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PROPOSED RULEMAKING

DEPARTMENT OF HEALTH

[4 PA. CODE CH. 255]

Confidentiality of Patient Records and Information

[37 Pa.B. 6529]
[Saturday, December 15, 2007]

   The Department of Health (Department) proposes to amend § 255.5 (relating to projects and coordinating bodies: disclosure of client-oriented information) by deleting the existing regulation, and replacing it with the proposed amendments in Annex A.

A.  Purpose of the Proposed Rulemaking

   The Department's regulations relating to disclosure of client-oriented information have become outdated and an impediment to service delivery and the coordination of care for individuals with substance abuse problems. The Department initially considered rescinding § 255.5(b), and amending portions of subsection (a) to conform it to those changes, but after consultation with, and upon the advice of, the Advisory Council on Drug and Alcohol Abuse, the Department decided against that course of action. Instead, after receiving comments from various stakeholders, the Department has chosen to propose amendments that would protect the interest of the patient in confidentiality of extremely sensitive and stigmatizing personal information, while at the same time providing sufficient information to persons providing treatment and benefits to those individuals, as well as allowing a client autonomy in choosing when and how to release that client's information. In general, the intent of the proposed rulemaking is to expand the amount of information treatment providers may release to other entities in accordance with the existing statute, and to clarify for treatment providers and patients what the rules relating to confidentiality and disclosure of patient-identifying information are.

B. Requirements of the Proposed Rulemaking

Subsection (a).  Definitions.

   The Department is proposing to add a definition subsection to clarify certain terms used in section 108 of the Pennsylvania Drug and Alcohol Abuse Control Act (Act 63) (71 P. S. § 1690.108). Section 255.5 is based on language included in section 108 of Act 63. That section contains several terms not defined in Act 63 that are integral to the understanding of the scope of confidentiality promised to the patient, for example, ''medical authorities and medical personnel'' and ''government officials.'' The Department has attempted to define those terms as well as the terms, ''program,'' ''patient record'' and ''third-party payer'' in keeping with the intent of the General Assembly contained in section 108 of Act 63, as well as the practice of the providers of drug and alcohol abuse treatment.

Subsection (b).  Scope and Policy.

   The Department is proposing to amend the subsection not only to set out who will be subject to the proposed amendments, and what information will be subject to it, but also to reaffirm the Department's commitment to confidentiality for persons seeking drug and alcohol abuse treatment, and to set out some basic tenets with regard to how the information should be treated by providers and persons to whom information is disclosed. (See proposed subsection (b)(2)--(5).) The Department is also clarifying to whom the record belongs (the facility), but stating that the individual has control over his record, except as limited by the proposed regulation itself. (See proposed subsection (b)(3).) Finally, this subsection would place limits on redisclosure. (See proposed subsection (b)(5) and (6).)

Subsection (c).  Consensual Release of Patient Records and Information.

   This proposed subsection would set out the circumstances under which a patient may consent to the release of records. This proposed subsection would expand the amount of information that treatment providers may disclose to other entities, and impose certain restrictions on the amount of information that may be disclosed to third-party payers. Subsection (c)(1) and (2) reflect the requirements of section 108 of Act 63, and would provide that a program may release a patient record to medical personnel for the purpose of diagnosis, treatment or referral for treatment, and to government officials and third-party payers to obtain benefits due the patient as the result of the patient's drug or alcohol abuse or dependence.

   Proposed subsection (c)(2) would limit the information that may be released to government officials or third-party payers to information necessary to accomplish the purpose of the disclosure. Proposed subsection (c)(2) incorporates the Federal standard relating to release of confidential patient-related information. Further, in the case of disclosure to these specified groups, information that is requested for the purposes of determining medical necessity for service admission, continued stay, discharge, referral, concurrent review, and coordination of care and payment would be limited to an even greater extent. (See subsection (c)(2)(i)--(vii).) This information is in keeping with the American Society of Addiction Medicine's six dimensional criteria accepted by drug and alcohol abuse treatment providers and payers of services as the appropriate criteria by which to assess an individual seeking or in treatment. Under the proposed regulation, a provider would have protection against requests by third-party payers for information that is highly personal and has no bearing on payment for treatment services. This provision would protect a patient's privacy rights.

