Generated Narrative: ValueSet R5-v3-ActCode-for-R4 This value set expansion contains 118 concepts. Code System Display Definition DV http://terminology.hl7.org/CodeSystem/v3-ActCode Discover Card CDEP http://terminology.hl7.org/CodeSystem/v3-ActCode certified depression care **Description:**Scope of responsibility taken on by an organization for care of a patient as defined by the disease management certification agency. CANPRG http://terminology.hl7.org/CodeSystem/v3-ActCode women's cancer detection program Definition: A program that provides low-income, uninsured, and underserved women access to timely, high-quality screening and diagnostic services, to detect breast and cervical cancer at the earliest stages. Example: To improve women's access to screening for breast and cervical cancers, Congress passed the Breast and Cervical Cancer Mortality Prevention Act of 1990, which guided CDC in creating the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which provides access to critical breast and cervical cancer screening services for underserved women in the United States. An estimated 7 to 10% of U.S. women of screening age are eligible to receive NBCCEDP services. Federal guidelines establish an eligibility baseline to direct services to uninsured and underinsured women at or below 250% of federal poverty level; ages 18 to 64 for cervical screening; ages 40 to 64 for breast screening. SUBSIDIZ http://terminology.hl7.org/CodeSystem/v3-ActCode subsidized health program Definition: A government health program that provides coverage for health services to persons meeting eligibility criteria such as income, location of residence, access to other coverages, health condition, and age, the cost of which is to some extent subsidized by public funds. MENTPOL http://terminology.hl7.org/CodeSystem/v3-ActCode mental health policy Definition: A health insurance policy that covers benefits for mental health services and prescriptions. HIRISK http://terminology.hl7.org/CodeSystem/v3-ActCode high risk pool program Definition: A government program that provides health coverage to individuals who are considered medically uninsurable or high risk, and who have been denied health insurance due to a serious health condition. In certain cases, it also applies to those who have been quoted very high premiums a" again, due to a serious health condition. The pool charges premiums for coverage. Because the pool covers high-risk people, it incurs a higher level of claims than premiums can cover. The insurance industry pays into the pool to make up the difference and help it remain viable. 22 http://terminology.hl7.org/CodeSystem/v3-ActCode appropriate indication or diagnosis Description: The patient has the appropriate indication or diagnosis for the action to be taken. ACOBS http://terminology.hl7.org/CodeSystem/v3-ActCode common observations access Description: Provide consent to collect, use, disclose, or access common observation information for a patient. SENDAPP http://terminology.hl7.org/CodeSystem/v3-ActCode sending application Transaction counts and value totals by each instance of a messaging application on a single processor. It is a registered identifier known to the receivers. W http://terminology.hl7.org/CodeSystem/v3-ActCode Ward Accommodations in which there are 3 or more beds. CPNDINDING http://terminology.hl7.org/CodeSystem/v3-ActCode compound ingredient invoice group A grouping of invoice element details including the one specifying an ingredient drug being invoiced. It may also contain generic detail items such as tax or markup. ADNPPPMNAT http://terminology.hl7.org/CodeSystem/v3-ActCode adjud. non-payee payable prior-period manual amount Identifies the total net amount of all Invoice Groupings that were adjudicated as payable prior to the specified time period (based on adjudication date) that do not match a specified payee (e.g. pay patient) and submitted manually. PDNFPPELAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid nullified prior-period electronic amount Identifies the total net amount of all Invoice Groupings that were paid prior to the specified time period (based on payment date), subsequently nullified in the specified period and submitted electronically. PDNFSPMNAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid nullified same-period manual amount Identifies the total net amount of all Invoice Groupings that were paid during the specified time period (based on payment date), subsequently nullified in the specified period and submitted manually. PDNPPPELAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid non-payee payable prior-period electronic amount Identifies the total net amount of all Invoice Groupings that were paid prior to the specified time period (based on payment date) that do not match a specified payee (e.g. pay patient) and submitted electronically. PDNPPPMNAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid non-payee payable prior-period manual amount Identifies the total net amount of all Invoice Groupings that were paid prior to the specified time period (based on payment date) that do not match a specified payee (e.g. pay patient) and submitted manually. PDNPSPELAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid non-payee payable same-period electronic amount Identifies the total net amount of all Invoice Groupings that were paid during the specified time period (based on payment date) that do not match a specified payee (e.g. pay patient) and submitted electronically. PDNPSPMNAT http://terminology.hl7.org/CodeSystem/v3-ActCode