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(3) The disclosure is made with the 82.35 Disclosures to elements of the Patient's written consent meeting the criminal justice system which have equirements of 82.31, except that:

referred patients. (i) The consent must list the name (a) A program may disclose informaund address of each central registry tion about a patient to those persons und each known detoxification within the criminal justice system naintenance treatment program to which have made participation in the vhich a disclosure will be made; and program a condition of the disposition

(ii) The consent may authorize a dis- of any criminal proceedings against the losure to any detoxification or main- patient or of the patient's parole or Fienance treatment program established

other release from custody if: within 200 miles of the program after

(1) The disclosure is made only to he consent is given without naming

those individuals within the criminal any such program.

justice system who have a need for the

information in connection with their (c) Use of information limited to preven

duty to monitor the patient's progress Pion of multiple enrollments. A central

(e.g., a prosecuting attorney who is registry and any detoxification

or

withholding charges against the pamaintenance treatment program to

tient, a court granting pretrial or which information is disclosed to pre

posttrial release, probation or parole went multiple enrollments may not

officers responsible for supervision of redisclose or use patient identifying in

the patient); and sformation for any purpose other than

(2) The patient has signed a written the prevention of multiple enrollments

consent meeting the requirements of unless authorized by a court order $2.31 (except paragraph (a)(8) which is

under subpart E of these regulations. inconsistent with the revocation provi3 (d) Permitted disclosure by a central sions of paragraph (c) of this section) registry to prevent a multiple enrollment. and the requirements of paragraphs (b) When a member program asks a central and (c) of this section. registry if an identified patient is en- (b) Duration of consent. The written

rolled in another member program and consent must state the period during the registry determines that the pa- which it remains in effect. This period tient is so enrolled, the registry may

must be reasonable, taking into ace disclose

count: (1) The name, address, and telephone

(1) The anticipated length of the a number of the member program(s) in

treatment; which the patient is already enrolled to

(2) The type of criminal proceeding the inquiring member program; and

involved, the need for the information (2) The name, address, and telephone

in connection with the final disposition number of the inquiring member pro

of that proceeding, and when the final ! gram to the member program(s) in

disposition will occur; and

(3) Such other factors as the prowhich the patient is already enrolled.

gram, the patient, and the person(s) The member programs may commu

who will receive the disclosure connicate as necessary to verify that no

sider pertinent. on error has been made and to prevent or

(c) Revocation of consent. The written eliminate any multiple enrollment.

consent must state that it is revocable (e) Permitted disclosure by a detoxifica

upon the passage of a specified amount tion or maintenance treatment program to of time or the occurrence of a specified, i prevent a multiple enrollment. A detoxi- ascertainable event. The time or occur

fication or maintenance treatment pro- rence upon which consent becomes revgram which has received a disclosure

ocable may be no later than the final under this section and has determined disposition of the conditional release that the patient is already enrolled or other action in connection with may communicate as necessary with which consent was given. the program making the disclosure to (d) Restrictions on redisclosure and use. verify that no error has been made and A person who receives patient informnsto prevent or eliminate any multiple tion under this section may redisclose enrollment.

and use it only to carry out that per

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son's official duties with regard to the patient's conditional release or other action in connection with which the consent was given.

Subpart D-Disclosures Without

Patient Consent

82.51 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.

(c) Procedures. Immediately following disclosure, the program shall document the disclosure in the patient's records, setting forth in writing:

(1) The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;

(2) The name of the individual making the disclosure;

(3) The date and time of the disclosure; and

(4) The nature of the emergency (or error, if the report was to FDA). (Approved by the Office of Management and Budget under control number 0930-0099)

(2) Has a research protocol under which the patient identifying informa tion:

(1) Will be maintained in accordance with the security requirements of $2:1 of these regulations (or more stringer: requirements); and

(ii) Will not be redisclosed except as permitted under paragraph (b) of this section; and

(3) Has provided a satisfactory written statement that a group of three or more individuals who are independent of the research project has reviewed the protocol and determined that:

(i) The rights and welfare of patients will be adequately protected; and

(ii) The risks in disclosing patient identifying information are outweighed by the potential benefits of the it search.

(b) A person conducting research may disclose patient identifying information obtained under paragraph (a) of this section only back to the program from which that information was obtained and may not identify any individual patient in any report of that research or otherwise disclose patient identities. (52 FR 21809, June 9, 1987, as amended at 50 FR 41997, Nov. 2, 1987)

$ 2.53 Audit and evaluation activities.