   At the same time, the proposed amendments would provide third-party payers, including managed care plans, with sufficient information with which to make a determination of the medical necessity of the service requested. Proposed subsection (c)(2) would make it more difficult for a third-party payer to refuse coverage for services on the basis of insufficient information.

   The proposed amendments would also include provisions allowing release with patient consent to probation and parole officers and to the patient's lawyer. (See proposed subsection (c)(3) and (4).) The current regulation allows for release to these individuals. (See subsection (a)(2) and (4)).

Subsection (d).  Nonconsensual Release of Patient Records and Information.

   This proposed subsection would be new, and would include Act 63 section 108's provisions allowing disclosure to be made without patient consent in emergency medical situations when the patient's life is in immediate jeopardy (see proposed subsection (d)(1)), and when there is a court order issued under the statute. (See proposed subsection (d)(2).)

   The proposed subsection would also import from the Federal rules relating to confidentiality of alcohol and drug abuse patient records (see 42 CFR Part 2 (relating to confidentiality of alcohol and drug abuse patient record)) several provisions intended to balance the rights and protections of the patient whose information is being released against the rights and safety of the other persons present in treatment. These sections include proposed subsection (d)(3), which would allow the release of patient identifying information without a patient's consent to law enforcement when a release is directly related either to the patient's commission of a crime on the treatment premises, or the threat to commit a crime. (See proposed subsection (d)(3).) To balance the need to protect the patient in question with the need to protect other patients at the facility, the Department has included in proposed subsection (d)(3) a limitation on what information could be released under these circumstances. The proposed paragraph only allows the release to law enforcement of that information that is related to the circumstances of the incident. (Id.) The disclosure would include the patient's name and address, the fact that the patient was a patient of the facility, and the patient's last known whereabouts. (Id.)

   Proposed subsection (d)(4) would allow programs to report child abuse under State law without violating patient confidentiality. The proposed language in this paragraph, too, is a provision that is included in Federal regulation (See 42 CFR 2.12(c)(6) (relating to applicability).) This provision is intended to protect a most vulnerable portion of society, children, and is particularly applicable since the Department does license facilities that serve parents and children.

   Another Federal regulation that the Department has chosen to include in this proposed rulemaking is the regulation relating to the conduct of scientific research. Proposed subsection (d)(5) would allow programs to disclose information from patient records for the conduct of scientific research if that disclosure is made in accordance with 42 CFR 2.52 (relating to research activities) and if there is an agreement in writing that patient names and other identifying information will not be disclosed. (See proposed subsection (d)(5).)

   The Department has also included in this proposed rulemaking language similar to the Federal regulation dealing with audit and evaluation activities. (See proposed subsection (d)(6)). This proposed regulation would allow State, Federal or local agency staff providing financial assistance or reimbursement to the program or authorized by law to regulate the program, or staff of third-party payers performing utilization or quality control review to have access to patient records on site for purposes of audit or evaluation activities. Disclosure under this proposed paragraph would be required to be in accordance with 42 CFR 2.53 (relating to audit and evaluation activities). The access and review is necessary for both fiscal and programmatic accountability on the part of the treatment provider. In actual practice, Department staff and local agency staff, along with the staff of third-party payers have reviewed patient records for these purposes; the inclusion of this language in the proposed regulation acknowledges existing practice. To protect the patient, the proposed regulation would include a prohibition on the inclusion of any patient identifying information in reports resulting from such reviews and audits.

   Finally, proposed subsection (d)(7) is a general provision that makes it clear that even though patient information may be disclosed without consent in those instances enumerated in the proposed subsection, the information made available must be limited to that information that is relevant and necessary to the purpose for which the information is sought.

Subsection (e).  Patient's Access to Records.

   This proposed subsection contains new subject matter. The Department has included a provision that would allow a patient to have access to the patient's own records. Again, in an effort to balance the need to protect the patient, the Department has acknowledged that a program may remove portions of the record prior to the patient's inspection, if the program determines the information may be detrimental to the patient. The patient may appeal this decision, request the removal of information the patient believes to be inaccurate, irrelevant, outdated or incomplete. The patient may also submit rebuttal data or memoranda if the patient chooses to do so.

Subsection (f).  Consent Form.