paid non-payee payable same-period manual amount Identifies the total net amount of all Invoice Groupings that were paid during the specified time period (based on payment date) that do not match a specified payee (e.g. pay patient) and submitted manually. OTC http://terminology.hl7.org/CodeSystem/v3-ActCode non prescription medicine Medicines designated in this way may be supplied for patient use without a prescription. The exact form of categorisation will vary in different realms. VRFPAPER http://terminology.hl7.org/CodeSystem/v3-ActCode verify paper **Definition:**Indicates that the paper version of the record has, should be or is being verified against the electronic version. FFP http://terminology.hl7.org/CodeSystem/v3-ActCode First Fill - Part Fill A first fill where the quantity supplied is less than one full repetition of the ordered amount. (e.g. If the order was 90 tablets, 3 refills, a partial fill might be for only 30 tablets.) RFFS http://terminology.hl7.org/CodeSystem/v3-ActCode refill partial strength (first fill this facility) The first fill against an order that has already been filled at least once at another facility and where the strength supplied is less than the ordered strength (e.g. 10mg for an order of 50mg where a subsequent fill will dispense 40mg tablets). RFPS http://terminology.hl7.org/CodeSystem/v3-ActCode refill part fill partial strength A refill where the quantity supplied is less than one full repetition of the ordered amount. (e.g. If the order was 90 tablets, 3 refills, a partial fill might be for only 30 tablets.) and where the strength supplied is less than the ordered strength (e.g. 10mg for an order of 50mg where a subsequent fill will dispense 40mg tablets). TB http://terminology.hl7.org/CodeSystem/v3-ActCode Trial Balance A fill where the remainder of a 'complete' fill is provided after a trial fill has been provided. NOCONSENT http://terminology.hl7.org/CodeSystem/v3-ActCode no consent 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. OIC http://terminology.hl7.org/CodeSystem/v3-ActCode opt-in to personal information or effect collection in a registry or repository 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". PROCESSINLINELABEL http://terminology.hl7.org/CodeSystem/v3-ActCode process inline security label Custodian security system must take note that the data object contains inline security labels and process them. PATDOC http://terminology.hl7.org/CodeSystem/v3-ActCode patient documentation task A person enters documentation about a given patient. 30972-4 http://terminology.hl7.org/CodeSystem/v3-ActCode age at onset of adverse event **Definition:**Age at onset of associated adverse event; no implied method of determination. SPLCOATING http://terminology.hl7.org/CodeSystem/v3-ActCode coating Definition: A characteristic of an oral solid dosage form of a medicinal product, indicating whether it has one or more coatings such as sugar coating, film coating, or enteric coating. Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration). Constraints: The Observation.value must be a Boolean (BL) with true for the presence or false for the absence of one or more coatings on a solid dosage form. SPLIMAGE http://terminology.hl7.org/CodeSystem/v3-ActCode image Description: A characteristic representing a single file reference that contains two or more views of the same dosage form of the product; in most cases this should represent front and back views of the dosage form, but occasionally additional views might be needed in order to capture all of the important physical characteristics of the dosage form. Any imprint and/or symbol should be clearly identifiable, and the viewer should not normally need to rotate the image in order to read it. Images that are submitted with SPL should be included in the same directory as the SPL file. SPLSCORING http://terminology.hl7.org/CodeSystem/v3-ActCode scoring Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s). Example: One score line creating two equal pieces is given a value of 2, two parallel score lines creating three equal pieces is given a value of 3. Constraints: Whether three parallel score lines create four equal pieces or two intersecting score lines create two equal pieces using one score line and four equal pieces using both score lines, both have the scoring value of 4. Solid dosage forms that are not scored are given a value of 1. Solid dosage forms that can only be divided into unequal pieces are given a null-value with nullFlavor other (OTH). SPLSIZE http://terminology.hl7.org/CodeSystem/v3-ActCode size Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the longest single dimension of the solid dosage form as a physical quantity in the dimension of length (e.g., 3 mm). The length is should be specified in millimeters and should be rounded to the nearest whole millimeter. Example: SPLSIZE for a rectangular shaped tablet is the length and SPLSIZE for a round shaped tablet is the diameter. NOI http://terminology.hl7.org/CodeSystem/v3-ActCode nature of injury The type of injury that the injury coding specifies. HHOBS http://terminology.hl7.org/CodeSystem/v3-ActCode household situation observation Indicates that the observation is of a person’s living situation in a household including the household composition and circumstances. NAT http://terminology.hl7.org/CodeSystem/v3-ActCode Insufficient authorization The requesting party has insufficient authorization to invoke the interaction. CODINGGAP http://terminology.hl7.org/CodeSystem/v3-ActCode