One aspect of the Data Segmentation for Privacy (DS4P) is the patient consent for a provider to "share all" or "part" of their medical information with another provider. This consent is required for situations where: 1) the patient is being treated by a federal funded substance abuse provider, or 2) is receiving treatment as a veteran. While there are two separate regulations governing the privacy: 42 CFR Part II for Substance Abuse Patients, and 38 CFR Part I for patients that are veterans... the 9 data elements required are effectively identical.
In the table below, you will find the 9 data elements identified by the DS4P use cases that require patient consent. Furthermore, you will find that they are equally represented in both regulations.
#
|
Data Element
|
Definition
|
42 CFR Part 2
|
38 CFR Part 1
|
1
|
Requester Name
|
The name or title of the individual or the name
of the organization to which disclosure is to be made.
|
X
|
X
|
2
|
Allowed Purpose(s)
|
The purpose of the disclosure.
|
X
|
X
|
3
|
Information
to be disclosed (i.e. Patient
Data)
|
How
much and what kind of information is to be disclosed.
“The response to the Query for Patient Data
Location transaction MUST contain only elements that the receiving system
user has the appropriate permissions to access.”
|
X
|
X
|
4
|
Consent Directive Effective Date/Time
|
The date on which the consent is signed.
|
X
|
X
|
5
|
Consent Directive Expiration Date/Time
|
The date, event, or condition upon which the
consent will expire if not revoked before. This date, event, or condition
must insure that the consent will last no longer than reasonably necessary to
serve the purpose for which it is given.
|
X
|
X
|
6
|
Obligation Text
|
A statement that the consent is subject to
revocation at any time except to the extent that the program or person which
is 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.
|
X
|
X
|
7
|
Patient/Subject
|
The name of the patient.
|
X
|
X
|
8
|
Signature
|
The signature of the patient and, when required
for a patient who is a minor, the signature of a person authorized to give
consent under § 2.14; or, when required for a patient who is incompetent
or deceased, the signature of a person authorized to sign under § 2.15
in lieu of the patient.
|
X
|
X
|
9
|
Consent Originator Organization
|
The specific name or general designation of the
program or person permitted to make the disclosure.
|
X
|
X
|
For those with interest in reading the regulation for yourselves you can either read below or click on the hyperlinks and read directly from the code or federal regulations.
38 CFR Part I
§ 1.475 Form of written consent.
(a) Required elements. A written consent to a disclosure under §§ 1.460 through 1.499 of this part must include:
(1) The name of the facility permitted to make the disclosure (such a designation does not preclude the release of records from other VA health care facilities unless a restriction is stated on the consent).
(2) The name or title of the individual or the name of the organization to which disclosure is to be made.
(3) The name of the patient.
(4) The purpose of the disclosure.
(5) How much and what kind of information is to be disclosed.
(6) The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under § 1.464 of this part; or, when required for a patient who is incompetent or deceased, the signature of a person authorized to sign under § 1.465 of this part in lieu of the patient.
(7) The date on which the consent is signed.
(8) A statement that the consent is subject to revocation at any time except to the extent that the facility which is 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.
(9) 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 given.
(b) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through a reasonable effort could be known, by responsible personnel of VA to be materially false.
(c) Notification of deficient consent. Other than the patient, no person or entity may be advised that a special consent is required in order to disclose information relating to an individual participating in a drug abuse, alcoholism or alcohol abuse, HIV, or sickle cell anemia program or activity. Where a person or entity presents VA with an insufficient written consent for information protected by 38 U.S.C. 7332, VA must, in the process of obtaining a legally sufficient consent, correspond only with the patient whose records are involved, or the legal guardian of an incompetent patient or next of kin of a deceased patient, and not with any other person.
(d) It is not necessary to use any particular form to establish a consent referred to in paragraph (a) of this section, however, VA Form 10-5345, titled Request for and Consent to Release of Medical Records Protected by 38 U.S.C. 7332, may be used for such purpose.
(Authority: 38 U.S.C. 7332(a)(2) and (b)(1))
§ 2.31 Form of written consent.
(a) Required elements. A written consent to a disclosure under these regulations must include:
(1) The specific name or general designation of the program or person permitted to make the disclosure.
(2) The name or title of the individual or the name of the organization to which disclosure is to be made.
(3) The name of the patient.
(4) The purpose of the disclosure.
(5) How much and what kind of information is to be disclosed.
(6) The signature of the patient and, when required for a patient who is a minor, the signature of a person authorized to give consent under § 2.14; or, when required for a patient who is incompetent or deceased, the signature of a person authorized to sign under § 2.15 in lieu of the patient.
(7) The date on which the consent is signed.
(8) A statement that the consent is subject to revocation at any time except to the extent that the program or person which is 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.
(9) The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must insure that the consent will last no longer than reasonably necessary to serve the purpose for which it is given.
(b) Sample consent form. The following form complies with paragraph (a) of this section, but other elements may be added.
1. I (name of patient) □ Request □ Authorize:
2. (name or general designation of program which is to make the disclosure)
3. To disclose: (kind and amount of information to be disclosed)
4. To: (name or title of the person or organization to which disclosure is to be made)
5. For (purpose of the disclosure)
6. Date (on which this consent is signed)
7. Signature of patient
8. Signature of parent or guardian (where required)
9. Signature of person authorized to sign in lieu of the patient (where required)
10. This consent is subject to revocation at any time except to the extent that the program which is to make the disclosure has already taken action in reliance on it. If not previously revoked, this consent will terminate upon: (specific date, event, or condition)
(c) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through a reasonable effort could be known, by the person holding the records to be materially false.
(Approved by the Office of Management and Budget under control number 0930-0099)
