Source: http://www.omh.ny.gov/omhweb/hipaa/preemption_html/MHLARTICLEFederalLaw.htm
Timestamp: 2013-05-23 23:31:21
Document Index: 489919660

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What's New New York State Office of Mental Health HIPAA Preemption Analysis Federal Law
HIPAA Regulation Compatability Analysis Federal Protection and Advocacy for the Mentally ill:
A system established in a State under section 10803 of this title to protect and advocate the rights of individuals with mental illness shall….(4) in accordance with section 10806 of this title, have access to all records of…(A) any individual who is a client of the system if such individual, or the legal guardian, conservator, or other legal representative of such individual, has authorized the system to have such access; (B) any individual(including an individual whose whereabouts are unknown) (i) who, by reason of the mental or physical condition of such individual is unable to authorize the system to have such access; (ii) who does not have a legal guardian, conservator, or other legal representative, or for whom the legal guardian is the State; and (iii) with respect to whom a complaint has been received by the system or with respect to whom as a result of monitoring or other activities…there is probable cause to believe that such individual has been subject to abuse or neglect; and (C) any individual with a mental illness, who has a legal guardian, conservator, or other legal representative, with respect to whom a complaint has been received bv the system or with respect to whom there is probable cause to believe the health or safety of the individual is in serious and immediate jeopardy, whenever (i) such representative has been contacted by such system upon receipt of the name and address of the representative; (ii) such system has offered assistance to such representative to resolve the situation; and (iii) such representative has failed or refused to act on behalf of the individual. §164.502(a)(1): A covered entity is permitted to use/disclose PHI to the patient (including a patient's personal representative, i.e., someone authorized to act on patient's behalf to make health care decisions).
§164.512(j): A covered entity may, consistent with applicable law and standards of ethical conduct, use/disclose PHI if it believes, in good faith, that the use/disclosure (i)(A) is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and (B) is to a person(s) reasonably able to prevent/lessen the threat. The two sets of federal regulations appear similar, in that disclosures to PAMI systems are not permitted unless the patient has authorized the disclosure, or in instances involving abuse that are accommodated in HIPAA; however, HIPAA should be followed to ensure requisite attempts to notify the individual are made. 42 CFR PART 2: Confidentiality of Alcohol and Drug Abuse Patient Records
§2.4 Criminal penalty for violation. Under 42 USC 290ee-3(f) and 42 USC 290-dd3(f), any person who violates any provision of those statutes or these regulations shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense. §160.312(a)(2): If a covered entity fails to adhere to the privacy regulations, it is subject to civil/criminal penalties initiated by HHS. Non-compliant entities are subject to civil monetary penalties ranging from $100 to $25,000, depending on the extent of non-compliance. Misdemeanor or felony criminal penalties apply if a covered entity wrongfully/knowingly discloses PHI in violation of HIPAA. Criminal violations are punishable by fines up to $250,000 or imprisonment (a maximum of 10 years) or both.
HIPAA penalties are more severe than those under 42 CFR Part 2; it is unclear which penalties would apply to a program covered by both in the event of an unauthorized use/disclosure of PHI, but may be fact dependent. §2.11 Definitions
Patient identifying information: means the name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient can be determined with reasonable accuracy and speed either directly or by reference to other publicly available information. The term does not include a number assigned to a patient by a program, if that number does not consist of, or contain numbers (such as a social security, or driver's license number) which could be used to identify a patient with reasonable accuracy and speed from sources external to the program. Record means any information, whether recorded or not, relating to a patient received or acquired by a federally assisted alcohol or drug program.
§160.103: Health Information means any information, whether oral or recorded in any medium, that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual. §160.103: Individually identifiable health information: is information that is a subset of health information, including demographic information collected from an individual, and: (1) is created or received by a health care provider, health plan, emploher, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) that identifies the individual; or (ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual. §160.103: Protected health information: is individually identifiable health information that is transmitted or maintained in any medium. §164.514(b): Requirements for de-identification of PHI: (2)(i): [Information is considered de-identifying if] …the following identifiersare removed: (A) Names; (B) all geographic subdivisions smaller than a State…; (C)all elements of dates, except year for dates directly related to an individual..;(D) telephone #s; (E)fax #s; (F) e-mail addresses; (G) SS#s; (H) medical record #s; (I) health plan beneficiary #s; (J) account #s; (K) certificate/license #s; (L)vehicle identifiers and serial #s…; (M)device identifers and serial #s; (N)URLs; (O) IP address #s; (P)biometric identifers; (Q) full face photographic images and any comparable images; and (R) any other unique identifying #, characteristic or code; and (ii) the covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is the subject of the information. 1. HIPAA broadly applies to "covered entities;" 42 CFR Part 2 applies to "federally assisted alcohol/drug program." Hence, unless a covered entity is also a federally assisted alcohol/drug program, it is not bound by 42 CFR Part 2. A federally assisted alcohol/drug program that is also a covered entity is bound both by HIPAA and 42 CFR Part 2.
2. The HIPAA definition of "protected health information" covers a wider scope of information than does 42 CFR Part 2. Hence, the HIPAA definition of PHI preempts the definition of "patient identifying information" in 42 CFR Part 2. §2.11 Definitions Patient means any individual who has applied for or been given diagnosis or treatment for alcohol/drug abuse at a federally assisted program and includes any individual who, after arrest on a criminal charge, is identified as an alcohol/drug abuser in order to determine that person's eligibility to participate in a program.
§164.502(g):A "personal representative" can fulfill the role of the individual about whom PHI pertains if the representative has authority to act on behalf of the individual in making decisions about health care. 1. The definitions of "patient" and "individual" are similar; although in some respects the 42 CFR Part 2 definition is more broad; therefore, a provider covered by both should follow the 42 CFR Part 2 definition.
