Confidentiality of Patient Records for Alcohol and Other Drug Treatment

Technical Assistance Publication (TAP) Series 13

DHHS Publication No. (SMA) 95-3018

Printed 1994

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Substance Abuse and Mental Health Services Administration

Rockwall II, 5600 Fishers Lane

Rockville, MD 20857

Chapter 1—Overview of Federal Alcohol and Other Drug Confidentiality Law 

and Regulations

The regulations that protect the identities of persons in alcohol or drug abuse treatment have their 

genesis in two statutes of the early 1970's: the Comprehensive Alcohol Abuse and Alcoholism 

Prevention, Treatment and Rehabilitation Act of 1970 and the Drug Abuse Prevention, 

Treatment and Rehabilitation Act of 1972. These statutes were implemented by regulations 

issued by the then Department of Health, Education and Welfare (HEW) in 1975. Revised in 

1987 by one of HEW's successors, the Department of Health and Human Services, the

regulations are set out at title 42, part 2, of the Code of Federal Regulations. Recently, Congress 

reaffirmed and reorganized the original confidentiality statutes by merging them into one act, the 

Public Health Service Act, now title 42, section 290dd–3, of the United States Code. The merger 

had no effect on the confidentiality regulations. Throughout this document, references to the 

confidentiality law or regulations will mean the regulations at title 42, part 2, of the Code of 

Federal Regulations. 

Purpose of the Law 

The Federal drug and alcohol confidentiality laws are predicated on the public health view that 

people with substance abuse problems are likelier to seek (and succeed at) treatment if they are 

assured that their need for treatment will not be disclosed unnecessarily to others. The 

congressional committee that put the original drug confidentiality statute into final form noted in 

its report: "The conferees wish to stress their conviction that the strictest adherence to . . . 

[confidentiality] is absolutely essential to the success of all drug abuse prevention programs. 

Every patient and former patient must be assured that his right to privacy will be protected. 

Without that assurance, fear of public disclosure of drug abuse or of records that will attach for 

life will discourage thousands from seeking the treatment they must have if this tragic national 

problem is to be overcome."1In keeping with this view, the drug and alcohol confidentiality 

regulations restrict both the disclosure and the use of information about individuals in federally 

assisted drug or alcohol abuse treatment programs.2
Scope of the Law 

The Federal alcohol and drug confidentiality regulations restrict the disclosure and use of 

"patient identifying" information about individuals in substance abuse treatment. Patientidentifying information is information that reveals that a person is receiving, has received, or has 

applied for substance abuse treatment.3 What the regulations protect is not the individual's 

identity per se, but rather his or her identity as a participant in or applicant for substance abuse 

treatment. 

To Whom Does the Law Apply? 

The regulations apply to holders, recipients, and seekers of patient-identifying information. An 

individual or program in possession of such information—for example, a federally assisted 

substance abuse program—may not release it except as authorized by the patient concerned or as 

otherwise permitted by the regulations. Anyone who receives such information from a substance 

abuse program may not redisclose it without patient consent or as otherwise authorized by the 

regulations and may not use it except for certain purposes discussed below under "Exceptions to 

the Rule for Holders of Patient-Identifying Information." Finally, anyone seeking such 

information may not compel its disclosure except as permitted by the regulations.4

The Strictness of the Federal Regulations 

The Federal drug and alcohol confidentiality regulations are stricter than most other 

confidentiality rules. In general, they apply whether the person seeking the information already 

has it, is seeking it for a judicial or administrative proceeding, is a law enforcement or other 

government official,5has a subpoena or a search warrant, or is the spouse, parent, relative, 

employer, or friend of the patient. 

What Are the Consequences of Violating or Disregarding the Law? 

Violators of the regulations are subject to a criminal penalty in the form of a fine of up to $500 

for the first offense and up to $5,000 for each subsequent offense.6 Violators that are licensed or 

State certified (which would include virtually all programs and their professional employees) 

jeopardize their license or certification. The patients concerned may also sue violators for 

unauthorized disclosure.7

Conflicts With State Laws 

State confidentiality law may be more restrictive than but may not override the Federal 

regulations. Where State law is not stricter and conflicts with the Federal regulations, State law 

must yield. Even where State law conflicts with the regulations, however, the State law can 

usually be complied with through one of the many exceptions to the regulations. 
General Rule for Holders of Patient-Identifying Information 

The general rule is that a federally assisted drug or alcohol abuse program may not disclose, 

directly or indirectly, the identity of its former, current, or would-be patients. However, the rule 

is not absolute, and most requests for patient-identifying information can be accommodated by 

one or another exception to the rule. This section explores the elements of the rule. 

What Is a Program? 

The regulations apply to federally assisted organizations and individual practitioners (for 

example, psychologists, physicians, or even acupuncturists) that specialize in providing, in whole 

or in part, individualized (that is, one-to-one)8alcohol or drug abuse diagnosis, treatment, or 

referral for treatment.9The regulations apply to both freestanding programs and programs that 

are part of larger organizations, for example, a detoxification unit in a general hospital or a 

substance abuse clinic in a county mental health department. Part- and full-time employees, 

volunteers, student interns, former staff, and executive, administrative, clinical, and support 

personnel must comply with the regulations. 

What Does It Mean To Be Federally Assisted? 

A program is federally assisted if it is directly funded by the Federal Government, is operated by 

the Federal Government, is certified for medicaid reimbursement, receives Federal block grant 

funds through a State or local government, is licensed by the Federal Government (for example, 

to dispense methadone), or is exempt from paying taxes under a provision of the Federal Internal 

Revenue Code. 

What Is a Disclosure of Patient-Identifying Information? 

A disclosure of patient-identifying information is any communication that directly or indirectly 

identifies someone as being in, having been in, or having applied for treatment in a substance 

abuse program. A program will have made a patient-identifying disclosure where it discloses a 

patient's record, permits an employee to testify about a patient's treatment, allows a receptionist 

to confirm that a particular person is a patient of the program, uses stationery that suggests that 

the addressee may be one of its patients, or discloses anecdotal material from which a patient's 

identity may be inferred. 

Who Is a Patient? 

A patient is anyone who has applied for or received a diagnostic examination or interview, 

treatment, or referral for treatment for drug or alcohol abuse from a drug or alcohol program. 

Applicants for such services are covered by the regulations even if they fail to show for their 

initial appointment or evaluation or, having been interviewed or diagnosed, elect not to follow up 

or enter treatment. The regulations protect current, former, and deceased patients. 
Exceptions to the Rule for Holders of Patient-Identifying Information 

The Federal confidentiality regulations are strict, but not absolute. They allow patient-identifying 

disclosures in several situations. 

Internal Program Communications 

Patient-identifying information may be disclosed within a program, or to an entity having direct 

administrative control over a program, if the recipient of the disclosure needs the information to 

provide substance abuse services to the patient. "Within the program" means within the 

organization or organizational unit that provides substance abuse services. This means, for 

example, that the staff of a detoxification unit within a hospital may share patient-identifying 

information with one another—and with hospital administrators with direct supervisory oversight 

for the program—where such sharing of information is needed to provide substance abuse 

services to the program's patients. The program may also share information, where necessary, 

with, for example, the hospital's recordkeeping or billing departments, since those units are 

integral to the program's functioning. However, the program may not freely share patientidentifying information with other parts or units of the hospital. Anyone within or in direct 

administrative control of a program who receives patient-identifying information is bound by the 

confidentiality regulations and may not redisclose the information except as allowed by the 

regulations. 

Consent 

Generally, a program may disclose any information about a patient if the patient authorizes it by 

signing a valid consent form.10 To be valid, a consent must specify the following: 

The name of the patient 

The name of the program making the disclosure 

The purpose of the disclosure 

Who is to receive the information 

The information to be released (described as exactly and as narrowly as possible in light of the 

purpose of the release) 

That the patient understands that he or she may revoke the consent at any time, except to the 

extent that action has been taken in reliance on it11

That revocation may be oral as well as written 

The date or condition upon which the consent expires, if it has not been revoked earlier 

The date the consent form is signed 

The signature of the patient12

A proper consent—that is, a consent that includes the foregoing features—will permit a holder of 

patient-identifying information to make patient-identifying disclosures to outsiders, such as 

probation officers, employers, or relatives of the patient. When making a disclosure pursuant to 

such a consent, a program need not send a copy of the consent to the recipient of the disclosed 

material. Where, however, the program is asked for a disclosure by someone outside the 

program, it will have to receive a copy of the consent before it may respond to the request. The 
regulations permit a program to make a patient-identifying disclosure pursuant to a copy (as 

opposed to the original) of a consent.13

Whenever a disclosure is made pursuant to a consent, it must be accompanied by a written notice 

prohibiting redisclosure.14 The notice prohibiting redisclosure warns the recipient that the 

information disclosed is protected by Federal law and may not be redisclosed except with the 

patient's consent or under an exception to the regulations. The prohibition-on-redisclosure notice 

must be sent to the recipient even where the disclosure was made orally.

Anonymous or Non-Patient-Identifying Information 

That programs may not disclose patient-identifying information does not mean that they may not 

disclose a patient's identity. (Patient-identifying information is information that reveals that the 

patient is in, has been in, or has applied for substance abuse treatment.) What programs are 

prohibited from disclosing—except where authorized by the patient or the regulations—is a 

patient's participation in treatment. Thus, a disclosure may reveal a patient's name, address, or 

even telephone number without violating the regulations.15 What a given disclosure may not 

reveal is the nature of the services received by the patient or provided by the program.16

Qualified Service Organization Agreement 

Programs may disclose information to a "qualified service organization" without the patient's 

consent.17 A "service organization" is a person or agency that provides services—such as data 

processing, dosage preparation, laboratory analyses, vocational counseling, or legal, medical, 

accounting, or other professional services—to a program that the program does not provide for 

itself. As the provision of such services may entail patient-identifying disclosures, the outside 

agency must be "qualified" to communicate freely with the treatment program. To become 

qualified, the service organization must enter a written agreement with the program in which it 

acknowledges that it is bound by the Federal confidentiality regulations, promises not to 

redisclose patient-identifying information to which it becomes privy, and promises to resist 

unauthorized efforts to gain access to any patient-identifying information that may come into its 

possession.18

Once the program and the outside agency have entered an agreement of this kind, the program 

may freely communicate information from patient records to the qualified service organization, 

but only that information needed by the organization to provide services to the program. 

