You are using an unsupported browser. Background and more details are available in the 702 (a) and 702 (b) (1) (A) ), the Maternal and Child Health (MCH) Federal Set-Aside project grant programs. (b) Notice not required. This restriction includes, but is not limited to, any disclosure of patient identifying information to the parent or guardian of a minor patient for the purpose of obtaining financial reimbursement. The proceeding may include an examination by the judge of the patient records referred to in the application. (2) Give to the patient a summary in writing of the federal law and regulations. will also bring you to search results. (i) Third-party payers, administrative entities, and others. SUBPART - Subpart CDisclosures With Patient Consent - GovRegs FAR). (1) Who is a patient or employee of a part 2 program or who becomes a patient or employee of a part 2 program at the request of a law enforcement agency or official; and. (a) Restrictions on disclosure. 290dd-3 and 42 U.S.C. At the time of admission to a part 2 program or, in the case that a patient does not have capacity upon admission to understand his or her medical status, as soon thereafter as the patient attains such capacity, each part 2 program shall: (1) Communicate to the patient that federal law and regulations protect the confidentiality of substance use disorder patient records; and Organization and Purpose Under 42 CFR Part 2 (hereafter referred to as "Part 2"), a patient can revoke consent to one or more parties named in a multi-party consent form while leaving the rest of the consent in effect. Under the 42 CFR Part 2 regulations, before information relating to a substance use disorder treatment program can be shared, consent must be obtained from the patient in writing, except in limited circumstances. A1. This document is available in the following developer friendly formats: Information and documentation can be found in our Statutory authority for confidentiality of substance use disorder patient records. Treating provider relationship means that, regardless of whether there has been an actual in-person encounter: (1) A patient is, agrees to, or is legally required to be diagnosed, evaluated, and/or treated, or agrees to accept consultation, for any condition by an individual or entity, and; (2) The individual or entity undertakes or agrees to undertake diagnosis, evaluation, and/or treatment of the patient, or consultation with the patient, for any condition. Pursuant to 42 U.S.C. Title 42 was last amended 6/13/2023. It is not an official legal edition of the CFR. contact the publishing agency. An application must use a fictitious name such as John Doe, to refer to any patient and may not contain or otherwise disclose patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny. 49 CFR 172.101 (C) Individuals or entities who receive patient records directly from a part 2 program or other lawful holder of patient identifying information and who are notified of the prohibition on re-disclosure in accordance with 2.32. Eased the requirement for patient record disclosures to allow patients to designate entities as recipients as well as individuals. Search & Navigation This document is available in the following developer friendly formats: Information and documentation can be found in our Subpart CDisclosures With Patient Consent. PART 2CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS. (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 2.14; or, when required for a patient who is incompetent or deceased, the signature of an individual authorized to sign under 2.15. However, no state law may either authorize or compel any disclosure prohibited by the regulations in this part. However, the regulations in this part would not apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary function of such personnel is the provision of substance use disorder diagnosis, treatment, or referral for treatment and they are identified as providing such services or the emergency room has promoted itself to the community as a provider of such services. The Federal Statutes 42 CFR Part 2 will be discussed with emphasis on confidentiality and consent to disclose information, . We recommend you directly contact the agency associated with the content in question. Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients. The patient has signed a written consent meeting the requirements of 2.31 (except paragraph (a)(6) . formatting. Thus, it is possible for an individual patient to benefit from federal support and not be covered by the confidentiality regulations because the program in which the patient is enrolled is not federally assisted as defined in paragraph (b) of this section. (2) There is a reasonable likelihood that the records will disclose information of substantial value in the investigation or prosecution. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. A general authorization for the release of medical or other information is NOT sufficient for this purpose (see 2.31). eCFR :: 42 CFR Part 2 Subpart A -- Introduction The part 2 program director must be given adequate notice of the application and an opportunity to appear and be heard (for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order in accordance with 2.67(c)), unless the application asserts that: (1) The part 2 program director is involved in the suspected criminal activities to be investigated by the undercover agent or informant; or. Organization and Purpose (ii) If necessary, will resist in judicial proceedings any efforts to obtain access to patient identifying information related to substance use disorder diagnosis, treatment, or referral for treatment except as permitted by the regulations in this part. (a) Required elements for written consent. An order authorizing the disclosure of patient records for purposes other than criminal investigation or prosecution may be applied for by any person having a legally recognized interest in the disclosure which is sought. user convenience only and is not intended to alter agency intent The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. (b) If a patient consents to a disclosure of their records under 2.31 for payment or health care operations activities, a lawful holder who receives such records under the terms of the written consent may further disclose those records as may be necessary for its contractors, subcontractors, or legal representatives to carry out payment and/or health care operations on behalf of such lawful holder. (2) The minor applicant's situation poses a substantial threat to the life or physical well-being of the minor applicant or any other individual which may be reduced by communicating relevant facts to the minor's parent, guardian, or other individual authorized under state law to act in the minor's behalf. Confidentiality of Substance Use Disorder Patient Records If you work for a Federal agency, use this drafting The part 2 