Codinggap Identifies the type of detected issue is a risk adjustment coding gap RD http://terminology.hl7.org/CodeSystem/v3-ActCode reduction diet A diet that seeks to reduce body fat, typically low energy content (800-1600 kcal). _ActConsent http://terminology.hl7.org/CodeSystem/v3-ActCode _ActConsent 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. GDPRCD http://terminology.hl7.org/CodeSystem/v3-ActCode GDPR Consent Directive 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 GDPRResearchCD http://terminology.hl7.org/CodeSystem/v3-ActCode GDPR Research Consent Directive 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/ OIS http://terminology.hl7.org/CodeSystem/v3-ActCode opt-in to personal information or effect sharing via a registry or repository 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". OOC http://terminology.hl7.org/CodeSystem/v3-ActCode opt-out of personal information or effect collection in a registry or repository 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". OOS http://terminology.hl7.org/CodeSystem/v3-ActCode opt-out of personal information or effect sharing via a registry or repository 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". 42CFRPart2CD http://terminology.hl7.org/CodeSystem/v3-ActCode 42 CFR Part 2 consent directive 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). CompoundResearchCD http://terminology.hl7.org/CodeSystem/v3-ActCode Compound HIPAA Research Authorization and Informed Consent for Research 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 HIPAAAuthCD http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Authorization Consent Directive 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). HIPAAConsentCD http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Consent Directive 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). HIPAAResearchAuthCD http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Authorization for Disclosure for Research Consent Directive 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 HIPAAROAD http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Right of Access Directive 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. MDHHS-5515 http://terminology.hl7.org/CodeSystem/v3-ActCode Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes 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 MDHHS-5515MMHC http://terminology.hl7.org/CodeSystem/v3-ActCode Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes-Michigan Mental Health Code 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 MDHHS-5515Part2 http://terminology.hl7.org/CodeSystem/v3-ActCode Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes-US 42 CFR Part 2 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 USResearchInformedAssent http://terminology.hl7.org/CodeSystem/v3-ActCode Informed Assent for Research 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 USResearchInformedConsent http://terminology.hl7.org/CodeSystem/v3-ActCode Informed Consent for Research 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 USBroadResearchConsent http://terminology.hl7.org/CodeSystem/v3-ActCode Broad Consent for Research 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 INFOACCESS http://terminology.hl7.org/CodeSystem/v3-ActCode access information Authorization to obtain information with no further permission to collect and store it. INFOCOLLECT http://terminology.hl7.org/CodeSystem/v3-ActCode collect information Authorization to gather and store information. INFODEIDENTIFIY http://terminology.hl7.org/CodeSystem/v3-ActCode deidentify information Authorization to alter or remove identifying characteristics of an entity or individual that is a subject of the information. INFODISCLOSE http://terminology.hl7.org/CodeSystem/v3-ActCode disclose information Authorization to make information known to another party. INFOMASK http://terminology.hl7.org/CodeSystem/v3-ActCode mask information Authorization to alter information in order to conceal it from unauthorized recipients. INFOREADONLY http://terminology.hl7.org/CodeSystem/v3-ActCode read only information Authorization to access information within a specific context for communication purposes only. Storing, manipulating, and further disclosure are prohibited and may be technically disabled. INFOREDACT http://terminology.hl7.org/CodeSystem/v3-ActCode redact information Authorization to remove information that a recipient is not authorized to access. INFOREDISCLOSE http://terminology.hl7.org/CodeSystem/v3-ActCode redisclose information Authorization to make disclosed information known to another party. INFOREIDENTIFY http://terminology.hl7.org/CodeSystem/v3-ActCode reidentify information Authorization to alter or relink deidentified information so that an entity or individual that is the subject of that information identifiable. INFOUSE http://terminology.hl7.org/CodeSystem/v3-ActCode use information Authorization to employ or alter information. JurisIP http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional information policy Jurisdictional policy on collection, access, use, or disclosure of information as defined by applicable jurisdictional law. JurisCUI http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional controlled unclassified information policy Jurisdictional policy on collection, access, use, or disclosure of controlled unclassified information as defined by applicable jurisdictional law. JurisDEID http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional de-identified information policy Jurisdictional