Although programs may enter into qualified service organization agreements with a variety of 

outside organizations, they are not permitted—according to a legal opinion of the Department of 

Health and Human Services, which revised the regulations in 1987—to enter them with one 

another (unless the one offers a service that the other cannot provide) or with law enforcement 

agencies. A program need not inform its patients of the qualified service organization agreements 

to which it is a party. 
Crimes on Program Premises or Against Program Personnel 

The regulations permit a program to release patient-identifying information to the police where a 

patient commits or threatens to commit a crime on the premises or against program staff. Under 

these circumstances, the program may give the police the patient's name, address, and last known 

whereabouts. The exception does not permit the program to report a patient's other crimes. 

Medical Emergencies 

Even without consent, patient-identifying information may be disclosed to certain persons in a 

medical emergency.19 A medical emergency is a situation that poses an immediate threat to the 

health of an individual (it need not be the patient) and requires immediate medical intervention.20

Under this exception, a program may release patient-identifying information to medical 

personnel who need the information to treat the medical condition. The medical-emergency 

exception may not be invoked to disclose patient-identifying information to the patient's family 

or other nonmedical personnel. 

Mandated Reports of Child Abuse or Neglect 

All States require people in certain positions or occupations to report cases of suspected child 

abuse or neglect to the relevant child welfare authorities. In 1986, the Federal regulations were 

amended to permit substance abuse programs to comply with such laws. Today, the Federal 

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."21 This means that program staff may 

make reports to local child abuse hotlines and even confirm the reports in writing. However, the 

regulations "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 and neglect." This means that while a program may 

make State-mandated child abuse reports, it must still protect patient records from subsequent 

disclosures (even as against local child welfare investigators) and, absent patient consent or a 

court order, may not permit them to be used in child abuse proceedings against the patient. 

Research 

Under certain circumstances, a program may allow a researcher to have access to its patients' 

records.22 In the event, the program director must determine that the researcher is qualified, that 

the researcher has a protocol under which the security of patient records is assured,23 and that 

patient-identifying information will not be redisclosed. Additionally, three or more independent 

evaluators must have reviewed the research protocol and determined that the rights and welfare 

of the patients concerned will be adequately protected and that the potential benefits of the 

research outweigh the risks to patient confidentiality. Researchers are barred from redisclosing 

patient-identifying information except back to the program itself. 
Audit and Evaluation 

Certain qualified individuals or organizations may have access to program records for audits or 

evaluations of the program.24 By definition, an audit or evaluation is a time-limited activity that 

may not be used to gain access to program records on an ongoing basis. Audits or evaluations 

may be conducted by regulatory agencies, funders, private third-party payers, and private peer 

review organizations.25 Information disclosed during an audit or evaluation may not be 

redisclosed except pursuant to a court order (where a program is being investigated) or to 

determine compliance by the program with medicaid or medicare regulations. If the auditor or 

evaluator wishes to copy or remove records, he or she must agree in writing to protect patientidentifying infor-mation, destroy all such information on completion of the audit or evaluation, 

and not use the information except for purposes of the audit or evaluation. 

Court Orders 

A Federal, State, or local court may authorize a program to make a disclosure of confidential 

patient-identifying information. A court may issue such an order, however, only after following 

certain procedures and making certain determinations specified in the regulations.26 A subpoena, 

search warrant, or arrest warrant, even when it is signed by a judge, is not sufficient, by itself, to 

require or even permit a program to make a disclosure.27

Procedures and Restrictions 

Before a court can issue an order authorizing a disclosure, the program and the patient whose 

records are sought must be given notice of the application for the order and some opportunity to 

make an oral or written statement in response. (However, if the information is being sought to 

investigate or prosecute a patient, the patient is not entitled to notice.28 Similarly, where the 

program is being investigated, the program is not entitled to notice.29) The application and any 

court order must use a fictitious name for the patient. All court order proceedings in connection 

with the application must be confidential unless the patient requests otherwise.30

Before it may order the disclosure of confidential patient information, a court must find that there 

is "good cause" for the disclosure. A court can find good cause only if it determines that the 

public interest and the need for disclosure outweigh any adverse effect that the disclosure may 

have on the patient, the doctor-patient relationship, or the effectiveness of the program's 

treatment services. If the information is available from another source, the court may not issue 

the order.31 The judge is entitled to examine the records before making a decision.32

Even where good cause for dis-closure exists, there are limits to the scope of the disclosure that 

the court may authorize. In fact, disclosure must be limited to the information essential to the 

purpose of the order, and the dissemination of the information must be restricted to those persons 

who need it to fulfill the purpose of the order. The court should also take steps to protect the 

patient's confidentiality, for example, by sealing the records of the proceeding.33

Where the information sought is a "confidential communication," it may not be disclosed unless 

the disclosure is necessary to protect against a threat to life or of serious bodily injury, is 
necessary to investigate or prosecute an extremely serious crime, or is connected with a 

proceeding in which the patient has already presented evidence concerning the confidential 

communication.34 In all other situations, not even a court can order disclosure of a confidential 

communication. 

Procedures in Criminal Investigations 

Where an investigative, law enforcement, or prosecutorial agency seeks an order authorizing a 

disclosure for the purpose of investigating or prosecuting a patient,35 it must demonstrate the 

following: 

The crime involved is extremely serious, that is, one that causes or threatens to cause death or 

serious injury36

The records sought are likely to contain information of significance to the investigation or 

prosecution 

There is no other practical way to obtain the information 

The public interest in disclosure outweighs any actual or potential harm to the patient, the 

doctor-patient relationship, or the ability of the program to provide services to other patients 

The program has had an opportunity to be represented by independent counsel 

(When the program is a governmental entity, it must be represented by counsel.)37

Where the order is sought to prosecute a patient, the court must follow the same 

procedures that apply to court-ordered disclosures generally (except that the patient need 

not be given notice). In addition, a court order authorizing a disclosure for the purpose of 

investigating or prosecuting a patient must limit the disclosure to those parts of the 

patient's record that are essential to the purpose of the order. Further, only those law 

enforcement and prosecutorial officials responsible for conducting the investigation or

prosecution may have access to the information. As with other applications, the court 

may not order the disclosure of "confidential communications" except in narrowly 

defined circumstances (see "Procedures and Restrictions" above). Under no 

circumstances may a court authorize a program to turn over a patient's entire record to a 

law enforcement, investigative, or prose-cutorial agency.38

Restrictions on Redisclosure 

That patient-identifying information may be disclosed pursuant to one of the many exceptions to 

the general rule does not mean that the disclosed information is no longer protected. Indeed, as 

noted above, information released pursuant to a consent must be accompanied by a written notice 

informing the recipient that the information he or she has received is protected by Federal law 

and may not be redisclosed except as provided for in the regulations. No one who receives 

patient-identifying information under the regulations—including third-party payers, government 

employees, program staff, administrators, criminal investigators and law enforcement personnel, 

court personnel, researchers, auditors, evaluators, and employees of qualified service 

organizations—may redisclose it unless authorized to do so by the patient, a court order, or 

another exception to the regulations. 
Restrictions on Use 

Except pursuant to a court order, information subject to the regulations may not be used to 

initiate, investigate, or substantiate criminal charges against a patient. In addition, patientidentifying information obtained in violation of the regulations can be excluded from evidence in 

both civil and criminal proceedings. 

Footnotes

1H.R. Rep. No. 92_920, 92d Cong., 2d Sess., p. 33 (in U.S. Code Cong. & Admin. News, 1972, 

p. 2072). 

2

42 CFR § 2.3(a). 

3

42 CFR § 2.11. 

442 CFR § 2.13(b). 

5

42 CFR §§ 2.13(b), 2.20. This includes public health officials. However, holders of patientidentifying information can invoke exceptions to the regulations to comply with their public 

health obligations, such as the reporting of cases of tuberculosis as mandated by State law. 

6

42 CFR § 2.4. Violations may be reported to the local U.S. attorney. Violations by methadone 

programs may be reported to the regional offices of the Food and Drug Administration (42 CFR 

§ 2.5). 

7

Evidence used or obtained in violation of the regulations may be excluded in both civil and 

criminal cases. See United States v. Eide, 875 F. 2d 1429 (9th Cir. 1989) (excluding illegally 

seized records in criminal prosecution), and Jeanette "A" v. Condon, 728 F. Supp. 204 (S.D.N.Y. 

1990) (prohibiting an employer from terminating an employee on the basis of an improperly 

disclosed urinalysis result). 

8

Programs that provide generalized services are not covered by the regulations. Thus, a 

classroom education program aimed at all the students in a class or a grade is not covered. 

However, should an employee of such a program engage a student in one-to-one or even group 

counseling, the program would become subject to the regulations. 

9

The regulations apply whether a program provides all three or just one of the following services 

for drug or alcohol abuse: diagnosis, treatment, or referral for treatment. 

1042 CFR §§ 2.31, 2.33. It should be noted that consents authorize but do not compel programs 

to make a disclosure. 
11Depending on State law, a consent for a patient referred by the criminal justice system may be 

made irrevocable for a period of time (42 CFR § 2.35). Some States have statutes that provide 

for the automatic expiration of such consents after 60 or 90 days. 

