Main Body
Regulatory Affairs - Statute and Regulations
Effective June 1, 2005
10 NYCRR
10 NYCRR
AIDS TESTING AND CONFIDENTIALITY OF HIV-RELATED INFORMATION
Section
Section 63-1 Definitions.
(a) "HIV-infection" means infection with
the human immunodeficiency viruses that are the cause of
AIDS or as the term may be defined from time to time by the
Centers for Disease Control and Prevention of the United
States Public Health Service.
(b) "AIDS" means acquired immune
deficiency syndrome, as may be defined from time to time by
the Centers for Disease Control and Prevention of the
United States Public Health Service.
(c) "HIV-related illness" means any
clinical illness that may result from or be associated with
HIV infection.
(d) "HIV-related test" means any
laboratory test or series of tests for any virus, antibody,
antigen or etiologic agent whatsoever, thought to cause or
to indicate the presence of HIV infection, HIV-related
illness or AIDS.
(e) "Capacity to consent" means an
individual's ability, determined without regard to the
individual's age, to understand and appreciate the
nature and consequences of a proposed health care service,
treatment, or procedure, or of a proposed disclosure of
confidential HIV-related information, and to make an
informed decision concerning the service, treatment,
procedure or disclosure.
(f) "Protected individual" means a
person who is the subject of an HIV related test or who has
been diagnosed as having HIV infection, AIDS or HIV-related
illness.
(g) "Confidential HIV-related
information" means any information, in the
possession of a person who provides health or social
services or who obtains the information pursuant to a
release of confidential HIV-related information, concerning
whether an individual has been the subject of an HIV
related test, or has HIV infection, HIV-related illness or
AIDS, or information which identifies or reasonably could
identify an individual as having one or more of such
conditions, including information pertaining to such
individual's contacts.
(h) "Health or social service" means any
care, treatment, clinical laboratory test, counseling or
educational service for adults or children, and acute,
chronic, custodial, residential, outpatient, home or other
health care; public assistance, including disability
payments available pursuant to the Social Security Act;
employment-related services, housing services, foster care,
shelter, protective services, day care, or preventive
services; services for the mentally disabled; probation
services; parole services; correctional services; detention
and rehabilitative services; and the activities of the
Health Care Worker HIV/HBV Advisory Panel (see Public
Health Law Article 27-DD), all as defined in section
2780(8) of the Public Health Law.
(i) "Health facility" means a hospital
as defined in section 2801 of the Public Health Law, blood
bank, organ procurement organization, tissue bank, clinical
laboratory, or facility providing care or treatment to
persons with a mental disability.
(j) "Health care provider" or
"provider" means any physician, nurse,
licensed or certified provider of diagnostic medical
services, including a nurse practitioner, a midwife and
physician assistant, provider of services for the mentally
disabled or other person involved in providing medical,
nursing, counseling, or other health care or mental health
service including those associated with, or under contract
to, a health maintenance organization or medical services
plan. Diagnostic providers include physicians, nurse
practitioners, physician assistants and midwives who are
authorized to order diagnostic tests and to make clinical
diagnoses.
(k) "Contact" means an identified spouse
or sex partner of the protected individual or a person
identified as having shared hypodermic needles or syringes
with the protected individual, or a person whom the
protected individual may have exposed to HIV under
circumstances that present a risk of transmission of HIV,
as noted in subdivision (m) of section 63.8 of this Part.
(l) "Contact tracing" shall mean the
process of notifying known contacts of protected
individuals as reported by the physician or as disclosed by
the protected individuals themselves, and of seeking the
cooperation of protected individuals to name contacts, as
described in section 63.8 of this Part. For the purposes of
this Part, the terms "contact notification",
"partner notification", "partner
assistance" and "partner counseling and referral
services" shall be synonymous with "contact
tracing". In all cases of contact tracing authorized
in this Part, the name or other identifying information
regarding the protected person shall not be disclosed to
contacts and the name of contacts shall not be disclosed to
other contacts.
(m) "Person" includes any natural
person, partnership, association, joint venture, trust,
public or private corporation or state or local government
agency.
(n) "Release of confidential HIV-related
information" means a written authorization for
disclosure of confidential HIV-related information which is
signed by the protected individual, or if the protected
individual lacks capacity to consent, a person authorized
pursuant to law to consent to health care for the
individual. Such release shall be dated and shall specify
to whom disclosure is authorized, the purpose for such
disclosure and the time period during which the release is
to be effective. A general authorization for the release of
medical or other information shall not be construed as a
release of confidential HIV-related information, unless
such authorization specifically indicates its dual purpose
as a general authorization and an authorization for the
release of confidential HIV- related information and
complies with this definition.