(a) Records not copied or removed. II patient records are not copied or removed, patient identifying information may be disclosed in the course of a review of records on program premises to any person who agrees in writing to comply with the limitations on redisclosure and use in paragraph (d) of this section and who:

(1) Performs the audit or evaluation activity on behalf of:

(i) Any Federal, State, or local governmental agency which provides financial assistance to the program or is authorized by law to regulate its activities; or

(ii) Any private person which provides financial assistance to the program, which is a third party payer covering patients in the program, or which is a peer review organization performing a utilization or quality control review; or

$ 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:

(1) Is qualified to conduct the research;

(2) Is determined by the program di- ministrative remedy, as those terms >ctor to be qualified to conduct the are used in paragraph (c)(1) of this secadit or evaluation activities.

tion, then a peer review organization (b) Copying or removal of records. which obtains the information under ecords containing patient identifying paragraph (a) or (b) may disclose the nformation may be copied or removed information to that person but only for com program premises by any person purposes of Medicare or Medicaid audit ho:

or evaluation. ! (1) Agrees in writing to:

(4) The provisions of this paragraph (i) Maintain the patient identifying do not authorize the agency, the prouformation in accordance with the se- gram, or any other person to disclose urity requirements provided in $2.16 or use patient identifying information f these regulations (or more stringent

obtained during the audit or evaluation equirements);

for any purposes other than those nec(ii) Destroy all the patient identify- essary to complete the Medicare or ng information upon completion of the Medicaid audit or evaluation activity udit or evaluation; and

as specified in this paragraph. $ (iii) Comply with the limitations on (d) Limitations on disclosure and use. isclosure and use in paragraph (d) of

Except as provided in paragraph (c) of his section; and

this section, patient identifying infor(2) Performs the audit or evaluation

mation disclosed under this section .ctivity on behalf of:

may be disclosed only back to the pro(i) Any Federal, State, or local gov

gram from which it was obtained and rnmental agency which provides fi

used only to carry out an audit or evalancial assistance to the program or is

uation purpose or to investigate or Luthorized by law to regulate its ac

prosecute criminal or other activities, ivities; or

as authorized by a court order entered (ii) Any private person which pro

under $2.66 of these regulations. Evides financial assistance to the program, which is a third part payer cov- Subpart E-Court Orders bring patients in the program, or which Authorizing Disclosure And Use

is a peer review organization performning a utilization or quality control re

$ 2.61 Legal effect of order. view.

(a) Effect. An order of a court of com(c) Medicare or Medicaid audit or eval- petent jurisdiction entered under this wuation. (1) For purposes of Medicare or subpart is a unique kind of court order. Medicaid audit or evaluation under Its only purpose is to authorize a disthis section, audit or evaluation in- closure or use of patient information cludes a civil or administrative inves- which would otherwise be prohibited by tigation of the program by any Fed- 42 U.S.C. 290ee-3, 42 U.S.C. 290dd-3 and eral, State, or local agency responsible these regulations. Such an order does for oversight of the Medicare or Medic- not compel disclosure. A subpoena or a aid program and includes administra- similar legal mandate must be issued tive enforcement, against the program in order to compel disclosure. This by the agency, of any remedy author- mandate may be entered at the same ized by law to be imposed as a result of time as and accompany an authorizing the findings of the investigation.

court order entered under these regula(2) Consistent with the definition of tions. ali program in $2.11, program includes an (b) Examples. (1) A person holding d employee of, or provider of medical records subject to these regulations reIl services under, the program when the ceives a subpoena for those records: a 10 employee or provider is the subject of a response to the subpoena is not per

civil investigation or administrative mitted under the regulations unless an 11 remedy, as those terms are used in authorizing court order is entered. The of paragraph (c)(1) of this section.

person may not disclose the records in (3) If a disclosure to a person is au- response to the subpoena unless a court thorized under this section for a Medi- of competent jurisdiction enters an authe care or Medicaid audit or evaluation, thorizing order under these regulaal' including a civil investigation or ad- tions.

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to the content of the confidential c munications.

(b) (Reserved)

(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. (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987)

82.62 Order not applicable to records

disclosed without consent to re

searchers, 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.