12If the patient has died, the executor or administrator of the estate or, if there is none, the spouse 

or closest other relative of the deceased patient may sign (42 CFR § 2.15(b)(2)). If the patient 

dies while in the program, no consent is needed to disclose information relating to the cause of 

death to such agencies as are empowered to collect vital statistics or inquire into causes of death 

(42 CFR § 2.15(b)(1)). If the patient is incompetent, a person appointed by a court to oversee his 

or her affairs may sign (42 CFR § 2.15(a)). If the patient is a minor, the patient must still always 

sign the consent form. If State law requires parental consent for treating a minor, a parent's 

signature will be required, in addition to the minor's, for any release (42CFR § 2.14(c)). If the 

State permits the minor to be treated without parental consent, the minor's signature alone may 

authorize a disclosure (42CFR § 2.14(b)). 

13Disclosures to a central methadone registry must be made with patient consent (42 CFR § 

2.34). A central registry collects information about patients applying for methadone maintenance 

or detoxification. (The registry is intended to prevent dual enrollments.) A program may disclose 

records to any central registry not more than 200 miles away. Such disclosures may be made 

only when a patient is accepted for treatment, changes type or dosage of drug, or ends, interrupts, 

or resumes treatment. Patient consent is required in writing, but programs may refuse to enroll 

patients who will not consent. Disclosed information must be limited to the patient's name and 

identifying information, dosage of drug, and relevant dates. The registry may disclose to its 

member programs the names, addresses, and telephone numbers of any other programs in which 

the patient is enrolled. Those programs may then communicate with one another without patient 

consent, but only to the extent necessary to verify that no error has been made or to prevent or 

eliminate any multiple enrollment. 

1442 CFR § 2.32. 

15Thus, if a patient threatened to harm his or her spouse, the program might make an anonymous 

telephone call to the spouse or even the police. To be effective, of course, such a call would 

require the program to disclose the patient's name. It would not, however, require the program to 

disclose its name or the fact that the patient is in substance abuse treatment. 

16Where a program is part of a larger organization, such as a general hospital, and is required to 

make reports of communicable diseases, such as tuberculosis or human immunodeficiency virus, 

it can discharge its reporting obligation by using the larger organization's name and address. 

Thus, the detoxification unit of a general hospital would make the necessary report under the 

name of the hospital. It should be noted that some courts have found a duty to warn where there 

is an identifiable victim. In such cases, a program may very well have to notify both the relevant 

authorities and the potential victim, and, in the process, may even have to disclose patientidentifying information. 

1742 CFR § 2.12(c)(4). 
1842 CFR § 2.11. 

1942 CFR § 2.51. 

20A typical example of a medical emergency is a suicide threat or a drug overdose. 

2142 CFR § 2.12(c)(6). 

2242 CFR § 2.52. 

2342 CFR § 2.16. 

2442 CFR § 2.53. 

25Accounting audits do not usually fall under the audit-and-evaluation exception to the 

regulations. These are usually conducted pursuant to a qualified service organization agreement. 

2642 CFR §§ 2.63–2.67. 

2742 CFR § 2.61. 

2842 CFR § 2.65. 

2942 CFR § 2.66. 

3042 CFR §§ 2.64–2.66. 

3142 CFR § 2.64(d). 

3242 CFR § 2.64(c). 

3342 CFR § 2.64(e). 

3442 CFR § 2.63. 

3542 CFR § 2.65. 

3642 CFR § 2.63 sets forth a list of serious crimes for which a court may order disclosure of 

patient records. The list does not include the possession or sale of illegal drugs. 

37Note that the regulations do not permit courts to order those "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." 42 CFR § 2.62. 
38 The regulations also contain special provisions regarding court orders authorizing disclosures 

for purposes of investigating or prosecuting a program or its employees and court orders 

authorizing a government agency to place an undercover agent or informant in a program to 

gather evidence of serious criminal conduct by the program or its employees (42 CFR §§ 2.66–

2.67). The regulations set strict prerequisites for obtaining such orders and prohibit the use of 

information obtained through these means to initiate or substantiate criminal prosecutions against 

patients. 

Chapter 2 —Confidentiality of Alcohol and Other Drug Treatment Records and 

Communicable Disease: Options for Successful Communication and 

Collaboration

In an effort to prevent, treat, and control the spread of communicable diseases, all States require 

health care providers and sometimes others to report cases of communicable disease to local 

public health authorities. These reports enable public health officials to locate, examine, counsel, 

treat, and monitor anyone presenting with a communicable disease. These mandated reporting 

requirements may appear to conflict with the Federal confidentiality regulations for drug and 

alcohol records, which, as discussed in Chapter 1, restrict patient-identifying disclosures about 

individuals in alcohol or drug treatment. Yet the Federal confidentiality regulations contain 

exceptions that allow substance abuse programs to discharge their State-mandated 

responsibilities with respect to the reporting of communicable diseases. In fact, the exceptions to 

the regulations not only permit programs to make the necessary communicable disease reports 

but also make it possible for them to cooperate on an ongoing basis with public health officials 

(and other health care providers) in efforts to treat and monitor those alcohol and other drug 

(AOD) patients who present with communicable disease. 

Public Health Activities With Respect to Communicable Disease 

For AOD programs to decide which exception or exceptions should be invoked (or are most apt) 

for purposes of meeting their State-mandated disease reporting and followup responsibilities, 

they need to understand what it is that public health officials (and other health care providers) 

may want or need to do in response to a communicable disease case report. At the least, public 

health officials want or need to—

Identify an actual or suspected case of communicable disease 

Verify the case by examination 

Counsel the infected patient with an eye toward preventing further transmission 

Prescribe appropriate treatment 

Locate contacts or trace partners for purposes of identifying other cases and preventing further 

transmission 

Monitor treatment for efficacy and compliance 

Identify the nonadherent or noncooperative patient for purposes of invoking either civil or 

criminal sanctions 
An appreciation of these activities will enable programs to ascertain exactly what information is 

needed for which public health purpose or activity and which of the available exceptions to the 

confidentiality regulations best fits the situation.1

How Programs Can Comply With Communicable Disease Reporting 

Requirements 

Reporting With Patient Consent 

The easiest way for an AOD program to comply with State-mandated communicable disease 

reporting and followup requirements is for the program to secure the patient's consent to both the 

mandated report and followup activities. Such a consent can be put in place at intake or 

screening, with periodic renewals as necessary. Depending on State law, the consent can be 

made to last for as long as the patient is in the program.2

Given a proper consent, a program may report nearly anything the patient authorizes it to report, 

including the patient's state of health and whereabouts. The ability to report the patient's 

whereabouts (something that is almost always problematic for patients in residential treatment, 

since, by definition, a disclosure of a residential treatment patient's address is patient identifying) 

is especially important in the case of patients who must be examined without delay, for example, 

pa-tients with suspected tuberculosis (TB). Easy location of the patient also facilitates followup 

activities, including counseling and education, interviewing for the purpose of identifying 

contacts and partners, treatment, and monitoring for compliance.

Moreover, a consent, unlike some other exceptions, can allow for the redisclosure of patientidentifying information. This is particularly important where different public health officials 

need to communicate with one another or other health care providers for purposes of tracking 

and controlling disease. Indeed, the only drawbacks to the consent option, at least from the point 

of view of public health (and leaving aside the question of having to explain a consent to a 

patient, which some programs find troublesome, depending on the populations they serve), are 

that a consent may be withdrawn at will by the patient and that a consent may not be the basis for 

imposing criminal sanctions on a noncompliant patient or a patient who engages in risky 

behavior. Only a court order may authorize the imposition of such sanctions against a 

noncompliant or risk-taking patient. 

Reporting "Anonymously" 

A program could conceivably discharge its State-mandated disease reporting obligations by 

making anonymous or non-patient-identifying disclosures. Under this exception, a program is 

allowed, for example, to disclose a patient's name and state of health and even his or her 

whereabouts as long as in doing so it does not also disclose that the patient is in substance abuse 

treatment. Notwithstanding its apparent attractions, there are problems with a program's electing

to rely on this exception to discharge its disease reporting or followup obligations. The most 

obvious of these has to do with the fact that most States require reporters to identify themselves. 

Obviously, a freestanding or residential treatment program would not be able to comply with an 

identification requirement without giving itself and the patient away. (A program that is part of a 
larger organization, such as a hospital, can simply report under the larger organization's name, 

assuming, of course, that the larger organization is not itself an identifiable substance abuse 

treatment provider.) A second problem arises where the recipient of the disclosure—here, a 

public health agency—wishes to establish ongoing communication with the program for the 

purpose of identifying and locating individuals who may have come in contact with, say, an 

AOD patient who is suspected of having TB. Under the circumstances, a program would not be 

able to cooperate with public health officials in locating, examining, counseling, educating, 

treating, or monitoring such contacts, since, in all likelihood, such cooperation would result in 

impermissible disclosures.3

Reporting by Use of a Qualified Service Organization Agreement 

Programs required to make communicable disease case reports to local public health officials 

may comply with their reporting obligations—and put in place a mechanism authorizing ongoing 

communications between the program and an outside agency involved in treating or monitoring a 

patient's care—by entering a qualified service organization agreement (QSOA) with an outside 

agency or individual (the qualified service organization). 

Thus, a treatment program can enter a QSOA with an outside medical care provider who would 

agree to provide screening and treatment to the program's patients and make mandated 

communicable disease reports to the State or local public health authorities. Such an arrangement 

would enable the AOD program and the outside service organization to share information 

(including AOD-patient-identifying information) without first obtaining individual patient 

consents.4 However, in making mandated reports to public health officials, the outside service 

provider would be forbidden from disclosing any AOD-patient-identifying information, unless 

the redisclosure was authorized by consent or by one of the other exceptions under the 

regulations. Such a QSOA arrangement would permit the program to discharge its Statemandated communicable disease case reporting obligations. However, depending on the nature 

of the qualified service organization, this arrangement probably would not permit the program to 

cooperate with local public health officials in following up on a given communicable disease 

report. 