(o) "Insurance institution" means any
corporation, association, partnership, reciprocal exchange,
interinsurer, fraternal benefits society, agent, broker or
other entity in the business of providing health, life and
disability coverage including, but not limited to, any
health maintenance organization, medical service plan, or
hospital plan which:
(1) is engaged in the business of insurance;
(2) provides health services coverage plans; or
(3) provides benefits under, administers, or provides
services for, an employee welfare benefit as defined in 29
U.S.C. 1002(1).
(p) "Municipal health commissioner"
shall mean, for purposes of this Part, a county health
commissioner, except, in New York City, the term shall mean
the New York City health commissioner. Such county health
commissioner and New York City health commissioner shall
conduct reporting, counseling and contact notification
activities consistent with guidelines acceptable to the
commissioner in compliance with Article 21, Title III and
Article 27-F of the Public Health Law.
(q) "District health officer" shall
mean, for the purposes of this Part, the commissioner or
his/her designee.
(r) For the purposes of this Part,
"commissioner" shall mean the New York
State Commissioner of Health.
(s) For the purposes of this Part, "authorized
public health official" shall mean New York State
Commissioner of Health, a municipal health commissioner or
a district health officer, or their designee.
Section 63.2 Application.
These regulations apply to physicians and other persons
authorized by law to order laboratory tests or to make
medical diagnoses, laboratories, blood banks, tissue banks
and organ procurement organizations, to persons who receive
confidential HIV-related information in the course of
providing any health or social service and to persons who
receive confidential HIV-related information pursuant to a
release. These regulations do not apply to information
which was received by the Commissioner under Subpart 24-1
of this Title and protected from disclosure pursuant to
Public Health Law section 206(1)(j). These regulations do
not apply to insurance institutions and insurance support
organizations, except as noted in section 63.6(a)(9), (10)
and (12). Health care providers associated with or under
contract to a health maintenance organization or other
medical services plan are subject to these regulations.
Section 63.3 HIV-related testing.
(a) Except as noted in paragraph (b)(2) below, no physician
or other person authorized pursuant to law may order an
HIV-related test without first obtaining written informed
consent. A physician or other person authorized pursuant to
law to order an HIV-related test to be used for patient
care shall provide to the laboratory the name and address
of the person who is the source of the specimen and other
such information as specified by the commissioner.
(1) Informed consent shall include providing pre-test
counseling to the person to be tested or, if such person
lacks capacity to consent, to the person lawfully
authorized to consent to health care for such person. In
situations in which a person other than the test subject
consents for the test, pre-test counseling shall also be
provided to the test subject to the extent that the person
responsible for ordering the test deems that the test
subject will benefit from counseling. Pretest counseling
shall include:
(i) explanations regarding the nature of HIV infection and
HIV related illness, an explanation of the HIV-related
test, including a description of the procedure to be
followed, meaning of the test results, including
preliminary positive results obtained prior to
confirmation, if applicable, and the benefits of taking the
test, including the importance and benefits of early
diagnosis and medical intervention;
(ii) an explanation that discrimination problems may result
from disclosure of confidential HIV-related information and
that legal protections exist which prohibit discrimination
(NYC and NYS Human Rights Law) and unauthorized disclosures
(PHL Article 27-F and/or Article 21, Title III);
(iii) information on preventing exposure or transmission of
HIV infection, including behavior which poses a risk of HIV
transmission;
(iv) an explanation that the test is voluntary, that
consent may be withdrawn at any time, information on the
benefits of testing and or early treatment, information
that HIV reporting is required by law and that such
information must be kept confidential and will be used for
the purposes of epidemiologic monitoring of the HIV/AIDS
epidemic, that persons who test positive will be requested
to cooperate in contact notification efforts, that known
contacts will be reported by the physician or other person
authorized to order a diagnostic test to the health
department for the purposes of contact notification as
needed, and that anonymous testing is available including
the location and telephone numbers of anonymous test sites,
and that for the purpose of insurance coverage,
confidential, as opposed to anonymous testing is required;
and
(v) information regarding psychological and emotional
consequences of receiving the test result;
(b)(1) Written informed consent must be executed on a form
developed by the department or on another form approved
specifically by the department. At the time at which
informed consent is obtained, the subject must be offered a
copy of the informed consent form or a document that
provides all pertinent information contained on the
informed consent form.
