&uri=CELEX%3A32016R0679 Communication on data protection - guidance on direct application of the GDPR http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1517578296944&uri=CELEX%3A52018DC0043 Intersoft GDPR briefing papers and navigating tool https://gdpr-info.eu/

Processing of personal data, inclusive of the special categories of data, is lawful only if the data subject has given explicit consent to the processing of his or her personal data, inclusive of the special categories of data, for one or more specific purposes, except where Union or Member State law provide that the prohibition to use the data may not be lifted by the data subject; and for personal data which are manifestly made public by the data subject.

Usage Note: The description is based on the following GDPR provisions: Article 6.1.a https://gdpr-info.eu/art-6-gdpr/ 1Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes. Article 9.1, 9.2a., 9.2.e https://gdpr-info.eu/art-9-gdpr/ 1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation shall be prohibited. 2. Paragraph 1 shall not apply if one of the following applies: (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject; and (e) processing relates to personal data which are manifestly made public by the data subject.

Definition: A jurisdictional mandate in the U.S. relating to privacy.

Usage Note: ActPrivacyLaw codes may be associated with an Act or a Role to indicate the legal provision to which the assignment of an Act.confidentialityCode or Role.confidentialtyCode complies. May be used to further specify rationale for assignment of other ActPrivacyPolicy codes in the US realm, e.g., ETH and 42CFRPart2 can be differentiated from ETH and Title38Part1.

A code representing 42 CFR Part 2 Confidentiality of Substance Use Disorder Patient Records. 42 CFR Part 2 stipulates the privacy rights of an individual who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program, which includes non-disclosure of health information relating to health care paid for by a federally assisted substance use disorder program without patient consent. https://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol1/pdf/CFR-2010-title42-vol1-part2.pdf

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, the collection, access, use, and disclosure of healthcare information is governed by 42 CFR Part 2 Confidentiality of Substance Use Disorder Patient Records https://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol1/pdf/CFR-2010-title42-vol1-part2.pdf use "42CFRPart2" as the security label policy code.

Since information governed by a 42 CFR Part 2 has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf assign the HL7 Confidentiality code "R" (restricted).

A code representing U.S. Federal laws governing research-related privacy policies known as the "Common Rule". The Common Rule is the U.S. Federal regulations governing the protection of human subjects in research (codified at Subpart A of 45 CFR part 46), which has been adopted by 15 U.S. Federal departments and agencies in an effort to promote uniformity, understanding, and compliance with human subject protections. Existing regulations governing the protection of human subjects in Food and Drug Administration (FDA)-regulated research (21 CFR parts 50, 56, 312, and 812) are separate from the Common Rule but include similar requirements.

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information or biospecimen is governed by the Common Rule use "COMMONRULE" as the security label policy code. Information or biospecimen disclosed under the Common Rule are not protected by the HIPAA Privacy Rule. If protected under other laws such as confidentiality provisions under the Common Rule, assign the HL7 Confidentiality code "M" (moderate).

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Section 164.508) Uses and disclosures for which an authorization is required https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which stipulates the process by which a covered entity seeks agreement from an individual to use or disclose protected health information for other purposes, or to authorize another covered entity to disclose protected health information to the requesting covered entity, are termed "authorizations".

An "authorization" is required by the Privacy Rule for uses and disclosures of protected health information not otherwise allowed by the Rule. Where the Privacy Rule requires patient authorization, voluntary consent is not sufficient to permit a use or disclosure of protected health information unless it also satisfies the requirements of a valid authorization. An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.

An authorization must specify a number of elements, including a description of the protected health information to be used and disclosed, the person authorized to make the use or disclosure, the person to whom the covered entity may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed. With limited exceptions, covered entities may not condition treatment or coverage on the individual providing an authorization. https://www.hhs.gov/hipaa/for-professionals/faq/264/what-is-the-difference-between-consent-and-authorization/index.html

Usage Note: Used to indicate the legal authority for assigning security labels to HIPAA governed information. In this case, where use or disclosure of healthcare information is governed by a covered entity's HIPAA Authorization for Disclosure, use "HIPAAAuth" as the security label policy code.

Information disclosed under a HIPAA Authorization for Disclosure no longer has the level of confidentiality protection afforded under the 45 CFR Section 164.506 - Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is considered the "norm", assign the HL7 Confidentiality code "M" (moderate), which may be protected under other laws such as the Federal Trade Commission privacy and security regulations.