   To eliminate questions over what makes a consent valid and to streamline the disclosure process, the Department has proposed minimum requirements for a valid consent form to be used by programs to obtain consent from a patient to disclose information. (See proposed subsection (f).) These elements must be present in a consent form for it to be valid. In addition to requirements such as the patient's name, the name of the program, the specific information being disclosed, the specific purpose of the disclosure and a signature, the proposed subsection would include a requirement that there be included on the form a place for a recordation of an oral consent to be made by a person physically unable to provide a signature. (See proposed subsection (f)(1)(viii).) There would also be a requirement that the consent include either a date of expiration, or an event or condition upon which expiration would be conditioned. (See proposed subsection (f)(1)(ix).) Finally, the consent would require a statement that the consent is subject to revocation at any time, except to the extent that the program or person who is to make the disclosure has already acted upon it. (See proposed subsection (f)(1)(x).)

C.  Affected Persons

   The proposed amendments to § 255.5 would benefit individuals seeking treatment for substance abuse problems. Individuals seeking treatment would benefit from the amendments because they would have greater access to services, more appropriate lengths of stay, and improved coordination between various levels and types of care. In addition, individuals seeking treatment would have the ability to control the disclosure of their confidential information by authorizing the release of specific protected information by a signed consent.

   Programs would also benefit from the proposed amendments because the proposed amendments would expand the amount of drug and alcohol treatment information that may be disclosed to third-party payers, while still restricting release of personal and possibly stigmatizing information that would not aid in the determination of appropriate levels of care or the need for treatment. Further, programs would be able to coordinate care by providing specific information that would be required for utilization and review of services as requested by third-party payers.

D.  Cost and Paperwork Estimate

   The proposed amendments would have no fiscal impact on the Commonwealth, local governments that do not operate licensed drug or alcohol abuse programs, or the general public, nor would they create any measurable additional fiscal or paperwork requirements for the regulated community or those local governments that operate licensed programs. Programs are already required to have in place policies and procedures relating to disclosure of confidential information; these proposed amendments would require some updating to those policies and procedures to address the expansion of what information may be released, but this should take minimal effort.

   Further, since several of the proposed amendments closely follow existing Federal requirements, again, little effort should be required to come into compliance with the proposed amendments. For example, there should be little additional paperwork or cost stemming from the proposed amendments setting out the minimum elements for a consent form; these requirements follow existing Federal regulatory provisions relating to consent forms for release of drug and alcohol abuse patient information. (See 42 CFR 2.31 (relating to form of written consent.)

   In addition, there should be no measurable additional paperwork or cost impact to the regulated community from the proposed amendments relating to patient access to records. The proposed requirements are similar to those currently contained in 28 Pa. Code § 709.30 (relating to client rights), which apply to all freestanding drug and alcohol treatment facilities. These proposed requirements are also similar to those requirements put in place by the privacy rules resulting from the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 CFR 164.524 (relating to access of individuals to protected health information)). Programs that are required to comply with HIPAA and to be licensed by the Department should already have in place systems allowing for patient accessibility to information, for appeals of patients whose access to that information is limited, and for allowing patients to correct that information and submit rebuttal data. These systems should be adequate for the requirements relating to patient access in these proposed amendments.

E.  Statutory Authority

   The Department is authorized to regulate drug and alcohol abuse treatment facilities under Articles IX and X of the Public Welfare Code (62 P. S. §§ 901--922 and 1001--1087) as transferred to the Department under Reorganization Plan No. 2. of 1977 (71 P. S. § 751-25) (transferring duties under the Public Welfare Code with regard to regulation, supervision and licensing of drug and alcohol abuse treatment facilities to the Governor's Council on Drug and Alcohol Abuse (Council)) and Reorganization Plan No. 4 of 1981 (71 P. S. § 751-31) (transferring the functions of the Council to the Department). The Department is also authorized to promulgate regulations under section 4 of the Pennsylvania Drug and Alcohol Abuse Control Act (71 P. S. § 1690.104).

F.  Effectiveness/Sunset Dates

   The proposed amendments would become effective upon their publication in the Pennsylvania Bulletin as final-form rulemaking. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.

G.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (act) (71 P. S. §§ 745.5(a)), the Department submitted a copy of these proposed amendments on November 29, 2007, to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. A copy of this material is available to the public upon request.