2. Both regulations permit "personal representatives" to stand in the patient's shoes with regard to consenting for the use/disclosure of health information. However, the HIPAA definition is more narrow in that it defines a "personal representatives" as a person who has authority to act on behalf of the individual in making decisions about health care. 42 CFR Part 2 would permit a person with power of attorney over fiscal affairs (i.e., he/she is authorized under law to act in the patient's behalf, albeit in limited regard) to provide such consent. Therefore, the HIPAA definition of "personal representative" is more stringent than 42 CFR Part 2 and controls. §2.11 Definitions Qualified Service organization: means a person which: (a) provides services to a program, such as data processing, bill collecting, dosage preparation, laboratory analyses, or legal, medical, accounting or other professional services, or services to prevent or treat child abuse or neglect, including training on nutrition and child care and individual and group therapy; and (b) Has entered into a written agreement with a program under which that person: (1) acknowledges that in receiving, storing, processing or otherwise dealing with any patient records from the programs, it is fully bound by 42 CFR Part 2; and (2) if necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as provided by 42 CFR Part 2. §2.12(c)(4): The restrictions on disclosure in these regulations do not apply to communications between a program and a QSOA of information needed by the organization to provide services to the program.
§164.504: Uses & disclosures; organizational requirements (e)(1): Business associate contracts: Business associate contracts must: (1) establish the BA's permitted and required uses and disclosures of PHI; (2) prohibit the BA from using/further disclosing PHI, except as permitted by HIPAA; (3) BA must use appropriate safeguards to prevent unauthorized use/disclosure of the information; (4) BA must report to the covered entity if it becomes aware of any use/disclosure of PHI in violation of the contract; (5) BA must ensure that its agents/subcontractors agree to the same restrictions on use/disclosure of PHI; (6) BA must make PHI available for amendment and incorporate any amendments to PHI; (7) BA's internal practices, books, and records relating to use/disclosure of PHI must be made to the HHS for purposes of determining compliance; (8) at termination of the contract: (a) if feasible, return or destroy all PHI the BA maintains in any form and retain no such copies of such information; (b) or, if return/destruction is not feasible, continue the protections of the contract to the PHI and limit further uses/disclosures to the purposes that make return or destruction of the PHI infeasible; (9) the contract must allow the covered entity to terminate the contract if the covered entity determines that the BA has violated a material term. Preamble: A covered entity may disclose PHI to a business associate, consistent with the other requirements of the final rule, as necessary to permit the business associate to perform functions and activities for or on behalf of the covered entity…..a business associate may only use the PHI it receives in its capacity as a business associate to a covered entity as permitted by its contract or agreement with the covered entity. (p. 82504:2) 1. A "qualified services organization" is a subset of a "business associate;" the HIPAA term "business associate" is more broad than is QSOA. Therefore, programs covered by both HIPAA and 42 CFR Part 2 should follow the definition of "business associate" in making determinations as to entities with which it needs to have formalized agreements. 2. Business Associate agreements under HIPAA have 9 required elements, while QSOAs under 42 CFR Part 2 have only 2. Therefore, programs covered by both will need to ensure all 11 elements are addressed in their formalized agreements. 3. If an entity covered by both HIPAA and 42 CFR has a QSOA relationship, but PHI is not necessarily needed in order to perform that service (which is not a requirement for something to be considered a QSOA) it would not constitute a "business associate" relationship for purposes of HIPAA. Hence, disclosures would not be permitted without patient authorization. In this regard, HIPAA is more stringent than 42 CFR Part 2 and prevails. §2.12(c)(1) Applicability: Veterans Administration: These regulations do not apply to information on alcohol and drug abuse patients maintained in connection with the Veterans Administration provisions of hospital care, nursing home care, domiciliary care, and medical services under title 38, United States Code. Those records are governed by 38 U.S.C. 4132 and regulations issued under that authority by the Administrator of Veterans Affairs. §160.103: Health Information means any information, whether oral or recorded in any medium, that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.
Further analysis is required to determine whether or not the provisions of 38 U.S.C. 4132 and corresponding regulations are equally, or more, stringent than HIPAA. If they are, this provision of 42 CFR Part 2 cannot be followed. If they are not, however, this provision of 42 CFR Part 2 will, in fact, prevail.
§2.12(c)(2) Applicability: Exceptions Armed Forces: These regulations apply to any information which was obtained by any component of the Armed Forces during a period when the patient was subject to the Uniform Code of Military Justice except: (i) any interchange of that information within the Armed Forces; and (ii) any interchange of that information between the Armed Forces and those components of the Veterans Administration furnishing health care to veterans. §160.103: Health Information means any information, whether oral or recorded in any medium, that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.
HIPAA applies to all health information; to the extent 42 CFR Part 2 "carves out" a subset of health information, depending on where/how it was obtained, to which the regulations do not apply, it provides less protection/access to health records than does HIPAA, and programs covered by both sets of regulations should comply with HIPAA in this regard. §2.12(c)(3) Applicability: Exceptions Communication within a program or between a program and an entity having direct administrative control over that program. The restrictions on disclosure in these regulations do not apply to communications of information between or among personnel having a need for the information in connection with their duties that arise out of the provision of diagnosis, treatment, or referral for treatment of alcohol/drug abuse if the communications are (1) within a program; or (2) between a program and an entity that has direct administrative control over the program. §164.502 (b)(2) Minimum necessary does not apply to: (i) disclosures to or requests by a health care provider for treatment…. §164.504 (a) Definitions: Common control exists if an entity has the power, directly or indirectly, significantly to influence or direct the actions or policies of another entity. Common ownership exists if an entity …possesses an ownership or equity interest of 5% or more in another entity.