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Section 164.522), which stipulates the process by which a covered entity seeks agreement from an individual regarding how it will use and disclose the individual's protected health information for treatment, payment, and health care operations is termed a "consent".

The Privacy Rule permits, but does not require, a covered entity to voluntarily obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations. Covered entities that do so have complete discretion to design a process that best suits their needs. From https://www.hhs.gov/hipaa/for-professionals/faq/264/what-is-the-difference-between-consent-and-authorization/index.html. The provisions relating to consent are largely contained in Section 164.522 Rights to request privacy protection for protected health information https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-522.pdf.

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by 45 CFR Section 164.522 use 'HIPAAConsent' as the security label policy code.

Since information governed by a 45 CFR Section 164.522 has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code 'R' (restricted).

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Section 164.520), which stipulates an individual's right to adequate notice of the uses and disclosures of protected health information that may be made by the covered entity, and of the individual's rights and the covered entity's legal duties with respect to protected health information. Relevant HIPAA Privacy Rule provisions are at Section 164.520 (a) Standard: Notice of privacy practices. https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-520.pdf

Usage Note: Used to indicate the legal authority for assigning security labels to HIPAA governed information. In this case, if collection, access, use, or disclosure of healthcare information is governed by a covered entity's HIPAA Notice of Privacy Practices, use "HIPAANOPP" as the security label policy code.

Information governed under a HIPAA Notice of Privacy Practices has the level of confidentiality protection afforded under the 45 CFR Section 164.506 - Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf , which is considered the "norm", assign the HL7 Confidentiality code "N" (normal).

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Section 164.508), which stipulates the privacy rights of an individual who is the subject of psychotherapy notes, and requires authorization for certain uses and disclosure of that information.

Definition of Psychotherapy notes 45 CFR Section 164.501 https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-501.pdf: Psychotherapy notes means notes recorded (in any medium) by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family counseling session and that are separated from the rest of the individual's medical record. Psychotherapy notes excludes medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: Diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date.

See Section 164.508 Uses and disclosures for which an authorization is required. (2)Authorization required: Psychotherapy notes https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf: Notwithstanding any provision of this subpart, other than the transition provisions in Section 164.532, a covered entity must obtain an authorization for any use or disclosure of psychotherapy notes, except: (i) To carry out the following treatment, payment, or health care operations: (A) Use by the originator of the psychotherapy notes for treatment; (B) Use or disclosure by the covered entity for its own training programs in which students, trainees, or practitioners in mental health learn under supervision to practice or improve their skills in group, joint, family, or individual counseling; or (C) Use or disclosure by the covered entity to defend itself in a legal action or other proceeding brought by the individual; and (ii) A use or disclosure that is required by Section 164.502(a)(2)(ii) or permitted by Section 164.512(a); Section 164.512(d) with respect to the oversight of the originator of the psychotherapy notes; Section 164.512(g)(1); Section 164.512(j)(1)(i).

Usage Note: Used to indicate the legal authority for assigning security labels to HIPAA governed information. In this case, the collection, access, use, or disclosure of healthcare information is governed by HIPAA 45 CFR 164.508 (2) Authorization required: Psychotherapy notes https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf , use "HIPAAPsyNotes" as the security label policy code.

Since information governed by a HIPAA 45 CFR 164.508 (2) has a level of confidentiality protection that is more stringent than the normal level of protection under 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR Section 164.524 Access of individuals to protected health information https://www.govinfo.gov/app/details/CFR-2017-title45-vol1/CFR-2017-title45-vol1-sec164-524, which stipulates that an individual has a right of access to inspect and obtain a copy of protected health information about the individual in a designated record set, for as long as the protected health information is maintained in the designated record set with exceptions stipulated in HIPAA Privacy Rule Section 164.524. Exceptions include psychotherapy notes and information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.

If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information.

For discussion on extent of right, grounds for denial, and documentation requirements see: HHS Individuals' Right under HIPAA to Access their Health Information 45 CFR Section 164.524 https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html and HHS FAQ on Right of Access vs. HIPAA Authorization https://www.hhs.gov/hipaa/for-professionals/faq/2041/why-depend-on-the-individuals-right/index.html

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed under 45 CFR Section 164.5224 use "HIPAAROA" as the security label policy code.

