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CON - Consent Segment

This segment identifies patient consent information relating to a particular message. It can be used as part of existing messages to convey information about patient consent to procedures, admissions, information release/exchange or other events discussed by the message. It may also be used in messages focusing on recording or requesting consent and for consents related to employees or service providers.

The segment will be used in conjunction with various other segments to identify the practitioner (PRA/STF) or patient (PID) the consent is for, the various individuals involved in the consent (ROL) as witnesses, consenting person (not always the patient), translators, consulting providers, etc., and the specific procedures being proposed (PR1).

HL7 Attribute Table - CON - Consent Segment
Seq# Data Element Name DataType Usage Vocabulary Cardinality Item # Length C.LEN Flags
CON
1 Set ID - CON SI R [1..1] 01776 [1..4]
2 Consent Type CWE O [0..1] 01777
3 Consent Form ID and Version ST O [0..1] 01778
4 Consent Form Number EI O [0..1] 01779
5 Consent Text FT O [0..*] 01780
6 Subject-specific Consent Text FT O [0..*] 01781
7 Consent Background Information FT O [0..*] 01782
8 Subject-specific Consent Background Text FT O [0..*] 01783
9 Consenter-imposed limitations FT O [0..*] 01784
10 Consent Mode CNE O [0..1] 01785
11 Consent Status CNE R [1..1] 01786
12 Consent Discussion Date/Time DTM O [0..1] 01787
13 Consent Decision Date/Time DTM O [0..1] 01788
14 Consent Effective Date/Time DTM O [0..1] 01789
15 Consent End Date/Time DTM O [0..1] 01790
16 Subject Competence Indicator ID O [0..1] 01791 [1..1]
17 Translator Assistance Indicator ID O [0..1] 01792 [1..1]
18 Language Translated To CWE O [0..1] 01793
19 Informational Material Supplied Indicator ID O [0..1] 01794 [1..1]
20 Consent Bypass Reason CWE O [0..1] 01795
21 Consent Disclosure Level ID O [0..1] 01796 [1..1]
22 Consent Non-disclosure Reason CWE O [0..1] 01797
23 Non-subject Consenter Reason CWE O [0..1] 01798
24 Consenter ID XPN R [1..*] 01909
25 Relationship to Subject CWE R [1..*] 01898

CON-1: Set ID - CON (SI) 01776

Definition: This field contains the number that identifies this segment instance within the message. For the first occurrence of the segment, the sequence number shall be one; for the second occurrence, the sequence number shall be two; etc.

CON-2: Consent Type (CWE) 01777

Definition: This field describes what the subject is consenting to, i.e., what type of service, surgical procedure, information access/release or other event. For values see User-Defined Table 0496 – Consent Type.

CON-3: Consent Form ID and Version (ST) 01778

Definition: Identifies a specific version of a consent form used to record the consent. A given version of a consent form implies a particular set of wording that appears on the form.

CON-4: Consent Form Number (EI) 01779

Definition: Uniquely identifies a specific recorded consent. This may be the number assigned to an electronic consent, or may be the number on a printed consent form.

CON-5: Consent Text (FT) 01780

Definition: Describes the specific procedures/information releases/events the subject is consenting to.

CON-6: Subject-specific Consent Text (FT) 01781

Definition: Describes any additions or variations to the standard procedures/information releases/events from a standard consent that are applicable to the subject whose consent is sought.

CON-7: Consent Background Information (FT) 01782

Definition: Describes any additional information relating to the procedure/information release/event that needs to be understood by the subject for informed consent. May include the reason for the service, the expected benefit, risks, etc.

CON-8: Subject-specific Consent Background Text (FT) 01783

Definition: Describes any additions or variations to the standard additional information that needs to be understood by the patient for informed consent. May include a description of benefits and risks that are specific to the subject from whom consent is sought. May also include an indication that there are no subject-specific risks/benefits.

CON-9: Consenter-imposed limitations (FT) 01784

Definition: Describes any restrictions or limitations placed on their consent by the subject.

CON-10: Consent Mode (CNE) 01785

Definition: The method in which a subject provides consent. For values see HL7 Table 0497 – Consent Mode.

CON-11: Consent Status (CNE) 01786

Definition: Indicates whether consent has been sought and granted. For values see HL7 Table 0498 – Consent Status.

CON-12: Consent Discussion Date/Time (DTM) 01787

Definition: Identifies the time when consent was discussed with the subject. This should only be specified if this differs from the time the consent decision is made.

CON-13: Consent Decision Date/Time (DTM) 01788

Definition: Identifies the time when the decision to grant/refuse consent was made. In the case of written consent, this is the time the consent form is signed.

CON-14: Consent Effective Date/Time (DTM) 01789

Definition: The time the consent becomes/became effective. This only needs to be specified if the time differs from the Consent Decision Date/Time

CON-15: Consent End Date/Time (DTM) 01790

Definition: The time the consent becomes ineffective. If not specified, the consent is assumed to be indefinite. For consents relating to information release, the end date/time is the date by which the released information must be returned/destroyed.

CON-16: Subject Competence Indicator (ID) 01791

Definition: Identifies whether the subject was deemed competent to provide consent. Refer to table HL7 Table 0136 – Yes/No Indicator.

CON-17: Translator Assistance Indicator (ID) 01792

Definition: Identifies whether translation was (or will be) required to obtain informed consent from the subject. Refer to table HL7 Table 0136 – Yes/No Indicator.

CON-18: Language Translated To (CWE) 01793

Definition: Identifies the language the consent material must be translated to. Refer to User Defined table 0296 – Primary Language which contains no suggested values. This table may be populated with values similar to those that may be found in ISO table 639 – Language Codes.

CON-19: Informational Material Supplied Indicator (ID) 01794

Definition: Identifies whether additional educational or reference material was provided to the subject as part of the consent process. Refer to table HL7 Table 0136 – Yes/No Indicator.

CON-20: Consent Bypass Reason (CWE) 01795

Definition: Identifies why the subject's consent was not sought. This field must be populated when CON-11 - Consent Status is B – Bypassed. Refer to User Defined table 0499 – Consent Bypass Reason for suggested values.

CON-21: Consent Disclosure Level (ID) 01796

Definition: Identifies how much information was disclosed to the subject as part of the informed consent process. Refer to table HL7 Table 0500 – Consent Disclosure Level.

CON-22: Consent Non-disclosure Reason (CWE) 01797

Definition: Identifies why the subject did not receive full disclosure. . Refer to User-Defined Table 0501 – Consent Non-Disclosure Reason for suggested values.

CON-23: Non-subject Consenter Reason (CWE) 01798

Definition: Identifies why consent was granted by a person other than the subject of the consent. Refer to User-defined Table 0502 – Non-Subject Consenter Reason for suggested values.

CON-24: Consenter ID (XPN) 01909

Definition: Identification of the individual(s) who is (are) consenting.

CON-25: Relationship to Subject (CWE) 01898

Definition: Identification of the relationship of the consenter to the subject. Receivers are required to inspect the Coding System component of the CWE data type to accurately interpret the meaning of the code. Senders transmitting messages to Receivers on earlier version of the standard may elect to negotiate business rules to ensure that expected data is not lost. HL7 does not assign positional meaning to user-defined codes. Refer to User-Defined Table 0548 – Signatory's Relationship to Subject for suggested values.