(d)(1) Affiliated covered entities. Legally separate covered entities that are affiliated may designate themselves as a single covered entity for purposes of this subpart. (2)(i) legally separate covered entities may designate themselves …as a single affiliated covered entity …if all of the covered entities designated are under common ownership or control. Programs covered by both 42 CFR Part 2 and HIPAA should follow 42 CFR Part 2 in regard to intra-program communications; while both rules are similar, 42 CFR Part 2 more strictly defines the concept of an affiliated entity. §2.12(c)(5) Applicability: Crimes on program premises: The restrictions on disclosure and use …do not apply to communications from program personnel to law enforcement officers which (i) are directly related to a patient's commission of a crime on the premises of the program or against program personnel or to a threat to commit such a crime; and (ii) are limited to the circumstances of the incident, including the patient status of the individual committing/threatening to commit the crime, that individual's name and address, and that individual's last known whereabouts. §164.512(f)(5): Crime on program premises. A covered entity may disclose to a law enforcement official PHI that the covered entity believes in good faith constitutes evidence of criminal conduct that occurred on the premises of the covered entity.
Programs covered by both 42 CFR Part 2 and HIPAA should follow 42 CFR Part 2 in regard to reporting crimes on program premises. While the rules are similar, 42 CFR Part 2 contains limitations on the amount of information that can be so disclosed.
§2.12(c)(6) Applicability: Exceptions: Reports of suspected child abuse or neglect. The restrictions on disclosure and use in these regulations do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities. However, the restrictions continue to apply to the original alcohol or drug abuse patient records maintained by the program including their disclosure and use for civil or criminal proceedings which may arise out of the report of suspected child abuse or neglect. §164.512(b): A covered entity may disclose PHI for the public health activities and purposes described in this paragraph to: (ii) a public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect.
Programs covered by both 42 CFR Part 2 and HIPAA should follow 42 CFR Part 2 in regard to child abuse reporting; while both rules are similar, 42 CFR Part 2 reinforces the confidentiality of such records for any purpose beyond the making of the report. §2.12(d) Applicability: Applicability to recipients of information (1) Restriction on use of information. The restriction on the use of any information subject to these regulations to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient applies to any person who obtains that information from a federally assisted alcohol or drug abuse program, regardless of the status of the person obtaining the information or of whether the information was obtained in accordance with these regulations. This restriction on use bars, …the introduction of that information as evidence in a criminal proceeding and any other use of that information to investigate or prosecute a patient with respect to a suspected crime. Information obtained by undercover agents or informants..or through patient access..is subject to the restriction on use. No comparable provision.
Programs covered by both 42 CFR Part 2 and HIPAA should follow this provision of 42 CFR Part 2.
§2.12(e) Explanation of applicability (1) Coverage: These regulations cover any information (including information on referral and intake) about alcohol and drug abuse patients obtained by a program, (a defined term) if the program is federally assisted in any manner (a defined term). Coverage includes, but is not limited to, those treatment or rehabilitation programs, employee assistance programs, programs within general hospitals, school-based programs, and private practitioners who hold themselves out as providing, and do provide, alcohol/drug abuse diagnosis, treatment, or referral for treatment. However, these regulations 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 alcohol/drug abuse diagnosis, treatment or referral and they are identified as providing such services or the emergency room has promoted itself to the community as a provider of such services. §160.103: Health Information means any information, whether oral or recorded in any medium, that: (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.
HIPAA covers a much wider range of providers and information than does 42 C.F.R. Part 2. Programs covered by both 42 CFR Part 2 and HIPAA should continue to follow this provision of 42 CFR Part 2 for guidance as to what information that is under the jurisdiction of such regulation. §2.12(e) Explanation of applicability (2) Federal assistance to program required: If a patient's alcohol/drug abuse diagnosis, treatment, or referral for treatment is not provided by a program which is federally conducted, regulated, or supported in a manner which constitutes federal assistance…..that patient's record is not covered by this regulation…. §160.103: Covered entity means: (1) a health plan; (2) a health care clearinghouse; (3) a health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter. HIPAA covers a much wider range of providers and entities than does 42 C.F.R. Part 2. Programs covered by both 42 CFR Part 2 and HIPAA should continue to follow this provision of 42 CFR Part 2 for guidance as to what providers/entities under the jurisdiction of such regulation. §2.12(e) Explanation of applicability (3) Information to which restrictions are applicable. Whether a restriction is on use/disclosure affects the type of information which may be available (sic). The restrictions on disclosure apply to any information which would identify a patient as an alcohol/drug abuser. The restriction on use of information to bring criminal charges against a patient for a crime applies to any information obtained by the program for the purpose of diagnosis, treatment or referral for treatment of alcohol/drug abuse.
§160.103: Protected health information: is individually identifiable health information that is transmitted or maintained in any medium. Programs covered by both 42 CFR Part 2 and HIPAA should follow this provision of 42 CFR Part 2
§160.103: Protected health information: is individually identifiable health information that is transmitted or maintained in any medium. 42 C.F.R. Part 2 "excepts out" a portion of information that is not given privacy protection under this regulation; HIPAA covers all individually identifiable health information used/disclosed by a covered entity or Business Associate. Programs covered by both must either extend HIPAA coverage to the information excepted out of 42 CFR Part 2 in this provision, or extend the reach of 42 CFR Part 2 to this excepted information. §2.13 Confidentiality restrictions. (a) General. The patient records to which these regulations apply may be disclosed/used only as permitted …and may not otherwise be disclosed/used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority. Any disclosure made under these regulations must be limited to that information which is necessary to carry out the purpose of the disclosure.