Information disclosed under a HIPAA 42 CFR Section 164.524 no longer has the level of confidentiality protection afforded under the 45 CFR Section 164.506 - Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-508.pdf, which is considered the "norm", assign the HL7 Confidentiality code "M" (moderate), which may be protected under other laws such as the Federal Trade Commission privacy and security regulations.

A code representing 45 CFR 164.522 Rights to request privacy protection for protected health information, which is a US Federal law stipulating the privacy rights of an individual to restrict disclosure of information related to health care items or services for which the individual pays out of pocket in full to a health plan or payer.

See 45 CFR 164.522 https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-522.pdf. (vi) A covered entity must agree to the request of an individual to restrict disclosure of protected health information about the individual to a health plan if: (A) The disclosure is for the purpose of carrying out payment or health care operations and is not otherwise required by law; and (B) The protected health information pertains solely to a health care item or service for which the individual, or person other than the health plan on behalf of the individual, has paid the covered entity in full.

Usage Note: Used to indicate the legal authority for assigning security labels to HIPAA governed information. In this case, the collection, access, use, or disclosure of healthcare information is governed by HIPAA 45 CFR 164.522 https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-522.pdf use "HIPAASelfPay" as the security label policy code.

Since information governed by a HIPAA 45 CFR 164.522 has a level of confidentiality protection that is more stringent than the normal level of protection under 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

A code representing Title 38 Section 7332, which is a US Federal law stipulating the privacy rights of veterans diagnosed and treated for substance use disorders, infection with the human immunodeficiency virus, or sickle cell anemia.

https://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html . (1) Records of the identity, diagnosis, prognosis, or treatment of any patient or subject which are maintained in connection with the performance of any program or activity (including education, training, treatment, rehabilitation, or research) relating to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus, or sickle cell anemia which is carried out by or for the Department under this title shall, except as provided in subsections (e) and (f), be confidential, and (section 5701 of this title to the contrary notwithstanding) such records may be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b). (2) Paragraph (1) prohibits the disclosure to any person or entity other than the patient or subject concerned of the fact that a special written consent is required in order for such records to be disclosed. (b) (1) The content of any record referred to in subsection (a) may be disclosed by the Secretary in accordance with the prior written consent of the patient or subject with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed in regulations prescribed by the Secretary. (2) Whether or not any patient or subject, with respect to whom any given record referred to in subsection (a) is maintained, gives written consent, the content of such record may be disclosed by the Secretary as follows: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency. (B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient or subject in any report of such research, audit, or evaluation, or otherwise disclose patient or subject identities in any manner. (C) (i) In the case of any record which is maintained in connection with the performance of any program or activity relating to infection with the human immunodeficiency virus, to a Federal, State, or local public-health authority charged under Federal or State law with the protection of the public health, and to which Federal or State law requires disclosure of such record, if a qualified representative of such authority has made a written request that such record be provided as required pursuant to such law for a purpose authorized by such law. (ii) A person to whom a record is disclosed under this paragraph may not redisclose or use such record for a purpose other than that for which the disclosure was made. (D) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient or subject, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure. (E) To an entity described in paragraph (1)(B) of section 5701(k) of this title, but only to the extent authorized by such section. (F) (i) To a representative of a patient who lacks decision-making capacity, when a practitioner deems the content of the given record necessary for that representative to make an informed decision regarding the patient's treatment. (ii) In this subparagraph, the term "representative" means an individual, organization, or other body authorized under section 7331 of this title and its implementing regulations to give informed consent on behalf of a patient who lacks decision-making capacity. (G) To a State controlled substance monitoring program, including a program approved by the Secretary of Health and Human Services under section 399O of the Public Health Service Act (42 U.S.C. 280g-3), to the extent necessary to prevent misuse and diversion of prescription medicines. (H) (i) To a non-Department entity (including private entities and other Federal agencies) for purposes of providing health care, including hospital care, medical services, and extended care services, to Veterans or performing other health care-related activities or functions. (ii) An entity to which a record is disclosed under this subparagraph may not disclose or use such record for a purpose other than that for which the disclosure was made or as permitted by law. (I) To a third party in order to recover or collect reasonable charges for care furnished to, or paid on behalf of, a Veteran in connection with a non-service connected disability as permitted by section 1729 of this title or for a condition for which recovery is authorized or with respect to which the United States is deemed to be a third party beneficiary under the Act entitled 'An Act to provide for the recovery from tortiously liable third persons of the cost of hospital and medical care and treatment furnished by the United States' (Public Law 87-693; 42 U.S.C. 2651 et seq.; commonly known as the 'Federal Medical Care Recovery Act').