$ 2.64 Procedures and criteria for

ders authorizing disclosures

noncriminal purposes. (a) Application. An order authoriz the disclosure of patient records purposes other than criminal investi tion or prosecution may be applied by any person having a legally rec nized interest in the disclosure wh: is sought. The application may be fil separately or as part of a pending a action in which it appears that the tient records are needed to provide e dence. An application mst use a fic tious name, such as John Doe, to rei to any patient and may not contain otherwise disclose any patient identit ing information unless the patient the applicant or has given a writte consent (meeting the requirements these regulations) to disclosure or to court has ordered the record of the pr ceeding sealed from public scrunity.

(b) Notice. The patient and the persis holding the records from whom discia sure is sought must be given:

(1) Adequate notice in a mano which will not disclose patient ident fying information to other persons: ei

(2) An opportunity to file a writte response to the application, or to a; pear in person, for the limited purpos of providing evidence on the statutors and regulatory criteria for the issuan of the court order.

(c) Review of evidence: Conduct hearing. Any oral argument, review evidence, or hearing on the application must be held in the judge's chamber or in some manner which ensures the patient identifying information is pc disclosed to anyone other than a party to the proceeding, the patient, or the person holding the record, unless the patient requests an open hearing in a manner which meets the written cor sent requirements of these regulations The proceeding may include an exam. ination by the judge of the patient records referred to in the application.

(d) Criteria for entry of order. An order under this section may be entered only if the court determines that good cause exists. To make this determination the court must find that:

82.63 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:

(1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties;

(2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or

(3) The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining

(1) Other ways of obtaining the infor- latory criteria for the issuance of the nation are not available or would not court order; and ve effective; and

(3) An opportunity to be represented (2) The public interest and need for by counsel independent of counsel for he disclosure outweigh the potential an applicant who is a person performnjury to the patient, the physician-pa- ing a law enforcement function. ient relationship and the treatment (c) Review of evidence: Conduct of services.

hearings. Any oral argument, review of 1 (e) Content of order. An order author- evidence, or hearing on the application zing a disclosure must:

shall be held in the judge's chambers or (1) Limit disclosure to those parts of in some other manner which ensures he patient's record which are essential that patient identifying information is to fulfill the objective of the order. not disclosed to anyone other than a

(2) Limit disclosure to those persons party to the proceedings, the patient, whose need for information is the basis or the person holding the records. The for the order; and

proceeding may include an examinaI (3) Include such other measures as tion by the judge of the patient records are necessary to limit disclosure for referred to in the application. the protection of the patient, the phy- (d) Criteria. A court may authorize sician-patient relationship and the the disclosure and use of patient treatment services; for example, seal- records for the purpose of conducting a ing from public scrutiny the record of criminal investigation or prosecution any proceeding for which disclosure of of a patient only if the court finds that La patient's record has been ordered. all of the following criteria are met:

(1) The crime involved is extremely § 2.65 Procedures and criteria for or- serious, such as one which causes or di

ders authorizing disclosure and use rectly threatens loss of life or serious of records to criminally investigate bodily injury including homicide, rape, or prosecute patients.

kidnapping, armed robbery, assault (a) Application. An order authorizing with a deadly weapon, and child abuse the disclosure or use of patient records and neglect. to criminally investigate or prosecute (2) There is a reasonable likelihood a patient may be applied for by the per- that the records will disclose informason holding the records or by any per- tion of substantial value in the invesson conducting investigative or pros- tigation or prosecution. ecutorial activities with respect to the (3) Other ways of obtaining the inforenforcement of criminal laws. The ap mation are not available or would not plication may be filed separately, as be effective. part of an application for a subpoena or (4) The potential injury to the paother compulsory process, or in a pend- tient, to the physician-patient relaing criminal action. An application tionship and to the ability of the promust use a fictitious name such as gram to provide services to other paJohn Doe, to refer to any patient and tients is outweighed by the public inmay not contain or otherwise disclose terest and the need for the disclosure. patient identifying information unless (5) If the applicant is a person perthe court has ordered the record of the forming a law enforcement function proceeding sealed from public scrutiny. that:

(b) Notice and hearing. Unless an (i) The person holding the records has order under $2.66 is sought with an been afforded the opportunity to be order under this section, the person represented by independent counsel; holding the records must be given:

and (1) Adequate notice (in a manner (ii) Any person holding the records which will not disclose patient identi- which is an entity within Federal, fying information to third parties) of State, or local government has in fact an application by a person performing been represented by counsel independa law enforcement function;

ent of the applicant. (2) An opportunity to appear and be (e) Content of order. Any order auheard for the limited purpose of provid- thorizing a disclosure or use of patient ing evidence on the statutory and regu- records under this section must:

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157-163 0-95—2

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