§164.502(b) Minimum Necessary: (1)When using or disclosing PHI or when requesting PHI from another covered entity, a covered entity must make reasonable efforts to limit PHI to the minimum necessary to accomplish the purpose of the use, disclosure, or request. (2) This does not apply to: (i) Disclosures to/ requests by a health care provider for treatment; (ii) Uses or disclosures made to the individual, as required by paragraph (a)(2)(i) of this section, or pursuant to an authorization; (iii) Disclosures made to the Secretary of HHS; (iv) Uses or disclosures that are required by law, and (v) Uses or disclosures that are required for compliance with applicable requirements of this Subchapter. (p. 82805,82806) Programs covered by both 42 CFR Part 2 and HIPAA should contined to follow this provision of 42 CFR Part 2, since it is more stringent than HIPAA.
§2.13 Confidentiality restrictions. (b) Unconditional compliance required. The restrictions on disclosure and use in these regulations apply whether the holder of the information believes that the person seeking the information already has it, has other means of obtaining it, is a law enforcement or other official, has obtained a subpoena, or asserts any other justification for a disclosure or use which is not permitted by these regulations. No comparable provision.
§164.508(a)(1): Except as otherwise permitted or required by this subchapter, a covered entity may not use or disclose PHI without an authorization that is valid under this section. (p. 82811:1) Generally, providers covered by both 42 CFR Part 2 and HIPAA should follow the former with regard to these provisions. However, HIPAA supersedes the provision in 42 CFR Part 2 which permits acknowledgment of the presence of an identified patient in a facility or part of a facility if the facility is not publicly identified as only an alcohol/drug abuse program and if the acknowledgment does not reveal that the patient is an alcohol/drug abuser. Under HIPAA, this is not permitted unless the individual has been given an opportunity to agree or object to these disclosures. §2.14 Minor patients. (a) Definition of minor. As used in these regulations the term "minor" means a person who has not attained the age of majority specified in the applicable State law, or if no age of majority is specified in the applicable State law, the age of eighteen years.
Not originally addressed in final rule, but see recent amendments: (8/02) §164.502: (g)(1)(ii) Implementation specification: unemancipated minors…(A).A covered entity may disclose PHI about an unemancipated minor to a parent, guardian, or other person acting in loco parentis if the applicable provision of State law or other law, including applicable case law, permits or requires such disclosure, and (B) a covered entity may not disclose PHI about about an unemancipated minor to a parent, guardian, or other person acting in loco parentis if the applicable provision of State law or other law, including applicable case law, prohibits such disclosure. Regulations are consistent: Inasmuch the adoption of recent amendments to HIPAA defer to State law with regard to parental consent/access to records of minors, and 42 CFR Part 2 essentially does the same, with additional more stringent provisions, 42 CFR and State law (MHL §22.11) control. § 2.15 Incompetent and deceased patients. (a) Incompetent patients other than minors (1) Adjudication of incompetence. In the case of a patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, to manage his or her own affairs, any consent which is required under these regulations may be given by the guardian or other person authorized under State law to act in the patient's behalf.
§164.506(a)(3)(i)(A),(B),(C) : In emergency treatment situations, if the covered health care provider is required by law to treat the individual, or if a covered health care provider is unable to obtain consent due to substantial barriers to communication and the covered health provider determines, in its professional judgment, that the patient's consent is inferred by the circumstances, and the covered health care provider attempts to obtain such consent but is unable to obtain such consent, a covered health care provider may use/disclose PHI to carry out treatment, payment, or health care operations without patient consent. Note: Recent amendments eliminate this requirement.
§164.506(c):(1) A covered entity may use/disclose PHI for its own treatment, payment, or health care operations. (2) A covered entity may disclose PHI for treatment activities of a health care provider. (3) A covered entity may disclose PHI to another covered entity or health care provider for the payment activities of the entity that receives the information…. revised 8/02 §164.512(g): A covered entity may disclose PHI to a coroner or medical examiner for the purpose of identifying a deceased person, determining cause of death, or other duties as authorized by law. (P. 82816: 1)
3. HIPAA and 42 CFR Part 2 are generally consistent with regard to disclosures about decedents for purposes of investigating cause of death; programs covered by both should follow 42 CFR Part 2. It should be noted, however, that HIPAA contains no provisions with regard to who may consent to the release of PHI upon a person's death; therefore, it is not clear if the provisions under 42 CFR Part 2 allowing such consent by an executor, personal representative, spouse or family member are permissible. § 2.16 Security for written records. (a) Written records which are subject to these regulations must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use; and
(b) Each program shall adopt in writing procedures which regulate and control access to and use of written records which are subject to these regulations. §164.530(c)(1): Safeguards: A covered entity must have in place appropriate administrative, technical, and physical safeguards to protect the privacy of PHI.(2) A covered entity must reasonably safeguard PHI from any intentional use/disclosure that is in violation of these standards, implementation specifications, or other requirements of this subpart. The security provisions of 42 CFR Part 2 apply only to written records. Once an entity is covered by HIPAA, the privacy protections apply to records created/stored/transmitted in any medium. Therefore, HIPAA would supersede 42 CFR Part 2 and programs covered by both should comply with the HIPAA safeguard requirements. § 2.17 Undercover agents and informants.
(b) Restriction on use of information. No information obtained by an undercover agent or informant, whether or not that undercover agent or informant is placed in a program pursuant to an authorizing court order, may be used to criminally investigate or prosecute any patient. No comparable provision
Programs covered by both HIPAA and 42 CFR Part 2 are bound by 42 CFR Part 2 with regard to this provision.