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by 38 U.S. Code Section 7332 - Confidentiality of certain medical records https://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html use "Title38Section7332" as the security label policy code.

Since information governed by a Title 38 Section 7332 has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

Code retired in December 2019 and replaced by code HIPAAConsent. Originally entered with copy/paste error in code value.

A code representing U.S. Public Law 104-191 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR Section 164.522), which stipulates the process by which a covered entity seeks agreement from an individual regarding how it will use and disclose the individual's protected health information for treatment, payment, and health care operations is termed a "consent." The Privacy Rule permits, but does not require, a covered entity to voluntarily obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations. Covered entities that do so have complete discretion to design a process that best suits their needs. From https://www.hhs.gov/hipaa/for-professionals/faq/264/what-is-the-difference-between-consent-and-authorization/index.html. The provisions relating to consent are largely contained in Section 164.522 Rights to request privacy protection for protected health information https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-522.pdf.

Usage Note: Used to indicate the legal authority for assigning security labels to governed information. In this case, where collection, access, use, or disclosure of healthcare information is governed by 45 CFR Section 164.522 use "HIPAAConsent" as the security label policy code.

Since information governed by a 45 CFR Section 164.522 has a level of confidentiality protection that is more stringent than the normal level of protection under HIPAA 45 CFR Section 164.506 Uses and disclosures to carry out treatment, payment, or health care operations https://www.gpo.gov/fdsys/pkg/CFR-2017-title45-vol1/pdf/CFR-2017-title45-vol1-sec164-506.pdf, assign the HL7 Confidentiality code "R" (restricted).

A mandate, obligation, requirement, rule, or expectation characterizing the value or importance of a resource and may include its vulnerability. (Based on ISO7498-2:1989. Note: The vulnerability of personally identifiable sensitive information may be based on concerns that the unauthorized disclosure may result in social stigmatization or discrimination.) Description: Types of Sensitivity policy that apply to Acts or Roles. A sensitivity policy is adopted by an enterprise or group of enterprises (a 'policy domain') through a formal data use agreement that stipulates the value, importance, and vulnerability of information. A sensitivity code representing a sensitivity policy may be associated with criteria such as categories of information or sets of information identifiers (e.g., a value set of clinical codes or branch in a code system hierarchy). These criteria may in turn be used for the Policy Decision Point in a Security Engine. A sensitivity code may be used to set the confidentiality code used on information about Acts and Roles to trigger the security mechanisms required to control how security principals (i.e., a person, a machine, a software application) may act on the information (e.g., collection, access, use, or disclosure). Sensitivity codes are never assigned to the transport or business envelope containing patient specific information being exchanged outside of a policy domain as this would disclose the information intended to be protected by the policy. When sensitive information is exchanged with others outside of a policy domain, the confidentiality code on the transport or business envelope conveys the receiver's responsibilities and indicates the how the information is to be safeguarded without unauthorized disclosure of the sensitive information. This ensures that sensitive information is treated by receivers as the sender intends, accomplishing interoperability without point to point negotiations.

Usage Note: Sensitivity codes are not useful for interoperability outside of a policy domain because sensitivity policies are typically localized and vary drastically across policy domains even for the same information category because of differing organizational business rules, security policies, and jurisdictional requirements. For example, an employee's sensitivity code would make little sense for use outside of a policy domain. 'Taboo' would rarely be useful outside of a policy domain unless there are jurisdictional requirements requiring that a provider disclose sensitive information to a patient directly. Sensitivity codes may be more appropriate in a legacy system's Master Files in order to notify those who access a patient's orders and observations about the sensitivity policies that apply. Newer systems may have a security engine that uses a sensitivity policy's criteria directly. The specializable InformationSensitivityPolicy Act.code may be useful in some scenarios if used in combination with a sensitivity identifier and/or Act.title.

Types of sensitivity policies that apply to Acts. Act.confidentialityCode is defined in the RIM as "constraints around appropriate disclosure of information about this Act, regardless of mood."