(2) Informed consent is not required in the following
situations:
(i) for court-ordered testing pursuant to Civil Practice
Law and Rules Section 3121;
(ii) when testing without informed consent is otherwise
specifically authorized or required by state or federal
law;
(iii) for testing related to procuring, processing,
distributing or use of a human body or human body part,
including organs, tissues, eyes, bones, arteries, blood,
semen or other body fluids for use in medical research or
therapy, or for transplantation to persons, provided that
if the test results are communicated to the tested person,
post-test counseling is required;
(iv) for research if the testing is performed in a manner
by which the identity of the test subject is not known and
may not be retrieved by the researcher;
(v) for testing of a deceased person to determine cause of
death or for epidemiological purposes; and
(vi) for comprehensive newborn testing pursuant to PHL
section 2500-f.
(c) A physician or other person authorized pursuant to law
to order an HIV-related test shall certify on a laboratory
requisition form that informed consent has been obtained,
except when not required pursuant to section 63.3(b)(2). In
approved anonymous testing sites, authorized employees or
agents of the department may order HIV-related tests and
certify that they obtained informed consent in approved
anonymous testing sites.
(d) In addition to an explanation of the test result, the
person who orders the test shall be responsible for
ensuring that post-test counseling or referrals as
appropriate with respect to a positive,
indeterminate/inconclusive, negative test result and
preliminary positive results obtained pursuant to Subpart
58-8, if applicable, shall be provided to the person who
consented to the test. Blood banks and tissue banks may
report results as specified in sections 58-2.23 and 52-3.6,
respectively. In situations in which a person other than
the test subject consents for the test, post-test
counseling and referrals should also be provided to the
test subject, to the extent the person responsible for
ordering the test deems that the test subject will benefit
from counseling. Such post-test counseling and referrals
shall include specific referral information and shall
address:
(1)(i) coping emotionally with the test results;
(ii) discrimination issues relating to employment, housing,
public accommodations, health care and social services;
(iii) information on the ability to release or revoke the
release of confidential HIV-related information; and
(iv) information on preventing exposure to or transmission
of HIV infection; and
(2) for persons who test positive, post-test counseling
shall, in addition, address:
(i) that HIV reporting is required by law for the purposes
of epidemiologic monitoring of the HIV/AIDS epidemic;
(ii) that contacts should be notified to prevent
transmission, and to allow early access of exposed persons
to HIV counseling and testing, health care, and prevention
services, and a description of notification options and
assistance available to the protected individual;
(iii) an assessment of the risk of domestic violence in
conformance with a domestic violence screening protocol
developed by the commissioner pursuant to law;
(iv) that known contacts, including a known spouse, will be
reported and that protected persons will also be requested
to cooperate in contact notification efforts of known
contacts and may name additional contacts they wish to have
notified with the assistance of the provider or authorized
public health officials;
(v) that the protected individual's name or other
information about them is not disclosed to any person
during the contact notification process;
(vi) information on the availability of medical services
and the location and telephone numbers of treatment sites,
information on the use of HIV chemotherapeutics for
propyhlaxis and treatment and peer group support, access to
prevention services and assistance, if needed, in obtaining
any of these services; and
(vii) a discussion of perinatal transmission.
(e) Nothing in this Part or Part 58 shall be construed to
prohibit a person from directly ordering an HIV test on a
specimen taken from his/her own body and directly receiving
the results of such HIV test. The test must be performed by
a laboratory using a specimen collection kit which has been
approved for home HIV specimen collection by the U.S. Food
and Drug Administration and which is available without a
prescription.
(f) In situations when HIV-related testing is intended to
aid in clinical disease monitoring, e.g., HIV nucleic acid
(RNA or DNA) detection tests, pre- and post-test counseling
may be tailored to the needs of the patient.
Section 63.4 Filing of reports.
(a)(1) All initial determinations or diagnoses of Human
Immunodeficiency Virus (HIV) infection, HIV-related illness
and Acquired Immune Deficiency Syndrome (AIDS) shall be
reported to the commissioner by physicians and other
persons authorized to order diagnostic tests or make
medical diagnoses or their agents as soon as possible after
post-test counseling but no later than 21 days after the
provider's receipt of a positive laboratory result or
after diagnosis, whichever is sooner.
