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Complete Overview of Regulations: 42 CFR Part 2

Topics: 
Care Coordination/Care Management
Federal and State Program Integrity
Medical Records Collection, Retention, and Access
Medicare Data Requirements
Privacy and Confidentiality
Quality Measurement and Reporting
Research
Security of Health Information

42 CFR 2 Part 2 (“Part 2”): Confidentiality of Alcohol and Drug Abuse Patient Records

In 1970, Congress passed the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act,1 part of which contained general rules establishing the confidentiality of alcohol abuse patient records.2 Congress subsequently passed the Drug Abuse Prevention, Treatment, and Rehabilitation Act in 1972,3 a law with identical confidentiality provisions applicable to drug abuse patient records.4 Both Acts authorized the Secretary of Health and Human Services to develop regulations restricting the disclosure and use of substance abuse patient records.5 In 1987, the Secretary issued such regulations,6 commonly referred to as “Part 2,” describing the ­­­circumstances in which information about a substance abuse patient’s treatment may be disclosed and used with and without the patient’s consent.

These Acts and the Part 2 regulations limit the availability of substance abuse records to insure that individuals in a treatment program are not more vulnerable with respect to their privacy than those who do not seek treatment.7 Covered information may only be disclosed or used as permitted by these regulations, and may not otherwise be disclosed or used in any civil, criminal, administrative, or legislative proceeding conducted by any federal, state, or local authority.8

1.) Applicability of the Part 2 Regulations

c.) Individuals Protected by Part 2

d.) Information Covered by Part 2

2.) Part 2 Restrictions

a.) Disclosure

b.) Use

c.) Other Requirements

3.) Regulations Do Not Apply

There are certain situations when substance abuse patient information can be disclosed or used without the patient’s written consent, which are discussed in more detail below in section 4. There are also seven circumstances in which some or all of the regulations do not apply, which are:

a.) Veteran’s Administration

b.) Armed Forces

c.) Program Communications

d.) Qualified Service Organizations

e.) Crimes

f.) Child Abuse and Neglect Reporting

g.) Vital Statistics

4.) Written Consent

If a patient consents to a disclosure of his/her records, a program may disclose those records in accordance with that consent to any named individual or organization. Disclosures to central registries and in connection with criminal justice referrals must meet different requirements, discussed below in Section 4(d)(4).

a.) Required Elements

b.) Consent Invalid

c.) Notification of the Restriction on Re-Disclosure

d.) Special Consent Circumstances

5.) Special Research Protections

6.) Patient Rights

7.) Disclosures without Patient Consent

a.) Medical Emergencies

b.) Research Activities

c.) Audit and Evaluation Activities

d.) Certain Minors

e.) Certain Incompetent Patients

8.) Court Orders Authorizing Disclosure and Use

A court order may authorize a disclosure or use of patient information that would other be prohibited by Part 2, but may not compel such disclosure. To compel disclosure of substance abuse records, a subpoena or similar legal mandate must also be issued. Entities holding substance abuse records that are subject to Part 2 may only disclose those records if an authorizing court order has been entered, even if a subpoena compelling their disclosure has been entered;conversely, if an authorizing court order has been entered, the entity may refuse to disclose the records unless a valid subpoena is also entered. If both an authorizing court order and a valid subpoena compelling disclosure have been entered, the entity authorized to disclose must do so, unless there is a valid legal defense other than the Part 2 confidentiality restrictions.

A court order may not authorize personnel who received patient identifying information without a patient’s consent to conduct research, an audit, or evaluation to re-disclose that information or use it to conduct any criminal investigation or prosecution of a patient.However, a court order may authorize disclosure and use of records to investigate or prosecute qualified personnel holding the records, as discussed below in Section 8(c).
 
A court order may authorize one of three things:

a.) Disclosure of Confidential Communications

b.) Use of Undercover Agents & Informants to Criminally Investigate a Program’s Employees or Agents

c.) Court Orders Authorizing Disclosure and Use of Records

 


Current View

Footnotes

  • 1.  42 U.S.C. §§ 4541, et seq. (2013).
  • 2.  42 U.S.C. § 4582, as amended and transferred to the Public Health Service Act § 523, codified at 42 U.S.C. § 290dd-3 (2013).
  • 3.  21 U.S.C. §§ 1101, et seq. (2013).
  • 4.  21 U.S.C. § 1175, as amended and transferred to the Public Health Service Act § 527, codified at 42 U.S.C. § 290ee-3 (2013).
  • 5.  42 U.S.C. § 290dd-3(g), as amended (alcohol abuse records) and § 290ee-3(g), as amended (drug abuse records).
  • 6.  52 Fed. Reg. 21809 (June 9, 1987), codified at 42 C.F.R. §§ 2.1, et seq. (2013).
  • 7.  42 CFR § 2.3(b)(2).
  • 8.  42 CFR § 2.13(a).