The program could overcome this problem by entering a QSOA directly with the State or local 

public health officials responsible for conducting communicable disease prevention, treatment, 

and control activities.A QSOA between an AOD program and a public health agency would 

open a channel of communication between the two that would permit the former to make 

mandated reports and allow the latter to follow up any such reports to the degree necessary.

Because qualified service organizations may not redisclose AOD-patient-identifying information 

except with the patient's consent or as otherwise authorized by the AOD confidentiality rules, a 

question arises as to whether a program can meet all its State-mandated communicable disease 

reporting obligations through a QSOA where those obligations require the redisclosure of 

patient-identifying information throughout the public health bureaucracy involved in controlling 

communicable disease. In some States, the State and local public health units are separate 

governmental entities. In those States, an AOD program could enter a QSOA with each of the 

units (assuming that each agreed to provide services to the program) and could communicate 
AOD-patient-identifying information back and forth with each public health unit. However, the 

State and local units could not share such information with each other—unless the patient 

consented or another exception to the Federal rules authorized such disclosures. This is because 

the QSOA between the AOD program and each of the public health units could not authorize 

either of the latter to redisclose AOD-patient-identifying information to any other entity, 

including other public health units. And since QSOA's may only be entered into between an 

AOD program and an outside service organization, the respective State and local health 

departments or units—neither of which would qualify as an AOD program—could not enter a 

QSOA with each other.

Thus, if the local public health agency and the State public health agency are separate entities, a 

QSOA with the local public health authorities will not permit the local public health agency to 

redisclose AOD-patient-identifying information to the State public health agency. In that event—

for example, where the qualified service organization is a private physician or other agency—the 

local public health office has three options: (1) delete patient-identifying information from its 

reports to the State, (2) get patient consent to the disclosure, or (3)contact the patient for 

followup and rely on the patient's self-disclosing that he or she is in substance abuse treatment. 

(The regulations do not prevent patients from disclosing their own treatment status. Selfdisclosures are not protected information and may be redisclosed without violating the 

regulations.)

However, where the qualified service organization is the local public health unit and the local 

public health unit is part of the same governmental entity as the State public health agency—that 

is, where the local public health unit is a subdivision of the State public health agency—a single 

QSOA can solve this problem. In such cases, the QSOA can specify that the qualified service 

organization that is to provide services to the program consists of both the local and State public 

health agencies. 

Reporting and Followup Under the Research Exception 

Under the research exception to the regulations, a program may permit a researcher to gather 

data for research purposes. Presumably, the exception would allow the program to give public 

health agencies access to patient records for purposes of gathering data on the presence of 

communicable disease within the program. The exception might even allow public health 

agencies to engage in examination, counseling, education, contact identification, treatment, and 

monitoring. It would not permit public health agencies to share patient-identifying information 

with other health care providers or patient contacts or partners. Indeed, inasmuch as it is 

predicated on the idea that the researcher is conducting research (as opposed to public health 

followup), requires the researcher to be possessed of a research protocol, and turns on an 

independent panel's evaluation of the benefits of the proposed research, this exception seems to 

be of only limited use for purposes of public health reporting and followup. A broader 

interpretation would distort the language and spirit of the regulations. 
Audit and Evaluation 

The audit-and-evaluation exception is plainly intended to permit regulatory agencies, funders, 

third-party payers, and peer review organizations to keep an eye on AOD programs to make sure 

that such programs are doing what they are supposed to be doing: providing effective substance 

abuse treatment. Accordingly, information disclosed during an audit or evaluation may not be 

used except for purposes of the audit or evaluation, and, in any case, may not be redisclosed 

except to medicaid or medicare officials or to law enforcement officials investigating a program 

pursuant to a court order. Under the circumstances, it would be inappropriate to rely on this 

exception for purposes of public health reporting or followup. Nonetheless, according to an 

opinion letter issued by the Department of Health and Human Services, this exception may be 

used for purposes of public health reporting and some followup—namely, patient counseling and 

interviewing—in cases of human immunodeficiency virus and acquired immunodeficiency 

syndrome (HIV/AIDS).5The Department has never opined formally as to whether the exception 

may also be used for purposes of reporting and following up sexually transmitted diseases, TB, 

or other communicable diseases. 

Reporting and Followup Under the Medical-Emergency Exception 

Under the medical-emergency exception, a program may make a patient-identifying disclosure to 

medical personnel in a medical emergency that requires immediate medical intervention. Under 

this rather narrow exception (which requires a case-by-case decision as to whether a threat exists 

or immediate medical intervention is required), a program could report a communicable disease 

to public health officials only if the following conditions are met: 

The presence of an infected or allegedly infected individual in the program could be said to 

constitute a medical emergency 

Public health officials are medical personnel 

Assuming that public health officials are medical personnel (a safe enough assumption), the real 

question is whether the presence in a treatment program of an individual who is infected with a 

communicable disease can be said to constitute a medical emergency for either the individual or 

others. (Under the regulations, a medical emergency is a situation that requires immediate 

medical intervention.) The answer to the question turns on the nature of the disease itself and 

how it is trans-mitted. Generally, sexually transmitted diseases—such as syphilis and gonorrhea, 

and even hepatitis—are not considered emergencies of the sort that require immediate medical 

intervention;6this is also the case with HIV/AIDS. These diseases, though communicable, are 

not emergencies because they do not pose immediate threats to life and because the threat posed 

by HIV/AIDS cannot be prevented or relieved by resort to immediate medical intervention. 

Accordingly, they may not be reported to public health officials under the medical-emergency 

exception to the regulations. 

The situation is different with TB or suspected TB. Because TB is transmitted by casual contact, 

is difficult to confirm, and is potentially deadly, the presence of a suspected case of TB in a 

treatment program may very well constitute the sort of emergency that can be reported to public 

health officials under the medical-emergency exception to the regulations. For the same reasons, 
it may also be that a suspected or confirmed case of TB will permit a program not only to make 

the required report to public health officials but also to cooperate with them in their followup 

activities. 

Court Orders 

A program that is required to report communicable diseases to local public health officials may 

always resort to a court order to make the necessary report. This is true whether the program is 

seeking to report sexually transmitted diseases, HIV/AIDS, or TB. A proper court order may 

authorize a program both to make mandated reports and to cooperate with public health followup 

activities. 

Nonetheless, there are serious drawbacks to the use of a court order in such a situation. In the 

first place, the procedure for obtaining a court order is complicated and time-consuming. Second, 

there is no guarantee that a court will grant the requested order, since the court must find that the 

information in question is not otherwise available and that the public interest outweighs the 

private interest at stake. Third, the benefit of a court order might be outweighed by its negative 

impact on client-program relations. (A program that readily resorts to court orders to meet public 

health reporting requirements is probably undermining itself, though this is not to deny the place 

of court orders in certain situations.)7

Options for Communicating and Collaborating in the Provision of 

Communicable Disease Treatment, Monitoring, and Followup:

What Is Possible? 

It is up to each program to decide what is the best or most apt exception for purposes of meeting 

State public health reporting requirements. Perhaps in an ideal world programs and patients 

would both agree to put in place appropriate consents that would allow programs to comply with 

all their public health obligations. Yet consents are not without their drawbacks. The most 

important of these drawbacks is that consents can be withdrawn at will. 

To be sure, a program might counter the revocation of a consent by making treatment contingent 

on a new consent (whether a program can do this depends on State law), but such a move—

smacking as it does of coercion—would not be without costs and could damage the therapeutic 

relationship.

Another option would be to put in place a QSOA with the local public health agency. This would 

permit the program to comply with both reporting and followup obligations. Since a program is 

not obligated to inform a client of the existence of a QSOA, this option may also be considered 

to have the added advantage of making the QSOA appear to be something of a fait accompli. 

(This is not to suggest that a program should be casual about its patients' concerns about 

confidentiality; it is actually to suggest something else: that programs are under obligations that 

they may not avoid, that these obligations sometimes involve the rights of their patients, and that 

programs should be open and matter-of-fact about meeting those obligations.)
Though they have less to recommend them, the other exceptions to the regulations have their 

uses. Thus, a program that cannot persuade a patient to consent to a disclosure and that does not 

have an appropriate QSOA in place may wish to report a communicable disease anonymously. 

(The limits of anonymous reports are discussed in "Reporting 'Anonymously'" above.) Programs 

wishing to report a case of HIV could invoke the unpersuasive but useful route recommended by 

the Department of Health and Human Services, namely, using the audit-and-evaluation exception 

for that purpose. With regard to TB or suspected TB, a program can probably rely on the 

medical-emergency exception to make a report. Finally, a program can always seek to discharge 

its reporting and followup obligations by going to court.

Footnotes

1

It goes without saying that collaboration and cooperation in this important area redound to 

everyone's benefit. This is particularly true with respect to cases of tuberculosis, which, unlike 

some other communicable diseases, can be spread by casual contact. 

2

Some States have laws that limit the validity of releases and consents to no more than 60 or 90 

days. In such States, a consent would have to be renewed at the appropriate juncture. 

3Of course, there is nothing to prevent the program from urging those of its staff and clients who 

may have been exposed to a communicable disease to call the appropriate officials or other 

providers for examination and followup. 

4AOD programs are not required to obtain patient consent prior to entering a QSOA, nor need 

they inform patients of the QSOA's to which they are a party. Naturally, to the extent that a 

patient (who, after all, proceeds with the assurance that his or her records are confidential) is 

surprised by a given QSOA, his or her confidence in the program or his or her therapist may be 

undermined. It is probably in a program's interest to inform its patients of existing or proposed 

QSOA's. 