(2) All determinations or diagnoses of HIV, HIV-related
illness and AIDS shall be reported to the commissioner by
blood banks as defined in Article 5, Title V of the Public
Health Law, by tissue banks and organ procurement
organizations as defined by Article 43-B of the Public
Health Law as soon as possible after post-test counseling
but no later than 21 days after receipt of a confirmed
positive laboratory result or after diagnosis, whichever is
sooner. Such banks and organizations shall report confirmed
positive HIV antibody test results.
(3) Pathologists, coroners and medical examiners or other
persons determining from examination of a corpse or from
the history of the events leading to death, that at the
time of death the individual was apparently affected with
HIV infection, HIV-related illness or AIDS shall also make
such report to the commissioner within 21 days after
receipt of a test result or determination.
(4)(i) Laboratories performing diagnostic tests shall
report to the Commissioner cases of initial determinations
or diagnoses of HIV infection, HIV-related illness and AIDS
on a schedule to be specified by the Commissioner.
Laboratories shall report the following: confirmed positive
HIV antibody test results, HIV nucleic acid (RNA or DNA)
detection test results, all CD4 lymphocyte counts unless
the test was known to be performed for reasons other than
HIV infection or HIV-related illness, HIV subtype and
antiviral drug resistance testing in a format designated by
the Commissioner, and the results of other tests as may be
determined by the Commissioner to indicate a diagnosis of
HIV infection, HIV-related illness or AIDS.
(ii) For the purposes of laboratory reporting, initial
diagnosis shall mean the first such test noted in (i) above
which is performed on a specimen submitted after the
effective date of these regulations.
(b) Reports, including names and addresses of the protected
individual, contact information and other information as
may be specified by the commissioner, shall be made in a
manner and format as prescribed by the commissioner.
Information reported shall also include names and
addresses, if available, of contacts, including spouses,
known to the physician or other person authorized to order
diagnostic tests or make medical diagnoses, or provided to
them by the protected person, and the date each contact was
notified if contact notification has already been done; and
information, in relation to each reported contact, required
by an approved domestic violence screening protocol. After
receiving the report, the commissioner or his/her
authorized representative may request the individual making
the report or the person who ordered the diagnostic tests
to provide additional information as may be required for
the epidemiologic investigation, case finding and analysis
of HIV infection, HIV-related illness and Acquired Immune
Deficiency Syndrome (AIDS) and to implement Article 21,
Title III. Notwithstanding this subdivision, test results
from New York State approved anonymous test sites shall not
be reported to the commissioner unless the test subject
chooses to supply identification and convert the anonymous
test result to a confidential test result.
(c) Confidentiality. Such reports and additional
information maintained by the commissioner or his/her
designated representative, including all information
generated by contact notification and domestic violence
screening activities, shall be kept confidential as
required by Public Health Law, Article 21, Title III, and
shall not be disclosed except when in the judgment of the
public health official, necessary to other authorized
public health officials for conducting accurate and
complete epidemiological monitoring of the HIV/AIDS
epidemic and for conducting contact notification
activities, except that contact names and locating
information may be disclosed to public health officials in
other jurisdictions when necessary to notify the contact;
no information about the protected individual will be
released to any person in this process.
Section 63.5 Disclosure pursuant to a release.
(a) No confidential HIV-related information, including such
information as related to domestic violence screening,
shall be disclosed pursuant to a general release except to
insurance companies as noted in section 63.6(a)(9).
Disclosure is permitted for HIV-related information
pursuant to a specific release form for a limited time
period which has been developed or approved by the
Department. The release must be signed by the protected
individual, or if the protected individual lacks capacity
to consent, by a person authorized pursuant to law to
consent to health care for the individual.
(b) All written disclosures of confidential HIV information
must be accompanied by a statement prohibiting
redisclosure. The statement shall include the following
language or substantially similar language: "This
information has been disclosed to you from confidential
records which are protected by state law. State law
prohibits you from making any further disclosure of this
information without the specific written consent of the
person to whom it pertains, or as otherwise permitted by
law. Any unauthorized further disclosure in violation of
state law may result in a fine or jail sentence or both. A
general authorization for the release of medical or other
information is not, except in limited circumstances set
forth in this part, sufficient authorization for further
disclosure. Disclosure of confidential HIV information that
occurs as the result of a general authorization for the
release of medical or other information will be in
violation of the state law and may result in a fine or a
jail sentence or both."
(c) If oral disclosures are necessary, they must be
accompanied or followed as soon as possible, but no later
than 10 days, by the statement required by subdivision (b).