Usage Note: ActSensitivity codes are used to bind information to an Act.confidentialityCode according to local sensitivity policy so that those confidentiality codes can then govern its handling across enterprises. Internally to a policy domain, however, local policies guide the access control system on how end users in that policy domain are able to use information tagged with these sensitivity values.

Policy for handling alcohol or drug-abuse information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to alcohol or drug-abuse information that is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling genetic disease information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to genetic disease information that is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling HIV or AIDS information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to HIV or AIDS information that is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to sexual assault or repeated, threatening sexual harassment that occurred while the patient was in the military, which is afforded heightened confidentiality.

Access control concerns for military sexual trauma is based on the patient being subject to control by a higher ranking military perpetrator and/or censure by others within the military unit. Due to the relatively unfettered access to healthcare information by higher ranking military personnel and those who have command over the patient, there is a need to sequester this information outside of the typical controls on access to military health records.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information about an individual's current or past pregnancy status, deemed sensitive by the individual or by policy, which may be afforded heightened confidentiality.

Usage Note:

Information about a patient's current or past pregnancy status may be considered sensitive in circumstances in which that status could result in discrimination or stigmatization.

Policy for handling sickle cell disease information, which is afforded heightened confidentiality. Information handling protocols are based on organizational policies related to sickle cell disease information, which is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then the Act valued with this ActCode should be associated with an Act valued with any applicable laws from the ActPrivacyLaw code system.

Policy for handling sexual assault, abuse, or domestic violence information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to sexual assault, abuse, or domestic violence information that is deemed sensitive.

SDV code covers violence perpetrated by related and non-related persons. This code should be specific to physical and mental trauma caused by a related person only. The access control concerns are keeping the patient safe from the perpetrator who may have an abusive psychological control over the patient, may be stalking the patient, or may try to manipulate care givers into allowing the perpetrator to make contact with the patient. The definition needs to be clarified.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling sexuality and reproductive health information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to sexuality and reproductive health information that is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information deemed specially protected by law or policy including substance abuse, substance use, psychiatric, mental health, behavioral health, and cognitive disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information related to behavioral and emotional disturbances affecting social adjustment and physical health, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information related to cognitive disability disorders and conditions caused by these disorders, which are afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Examples may include dementia, traumatic brain injury, attention deficit, hearing and visual disability such as dyslexia and other disorders and related conditions which impair learning and self-sufficiency. However, the cognitive disabilities to which this term may apply versus other behavioral health categories varies by jurisdiction and organizational policy in part due to overlap with other behavioral health conditions. Implementers should constrain to those diagnoses applicable in the domain in which this code is used.

Policy for handling information related to developmental disability disorders and conditions caused by these disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

A diverse group of chronic conditions that are due to mental or physical impairments impacting activities of daily living, self-care, language acuity, learning, mobility, independent living and economic self-sufficiency. Examples may include Down syndrome and Autism spectrum. However, the developmental disabilities to which this term applies versus other behavioral health categories varies by jurisdiction and organizational policy in part due to overlap with other behavioral health conditions. Implementers should constrain to those diagnoses applicable in the domain in which this code is used.

Policy for handling information related to emotional disturbance disorders and conditions caused by these disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Typical used to characterize behavioral and mental health issues of adolescents where the disorder may be temporarily diagnosed in order to avoid the potential and unnecessary stigmatizing diagnoses of disorder long term.

Policy for handling information related to psychological disorders, which is afforded heightened confidentiality. Mental health information may be deemed specifically sensitive and distinct from physical health, substance use disorders, and behavioral disabilities and disorders in some jurisdictions.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling psychiatry psychiatric disorder information, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling psychotherapy note information, which is afforded heightened confidentiality.

Usage Note: In some jurisdiction, disclosure of psychotherapy notes requires patient consent.

If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to alcohol or drug use disorders and conditions caused by these disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information related to alcohol use disorders and conditions caused by these disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information related to opioid use disorders and conditions caused by these disorders, which is afforded heightened confidentiality.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling sexually transmitted disease information, which will be afforded heightened confidentiality. Information handling protocols based on organizational policies related to sexually transmitted disease information that is deemed sensitive.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information not to be initially disclosed or discussed with patient except by a physician assigned to patient in this case. Information handling protocols based on organizational policies related to sensitive patient information that must be initially discussed with the patient by an attending physician before being disclosed to the patient.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Open Issue: This definition conflates a rule and a characteristic, and there may be a similar issue with ts sibling codes.