No person may require any patient to carry on his or her person while away from the program premises any card or other object which would identify the patient as an alcohol or drug abuser. This section does not prohibit a person from requiring patients to use or carry cards or other identification objects on the premises of a program. No comparable provision
Programs covered by both HIPAA and 42 CFR Part 2 are bound by 42 CFR Part 2 with regard to this provision
§ 2.19 Disposition of records by discontinued programs. (a) General. If a program discontinues operations or is taken over or acquired by another program, it must purge patient identifying information from its records or destroy the records unless--
§2.21 Relationship to Federal statutes protecting research subjects against compulsory disclosure of their identity.(a) Research privilege description. There may be concurrent coverage of patient identifying information by these regulations and by administrative action taken under: Section 303(a) of the Public Health Service Act…and implementing regulations at 42 CFR Part 2a); or section 502(c) of the Controlled Substances Act (21 USC 872(c) and the implementing regulations at 21 CFR 1316.21. These "research privilege" statutes confer on the Secretary of Health and Human Services and on the Attorney General, respectively, the power to authorize researchers conducting certain types of research to withhold from all persons not connected with the research the names and other identifying information concerning individuals who are the subjects of the research.(b) Effect of concurrent coverage. These regulations restrict the disclosure and use of information about patients, while administrative action taken under the research privilege statutes and implementing regulations protects a person engaged in applicable research from being compelled to disclose any identifying characteristics of the individuals who are the subjects of that research. The issuance under Subpart E of these regulations of a court order authorizing a disclosure of information about a patient does not affect an exercise of authority under these research privilege statutes. However, the research privilege granted under 21 CFR 291.505(g) to treatment programs using methadone for maintenance treatment does not protect from compulsory disclosure any information which is permitted to be disclosed under those regulations. Thus, if a court order entered in accordance with Subpart E of these regulations authorizes a methadone maintenance treatment program to disclose certain information about its patients, that program may not invoke the research privilege under 21 CFR 291.505(g)as a defense to a subpoena for that information.
Covered entities subject to these rules are also subject to other statutes and regulations. Thus, covered entities will need to determine how the privacy regulation will affect their ability to comply with these other laws…Ordinarily, later, general statutes will not repeal the special provisions of an earlier, specific statute. In somce cases, when a later, general statute creates an irreconcilable conflict or is manifestly inconsistent with the earlier, specific statute in a manner that represents a clear and manifest Congressional intent to repeal the earlier statute, courts will find that the later statute repeals the earlier statute by implication. In these cases, the latest legislative action may prevail and repeal the prior law, but only to the extent of the conflict. (Preamble, p. 82481) As the federal research statutes identified in 42 CFR Part 2 do not appear inconsistent with, or contrary to the HIPAA privacy regulations, providers subject to both HIPAA and 42 CFR Part 2 should continue to follow this provision. §2.22 Notice to patients of Federal confidentiality requirements.(a) Notice required. At the time of admission or as soon thereafter as the patient is capable of rational communication. each program shall:(1) Communicate to the patient that Federal law and regulations protect the confidentiality of alcohol and drug abuse patient records; and
(d) Sample notice….(is provided) §164.520 Notice of privacy practices for PHI 1. An individual has a right to adequate notice of the uses and disclosures of PHI that may be made by the covered entity, and the individual's rights and the covered entity's legal duties with respect to PHI.
10. Provisions for optional contents are also included. 11. A covered health care provider with a direct treatment relationship with the patient must provide the notice no later than the date of first service delivery, and, except in an emergency situation, make a good faith effort to obtain a written acknowledgment. 12. Whenever the notice is revised, the notice must be made available upon request on or after the effective date of the revision and promptly comply with the acknowledgment requirements.
13. Electronic notice is permitted. It would appear that a program covered by both HIPAA and 42 CFR Part 2 could comply with both provisions; however,extensive revision of the notice required under 42 CFR is required in order to comport with the HIPAA notice requirements. § 2.23 Patient access and restrictions on use.
(b) Restriction on use of information. Information obtained by patient access to his or her patient record is subject to the restriction on use of his information to initiate or substantiate any criminal charges against the patient or to conduct any criminal investigation of the patient as provided for under § 2.12(d)(1).
§164.524(c)(2)(i): The covered entity must provide the individual with access to the PHI in the form or format requested by the individual, if it is readily producible in such form or format; if not, a readable hard copy form or such other form or format as agreed to by the covered entity and the individual. It would appear that a program covered by both HIPAA and 42 CFR Part 2 could comply with both provisions; however, HIPAA provides an articulated right to access while 42 CFR Part 2 simply indicates a program is not prohibited from providing such access. Additional provisions of HIPAA give an individual the right to request access to information in a specific format. Therefore, a program covered by both regulations should refer to both to determine how to respond to requests for access to a record by a patient and to ensure compliance with patient rights under HIPAA. § 2.31 Form of written consent.