5

The Legal Action Center disagrees with the Department of Health and Human Services on this 

matter (see letter from Margaret K. Brooks, President/Director, Legal Action Center, to Richard 

Riseberg, Esq., General Counsel, Office of the General Counsel, September 25, 1990, in

AppendixB). 

6

This is the opinion of the Department of Health and Human Services (see letter from Susan K. 

Zagame, Acting General Counsel, Health and Human Services, to Peter J. Millock, General 

Counsel, Department of Health, State of New York, May 17, 1989, in Appendix B). 

7Court orders are not a panacea. They do not permit redisclosure and are not readily available for 

the purpose of imposing criminal sanctions on a patient.
Appendix A—Sample Forms

Sample Form #1

CONSENT FOR THE RELEASE OF CONFIDENTIAL ALCOHOL OR DRUG TREATMENT INFORMATION 

I,________________________________________________________, authorize 

(Name of patient) 

__________________________________________________________________ 

(Name or general designation of program making disclosure) 

to disclose to _________________________________________________the 

(Name of person or organization to which disclosure is to be made) 

following information: ______________________________________________ 

(Nature of the information, as limited as possible) 

______________________________________________________________ 

______________________________________________________________ 

The purpose of the disclosure authorized herein is to: _____________________________ 

(Purpose of disclosure, as specific as possible) 

_________________________________________________________________________ 

I understand that my records are protected under the federal regulations governing 

Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2, and cannot be 

disclosed without my written consent unless otherwise provided for in the regulations. I also 

understand that I may revoke this consent at any time except to the extent that action has been 

taken in reliance on it, and that in any event this consent expires automatically as follows: 

________________________________________________________________ (Specification of 

the date, event, or condition upon which this consent expires) 

________________________________________________________________ 

Dated:____________________ ________________________________
Signature of participant

_______________________________ 

Signature of parent, guardian or authorized 

representative when required

Sample Form #2

PROHIBITION ON REDISCLOSURE

OF INFORMATION CONCERNING CLIENT

IN ALCOHOL OR DRUG ABUSE TREATMENT 

This notice accompanies a disclosure of information concerning a client in alcohol/drug abuse 

treatment, made to you with the consent of such client. This information has been disclosed to you from 

records protected by Federal confidentiality rules (42 CFR Part 2). The Federal rules prohibit you from 

making any further disclosure of this information unless further disclosure is expressly permitted by the 

written consent of the person to whom it pertains or as otherwise permitted by 42 CFR Part 2. A general 

authorization for the release of medical or other information is NOT sufficient for this purpose. The 

Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or 

drug abuse patient.

Sample Form #3

CONSENT FOR THE RELEASE OF CONFIDENTIAL ALCOHOL OR DRUG TREATMENT 

AND [TB] [STD] [HIV/AIDS] INFORMATION TO COMPLY WITH DISEASE REPORTING 

REQUIREMENTS

I,____________________________________________________________________authorize 

(Name of Patient) 
The ABC Substance Abuse Program

(Name or general designation of program making disclosure) 

to disclose to the [State and/or local] Department of Health officials authorized to require and

(Name of person or organization to which disclosure is to be made) 

receive mandated [HIV/AIDS/STD/TB] reports

the following information: (Nature of the information as limited as possible) 

(1) information that State law requires to be reported about my diagnosis and treatment for—

[initial any which apply] 

____HIV infection 

____AIDS 

____STD (sexually transmitted disease) 

____TB (tuberculosis). 

(2) my name and other personal identifying information, if required to be reported by State law; 

and 

(3) information about my status as a patient in alcohol or drug treatment, if required to be 

reported by State law. 

The purpose of the disclosure authorized herein is to: allow my alcohol or drug treatment program

(Purpose of disclosure as specific as possible)

(named above) to comply with State law(s) requiring the reporting of cases of 

[HIV/AIDS/STD/TB]

I understand that my records are protected under the federal regulations governing 

Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2, and cannot be 

disclosed without my written consent unless otherwise provided for in the regulations. I also 

understand that HIV-related information about me, STD-related information about me, and TBrelated information about me is protected by State law and cannot be disclosed unless the 

disclosure is authorized by State law. I also understand that I may revoke this consent at any time 
except to the extent that action has been taken in reliance on it, and that in any event this consent 

expires automatically as follows: 

________________________________________________________________________ 

(Specification of the date, event, or condition upon which this consent expires) 

________________________________________________________________________ 

________________________________________________________________________ 

________________________________________________________________________ 

Dated:_________________________ ______________________________

Signature of patient

Sample Form #4

CONSENT FOR THE RELEASE OF CONFIDENTIAL INFORMATION ABOUT ALCOHOL 

OR DRUG TREATMENT AND [TB] [STD] [AND/OR] [HIV/AIDS] CARE 

I [name and address of patient], authorize—

(1) the following alcohol or drug treatment program(s): [name and address of each treatment 

program authorized to make and receive disclosures], 

AND 

(2) the following health care provider(s): [name and addresses of each [TB] [STD] [and/or] 

[HIV/AIDS] care provider authorized to make and receive disclosures], 

AND 

(3) [designate staff of the State/local Department of Health responsible for [TB] [STD] [and/or] 

[HIV/AIDS] prevention, control and care; specify appropriate name and address]—

to communicate with and disclose to one another the following information: 

[initial each category that applies]* 

*____ (1) Alcohol or drug treatment: information about my participation and attendance in the 

alcohol or drug treatment program(s) named above that is needed to enable the persons and 

agencies listed above to provide, coordinate and monitor my treatment for [TB] [STD] [and/or] 

[HIV/AIDS]. 
*____ (2) Tuberculosis (TB): information about my diagnosis and treatment for TB that is 

needed to enable the persons and agencies listed above to provide, coordinate and monitor my 

treatment for {TB] [STD] [and/or] [HIV/AIDS]. 

*____ (3) Sexually transmitted disease(s) (STD): information about my diagnosis and treatment 

for any STD that is needed in order to enable the persons named above to provide, coordinate 

and monitor my treatment for the [TB] [STD] [and/or] [HIV/AIDS]. 

*____ (4) HIV/AIDS: information about my HIV status (including HIV test results and 

information about my diagnosis and treatment for HIV-related conditions, including AIDS) that 

is needed to enable the persons and agencies listed above to provide, coordinate and monitor my 

treatment for [TB] [STD] [and/or] [HIV/AIDS]. 

The purpose of these disclosures is to (1) enable the persons and agencies listed above to 

provide, coordinate and monitor the treatment I receive for [TB] [STD] [and/or] [HIV/AIDS]; 

and (2) discuss with me any [sexual/needle sharing] partners or contacts and/or family members 

who might be infected [with [TB] [STD] [HIV] and need treatment. 

I understand that my alcohol and drug treatment records are protected under the federal 

regulations governing Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. 

Part 2, and cannot be disclosed without my written consent unless otherwise provided for in the 

regulations. I also understand that HIV-related information about me, STD-related information 

about me, and TB-related information about me is protected by State law, and cannot be 

disclosed except as authorized by State law. 

I understand that I may revoke this consent at any time except to the extent that action has 

already been taken in reliance on it, and that in any event this consent expires automatically as 

follows: 

____________________________________________________________________________ 

[Specify the date, event or condition upon which this consent expires. This could be one of the 

following: 

(1) The date on which my treatment for [TB] [the STD] is completed. 

(2) A specific date (such as six months or one year) after the consent form is signed.] 

Dated:_________________________ ______________________________

Signature of patient
Sample Form #5

QUALIFIED SERVICE ORGANIZATION AGREEMENT ON COORDINATION OF [HIV/STD/TB] CARE (AOD 

TREATMENT PROGRAM & [HIV/STD/TB] HEALTH CARE PROVIDER) 

[Name of health care facility providing [HIV/AIDS/STD/TB] care to Program patients] ("the 

[HIV/AIDS/STD/TB] Care Provider") and the [name of alcohol or drug treatment program] ("the 

Program") hereby enter into a qualified service organization agreement, whereby the 

[HIV/AIDS/STD/TB] Care Provider agrees to [provide, coordinate and/or monitor] the treatment 

and/or related services for [HIV/AIDS/STD/TB] being provided to patients of the Program who 

are diagnosed, treated and/or provided related services for [HIV/AIDS/STD/TB] by the 

[HIV/AIDS/STD/TB] Care Provider. 

Furthermore, the [HIV/AIDS/STD/TB] Care Provider: 

(1) acknowledges that in receiving, storing, processing or otherwise dealing with any information 

from the Program about the patients in the Program, it is fully bound by the provisions of the 

federal regulations governing Confidentiality of Alcohol and Drug Abuse Patient Records, 42 

C.F.R. Part 2; and 

(2) undertakes to resist in judicial proceedings any effort to obtain access to information 

pertaining to patients otherwise than as expressly provided for in the federal confidentiality 

regulations, 42 C.F.R. Part 2. 

Executed this ______ day of ___________, 199__. 

___________________________ ___________________________

President AOD Program Director

[Name of [HIV/AIDS/STD/TB Care Provider] [Name of Program]

[address] [address]

Sample Form #6

QUALIFIED SERVICE ORGANIZATION AGREEMENT ON REPORTING OF [HIV/AIDS/STD/TB] AND 

COORDINATION OF [HIV/AIDS/STD/TB] CARE (AOD TREATMENT PROGRAM & HEALTH DEPARTMENT 

[HIV/STD/TB] STAFF) 
[Name of relevant Health Department [HIV/AIDS/STD/TB] unit and staff] ("the Health 

Department [HIV/AIDS/STD/TB] Unit") and the [name of alcohol or drug treatment program] 

("the Program") hereby enter into a qualified service organization agreement, whereby the Health 

Department [HIV/AIDS/STD/TB] Unit agrees to [provide, coordinate and/or monitor] the 

treatment and/or related services for [HIV/AIDS/STD/TB] being provided to patients of the 

Program who are diagnosed and reported as having [HIV/AIDS/STD/TB] and are provided 

[HIV/AIDS/STD/TB]-related services by the Health Department [HIV/AIDS/STD/TB] Unit. 

