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Complete Overview of Regulations: 42 CFR Part 2
Written Consent: Required Elements

 

a.) Required Elements

There are nine required elements of a written consent to a disclosure, which are:

  1. The name/general designation of the program/person permitted to make the disclosure.68
  2. The name/title of the individual or the organization to which disclosure is to be made.69
  3. The name of the patient.70
  4. The purpose of the disclosure.71
  5. How much and what kind of information is to be disclosed.72
  6. The signature of the patient and/or the patient’s authorized representative, as required.73
  7. The date on which the consent is signed.74
  8. A statement that the consent may be revoked at any time except where the entity originally permitted to make the disclosure has already acted in reliance on the consent.75

The date, event, or condition that the consent will expire, which must insure that consent only lasts as long as reasonably necessary to accomplish the purpose of the disclosure.76

 

Footnotes

  • 68. 42 CFR § 2.31(a)(1).
  • 69. 42 CFR § 2.31(a)(2).
  • 70. 42 CFR § 2.31(a)(3).
  • 71. 42 CFR § 2.31(a)(4).
  • 72. 42 CFR § 2.31(a)(5).
  • 73. 42 CFR § 2.31(a)(6).
  • 74. 42 CFR § 2.31(a)(7).
  • 75. 42 CFR § 2.31(a)(8).
  • 76. 42 CFR § 2.31(a)(9).