§164.506(c): Consent: Content requirements.A consent under this section must be in plain language and: (1) Inform the individual that PHI may be used/disclosed to carry out treatment, payment, and health care operations; (2) refer the individual to the notice required by §164.520 for a more complete description of such uses/disclosures and state that the individual has the right to review the notice prior to signing the consent; (3) if the covered entity has reserved the right to change its privacy practices that are described in the notice in accordance with §164.520(b)(1)(v)(C), state that the terms of its notice may change and describe how the individual may obtain a revised notice; (4) state that: (i) the individual has the right to request that the covered entity restrict how PHI is used/disclosed to carry out treatment, payment, or health care operations; (ii) the covered entity is not required to agree to requested restrictions; and (iii) if the covered entity agrees to a requested restriction, the restriction is binding on the covered entity; (5) state that the individual has the right to revoke the consent in writing, except to the extent the covered entity has acted in reliance on it; and (6) be signed by the individual and dated. ( Note: Recent amendments eliminate this requirement). §164.506(c):(1) A covered entity may use/disclose PHI for its own treatment, payment, or health care operations. (2) A covered entity may disclose PHI for treatment activities of a health care provider. (3) A covered entity may disclose PHI to another covered entity or health care provider for the payment activities of the entity that receives the information…. revised 8/02 §164.508(c): Authorization: Core elements and requirements: A valid authorization under this section must contain at least the following elements: (i) a description of the information to be used/disclosed that identifies the information in a specific and meaningful fashion (ii) the name/other specific identification of the person(s) or class of person authorized to make the requested use/disclosure; (iii) the name/other specific identification of the person(s) or class of persons to whom the covered entity may make the requested use/disclosure; (iv) an expiration date/expiration event that relates to the individual/purpose of use/disclosure; (v) a statement of the individual's right to revoke the authorization in writing and the exceptions to the right to revoke, together with a description of how the individual may revoke the authorization; (vi) a statement that information used/disclosed pursuant to the authorization may be subject to redisclosure by the recipient and no longer be protected by HIPAA; (vii) signature of individual and date; and (viii) if the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual. (2) Required statements. In addition to the core elements, the authorization must contain statements adequate to place the individual on notice of all of the following:
(B) The consequences to the individual of a refusal to sign the authorization when, in accordance with paragraph (b)(4) of this section, the covered entity can condition treatment, enrollment in the health plan, or eligibility for benefits on failure to obtain such authorization. (iii) The potential for information disclosed pursuant to the authorization to be subject to redisclosure by the recipient and no longer be protected by this rule.
(4) Copy to the individual. If a covered entity seeks an authorization from an individual for a use or disclosure of protected health information, the covered entity must provide the individual with a copy of the signed authorization. revised 8/02 With a limited exception, programs covered by both 42 CFR Part 2 and HIPAA should follow 42 CFR Part 2 with regard to form of consent. However, since a "consent" under 42 CFR Part 2 more closely resembles a HIPAA "authorization" than a HIPAA "consent," a program covered by both needs to ensure that its consent form includes all of the elements necessary for a valid HIPAA authorization for all uses/disclosures of PHI for which a patient authorization is needed under HIPAA. A 42 CFR Part 2 "consent" is more stringent than a HIPAA consent, in light of the amount of detail it requires. Furthermore, the "minimum necessary" rule, which does not apply to HIPAA uses/disclosures for payment, and health care operations purposes, continues to apply to all 42 CFR Part 2 uses and disclosures, with no exceptions. Therefore, the "minimum necessary" rule of 42 CFR Part 2 should continue to be applied in all uses/disclosures for which a consent is needed under 42 CFR Part 2 and a consent/authorization is needed under HIPAA.
42 CFR Part 2 does not require any type of consent for use/disclosure of PHI for treatment purposes; this is consistent with the recent amendments to HIPAA. Thus, the two sets of regulations are consistent on this point. § 2.32 Prohibition on redisclosure.
Programs covered by both sets of federal regulations should continue to follow 42 CFR Part 2 with regard to this requirement.
NYS Mental Hygiene Law §19.16 Methadone registry. The office shall establish and maintain, either directly or through contract, a central registry for purposes of preventing multiple enrollment in methadone programs. The office shall require all methadone programs to utilize such registry and shall have the power to assess methadone programs such fees as are necessary and appropriate. §160.203 General rule and exceptions A standard, requirement, or implementation specification adopted under this subchapter that is contrary to a provision of State law preempts the provision of State law . This general rule applies, except if one or more of the following conditions is met: (a) A determination is made by the Secretary under §160.204 that the provision of State law:…(2) Has as its principal purpose the regulation of the manufacture, registration, distribution, dispensing, or other control of any controlled substances (as defined in 21 USC 802), or that is deemed a controlled substance by State law. Although HIPAA appears to require a written determination by the Secretary, it appears likely that reports to the methadone registry will continue to be permitted under HIPAA in accordance with this provision. § 2.35 Disclosures to elements of the criminal justice system which have referred patients. (a) A program may disclose information about a patient to those persons within the criminal justice system which have made participation in the program a condition of the disposition of any criminal proceedings against the patient or of the patient's parole or other release from custody if:
However, under HIPAA, authorizations are revocable by the patient at any time. Compliance with both HIPAA and 42 CFR Part 2 would require providers to utilize consents/authorizations that meet the requirements of both. Therefore, it would appear that criminal justice consents, like any HIPAA consent/authorization, would be revocable by patients at any time. § 2.51 Medical emergencies. (a) General Rule. Under the procedures required by paragraph (c) of this section, patient identifying information may be disclosed to medical personnel who have a need for information about a patient for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention. (b) Special Rule. Patient identifying information may be disclosed to medical personnel of the Food and Drug Administration (FDA) who assert a reason to believe that the health of any individual may be threatened by an error in the manufacture, labeling, or sale of a product under FDA jurisdiction, and that the information will be used for the exclusive purpose of notifying patients or their physicians of potential dangers.
(4) The nature of the emergency (or error, if the report was to FDA). §164.506(a)(3)(i)(A): A covered health care provider may use/disclose PHI without patient consent in emergency treatment situations, if the covered health care provider attempts to obtain consent as soon as reasonably practical after the delivery of treatment.
§164.506(c):(1) A covered entity may use/disclose PHI for its own treatment, payment, or health care operations. (2) A covered entity may disclose PHI for treatment activities of a health care provider. (3) A covered entity may disclose PHI to another covered entity or health care provider for the payment activities of the entity that receives the information…. revised 8/02 §164.512(b): A covered entity may disclose PHI for the public health activities and purposes described in this paragraph to: (ii) a public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect.,,,(iii) a person subject to the jurisdiction of the FDA (A) to report adverse events….