(d) The statement required by subdivisions (b) and (c) is
not required for release to the protected person or when a
person lacks the capacity to consent, to a person
authorized pursuant to law to consent to health care for
the person, for releases made by a physician or their agent
or public health officer to a contact; or for releases made
by a physician or their agent to a person authorized
pursuant to law to consent to the health care of the
protected person when the person has been counseled and has
refused to disclose and the disclosure is medically
necessary. For disclosures of confidential HIV-related
information from the patient's medical record to
persons who are permitted to access this information
pursuant to sections 63.6(a)(3), (4), (5), (6), (7), (9)
and (10) and 63.6(e) and (f), it shall be sufficient for
the statement required by subdivisions (b) and (c) to
appear as part of the medical record when a medical record
is disclosed.
Section 63.6 Confidentiality and disclosure.
(a) No person who obtains confidential HIV-related
information in the course of providing any health or social
service or pursuant to a release of confidential
HIV-related information may disclose or be compelled to
disclose such information, except to the following:
(1) the protected individual or, when the protected
individual lacks capacity to consent, a person authorized
pursuant to law to consent to health care for the
individual;
(2) any person to whom disclosure is authorized pursuant to
a release of confidential HIV-related information in
accordance with section 63.5(a);
(3) an agent or employee of a health facility or health
care provider if (i) the agent or employee is authorized to
access medical records; (ii) the health facility or health
care provider itself is authorized to obtain the
HIV-related information; and (iii) the agent or employee
provides health care to the protected individual, or
maintains or processes medical records for billing or
reimbursement;
(4)(i) a health care provider or health facility when
knowledge of the HIV-related information is necessary to
provide appropriate care or treatment to the protected
individual or a child of the individual;
(ii) a health care provider or health facility when
knowledge of HIV-related information is necessary to
provide appropriate care or treatment to a contact,
provided the requirements in subdivision (m) of section
63.8 are followed for disclosures involving exposures in
risk situations;
(iii) in circumstances when consent for health care is
necessary, disclosure may also be made to a person
authorized to consent to health care for such contact or
for such protected individual, provided that if disclosure
is to a person authorized to consent to the health care of
a contact or to a contact when such contact has been
exposed to HIV under circumstances which present a risk of
transmission, the requirements in subdivision (m) of
section 63.8 must be followed;
(5) a health facility or health care provider, in relation
to the procurement, processing, distributing or use of a
human body or a human body part, including organs, tissues,
blood, semen, or other body fluids, for use in medical
education, research, therapy, or for transplantation to
individuals;
(6) health facility staff committees, or accreditation or
oversight review organizations authorized to access medical
records, provided that such committees or organizations may
only disclose confidential HIV-related information:
(i) back to the facility or provider of a health or social
service;
(ii) to carry out the monitoring, evaluation, or service
review for which it was obtained; or
(iii) to a federal, state or local government agency for
the purposes of and subject to the conditions provided in
paragraph (e) of this section;
(7) a federal, state, county or local health officer when
such disclosure is mandated by federal or state law,
including reporting and contact notification processes
authorized pursuant to Article 21, Title III, or pursuant
to Article 27-F;
(8) authorized agencies as defined by Social Services Law,
Section 371 and corporations incorporated or organized to
receive children for adoption or foster care, in connection
with foster care or adoption of a child. Such agency shall
be authorized to redisclose such information only pursuant
to the provisions of Article 27-F of the Public Health Law
or in accordance with the provisions of Social Services Law
Section 373-A and regulations promulgated thereunder;
(9) third party reimbursers or their agents to the extent
necessary to reimburse health care providers, including
health facilities, for health services, provided that, an
otherwise appropriate authorization for such disclosure has
been secured;
(10) an insurance institution, for other than the purpose
set forth in paragraph (9) of this subdivision, provided
the insurance institution secures a dated and written
authorization that indicates that health care providers,
health facilities, insurance institutions, and other
persons are authorized to disclose information about the
protected individual, the nature of the information to be
disclosed, the purposes for which the information is to be
disclosed and which is signed by:
(i) the protected individual;
(ii) if the protected individual lacks the capacity to
consent, such other person authorized pursuant to law to
consent for such individual; or
(iii) if the protected individual is deceased, the
beneficiary or claimant for benefits under an insurance
policy, a health services plan, or an employee welfare
benefit plan as authorized in Article 27-F of the Public
Health Law;
(11) to a funeral director upon taking charge of the
remains of a deceased person when such funeral director has
access in the ordinary course of business to HIV-related
information on the death certificate of the deceased
individual, as authorized by Public Health Law Section
4142;
(12) any person to whom disclosure is ordered by a court of
competent jurisdiction pursuant to Public Health Law
Section 2785;