   If IRRC has any objections to any portion of the proposed amendments, it will notify the Department within 30 days of the close of the public comment period. The notifications shall specify the regulatory review criteria which have not been met by that portion. The act specifies detailed procedures for review, prior to final publication of the regulation by the Department, the General Assembly and the Governor, of objections raised.

H.  Contact Person

   Interested persons are invited to submit written comments, suggestions or objections regarding the proposed amendments to Janice Staloski, Director, Bureau of Community Program Licensure and Certification, Department of Health, 132 Kline Plaza, Suite A, Harrisburg, PA 17104-1579, (717) 783-8665, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed rulemaking may do so by using the previous number or address. Speech or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document may contact Janice Staloski so that necessary arrangements may be made.

CALVIN B. JOHNSON, M. D., M.P.H.,   
Secretary

   Fiscal Note: 10-186. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 4.  ADMINISTRATION

PART XI.  GOVERNOR'S COUNCIL ON DRUG AND ALCOHOL ABUSE

CHAPTER 255.  MANAGEMENT INFORMATION, RESEARCH[,] AND EVALUATION

§ 255.5.  [Projects and coordinating bodies: disclosure of client-oriented information] Confidentiality of patient records and information.

   [(a)  Disclosure. Information systems and reporting systems shall not disclose or be used to disclose client oriented data which reasonably may be utilized to identify the client to any person, agency, institution, governmental unit, or law enforcement personnel. Project staff may disclose client oriented data only under the following situations:

   (1)  With or without the consent of the client information may be released to those judges who have imposed sentence on a particular client where such sentence is conditioned upon the client entering a project. Information released shall be limited to that provided for in subsection (b).

   (2)  With or without the consent of the client, information may be released to those duly authorized probation or parole officers or both who have assigned responsibility to clients in treatment if the probation or parole of the client is conditioned upon his being in treatment. Information released shall be limited to that provided for in subsection (b).

   (3)  With or without the consent of the client, to judges who have assigned a client to a project under a pre-sentence, conditional release program. Presentence conditional release programs include preindictment or preconviction conditional release such as Accelerated Rehabilitative Disposition, probation without verdict or disposition in lieu of trial under sections 17 and 18 of Act 64 (35 P. S. §§ 780-117 and 780-118).

   (4)  With the consent of the client, in writing, to a judge in order to assist that judge in deciding whether to initiate conditional release programs including those specified in paragraph (3).

   (5)  Projects may disclose any information to the attorney of a client provided as follows:

   (i)  The client consents, in writing to the disclosure of information.

   (ii)  The attorney is representing the client in a criminal, civil or administrative proceeding.

   (6)  Projects may disclose with the consent of a client, in writing, the information to employers of a client to further the rehabilitation of a client; or, to a prospective employer who affirmatively expresses that information is sought to enable the employer to engage the client as an employe. Such information shall be limited to whether the client has or is receiving treatment with the project.

   (7)  Projects may disclose information as set forth in subsection (b) with the consent of a client, in writing, to an insurance company, health, or hospital plan or facsimile thereof, which has contracted with the client to provide or will provide medical, hospital, disability or similar benefits. In the event that an insurance company, health, or hospital plan remains dissatisfied with the content of the information released with regard to a client in accordance with this paragraph, such insurance company, health or hospital plan may apply to the Executive Director for additional information with the written consent of the client and, upon approval by the Executive Director, such information may be released.

   (8)  Projects may disclose information as set forth in subsection (b) with the consent of a client, in writing, to governmental officials for the purpose of obtaining governmental benefits due the client as a result of his drug or alcohol abuse or dependence.

   (9)  In emergency medical situations where the life of the client is in immediate jeopardy, projects may release client records without the consent of the client to proper medical authorities solely for the purpose of providing medical treatment to the client.

   (10)  Projects shall keep and maintain a written record of all information and data which are disclosed under this section.

   (b)  Restrictions. Information released to judges, probation or parole officers, insurance company health or hospital plan or governmental officials, under subsection (a)(1), (2), (4), (7) and (8), is for the purpose of determining the advisability of continuing the client with the assigned project and shall be restricted to the following:

   (1)  Whether the client is or is not in treatment.

   (2)  The prognosis of the client.

   (3)  The nature of the project.

   (4)  A brief description of the progress of the client.

   (5)  A short statement as to whether the client has relapsed into drug, or alcohol abuse and the frequency of such relapse.