§164.512(j): A covered entity may, consistent with applicable law and standards of ethical conduct, use/disclose PHI if it believes, in good faith, that the use/disclosure (i)(A) is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and (B) is to a person(s) reasonably able to prevent/lessen the threat. In general, programs covered by 42 CFR Part 2 and HIPAA can continue to follow the provisions of 42 CFR Part 2 with regard to disclosures for medical emergencies.
§ 2.52 Research activities. (a) Patient identifying information may be disclosed for the purpose of conducting scientific research if the program director makes a determination that the recipient of the patient identifying information:
(2) Documentation of waiver approval. For a use/disclosure to be permitted,…documentation must include.. Ii) Waiver criteria: A statement that the IRB or privacy board has determined that the alteration or waiver, in whole or in part, of authorization satisfies the following criteria: (A) the use/disclosure of PHI involves no more than minimal risk to the individuals;(B) the alteration/waiver will not adversely affect the privacy rights/welfare of the individuals; (C) the research could not practicably be conducted without the alteration/waiver; (D) the research could not practicably be conducted without access to/use of the PHI; (E) the privacy risks to individuals whose PHI are reasonable in relation to the anticipated benefits if any to the individuals, and the importance of the knowledge that may reasonably be expected to result from the research; (F) there is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and (H there is adequate written assurances that the PHI will not be reused/disclosed to any person/entity except as required by law, for authorized oversight of the research project, or for other research for which the use/disclosure of the PHI would be permitted by this subpart. In this instance, HIPAA is generally more restrictive on use/disclosure of PHI for research purposes. Therefore, programs covered by both 42 CFR Part 2 and HIPAA should refer to HIPAA in determining how to respond to requests for PHI for research purposes. It should be noted, however, the 42 CFR Part 2
§164.512(d) A covered entity may disclose PHI to a health oversight agency for oversight activities authorized by law. §164.506 A covered entity must obtain the consent of a patient to use or disclose PHI for treatment, payment, or health care operations purposes (p.82810:1)
§164.506(c):(1) A covered entity may use/disclose PHI for its own treatment, payment, or health care operations. (2) A covered entity may disclose PHI for treatment activities of a health care provider. (3) A covered entity may disclose PHI to another covered entity or health care provider for the payment activities of the entity that receives the information…. revised 8/02 With regard to audit and evaluation activities, 42 CFR Part 2 is generally more restrictive on use/disclosure of PHI for these purposes. Therefore, programs covered by both 42 CFR Part 2 and HIPAA should refer to 42 CFR Part 2 in determining how to respond to requests for PHI for audit and evaluation activities. (c) Medicare or Medicaid audit or evaluation.
(d) Limitations on disclosure and use. Except as provided in paragraph (c) of this section, patient identifying information disclosed under this section may be disclosed only back to the program from which it was obtained and used only to carry out an audit or evaluation purpose or to investigate or prosecute criminal or other activities, as authorized by a court order entered under § 2.66 of these regulations § 2.61 Legal effect of order. (a) Effect. An order of a court of competent jurisdiction entered under this subpart is a unique kind of court order. Its only purpose is to authorize a disclosure or use of patient information which would otherwise be prohibited by 42 U.S.C. 290ee-3, 42 U.S.C. 290dd-3 and these regulations. Such an order does not compel disclosure. A subpoena or a similar legal mandate must be issued in order to compel disclosure. This mandate may be entered at the same time as and accompany an authorizing court order entered under these regulations.
(2) An authorizing court order is entered under these regulations, but the person authorized does not want to make the disclosure. If there is no subpoena or other compulsory process or a subpoena for the records has expired or been quashed, that person may refuse to make the disclosure. Upon the entry of a valid subpoena or other compulsory process the person authorized to disclose must disclose, unless there is a valid legal defense to the process other than the confidentiality restrictions of these regulations.
§164.512(a): A covered entity may use/ disclose PHI to the extent that such use/ disclosure is required by law and the use/ disclosure complies with and is limited to the relevant requirements of such law. Because 42 CFR Part 2 is more strict than HIPAA in specifying the necessary content of court orders under which PHI can be disclosed, programs covered by both 42 CFR Part 2 and HIPAA should continue to refer to the former when releasing PHI pursuant to court order. § 2.62 Order not applicable to records disclosed without consent to researchers, auditors and evaluators. A court order under these regulations may not authorize qualified personnel, who have received patient identifying information without consent for the purpose of conducting research, audit or evaluation, to disclose that information or use it to conduct any criminal investigation or prosecution of a patient. However, a court order under § 2.66 may authorize disclosure and use of records to investigate or prosecute qualified personnel holding the records. §164.501: Required by law: a mandate contained in law that compels a covered entity to make a use/disclosure of PHI and that is enforceable in a court of law; includes, but is not limited to, court orders and court ordered warrants, subpoenas or summons issued by a court, grand jury, a gov'tal…inspector general, or an administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation…; and statutes/ regulations that require the production of information, including statutes/ regulations that require such information if payment is sought under a government program providing public benefits.
§164.512(a): A covered entity may use/ disclose PHI to the extent that such use/ disclosure is required by law and the use/ disclosure complies with and is limited to the relevant requirements of such law. Because 42 CFR Part 2 is more strict than HIPAA in restricting the ability of court orders to authorize disclosure of PHI in certain circumstances, programs covered by both 42 CFR Part 2 and HIPAA should continue to refer to the former when considering releases of PHI obtained in the course of research, audit, or evaluation activities in the context of criminal investigations of patients. § 2.63 Confidential communications. (a) A court order under these regulations may authorize disclosure of confidential communications made by a patient to a program in the course of diagnosis, treatment, or referral for treatment only if:
§164.512(a): A covered entity may use/ disclose PHI to the extent that such use/ disclosure is required by law and the use/ disclosure complies with and is limited to the relevant requirements of such law. In limiting the scope of authorizing court orders, 42 CFR Part 2 is more strict than HIPAA, which provides for no such limitations. Therefore, for programs covered by both regulations, 42 CFR Part 2 shall continue to control in this circumstance.