(13) an employee or agent of the Division of Probation and
Correctional Alternatives, Division of Parole, Commission
of Correction, or any local probation department, to the
extent the employee or agent is authorized to access
records containing such information in order to carry out
functions, powers and duties with respect to the protected
person and in accordance with regulations promulgated
pursuant to Public Health Law Article 27-F;
(14) a medical director of a local correctional facility in
accordance with regulations promulgated pursuant to Article
27-F to the extent the medical director is authorized to
access records to carry out his/her functions relating to
the protected person. Redisclosure by the medical director
is prohibited except as permitted under Public Health Law
Article 27-F, Article 21, Title III and implementing
regulations;
(15) an employee or agent of the New York City Board of
Corrections so that the board may continue to access
records of inmates who die while in the custody of the New
York City Department of Corrections when necessary for the
board to carry out its duties, functions, and powers with
respect to the protected individual, pursuant to the New
York City charter; or
(16) a law guardian, appointed to represent a minor
pursuant to the social services law or the family court
act, for the purpose of representing that minor. If the
minor has the capacity to consent, the law guardian may not
redisclose confidential HIV related information without the
minor's permission. If the minor lacks capacity to
consent, the law guardian may redisclose confidential
HIV-related information for the purpose of representing the
minor.
(b) A state, county or local health officer may disclose
confidential HIV-related information when:
(1) disclosure is specifically authorized or required by
federal or state law including, but not limited to Public
Health Law, Article 21, Title III and Public Health Law,
Article 27-F; or
(2) disclosure is made pursuant to a release of
confidential HIV related information; or
(3) disclosure of information regarding a contact is
requested by a physician pursuant to section 63.8 of this
Part; or if the contact resides outside the jurisdiction of
the authorized public health official, the official shall
inform the public health official in the contact's
jurisdiction in order to confidentially inform such
contact; or
(4) disclosure is authorized by court order pursuant to the
provisions of Public Health Law Section 2785.
(c) A physician or his/her agent may disclose the
confidential HIV-related information to a contact and to a
public health officer for the purpose of making a
disclosure to the contact.
(d) A physician or his/her agent may, upon the consent of a
parent or guardian, disclose confidential HIV-related
information to a state, county, or local health officer for
the purpose of reviewing the medical history of a child to
determine the fitness of the child to attend school.
(e) Confidential HIV-related information of a protected
person may be disclosed to authorized employees or agents
of a governmental agency pursuant to the regulations of the
governmental agency when the person providing health or
social services is regulated, supervised or monitored by
the governmental agency or when the governmental agency
administers the health program or a social service program
and when such employees or agents have access to records in
the ordinary course of business and when access is
reasonably necessary for regulation, supervision,
monitoring, administration or provision of services. Such
authorized employees or agents may include attorneys
authorized by a government agency when access occurs in the
ordinary course of providing legal services and is
reasonably necessary for supervision, monitoring,
administration or provision of services. Such authorized
employees or agents may also include public health officers
as required for conducting epidemiological or surveillance
investigations pursuant to the State Sanitary Code or this
Part. Such surveillance or investigational data shall also
be disclosed by the public health officer to the State
Department of Health as required by the State Sanitary Code
or this Part.
(f) Confidential HIV-related information of a protected
person may be disclosed to authorized employees or agents
of a provider of health or social services when such
provider is either regulated, supervised or monitored by a
governmental agency or when a governmental agency
administers the provider's health or social service
program, and when such employees or agents have access to
records in the ordinary course of business and when access
is reasonably necessary for regulation, supervision,
monitoring, administration or provision of services. Such
authorized employees or agents may include attorneys
authorized by persons providing health services when access
occurs in the ordinary course of providing legal services
and is reasonably necessary for supervision, monitoring,
administration or provision of services.
(g) A physician or his/her agent may disclose confidential
HIV-related information pertaining to a protected
individual to a person, known to the physician or his/her
agent, authorized pursuant to law to consent to the health
care for the protected individual when the physician
reasonably believes that:
(1) disclosure is medically necessary in order to provide
timely care and treatment for the protected individual; and
(2) after appropriate counseling as to the need for such
disclosure the protected individual will not inform a
person authorized by law to consent to health care;
provided, however, that the physician shall not make such
disclosure if, in the judgment of the physician:
(i) the disclosure would not be in the best interest of the
protected individual; or
(ii) the protected individual is authorized pursuant to law
to consent to such care and treatment. A physician's
decision to disclose pursuant to this paragraph, and the
basis for that decision shall be recorded in the medical
record.