   (c)  Record transfer. The Client Admission Forms, the Treatment/Discharge Forms, and Discharge Summary Records are the only client records which may be transferred for treatment purposes. The transfer may be initiated upon the request of a client or by the present project of a client. In any case, the client shall fully understand the nature of the information, the purpose of the record transfer, and the identity of the recipient of the information. Only after these conditions are met, may the client authorize the transfer by signing a Release Form provided by the UDCS.

   (d)  Coordinating bodies. Coordinating bodies can gather and retain client oriented data provided they will receive or send only those forms as listed in subsection (c) in assigning or transferring clients and those bodies will not disclose such data, except to the Council, in manner that is consistent with this chapter and Act 63.]

   (a)  Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

   Government officials--Officials or employees of Federal, State or local government agencies responsible for assisting a patient to obtain benefits or services due to the patient as a result of the patient's drug or alcohol abuse or dependence.

   Medical authorities and medical personnel--A physician, nurse, emergency medical technician or other person employed, licensed, certified, or otherwise authorized by law to provide medical, mental health or addiction treatment to a patient.

   Patient information--A patient record.

   Patient record--A record, document or other information, whether written, electronic, or in any other form or format, relating to a patient's treatment for drug or alcohol abuse or dependence that is prepared or obtained by a program. A patient record may include medical, psychological, social, occupational, financial and other data prepared or obtained as part of the diagnosis, classification and treatment of a patient.

   Program--A medical facility, clinic, rehabilitation or treatment program, institution, practitioner, project or other entity licensed or holding itself out to provide treatment for drug or alcohol abuse or dependence or any government agency authorized to provide treatment for drug or alcohol abuse or dependence.

   Third-party payer--An entity, such as an insurance company, that pays for diagnosis, treatment, or referral for treatment services provided to a patient as a result of the patient's drug or alcohol abuse or dependence.

   (b)  Scope and policy.

   (1)  This section applies to the record of a patient seeking, receiving or having received addiction treatment services from any program.

   (2)  A patient seeking or receiving services from an addiction treatment program is entitled to do so with the expectation that information about the patient will be treated with respect and confidentiality by those providing services. Confidentiality between a provider of addiction treatment services and the provider's patient is necessary to develop the trust and confidence that is important for therapeutic intervention.

   (3)  The patient record of a patient receiving addiction treatment services is the property of the program providing services. The patient shall exercise control over the release of information contained in the patient record except as limited by subsections (c) and (d), and shall be provided with access to the patient record except as limited by subsection (e).

   (4)  Program staff shall respect the patient's privacy and confidentiality when using or discussing patient information.

   (5)  Unless otherwise noted, redisclosure of patient information is prohibited unless specifically reauthorized by the patient.

   (6)  The disclosure of a patient record or information from the patient record may not be used to initiate or substantiate criminal charges against the patient.

   (c)  Consensual release of patient records and information.

   (1)  With the patient's written consent, a program may release a patient record to medical personnel, as defined in subsection (a), for the purpose of diagnosis, treatment or referral for treatment.

   (2)  With the patient's written consent, a program may release a patient record to government officials and third-party payers to obtain benefits due the patient as a result of his drug or alcohol abuse or dependence.

   (i)  A program shall limit the patient information released to government officials and third-party payers to the information necessary to accomplish the specific purpose for the disclosure.

   (ii)  If the patient information requested by a government official or third-party payer is necessary to determine medical necessity for service admission, continued stay, discharge, referral, concurrent review, coordination of care and payment for entitled service benefits, a program shall limit the patient information released to the government official or third-party payer to the following:

   (A)  A statement of whether or not the patient is in treatment for drug or alcohol abuse or dependence.

   (B)  The patient's level of intoxication from alcohol, illicit drugs or medication, including the quantity, frequency and duration of use, and any specific withdrawal symptoms exhibited by the patient currently or in the past.

   (C)  The patient's vital signs, specific medical conditions to include pregnancy, specific medications taken and laboratory test results.

   (D)  The patient's specific diagnosis, mental status, level of functioning and treatment history.

   (E)  A brief description of the patient's progress in treatment related to the impact of substance use, abuse or dependence on life problems, participation in program activities and motivation to change.