Policy for handling information related to harm by violence, which is afforded heightened confidentiality. Harm by violence is perpetrated by an unrelated person.

Access control concerns for information about mental or physical harm resulting from violence caused by an unrelated person may include manipulation of care givers or access to records that enable the perpetrator contact or locate the patient, but the perpetrator will likely not have established abusive psychological control over the patient.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

Policy for handling information related to an identifier of an information subject, which will be afforded heightened confidentiality. Usage Note: Such policies may govern the sensitivity of information related to an identifier of an act, such as the identifier of a contract; a role, such as a citizen, a patient, a practitioner, or an organization; or an entity such as a medical device due to potential impact on the privacy, well-being, safety or integrity of an information subject. For example, protection against identity fraud or counterfeit.

Types of sensitivity policies that apply to Acts. Act.confidentialityCode is defined in the RIM as "constraints around appropriate disclosure of information about this Act, regardless of mood."

Usage Note: ActSensitivity codes are used to bind information to an Act.confidentialityCode according to local sensitivity policy so that those confidentiality codes can then govern its handling across enterprises. Internally to a policy domain, however, local policies guide the access control system on how end users in that policy domain are able to use information tagged with these sensitivity values.

Types of sensitivity policies that may apply to a sensitive attribute on an Entity.

Usage Note: EntitySensitivity codes are used to convey a policy that is applicable to sensitive information conveyed by an entity attribute. May be used to bind a Role.confidentialityCode associated with an Entity per organizational policy. Role.confidentialityCode is defined in the RIM as "an indication of the appropriate disclosure of information about this Role with respect to the playing Entity."

Policy for handling all demographic information about an information subject, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to all demographic about an information subject, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an information subject's date of birth, which will be afforded heightened confidentiality.Policies may govern sensitivity of information related to an information subject's date of birth, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an information subject's gender and sexual orientation, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to an information subject's gender and sexual orientation, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an information subject's living arrangement, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to an information subject's living arrangement, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an information subject's marital status, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to an information subject's marital status, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an individual's location, which is deemed sensitive when the disclosure could impact the privacy, well-being, or safety of that subject, and requires additional protection.

Usage Note: If there is a jurisdictional, organizational, or individual mandate, then use the applicable ActPrivacyLaw or ActConsentDirective code from the ActCode system to and specify the law in addition to this more generic code.

Policy for handling information related to an information subject's race, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to an information subject's race, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an information subject's religious affiliation, which will be afforded heightened confidentiality. Policies may govern sensitivity of information related to an information subject's religion, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Notes: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Types of sensitivity policies that apply to Roles.

Usage Notes: RoleSensitivity codes are used to bind information to a Role.confidentialityCode per organizational policy. Role.confidentialityCode is defined in the RIM as "an indication of the appropriate disclosure of information about this Role with respect to the playing Entity."

Policy for handling trade secrets such as financial information or intellectual property, which will be afforded heightened confidentiality. Description: Since the service class can represent knowledge structures that may be considered a trade or business secret, there is sometimes (though rarely) the need to flag those items as of business level confidentiality.

Usage Notes: No patient related information may ever be of this confidentiality level. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an employer which is deemed classified to protect an employee who is the information subject, and which will be afforded heightened confidentiality. Description: Policies may govern sensitivity of information related to an employer, such as law enforcement or national security, the identity of which could impact the privacy, well-being, or safety of an information subject who is an employee.

Usage Notes: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to the location of the information subject, which will be afforded heightened confidentiality. Description: Policies may govern sensitivity of information related to the location of the information subject, the disclosure of which could impact the privacy, well-being, or safety of that subject.

Usage Notes: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to a provider of sensitive services, which will be afforded heightened confidentiality. Description: Policies may govern sensitivity of information related to providers who deliver sensitive healthcare services in order to protect the privacy, well-being, and safety of the provider and of patients receiving sensitive services.

Usage Notes: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an adolescent, which will be afforded heightened confidentiality per applicable organizational or jurisdictional policy. An enterprise may have a policy that requires that adolescent patient information be provided heightened confidentiality. Information deemed sensitive typically includes health information and patient role information including patient status, demographics, next of kin, and location.