No comparable provision. but see:
§164.501: Required by law: a mandate contained in law that compels a covered entity to make a use/disclosure of PHI and that is enforceable in a court of law; includes, but is not limited to, court orders and court ordered warrants, subpoenas or summons issued by a court, grand jury, a gov'tal…inspector general, or an administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation…; and statutes/ regulations that require the production of information, including statutes/ regulations that require such information if payment is sought under a government program providing public benefits. §164.512(a): A covered entity may use/ disclose PHI to the extent that such use/ disclosure is required by law and the use/ disclosure complies with and is limited to the relevant requirements of such law. Programs covered by both HIPAA and 42 CFR Part 2 should continue to refer to 42 CFR Part 2 with regard to the procedure/criteria for authorizing court orders for disclosures for noncriminal purposes. § 2.66 Procedures and criteria for orders authorizing disclosure and use of records to investigate or prosecute a program or the person holding the records.
§160.501:Law enforcement official means an officer or employee of any agency or authority, of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, who is empowered by law to: (1) investigate or conduct an official inquiry into a potential violation of law; or (2) prosecute or otherwise conduct a criminal, civil, or administrative proceeding arising from an alleged violation of law. §164.512(f)(1): A covered entity may
§164.501: Required by law: a mandate contained in law that compels a covered entity to make a use/disclosure of PHI and that is enforceable in a court of law; includes, but is not limited to, court orders and court ordered warrants, subpoenas or summons issued by a court, grand jury, a gov'tal…inspector general, or an administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation…; and statutes/ regulations that require the production of information, including statutes/ regulations that require such information if payment is sought under a government program providing public benefits. §164.512(a): A covered entity may use/ disclose PHI to the extent that such use/ disclosure is required by law and the use/ disclosure complies with and is limited to the relevant requirements of such law. Programs covered by both HIPAA and 42 CFR Part 2 should continue to refer to 42 CFR Part 2 with regard to the procedure/criteria for authorizing court orders for disclosures for prosecutorial purposes. § 2.67 Orders authorizing the use of undercover agents and informants to criminally investigate employees or agents of a program.
Programs covered by both HIPAA and 42 CFR Part 2 should continue to refer to 42 CFR Part 2 with regard to the procedure/criteria for orders authorizing the use of undercover agents and informants.
Patient Access to Records Not addressed in 42 CFR Part 2.
§164.524(b)(1): The covered entity must permit an individual to request access to inspect or obtain a copy of the PHI about the individual that is maintained in a designated record set. The covered entity may require individuals to make requests for access in writing, provided that it informs individuals of such a requirement. §164.524(b)(2): The covered entity must act on a request for access no later than 30 days after receipt of the request. Programs covered by both 42 CFR Part 2 and HIPAA must follow the HIPAA rules in reqard to this requirement.
Right to request Restrictions Not addressed in 42 CFR Part 2.
Right to request Accountings Not addressed in 42 CFR Part 2.
§164.528 (a)(1) Right to request accountings. An individual has a right to receive an accounting of disclosures of PHI made by a covered entity in the 6 years prior to the date on which an accounting is requested, except for disclosures: (1) to carry out treatment, payment, and health care operations; (2) to the individuals themselves; (3) that are made for national security or intelligence purposes; (4) that are related to certain custodial situations; (5) to correctional institutions and law enforcement officials; and (6) which occurred prior to the compliancedate for the covered entity. §164.528 (c): The covered entity must act on the individual's request for an accounting no later than 60 days after receipt of such request by providing the accounting or requesting an extension of no more than 30 days. The first accounting must be provided without charge, and thereafter a reasonable, cost-based fee for each subsequent accounting may be charged if the individual is informed in advance of the fee and an opportunity to modify the request to reduce or avoid the fee.
§164.528 (d): Documentation. A covered entity must retain documentation of the information required to be included in an accounting, the written accounting provided to the individual, and titles of persons or responsible officers who process/receive accountings. Programs covered by both 42 CFR Part 2 and HIPAA must follow the HIPAA rules in reqard to this requirement.
Administrative Requirements: Not addressed, (or in the case of safeguard requirements, not adequately addressed), in 42 CFR Part 2.
§164.530 (a)(1): Personnel Designations: A covered entity myst designate a privacy official who is responsible for the development and implementation of the policies/procedures of the entity. §164.530 (a)(2) Documentation: A covered entity must document the required personnel designations.
§164.530 (d)(2) Documentation of complaints: A covered entity must document all complaints received, as well as their disposition. §164.530 (e)(1),(2) Sanctions: A covered entity must have and apply appropriate sanctions against members of its workforce who fail to comply with HIPAA… Those sanctions must be documented.
§164.530 (h): Waiver: A covered entity may not require individuals to waive their rights to file complaints or any other rights under HIPAA as a condition of provision of treatment, payment, enrollment in a health plan, or eligibility for benefits. §164.530 (i)(1),(2),(3),(4) Policies and procedures: A covered entity must implement policies and procedures with respect to PHI designed to comply with the requirements of HIPAA…. Such policies/procedures must be changed as necessary to comply with changes in the law ..must document and implement the revised policies/procedures promptly….and must revise its Notice of Privacy Practices. §164.530 (j)(1),(2) Retention of policies: A covered entity must maintain the required policies/procedures in written or electronic form, copies of communications HIPAA requires, and records of any action, activity, or designation HIPAA requires to be documented. Such documentation must be retained for 6 years from date of creation or date last in effect, whichever is later. Programs covered by both 42 CFR Part 2 and HIPAA must follow the HIPAA rules in reqard to these requirements.