Furthermore, the Health Department [HIV/AIDS/STD/TB] Unit: 

(1) acknowledges that in receiving, storing, processing or otherwise dealing with any information 

from the Program about the patients in the Program, it is fully bound by the provisions of the 

federal regulations governing Confidentiality of Alcohol and Drug Abuse Patient Records, 42 

C.F.R. Part 2; and 

(2) undertakes to resist in judicial proceedings any effort to obtain access to information 

pertaining to patients otherwise than as expressly provided for in the federal confidentiality 

regulations, 42 C.F.R. Part 2. 

Executed this ______ day of ___________, 199__. 

_________________________ _________________________

Director AOD Program Director

[Name of Health Department [Name of Program]

HIVAIDS/STD/TB Unit] [address]

[address]

Appendix B—Opinion Letters

September 25, 1990 

Richard Riseberg, Esq. 

General Counsel 

Office of the General Counsel 

Alcohol, Drug Abuse, and Mental Health Administration 

Room 4A_53 Parklawn 

5600 Fishers Lane 

Rockville, MD 20857 

Dear Mr. Riseberg: 
We are writing to offer our comments on two opinion letters issued in the past two years about 

disclosure of HIV-related information to state health departments under 42 C.F.R., Part 2. 

(Opinion letter by the Legal Advisor to the Alcohol, Drug Abuse, and Mental Health 

Administration to the Oklahoma State Department of Health (September 2, 1988) and Opinion 

letter by Acting General Counsel to the Department of Health and Human Services (Office of the 

Secretary) to the New York State Department of Health (May 17, 1989).) 

These two letters suggest a variety of ways in which HIV-related information contained in 

alcohol or drug abuse patient records protected by 42 U.S.C. § 290 dd–3 and § 290 ee–3 and 42 

C.F.R. Part 2 can be disclosed to state health departments pursuant to mandatory reporting 

requirements. We think that some of the advice offered in the letters is excellent. For example, 

we agree that obtaining patient consent is the best way to report such information while abiding 

by the federal law and regulations; and we agree that reports can be made by some programs by 

deleting alcohol or drug abuse information from the report. However, a number of suggestions 

the letters make disturb us profoundly. 

1. Use of the "audit or evaluation" exception of 42 C.F.R. § 2.53

Both letters suggest that reports of HIV information may be made by a drug or alcohol program 

to the state health department pursuant to 42 C.F.R. § 2.53, the "audit or evaluation" exception of 

the regulations. The letters approve the use of § 2.53 whether the purpose of the state's reporting 

law is research or whether it also includes measures to control the spread of infection, such as 

contact tracing. The letters state that HIV reports made for the purposes of audit or evaluation 

could be used for contact tracing purposes if the identity of the infected individual remains 

anonymous. The letters also state that the health department can contact the patient to discuss his 

or her HIV status, and presumably, sexual and needle contacts. In other words, the public health 

authority can use the information disclosed by the programs to contact the HIV-infected patient 

directly to offer counseling and contact notification services and then approach those contacts, 

provided that the patient's name is not revealed to the contacts. 

We believe that using § 2.53 to report HIV data to public health authorities distorts the meaning 

and purpose of that section.1

Section 2.53 is designed to permit financial and programmatic evaluation of programs' 

functioning. The section contemplates an outside agency such as an accounting firm or a state 

regulatory agency entering the program's premises and examining and/or copying its books and 

records for the purposes of determining how the program is functioning financially or otherwise. 

Reporting the HIV status of patients to public health authorities pursuant to a mandatory 

reporting law serves no audit or evaluation function. The purpose of reporting patients' HIV 

status is clearly not to determine how the program is functioning but to permit the public health 

authorities to use patient-identifying information gained by the program for other purposes. 

Moreover, the public health department's use of patient-identifying information to perform 

contact tracing would likely violate subsection (d) of § 2.53, which states that "patient 

identifying information disclosed under [§ 2.53] may be disclosed only back to the program from 

which it was obtained and used only to carry out an audit or evaluation purpose ...." (emphasis 
added). Since contact tracing is not an audit or evaluation and does not serve such a purpose, § 

2.53(d) appears to prohibit the use of information about a patient to perform contact tracing 

functions, even when the name of the patient is not disclosed to his or her contact. 

2. Use of patient consent when the reporting may lead to civil or criminal sanctions

The May 17, 1989 letter from the Acting General Counsel to the New York State Health 

Department notes that it would clearly be improper to use either § 2.52 or § 2.53 to make reports 

to public health officials "if the purpose of the initial report ... is to investigate an alcohol or drug 

abuse patient for purposes of civil or criminal sanctions...." However, the letter then suggests that 

a program making an initial report to investigate a patient in order to punish that patient might 

make the report with patient consent under § 2.31. In fact, 42 U.S.C. §§ 290 dd–3(c) and ee–3(c) 

make clear that only a court order—not written consent—can authorize use of records for 

criminal investigations. That prohibition is carried over into the regulations at 42 C.F.R. § 

2.12(d)(1). 

We thought we would share with you another solution to the problem of complying with a 

mandatory reporting law that has occurred to us: using a "qualified service organization 

agreement" to make such mandated reports. This might be especially useful for programs that are 

not part of a general medical or mental health facility and are therefore barred in a practical sense 

from making a report by deleting alcohol or drug information. Such a "free-standing" program 

could enter into a QSOA with a laboratory or medical care provider that conducts HIV testing or 

other diagnostic services for the program. As part of its service the QSO could report the HIV 

information to the public health department and delete the alcohol and drug information from the 

report. We recognize that this solution would not be available in some states (New York is 

among them) that have strict laws restricting disclosure of HIV-related information. 

We would be pleased to discuss the issues this letter raises with you, at your convenience. 

Sincerely, 

Margaret K. Brooks 

President/Director 

Legal Action Center 

153 Waverly Place 

New York, NY 10014 

__________________________________ 

1However, we believe that if the purpose of the state's reporting law is solely to collect research 

data about the existence, incidence and impact of HIV/AIDS, alcohol and drug programs can 

comply if the procedural requirements of § 2.52 are met, i.e., (1) if the public health authority is 

qualified to conduct the research (which it probably is), (2) if it has a research protocol to protect 

patient-identifying information and if a group of three or more individuals independent of the 

research project has reviewed the protocol and found it adequate, and (3) if the public health 

authority agrees not to disclose patient-identifying information except back to the program and 
not to identify any individual patient in any report or otherwise disclose patient identities. 

Opinion Letters

May 17, 1989 

Peter J. Millock 

General Counsel 

Department of Health 

State of New York 

Corning Tower, Empire State Plaza 

Albany, New York 12237 

Dear Mr. Millock: 

We are responding to your letter of April 21 seeking our advice on how the Federal 

confidentiality regulations on alcohol and drug abuse patient records, 42 C.F.R. Part 2, affect the 

reporting of communicable diseases under New York law. In our opinion, such disclosures may 

be made by deletion of all alcohol or drug abuse information from the report consistent with 42 

C.F.R. § 2.13(c)(1), with written patient consent under 42 C.F.R. § 2.31–2.33, or as disclosure 

for purposes of research, audit, or evaluation under 42 C.F.R. § 2.52–2.53. In addition, in 

selected cases, reports may be made for purposes of treating a bona fide medical emergency 

under section 2.51. Finally, where a civil or criminal investigation of a particular individual is 

envisioned, it may be necessary to obtain an appropriate court order under section 2.64 or 2.65 of 

the regulations. 

As we understand it, New York law requires that physicians and institutions report cases of 

communicable disease to the local health officer, who in turn is required to report the 

information to the State Department of Health. Your letter states that the purpose of such 

reporting is to enable State and local health officials to "investigate cases of communicable 

disease and take whatever action is necessary and appropriate to deter the spread of a 

communicable disease." In this regard, you indicate that in at least two cases alcohol abuse 

facilities have refused to cooperate with "communicable disease investigations" based on the 

Federal confidentiality regulations. Because of your concern that the Federal law impedes the 

implementation of State reporting requirements, you have sought our advice on the matter. 

We have recently responded to a similar inquiry from the State of Oklahoma on HIV reporting 

and are enclosing a copy of our reply for your review. We advised in that situation that HIV 

reports may be made to Oklahoma public health officials as audit or evaluation disclosures under 

42 C.F.R. § 2.53 if the purpose of such reports was to increase the knowledge of the incidence 

and prevalence of HIV and for health planning purposes. We also suggested, and now conclude, 
that under appropriate circumstances such reports could also be made for purposes of research 

under section 2.52. Finally, we advised that such reports could be made with the patient's written 

consent under sections 2.31 and 2.33 of the regulations. In this regard, we enclosed an opinion to 

Beth Israel Medical Center in New York City which discusses making venereal disease reports 

under State law either with written patient consent or by deletion of alcohol or drug abuse 

identifying information from the report. See 42 C.F.R. § 2.12(a)(1)(I) and (e)(3) and 2.13(c)(1). 

In the Oklahoma opinion, we concluded that HIV reports made for purposes of audit or 

evaluation could be redisclosed back to the alcohol or drug abuse program from which the 

information was obtained and could otherwise be used for contact tracing purposes if the identity 

of the infected individual remained anonymous. However, we should emphasize that both the 

authorizing legislation and the regulations would otherwise generally prohibit the redisclosure of 

alcohol or drug abuse patient identities where the original disclosure was made for purposes of 

research, audit, or evaluation. 42 U.S.C. § 290dd–3; 42 U.S.C. § 290ee–3; 42 C.F.R. §§ 

2.52(a)(2)(ii) and (b) and 2.53(d). 