policy on collection, access, use, or disclosure of de-identified information as defined by applicable jurisdictional law. JurisLDS http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional limited data set Jurisdictional policy on collection, access, use, or disclosure of information in a limited data set as defined by applicable jurisdictional law. JurisNSI http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional non-sensitive information policy Jurisdictional policy on collection, access, use, or disclosure of information deemed non-sensitive by applicable jurisdiction law. JurisPI http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional public information policy Jurisdictional policy on collection, access, use, or disclosure of information deemed public by applicable jurisdiction law. JurisSP-CUI http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional specified controlled unclassified information policy Jurisdictional policy on collection, access, use, or disclosure of specified controlled unclassified information as defined by applicable jurisdictional policy. JurisUUI http://terminology.hl7.org/CodeSystem/v3-ActCode jurisdictional uncontrolled unclassified information policy Jurisdictional policy on collection, access, use, or disclosure of uncontrolled unclassified information as defined by applicable jurisdictional policy. OrgIP http://terminology.hl7.org/CodeSystem/v3-ActCode organizational information policy Organizational policy on collection, access, use, or disclosure of information, which does not conflict with jurisdictional law. OrgCUI http://terminology.hl7.org/CodeSystem/v3-ActCode organizational basic controlled unclassified information policy Organizational policy on collection, access, use, or disclosure of basic controlled unclassified information as defined by the organization or by applicable jurisdictional law. OrgDEID http://terminology.hl7.org/CodeSystem/v3-ActCode organizational de-identified informati)on policy Organizational policy on collection, access, use, or disclosure of de-identified information as defined by the organization or by applicable jurisdictional law. OrgLDS http://terminology.hl7.org/CodeSystem/v3-ActCode organizational limited data set information policy 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. OrgNSI http://terminology.hl7.org/CodeSystem/v3-ActCode organizational non-sensitive information policy Organizational policy on collection, access, use, or disclosure of information deemed non-sensitive by the organization or by applicable jurisdictional law. OrgPI http://terminology.hl7.org/CodeSystem/v3-ActCode organizational public information policy Organizational policy on collection, access, use, or disclosure of public information as defined by the organization or by applicable jurisdictional law. OrgSP-CUI http://terminology.hl7.org/CodeSystem/v3-ActCode organizational specified controlled unclassified information policy Organizational policy on collection, access, use, or disclosure of specified controlled unclassified information as defined by the organization or by applicable jurisdictional law. OrgUUI http://terminology.hl7.org/CodeSystem/v3-ActCode organizational uncontrolled unclassified information policy Organizational policy on collection, access, use, or disclosure of uncontrolled unclassified information as defined by the organization or governing jurisdiction. PersIP http://terminology.hl7.org/CodeSystem/v3-ActCode personal information policy Personal policy on collection, access, use, or disclosure of information. PersDEID http://terminology.hl7.org/CodeSystem/v3-ActCode personal de-identified information policy Personal policy on collection, access, use, or disclosure of de-identified information as defined by the information subject or by applicable jurisdictional law. PersLDS http://terminology.hl7.org/CodeSystem/v3-ActCode personal limited data set information policy Personal policy personal policy on collection, access, use, or disclosure of information in a limited data set by the information subject. PersNSI http://terminology.hl7.org/CodeSystem/v3-ActCode personal non-sensitive information policy Personal policy on collection, access, use, or disclosure of information deemed non-sensitive by the information subject. PersPI http://terminology.hl7.org/CodeSystem/v3-ActCode personal public information policy Personal policy on collection, access, use, or disclosure of information deemed public by the information subject. GDPRCONSENT http://terminology.hl7.org/CodeSystem/v3-ActCode GDPR Consent 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. HIPAAAuth http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Authorization for Disclosure 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. HIPAAConsent http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Consent 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). HIPAAROA http://terminology.hl7.org/CodeSystem/v3-ActCode HIPAA Right of Access 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. PREGNANT http://terminology.hl7.org/CodeSystem/v3-ActCode pregnancy information sensitivity 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. IDS http://terminology.hl7.org/CodeSystem/v3-ActCode Identifier Sensitivity 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. PATLOC http://terminology.hl7.org/CodeSystem/v3-ActCode patient location 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. VIP http://terminology.hl7.org/CodeSystem/v3-ActCode celebrity information sensitivity 