(h) No person to whom confidential HIV information has been
disclosed shall disclose the information to another person
except as authorized by law, (including, but not limited
to, disclosure authorized by PHL Article 21, Title III),
except that this provision shall not apply to:
(1) the protected individual;
(2) a natural person who is authorized pursuant to law to
consent to health care for the protected individual;
(3) a protected individual's foster parent, subject to
Department of Social Services regulations, for the purpose
of providing care, treatment or supervision to the
protected individual; or
(4) a prospective adoptive parent, subject to Department of
Social Services regulations, with whom a child has been
placed for adoption.
(i) Nothing in this section shall limit a person's or
agency's responsibility or authority to report,
investigate, or redisclose child protective and adult
protective services information in accordance with title
six of article six and titles one and two of article nine-b
of the Social Services Law, or to provide or monitor the
provision of child and adult protective or preventive
services.
(j) Confidential HIV-related information shall not be
disclosed to a health care provider or health care facility
for the sole purpose of implementing infection control
precautions when such provider or facility is regulated
under the Public Health Law and required to implement such
precautions with all individuals pursuant to this Title.
This restriction shall not limit access to HIV-related
information by a facility's infection control personnel
for purposes of fulfilling their designated
responsibilities in the facility.
(k) Confidential HIV-related information shall not be
released pursuant to a subpoena. A court order pursuant to
Public Health Law section 2785 is required for release of
confidential HIV-related information.
(l) Confidential HIV related information shall be disclosed
upon the request of the Health Care Worker HIV/HBV Advisory
Panel (see Public Health Law Article 27-DD) to the Panel or
its designee(s) only when the Panel considers the
information reasonably necessary for the evaluation and
monitoring of a worker who has voluntarily sought the
Panel's review.
Section 63.7 Documentation of HIV-related information and disclosures.
(a) Confidential HIV-related information shall be recorded
in the medical record such that it is readily accessible to
provide proper care and treatment.
(b) All disclosures of confidential HIV-related information
must be noted in the record, except:
(1) only initial disclosures to insurance institutions must
be noted;
(2) notation is not required for disclosure to agents or
employees of health facilities or health care providers
authorized under section 63.6(a)(3);
(3) notation is not required for persons engaged in quality
assurance, program monitoring or evaluation, nor for
governmental payment agents acting pursuant to contract or
law.
(c) Confidential HIV-related information shall be noted, as
appropriate, in a certificate of death, autopsy report or
related documents prepared pursuant to Public Health Law,
Article 41 or other laws relating to documentation of cause
of death.
(d) The protected person shall be informed of disclosures
of HIV information upon request of the protected person.
(e) Confidential HIV-related information shall not be
disclosable pursuant to Public Officers Law, Article 6 (the
Freedom of Information Law).
Section 63.8 Contact notification.
(a) When contact notification is conducted based on the
mandated reporting of cases of HIV infection, HIV-related
illness and AIDS and the reporting of known contacts of
such cases, and/or provided by the protected individual,
all information collected in the course of these contact
notification activities, including screening to assess risk
of domestic violence, shall be kept confidential as
required by Public Health Law, Article 21, Title III, and
shall not be disclosed except when in the judgment of the
public health official necessary to other authorized public
health officials for conducting accurate and complete
epidemiological monitoring of the HIV/AIDS epidemic and for
conducting contact notification activities except that
contact names and locating information may be disclosed to
public health officials in other jurisdictions when
necessary to notify the contact; no information about the
protected individual will be released to any person in this
process. Disclosures and notifications shall be made as
follows:
(1) Physicians and other persons required to report as
provided for in section 63.4 must indicate on the reporting
form whether they have conducted post-test counseling and
an assessment of the risk of domestic violence in
conformance with a domestic violence screening protocol
developed by the commissioner, whether they plan to
undertake contact notification activities, have completed
notification of contacts or are making a referral for
partner notification assistance to authorized public health
officials. If the physician or other mandated reporter
chooses to conduct notification, the results of those
activities, including information specified by the
commissioner on forms supplied by the commissioner, or
their equivalent, must be forwarded to the appropriate
authorized public health official within 60 days of the
initial report, pursuant to section 63.4.