Usage Note: For use within an enterprise in which an adolescent is the information subject. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to a celebrity (people of public interest (VIP), which will be afforded heightened confidentiality. Celebrities are people of public interest (VIP) about whose information an enterprise may have a policy that requires heightened confidentiality. Information deemed sensitive may include health information and patient role information including patient status, demographics, next of kin, and location.

Usage Note: For use within an enterprise in which the information subject is deemed a celebrity or very important person. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to a celebrity (people of public interest (VIP), which will be afforded heightened confidentiality. Celebrities are people of public interest (VIP) about whose information an enterprise may have a policy that requires heightened confidentiality. Information deemed sensitive may include health information and patient role information including patient status, demographics, next of kin, and location.

Usage Note: For use within an enterprise in which the information subject is deemed a celebrity or very important person. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to a diagnosis, health condition or health problem, which will be afforded heightened confidentiality. Diagnostic, health condition or health problem related information may be deemed sensitive by organizational policy, and require heightened confidentiality.

Usage Note: For use within an enterprise that provides heightened confidentiality to diagnostic, health condition or health problem related information deemed sensitive. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to a drug, which will be afforded heightened confidentiality. Drug information may be deemed sensitive by organizational policy, and require heightened confidentiality.

Usage Note: For use within an enterprise that provides heightened confidentiality to drug information deemed sensitive. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Policy for handling information related to an employee, which will be afforded heightened confidentiality. When a patient is an employee, an enterprise may have a policy that requires heightened confidentiality. Information deemed sensitive typically includes health information and patient role information including patient status, demographics, next of kin, and location.

Usage Note: Policy for handling information related to an employee, which will be afforded heightened confidentiality. Description: When a patient is an employee, an enterprise may have a policy that requires heightened confidentiality. Information deemed sensitive typically includes health information and patient role information including patient status, demographics, next of kin, and location.

Policy for specially protecting information reported by or about a patient, which is deemed sensitive within the enterprise (i.e., by default regardless of whether the patient requested that the information be deemed sensitive for another reason.) For example information reported by the patient about another person, e.g., a family member, may be deemed sensitive by default. Organizational policy may allow the sensitivity tag to be cleared on patient's request.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law in addition to this more generic code.

For example, VA deems employee information sensitive by default. Information about a patient who is being stalked or a victim of abuse or violence may be deemed sensitive by default per a provider organization's policies.

Policy for handling information about a patient, which a physician or other licensed healthcare provider deems sensitive. Once tagged by the provider, this may trigger alerts for follow up actions according to organizational policy or jurisdictional law.

Usage Note: For use within an enterprise that provides heightened confidentiality to certain types of information designated by a physician as sensitive. If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

Use cases in which this code could be used are, e.g., in systems that lack the ability to automatically detect sensitive information and must rely on manual tagging; a system that lacks an applicable sensitivity tag, or for ad hoc situations where criticality of the situation requires that the tagging be done immediately by the provider before coding or transcription of consult notes can be completed, e.g., upon detection of a patient with suicidal tendencies or potential for violence.

Policy for specially protecting information reported by or about a patient, which the patient deems sensitive, and the patient requests that collection, access, use, or disclosure of that information be restricted. For example, a minor patient may request that information about reproductive health not be disclosed to the patient's family or to particular providers and payers.

Usage Note: If there is a jurisdictional mandate, then use the applicable ActPrivacyLaw code system, and specify the law rather than or in addition to this more generic code.

This is the healthcare analog to the US Intelligence Community's concept of a Special Access Program. Compartment codes may be used in as a field value in an initiator's clearance to indicate permission to access and use an IT Resource with a security label having the same compartment value in security category label field.

Map: Aligns with ISO 2382-8 definition of Compartment - "A division of data into isolated blocks with separate security controls for the purpose of reducing risk."

A group of health care entities, which may include health care providers, care givers, hospitals, facilities, health plans, and other health care constituents who coordinate care for reimbursement based on quality metrics for improving outcomes and lowering costs, and may be authorized to access the consumer's health information because of membership in that group.

Security Compartment Labels assigned to a consumer's information use in accountable care workflows should be met or exceeded by the Security Compartment attribute claimed by a participant in a an accountable care workflow who is requesting access to that information

This compartment code may be used as a field value in an initiator's clearance to indicate permission for its Clinical Decision Support system (CDSS) to access and use an IT Resource with a security label having the same compartment value in the security category label field.