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. CDSSCOMPT http://terminology.hl7.org/CodeSystem/v3-ActCode CDS system compartment 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. CPLYCUI http://terminology.hl7.org/CodeSystem/v3-ActCode comply with controlled unclassified information policy 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 CPLYJSP http://terminology.hl7.org/CodeSystem/v3-ActCode comply with jurisdictional security 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. CUIMark http://terminology.hl7.org/CodeSystem/v3-ActCode CUI Mark 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 CONTROLLED http://terminology.hl7.org/CodeSystem/v3-ActCode CONTROLLED 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. CUI http://terminology.hl7.org/CodeSystem/v3-ActCode CUI 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. CUIHLTH http://terminology.hl7.org/CodeSystem/v3-ActCode CUI//HLTH 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 CUIHLTHP http://terminology.hl7.org/CodeSystem/v3-ActCode (CUI//HLTH) 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 CUIP http://terminology.hl7.org/CodeSystem/v3-ActCode (CUI) 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 CUIPRVCY http://terminology.hl7.org/CodeSystem/v3-ActCode CUI//PRVCY 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. CUIPRVCYP http://terminology.hl7.org/CodeSystem/v3-ActCode (CUI//PRVCY) 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. CUISP-HLTH http://terminology.hl7.org/CodeSystem/v3-ActCode CUI//SP-HLTH 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. CUISP-HLTHP http://terminology.hl7.org/CodeSystem/v3-ActCode (CUI//SP-HLTH) 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 CUISP-PRVCY http://terminology.hl7.org/CodeSystem/v3-ActCode CUI//SP-PRVCY 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-17-12ï‡? 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. CUISP-PRVCYP http://terminology.hl7.org/CodeSystem/v3-ActCode (CUI//SP-PRVCY) 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-17-12ï‡? 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. UUI http://terminology.hl7.org/CodeSystem/v3-ActCode (U) 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) ConfidentialMark http://terminology.hl7.org/CodeSystem/v3-ActCode confidential mark 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. COPYMark http://terminology.hl7.org/CodeSystem/v3-ActCode copy of original mark 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. DeliverToAddresseeOnlyMark http://terminology.hl7.org/CodeSystem/v3-ActCode deliver only to addressee mark 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. RedisclosureProhibitionMark http://terminology.hl7.org/CodeSystem/v3-ActCode prohibition against redisclosure mark 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 RestrictedConfidentialityMark http://terminology.hl7.org/CodeSystem/v3-ActCode restricted confidentiality mark 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. DRAFTMark http://terminology.hl7.org/CodeSystem/v3-ActCode Draft Mark 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. CAREGAP http://terminology.hl7.org/CodeSystem/v3-ActCode Caregap Identifies the type of detected issue is a care gap
Cross-version VS for R5.ActCode for use in FHIR R4
HL7 International / Terminology Infrastructure
This cross-version ValueSet represents concepts from http://terminology.hl7.org/ValueSet/v3-ActCode|2.0.0 for use in FHIR R4. Concepts not present here have direct `equivalent` mappings crossing all versions from R5 to R4.
adjud. non-payee payable prior-period manual amount
paid nullified prior-period electronic amount
paid nullified same-period manual amount
paid non-payee payable prior-period electronic amount
paid non-payee payable prior-period manual amount
paid non-payee payable same-period electronic amount
paid non-payee payable same-period manual amount
refill partial strength (first fill this facility)
opt-in to personal information or effect collection in a registry or repository
opt-in to personal information or effect sharing via a registry or repository
opt-out of personal information or effect collection in a registry or repository
opt-out of personal information or effect sharing via a registry or repository
Compound HIPAA Research Authorization and Informed Consent for Research
HIPAA Authorization for Disclosure for Research Consent Directive
Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes
Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes-Michigan Mental Health Code
Michigan Consent to Share Behavioral Health Information for Care Coordination Purposes-US 42 CFR Part 2
jurisdictional controlled unclassified information policy
jurisdictional de-identified information policy
jurisdictional non-sensitive information policy
jurisdictional public information policy
jurisdictional specified controlled unclassified information policy
jurisdictional uncontrolled unclassified information policy
organizational basic controlled unclassified information policy
organizational de-identified informati)on policy
organizational limited data set information policy
organizational non-sensitive information policy
organizational public information policy
organizational specified controlled unclassified information policy
organizational uncontrolled unclassified information policy
personal de-identified information policy
personal limited data set information policy
personal non-sensitive information policy
comply with controlled unclassified information policy
comply with jurisdictional security policy