   (F)  The patient's risk level for resuming substance use, abuse or dependence based on patterns of use, relapse history, existing relapse triggers and coping skills to maintain recovery.

   (G)  The patient's social support system, environmental supports and stressors that may impact ongoing recovery.

   (3)  With the patient's written consent that includes confirmation of legal representation, a program may disclose patient information to any lawyers representing the patient as a client.

   (4)  With the patient's written consent, a program may disclose patient information to the patient's probation or parole office if the following occur:

   (i)  Participation in the program is a condition of the patient's probation or parole.

   (ii)  The probation or parole office has a need for the information in connection with its duty to monitor the patient's progress. The probation or parole office that receives patient information under this section may only use or redisclose the information to carry out its official duties with regard to the patient's conditional release from custody.

   (d)  Nonconsensual release of patient records and information.

   (1)  A program may disclose a patient record, without the patient's consent, to proper medical authorities in emergency medical situations when the patient's life is in immediate jeopardy.

   (2)  A program may disclose a patient record, without the patient's consent, under an order of a court of competent jurisdiction issued after an application showing good cause for the disclosure.

   (3)  A program may disclose the following communications from programs to law enforcement personnel:

   (i)  Communications that are directly related to a patient's commission of a crime on the premises of the program or against program personnel or a threat to commit a crime.

   (ii)  Communications that are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual's name and address and that individual's last known whereabouts.

   (4)  A program may disclose information from patient records when reporting incidents of suspected child abuse in accordance with the 23 Pa.C.S. Chapter 63 (relating to child protective services) to the appropriate State or local authorities, except that restrictions on redisclosure of patient records in this section and in Federal law and regulations relating to confidentiality of drug and alcohol abuse client information, including the prohibition against redisclosure and use in civil or criminal proceedings that may arise out of the report of suspected child abuse and neglect continue to apply.

   (5)  A program may disclose information from patient records for the purpose of conducting scientific research if the disclosure is made in accordance with 42 CFR 2.52 (relating to research activities) and upon agreement in writing that patient names and other patient identifying information will not be disclosed.

   (6)  A program may disclose information from patient records to persons reviewing records on program premises in the course of performing audits or evaluations on behalf of any Federal, State or local agency which provides financial assistance to the program or is authorized by law to regulate its activities, or on behalf of any third-party payer providing financial assistance or reimbursement to the program or performing utilization or quality control reviews of the program.

   (i)  A disclosure made in the course of audit or evaluation activities shall be made in accordance with 42 CFR 2.53 (relating to audit and evaluation activities).

   (ii)  A report produced as a result of an audit or evaluation may not disclose patient names or other patient identifying information.

   (7)  Patient information made available under this section shall be limited to that information relevant and necessary to the purpose for which the information is sought.

   (e)  Patient's access to records.

   (1)  A patient has the right to inspect the patient's own records.

   (i)  The program may temporarily remove portions of the records prior to inspection by the patient if the program determines that the information may be detrimental if presented to the patient.

   (ii)  The program shall document reasons for removing portions of the records keep them on file.

   (2)  The patient has the right to appeal a decision limiting access to his own records to the program.

   (3)  The patient has the right to request the correction of inaccurate, irrelevant, outdated or incomplete information from his records.

   (4)  The patient has the right to submit rebuttal data or memoranda to his own records.

   (f)  Consent form.   A patient's consent to disclose information must be in writing and include the following:

   (1)  The name of the patient.

   (2)  The name of the program or person making the disclosure.

   (3)  The name and title of the person to whom disclosure is being made or the name of the organization to which disclosure is being made, or both.

   (4)  The specific information being disclosed.

   (5)  The specific purpose of the disclosure.

   (6)  The dated signature of the patient, following a statement that the patient understands the nature of the release.

   (7)  The dated signature of the person obtaining the consent from the patient.

   (8)  A place to record an oral consent to release of information given by a person physically unable to provide a signature and a place for the signatures of two responsible persons who witnessed that the person understood the nature of the release and freely gave oral consent.

   (9)  The expiration date of the consent, or the event or condition the occurrence of which will cause the consent to expire.

   (10)  A statement that the consent is subject to revocation at any time except to the extent that the program or person who is to make the disclosure has already acted in reliance on it.

[Pa.B. Doc. No. 07-2307. Filed for public inspection December 14, 2007, 9:00 a.m.]



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