This code permits a CDS system to algorithmically process information with this compartment tag for the purpose of alerting an unauthorized end user that masked information is needed to address an emergency or a patient safety issue, such as a contraindicated medication. The alert would advise the end user to "break the glass", to access the masked information in an accountable manner, or to ask the patient about possibly masked information.

For example, releasing a list of sensitive medications with this compartment tag means that while the CDS system is permitted to use this list in its contraindication analysis, this sensitive information should not be shared directly with unauthorized end-users or end-user-facing Apps. Based on the results of the CDS system analysis (e.g., warnings about prescriptions) the end-user (e.g., a clinician) may still have the ability to access to the sensitive information by invoking "break-the-glass protocol".

Usage Note: A security label with the CDS system compartment may be used in conjunction with other security labels, e.g., a label authorizing an end user with adequate clearance to access the same CDS system compartment tagged information. For example, a patient may restrict sharing sensitive information with most care team members except in an emergency or to prevent an adverse event, and may consent to sharing with their sensitive service care team providers, e.g., for mental health or substance abuse.

Care coordination across participants in a care plan requires sharing of a healthcare consumer's information specific to that workflow. A care team member should only have access to that information while participating in that workflow or for other authorized uses.

Security Compartment Labels assigned to a consumer's information use in care coordination workflows should be met or exceeded by the Security Compartment attribute claimed by a participant in a care team member workflow who is requesting access to that information

Financial management department members who have access to healthcare consumer information as part of a patient account, billing and claims workflows.

Security Compartment Labels assigned to consumer information used in these workflows should be met or exceeded by the Security Compartment attribute claimed by a participant in a financial management workflow who is requesting access to that information.

A security category label field value, which indicates that access and use of an IT resource is restricted to members of human resources department or workflow.

Providers and care givers who have an established relationship per criteria determined by policy are considered to have an established care provision relations with a healthcare consumer, and may be authorized to access the consumer's health information because of that relationship. Providers and care givers should only have access to that information while participating in legitimate relationship workflows or for other authorized uses.

Security Compartment Labels assigned to a consumer's information use in legitimate relationship workflows should be met or exceeded by the Security Compartment attribute claimed by a participant in a legitimate relationship workflow who is requesting access to that information.

Patient administration members who have access to healthcare consumer information as part of a patient administration workflows.

Security Compartment Labels assigned to consumer information used in these workflows should be met or exceeded by the Security Compartment attribute claimed by a participant in a patient administration workflow who is requesting access to that information.

A security category label field value, which indicates that access and use of an IT resource is restricted to members of a research project.

A security category label field value, which indicates that access and use of an IT resource is restricted to members of records management department or workflow.

A mandate, obligation, requirement, rule, or expectation conveyed as security metadata between senders and receivers required to establish the reliability, authenticity, and trustworthiness of their transactions.

Trust security metadata are observation made about aspects of trust applicable to an IT resource (data, information object, service, or system capability).

Trust applicable to IT resources is established and maintained in and among security domains, and may be comprised of observations about the domain's trust authority, trust framework, trust policy, trust interaction rules, means for assessing and monitoring adherence to trust policies, mechanisms that enforce trust, and quality and reliability measures of assurance in those mechanisms. [Based on ISO IEC 10181-1 and NIST SP 800-63-2]

For example, identity proofing , level of assurance, and Trust Framework.

Type of security metadata 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.

Type of security metadata about privacy and security requirements with which a security domain must comply. [ISO IEC 10181-1]

Type of security metadata about the digital quality or reliability of a trust assertion, activity, capability, information exchange, mechanism, process, or protocol.

Type of security metadata 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]

Type of security metadata 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]

Type of security metadata about a security architecture system component that supports enforcement of security policies.

**Description:**A mandate, obligation, requirement, rule, or expectation unilaterally imposed on benefit coverage under a policy or program by a sponsor, underwriter or payor on:

• The activity of another party
• The behavior of another party
• The manner in which an act is executed

**Examples:**A clinical protocol imposed by a payer to which a provider must adhere in order to be paid for providing the service. A formulary from which a provider must select prescribed drugs in order for the patient to incur a lower copay.

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.