program is not required to obtain a patient's written consent or other authorization under the regulations in this part in order to provide such access to the patient. Notwithstanding paragraph (a)(4)(i) of this section, if the recipient entity facilitates the exchange of health information or is a research institution, a written consent must include the name(s) of the entity(-ies) and, (A) The name(s) of individual or entity participant(s); or. will bring you directly to the content. Regulation Y The name(s) of the individual(s) or the name(s) of the entity(-ies) to which a disclosure is to be made. Navigate by entering citations or phrases eCFR :: 42 CFR 435.2 -- Purpose and applicability. In making any such disclosures, the lawful holder must furnish such recipients with the notice required under 2.32; require such recipients to implement appropriate safeguards to prevent unauthorized uses and disclosures; and require such recipients to report any unauthorized uses, disclosures, or breaches of patient identifying information to the lawful holder. 2.35 Disclosures to elements of the criminal justice system which have referred patients. 2.21 Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity. No information obtained by an undercover agent or informant, whether or not that undercover agent or informant is placed in a part 2 program pursuant to an authorizing court order, may be used to criminally investigate or prosecute any patient. [82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43037, July 15, 2020]. (d) Criteria for entry of order. An order under this section may be entered only if the court determines that good cause exists. (vi) As soon as practicable after the end of the required retention period specified on the label, the portable electronic device or the original and backup electronic media must be sanitized to render the patient identifying information non-retrievable consistent with the policies established under 2.16. An order authorizing the disclosure or use of patient records to investigate or prosecute a patient in connection with a criminal proceeding may be applied for by the person holding the records or by any law enforcement or prosecutorial officials who are responsible for conducting investigative or prosecutorial activities with respect to the enforcement of criminal laws. However, a court order under 2.66 may authorize disclosure and use of records to investigate or prosecute qualified personnel holding the records. (b) Notice and hearing. (2) The part 2 program or other lawful holder of part 2 data is a HIPAA covered entity or business associate, and the disclosure is made in accordance with the HIPAA Privacy Rule requirements at 45 CFR 164.512(i). Government Policy and OFR Procedures. (3) Because there is a criminal penalty for violating the regulations, they are to be construed strictly in favor of the potential violator in the same manner as a criminal statute (see M. Kraus & Brothers v. United States, 327 U.S. 614, 62122, 66 S. Ct. 705, 70708 (1946)). 290dd -2 (g), the regulations in this part impose restrictions upon the disclosure and use of substance use disorder patient records which are maintained in connection with the performance of any part 2 program. (b) Any individual or entity conducting scientific research using patient identifying information obtained under paragraph (a) of this section: (1) Is fully bound by the regulations in this part and, if necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by the regulations in this part. site when drafting amendatory language for Federal regulations: 2.23 Patient access and restrictions on use. When, for the purpose of preventing multiple program enrollments or duplicative prescriptions, or to inform prescriber decision making regarding prescribing of opioid medication(s) or other prescribed substances, a provider with a treating provider relationship that is not a member program asks a central registry if an identified patient is enrolled in a member program, the registry may disclose: (1) The name, address, and telephone number of the member program(s) in which the patient is enrolled; (2) Type and dosage of any medication for substance use disorder being administered or prescribed to the patient by the member program(s); and. (d) List of disclosures. This is an automated process for (a) General. This is an automated process for Restrictions on the use of identification cards. (a) General rule. (5) Crimes on part 2 program premises or against part 2 program personnel. 872(c) and the implementing regulations at 21 CFR part 1316); or section 301(d) of the Public Health Service Act (42 U.S.C. Use the navigation links in the gray bar above to view the table of contents that this content belongs to. (3) The disclosure is made with the patient's written consent meeting the requirements of 2.31, except that: (i) The consent must list the name and address of each central registry and each known withdrawal management or maintenance treatment program to which a disclosure will be made; and. If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency. (iv) Any combination of a HIPAA covered entity or business associate, and/or subject to the HHS regulations regarding the protection of human subjects, and/or subject to the FDA regulations regarding the protection of human subjects; and has met the requirements of paragraph (a)(1)(i), (ii) (iii), and/or (iv) of this section, as applicable. Substance use disorder means a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues using the substance despite significant substance-related problems such as impaired control, social impairment, risky use, and pharmacological tolerance and withdrawal. In this written summary, the part 2 program also may include information concerning state law and any of the part 2 program's policies that are not inconsistent with state and federal law on the subject of confidentiality of substance use disorder patient records. Navigate by entering citations or phrases They are intended to ensure that a patient receiving treatment for a substance use disorder in a part 2 program is not made more vulnerable by reason of the availability of their patient record than an individual with a substance use disorder who does not seek treatment. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. Those records are governed by 38 U.S.C. (eg: Procedures and criteria for orders authorizing disclosures for noncriminal purposes. Unless an order under 2.66 is sought in addition to an order under this section, the person holding the records must be provided: (1) Adequate notice (in a manner which will not disclose patient identifying information to other persons) of an application by a law enforcement agency or official; (2) An opportunity to appear and be heard for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order as described in 2.65(d); and.
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