Thus, it is unclear to us whether the type of "communicable disease investigations" to which you 

refer in your letter could be carried out under section 2.52 or 2.53 of the regulations. In 

particular, it is our view that if the purpose of the initial report to public health officials is to 

investigate an alcohol or drug abuse patient for purposes of civil or criminal sanctions the report 

could not be made as a disclosure for purposes of research, audit, or evaluation. In those 

circumstances, the report would need to be authorized with written patient consent or a court 

order under 42 C.F.R. § 2.64 or 2.65. With respect to section 2.65, we note, however, that it only 

authorizes disclosures for purposes of criminally investigating or prosecuting an alcohol or drug 

abuse patient in cases of "extremely serious" crimes. 42 C.F.R. § 2.65(d)(1). 

In your letter, you have particularly sought our advice on whether the authority in section 2.51 

for disclosing alcohol or drug abuse patient records in cases of a bona fide medical emergency 

would permit communicable disease reports. We have advised under prior regulations that a 

positive venereal disease test did not constitute a bona fide medical emergency under the 

authorizing legislation and regulations because the need for medical treatment of the infected 

individual was not sufficiently immediate to consider it an emergency and, thereby, to justify 

bypassing the normal procedures for obtaining a written consent or a court order. However, as 

the revised regulations provide that the medical emergency which justifies the disclosure could 

be a threat to the health of "any individual" and not just the patient (42 C.F.R. § 2.51(a); 48 Fed. 

Reg. 38767, August 25, 1983) and in recognition of the varying seriousness of different diseases, 

we now conclude that the incidence of venereal and other communicable diseases should be 

assessed on an individual basis to determine whether they constitute a bona fide medical 

emergency for which a disclosure could be made under section 2.51. 

To justify such a disclosure, it is necessary to determine that the information would be disclosed 

to "medical personnel" for the purpose of treating a condition which poses an "immediate threat" 

to the health of any individual and which requires "immediate medical intervention." 42 C.F.R. § 

2.51(a). Furthermore, the alcohol or drug abuse program making the disclosure is required to 

document the circumstances surrounding the disclosure, including the medical personnel to 
whom the disclosure was made and the nature of the emergency. 42 C.F.R. § 2.51(c). 

Because of the nature of these determinations and the documentation required, we believe that a 

medical emergency disclosure would normally have to be made on a case-by-case basis. Thus, 

we do not find that it constitutes a general authority for making communicable disease reports. In 

addition, while the authorizing legislation and regulations do not contain a prohibition on 

redisclosure as is done for research, audit, and evaluation disclosures (42 U.S.C. § 290dd–

3(b)(2)(A); 42 U.S.C. § 290ee–3(b)(2)(A); 42 C.F.R. § 2.51), they do prohibit use of the 

information to criminally investigate or prosecute the alcohol or drug abuse patient absent the 

appropriate court order. 42 U.S.C. § 290dd–3(c); 42 U.S.C. § 290ee–3(c); 42 C.F.R. § 2.12(d)(1). 

Thus, once again we are unsure whether this authority would permit the type of "communicable 

disease investigations" you envision. 

In summary, subject to the constraints discussed above, we conclude that communicable disease 

reports may be made by alcohol and drug abuse treatment programs under New York law by 

deletion of alcohol or drug abuse information from the report, with written patient consent, for 

purposes of research, audit, or evaluation, to medical personnel in cases of a bona fide medical 

emergency, or pursuant to an authorizing court order. If you have any further questions, you may 

wish to discuss them directly with Chris Pascal of my staff who advises the Department on the 

Federal confidentiality laws. If you wish to contact him, he may be reached at 301–443–1212. 

Sincerely, 

Susan K. Zagame 

Acting General Counsel 

Office of the Secretary 

Department of Health and Human Services 

Washington, D.C. 20201 

Enclosures 

bcc: Dr. Pickens 

Sandy Garcia 

Barbara McGarey 

Verla Neslund 

Dr. Jones, CDC 

Aaron Handler, IHS 

Robert Allen, Ph.D., VA 

Opinion Letters
National Institute on Drug Abuse, Opinion 78_3, February 1, 1978 (Legal Opinions on the Confidentiality 

of Alcohol and Drug Abuse Patient Records (1975_1978), at p. 13 (1980)) 

REPORTING OF POSITIVE FINDINGS OF VENEREAL DISEASE IN HOSPITAL 

PATIENTS WITHOUT IDENTIFYING THEM AS RECIPIENTS OF METHADONE 

MAINTENANCE TREATMENT (2.11(p)(3); 2.11(j)) 

To Mr. Karten, Beth Israel Medical Center, New York, NY 

You request an opinion on whether, consistent with the "Confidentiality of Alcohol and Drug 

Abuse Patient Records" regulations, 42 CFR Part 2, Beth Israel Medical Center may report to 

local health authorities positive venereal disease results of hospital patients enrolled in a 

Methadone Maintenance Treatment Program (MMTP), if those patients are not identified in any 

way as MMTP patients. 

It is our opinion that the confidentiality regulations permit Beth Israel Medical Center (BIMC) to 

report, without patient consent, to local health authorities positive venereal disease results of 

BIMC patients who are enrolled in a Methadone Maintenance Treatment Program, if the patients 

are not identified in any way to the health authorities as MMTP patients. 

BIMC is a voluntary hospital which operates a Methadone Maintenance Treatment Program. 

Under section 11.03 of New York City's Health Code, the hospital is required to report all 

patients with positive findings of venereal disease to local health authorities. Due to the possible 

conflict between the confidentiality regulations which restrict disclosure of drug abuse patient 

records and local health laws which require disclosure to health authorities of the identity of all 

patients with positive venereal disease results, the Division of Methadone Monitoring, Food and 

Drug Administration, has recommended that as part of their intake procedure drug abuse 

treatment programs, including MMTP, routinely obtain patient consent to release identifying 

information in cases of positive findings of venereal disease. 

You have indicated dissatisfaction with this method of releasing positive venereal disease results 

of MMTP patients, expressing concern that seeking consent at intake for disclosure of patient 

identifying information under such circumstances will be perceived as coercive by prospective 

patients, and thus render the consent involuntary. As an alternative, Beth Israel Medical Center 

has proposed to report the positive venereal disease results of its MMTP patients by identifying 

them as BIMC patients without indicating that they are MMTP patients. In you inquiry, you have 

asked us whether this proposed method of reporting is allowed under the confidentiality 

regulations. 

It is our opinion that BIMC's proposed method of reporting positive venereal disease results is 

consistent with the confidentiality regulations.142 CFR § 2.13(a) states that "[r]ecords to which 

this part applies shall be confidential and may be disclosed only as authorized by this part ...." 42 

CFR § 2.11(p) states: 

"The following types of communications do not constitute disclosures of records: 
"(3) Communications of information which includes neither patient identifying information nor 

identifying numbers assigned by the program to patients."2

Read together, these two provisions of the regulations provide that communications of 

information which include neither patient identifying information nor identifying numbers 

assigned by the program to patients are not disclosures of records subject to the restrictions of 42 

CFR Part 2. Thus, BIMC may report the positive venereal disease results of its MMTP patients 

without patient consent, if the reports do not disclose "patient identifying information" or 

"identifying numbers assigned by the program to patients." 

Section 2.11(j) of the regulations defines "patient identifying information", in pertinent part, as 

"... 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." Furthermore, 

"patient" is defined, in pertinent part, by §2.11(i) as "any individual ... who has applied for or 

been given diagnosis or treatment for drug abuse or alcohol abuse ...." (Emphasis added.) Thus, 

we conclude that "patient identifying information" as used in 42CFR§2.11(p)(3) refers to 

information which can be used to identify a patient, with reasonable accuracy and speed, as an 

"individual ... who has applied for or been given diagnosis or treatment for drug abuse or alcohol 

abuse." Accordingly, when reporting its patients' positive venereal disease results, if BIMC does 

not identify a patient as having applied for or been given diagnosis or treatment for drug or 

alcohol abuse nor provide his or her program identifying number, it is not making a disclosure of 

a record for purposes of the regulations. 

This conclusion is consistent with 42 CFR § 2.13(f) which provides that: 

"The presence of any in-patient in a medical facility for the treatment of drug or alcohol abuse 

may be acknowledged to callers and visitors with his written consent. Without such consent, the 

presence of any in-patient or resident in a facility for the treatment of a variety of conditions may 

be acknowledged if done in such a way as not to indicate that the patient is being treated for 

drug or alcohol abuse." (Emphasis added.) 

Since Beth Israel Medical Center is a "voluntary hospital" which, we presume, treats a variety of 

conditions, it qualifies under section 2.13(f) as a facility that may report the presence of a drug or 

alcohol abuse patient in its facility without the patient's consent if this reporting is done "in such 

a way as not to indicate that the patient is being treated for drug or alcohol abuse." 

In summary, we conclude that BIMC may report, without patient consent, the positive venereal 

disease results of its MMTP patients to local health authorities, if these patients are not identified 

as MMTP patients in accord with the provisions of 42 CFR §§ 2.11(p)(3) and 2.13(f). 

1We note that we do not find anything legally incorrect in the Division of Methadone 

Monitoring's recommendation that patient consent to disclosure of positive venereal disease 
results be routinely obtained at intake. This recommendation is consistent with our prior advice. 

Letter, GH (Greene) to Young, July 18, 1977 (DF #25B). 

2

For a general discussion of 42 CFR § 2.11(p)(3), see, letter, GH (Edelman) to Ichord, May 17, 

1977 (DF #25B).

Opinion Letters

September 2, 1988 

John Harkess, M.D. 

Assistant State Epidemiologist 

Oklahoma State Department of Health 

P.O. Box 53551 

1000 N.E. Tenth 

Oklahoma City, Oklahoma 73152 

Re: Disclosure of HIV Records to State Health Department Under 42 C.F.R. Part 2—GH Ref. 

#88–1776 (DF#92, #25B) 

Dear Dr. Harkess: 

We are responding to your letter of July 12, 1988, and our subsequent phone conservation in 

which you requested legal advice on the disclosure of HIV information from drug abuse 

treatment records subject to 42C.F.R.Part 2 to the Oklahoma State Department of Health. This 

disclosure is now required in Oklahoma under a change in State law which makes HIV infection 

a reportable disease. Okla. Stat. tit. 63, § 1–503 (1981) (an emergency rule was adopted Jan. 20, 

1988, by the Oklahoma State Board of Health adding HIV to the list of reportable diseases). 

As we understand it, the procedure for reporting HIV infections to the health department is as 

follows. The infected person's name and birthdate is reported, although no address is included. 

The health department uses this information to increase its knowledge of the incidence and 

prevalence of the disease and for health planning purposes. It also will use this information 

internally to eliminate double-counting of HIV cases (where reports on the same person are 

received from more than one source) and to contact the infected person to offer services, such as 

HIV counseling and assistance with contact notification. Although HIV reports may be made in 

other instances as well, most reports involving drug abusers are expected as a result of a State 

health department initiative which offers drug abuse patients HIV testing with informed consent

and pre- and post-test counseling. Your legal questions concern how the Federal confidentiality 

regulations for drug abuse treatment programs, 42C.F.R. Part 2, affect compliance with 

Oklahoma's HIV reporting requirement and the health department's use of this information once 

received. 
We have previously advised that identifiable HIV records may be disclosed from drug abuse 

treatment programs to public health authorities without patient consent to the extent that the 

information is needed to research the causation of AIDS, to conduct epidemiological studies or 

health program planning, or to evaluate the incidence and treatment of the disease.1 Although the 

regulatory provisions on which this prior advice was based have changed, we believe that HIV 

reports may be made by drug abuse treatment programs to the Oklahoma health department 

without patient consent under 42 C.F.R. 2.53 as a disclosure for the purposes of audit or 

evaluation.2 Although section 2.52 which authorizes disclosures for research activities could also 

be used for making HIV reports to the health department, it requires the researcher to obtain an 

independent review of the research protocol for purposes of protecting the research subjects 

before any drug abuse records may be disclosed. 42 C.F.R. 2.52(a)(3) (as amended by 52 F.R. 

41997, Nov. 2, 1987).3Thus, it might be unsuitable for the type of mandatory HIV reporting 

envisioned here.4In any event, reliance on section 2.52 does not appear necessary as disclosures 

to the health department could be made under section 2.53. Although 2.53 authorizes the initial 

disclosure of HIV information to the health department, the health department may not identify 

any individual patient in any report of its audit or evaluation activities or otherwise redisclose 

information except back to the program from which it was obtained. 42 C.F.R. 2.53(d); 42 

U.S.C. § 290ee–3(b)(2)(B).5

This limited authority to make redisclosures would permit the State health authority to contact 

the drug abuse treatment program that made the HIV report to offer counseling and contact 

notification services to the HIV infected individual. It would also permit the public health 

authority to notify the sexual and needle contacts of the HIV individual because, as we 

understand it, such notification keeps the name of the infected person anonymous, thus 

exempting this communication of information from the meaning of disclosure under the 

regulations. 42 C.F.R. 2.11 ("disclosure"); 42 C.F.R. 2.12(a)(1)(I).6 However, there is no explicit 

authorization in the regulations for contacting the HIV infected individual directly if the 

individual is no longer at the drug abuse program. We previously advised under the prior 

regulations that we did not believe the confidentiality protections were intended to restrict 

disclosures to the patient of information in his or her records of which the patient was already 

aware.7 We find that this position continues to be sound under the revised regulations and, 

accordingly, conclude that the State health authority may contact the HIV infected individual 

directly to offer counseling and contact notification services. However, in doing so, the authority 

must ensure that it does not disclose information that would identify the individual as a drug 

abuse patient to others. 

In addition to the nonconsensual disclosures which may be made for purposes of research, audit, 

or evaluation, HIV reports may be made to public health authorities with written patient consent. 

The use of written patient consent has a number of advantages, including placing the patient on 

notice of the existence of the State HIV reporting law and ensuring that the State health 

department may make all disclosures necessary to fulfill their contact notification 

responsibilities. 

In obtaining the patient's consent, the confidentiality regulations require that a special consent 

form must be used and that any needed redisclosures must be expressly permitted. 42 C.F.R. 2.31 

and 2.32. Because HIV testing on drug abusers in Oklahoma will largely be performed with 
patient consent at drug abuse treatment programs, it may be convenient to obtain the patient's 

written consent to disclosure at the same time consent to the HIV test is obtained. Since the 

confidentiality regulations themselves and Oklahoma law provide for confidentiality of the HIV 

report, those individuals who wish to be tested would presumably be willing to consent to 

disclosure of the HIV information to the State health authority. Nevertheless, in those cases 

where consent was not obtained, the HIV information could be reported for purposes of research, 

audit, or evaluation as previously discussed. 

In summary, we believe that the reports of HIV infection required under Oklahoma law may be 

made in compliance with the Federal confidentiality laws for drug abuse treatment records, 42 

U.S.C. § 290ee–3 and 42C.F.R. Part 2, either with written patient consent or, without such 

consent, as a disclosure for purposes of research, audit, or evaluation. 

We hope this information has been helpful. Please let me know if you have any further questions. 

Sincerely, 

Chris B. Pascal, Legal Advisor 

Alcohol, Drug Abuse, and Mental Health Administration 

Public Health Division 

Department of Health and Human Services 

Room 4A-53 Parklawn Bldg. 

5600 Fishers Lane 

Rockville, MD 20857 

bcc: Dr. Pickens Gene Matthews 

Verla Neslund Sandy Garcia 

Barbara McGarey Bill Quinlin 

Dr. Allen, VA Dick Riseberg 

John Holliday 

1Memorandum, GH (Pascal) to NIDA (Gardner), Nov. 3, 1983 (DF #25B); See also, C. Pascal, 

"Selected Legal Issues About AIDS for Drug Abuse Treatment Programs," Journal of 

Psychoactive Drugs, Vol. 19, P. 2, Jan.–Mar. 1987. 

2Although revised section 2.53 refers to an evaluation or audit activity encompassing a "review 

of records on program premises" (which is not envisioned here since the program will transmit 

the information to the State), we do not believe this is intended as a limitation on the type of 

audit and evaluation activities which could be conducted but rather as a description of perhaps its 

most common form. In this regard, we do not find that there was any intention during the 

revision of the regulations to restrict disclosures for audit or evaluation activities to an on-site 

review of records and note that the definition of "program evaluation" in the prior regulations 

was much broader in scope than the evaluation of an individual alcohol or drug abuse program. 

See 52F.R. 21800, 21801, June 9, 1987; 42 C.F.R. 2.11(f)(2) and (g)(2) (1986) (prior 
regulations). Accordingly, we conclude that an HIV report to the Oklahoma State Health 

Department may be made as a nonconsensual disclosure for purposes of audit or evaluation 

under 42 C.F.R. 2.53 and 42 U.S.C. § 290ee–3(b)(2)(B). 

It is interesting to note that the authority of the Veterans Administration for protection of alcohol 

and drug abuse patient records (which is modeled after the Department of Health and Human 

Services authority discussed here) was recently amended to add HIV records to the 

confidentiality protections and to give explicit authority for disclosing the HIV records to State 

or local public health authorities without consent. 38 U.S.C. 4132(b)(2)(C), as amended by 

section 121 of Pub. L. 100–322, the "Veterans' Benefits and Services Act of 1988," enacted May 

20, 1988. 

3We have doubts that the provisions of section 2.52 requiring a research protocol and its 

independent review are intended to apply to the type of non-experimental research contemplated 

here, i.e., tracking the causation and incidence of disease. In this regard, the prior regulations did 

not restrict the meaning of "scientific research" in any way and there is no indication that the 

Department intended to change this position in the revised regulations. 42 C.F.R. 2.52(a), 2.52–

1(n), and 2.53(c)(1986); 48F.R.38765,38766, Aug. 25, 1983; 52 F.R. 21800, 21801, June 9, 

1987. This suggests that the conduct of research which does not include a formal research 

protocol would not be barred by section 2.52 nor would it be subject to the protocol review 

requirements. However, we need not formally resolve this issue because we believe that the type 

of reporting required by the State health department falls within the scope of disclosures for 

purposes of audit or evaluation as discussed above. 

4We note, however, that, even assuming the research protocol provisions of section 2.52 apply, 

certain Federally sponsored HIV testing, such as that performed under the national 

seroprevalence survey, has received Institutional Review Board approval and, thus, would 

comply with these provisions. 

5

Section 2.53(a) requires the person performing the audit or evaluation activity to agree in 

writing to abide by the prohibitions on redisclosure. We believe the State health department may 

comply with this provision by simply adopting a written policy to this effect and notifying the 

pertinent drug abuse providers of its existence. 

6We note that the Veterans Administration statute discussed in Note 2 also provides for 

nonconsensual notification of a positive finding of HIV to the infected person's spouse or sexual 

partner. 38 U.S.C. 4132(f). This is consistent with recommendation 9–36 of the Report of the 

Presidential Commission on the Human Immuno-deficiency Virus, p. 129 (June 1988). 

7

In Opinion 77–14, we advised that "neither the confidentiality statutes, 21 U.S.C. § 1175 and 42 

U.S.C. 4582, nor the regulations, are intended to restrict the communication to a patient of 

limited information, necessary for purposes of bill collection, which he knows by reason of his 

participation in the program...." We believe this same analysis would apply to a disclosure to the 

patient of his HIV status by the State health department in those cases in which the patient has 

already received the information from the program.