(2) The commissioner shall forward initial reports from
physicians and other mandated reporters, including the
names and addresses of the reported case and of the known
contacts, and/or contacts provided by the protected person,
the status of provider initiated contact notification
activities and the determination of risk of domestic
violence, if any, to the authorized public health official
in the county where the reported case resides.
(3) Consistent with guidelines acceptable to the
commissioner in conformance with Article 21 of the Public
Health Law, authorized public health officials, upon
determination that the reported case, reported contacts, or
any other case merits contact notification in order to
protect the public health, shall make a good faith effort
to seek the cooperation of the protected individual to name
contacts they wish to have notified, to notify the known
contacts and to inform the public health official in the
jurisdiction where any additional contacts reside, when
necessary to notify such contacts. No information about the
protected individual will be released to any person in this
process.
(b) Authorized public health officials shall consider the
following as important factors in determining the priority
for which cases merit contact notification in order to
protect the public health:
(1) reported contacts, including spouses known to the
reporting physician or other diagnostic provider, or who
the protected person wishes to have notified, unless the
provider certifies that these known contacts have already
been notified; and
(2) protected persons who are newly diagnosed with HIV
infection.
(c) In cases which merit contact notification, if an
indication of risk of domestic violence has been
identified, pursuant to a protocol acceptable to the
commissioner, the authorized public health official, in
consultation with the reporting physician, must be
satisfied in his/her professional judgment that reasonable
arrangements, efforts or referrals to address the safety of
affected persons have been made if and when the
notification is to proceed. Such consultation shall also
consider information, if available, requested from the
protected person, or from a domestic violence service
provider pursuant to a signed release.
(d) Authorized public health officials shall conduct
contact notification activities consistent with guidelines
acceptable to the commissioner which will recognize the
special needs of adolescents, individuals in residential
and institutional settings, and other vulnerable
populations.
(e) Authorized public health officials will respond to all
requests from HIV infected individuals and their health
care providers for assistance in notifying contacts.
(f) When contact notification is conducted by authorized
public health officials, such officials shall:
(1) confirm that post-test counseling of the protected
person is completed;
(2) when communication with the protected person is
necessary, communicate with the protected person in a
confidential, private and safe manner to seek cooperation
in contact notification activities, to verify the
information about the identity or location of known
contacts, to conduct or confirm a screen for domestic
violence and if applicable, to make referrals regarding
domestic violence, prior to any notification of contacts.
If communication cannot be made in a confidential, private
and safe manner, it shall be deferred until these
requirements can be met; and
(3) in circumstances where the protected individual cannot
be contacted for post-test counseling or declines to be
assessed for risk of domestic violence in relation to known
contacts, the authorized public health official shall make
the determination of whether to proceed with notification
of known contacts, in consultation with the reporting
physician.
(g) All persons notifying contacts shall provide counseling
or make referrals or appointments for counseling and
testing as appropriate. Such counseling must address coping
emotionally with potential exposure to HIV, domestic
violence issues, an explanation regarding the nature of HIV
infection and HIV-related illness, availability of
anonymous and confidential testing, information on
preventing exposure or transmission of HIV infection,
information regarding discrimination problems that might
occur as a result of disclosure of HIV-related information,
and legal protections against such disclosures. All
notifications shall be in person, except where
circumstances reasonably prevent doing so, e.g., at the
request of the contact.
(h) If a protected person is now deceased, contacts (e.g.,
spouse) are known to the physician and the physician
believes the protected person had not informed such
contacts, the physician or his/her agent may notify such
contacts or shall request the authorized public health
official to notify the contacts, without identifying the
protected individual to the contact.
(i) A physician or authorized public health official shall
have no obligation to identify or locate any contact,
except as provided pursuant to Public Health Law Article
21, Title III. No criminal sanction or civil liability
shall arise against a physician, his/her employer or
designated agent, health facility, health care provider or
authorized public health official for the disclosure of
confidential HIV-related information to a contact or to a
person consenting to health care for the contact when in
compliance with Article 27-F, or for the failure to
disclose such information to a contact or to a person
consenting to health care for the contact.
(j) Municipal health commissioners must provide HIV contact
notification services and shall forward to the department,
summary data and all identifiable information related to
notification activities upon completion of such activity
unless otherwise determined by the commissioner.
Information identifying the contact collected in the course
of contact notification activities by authorized public
health officials shall not be maintained at the state or
local level for more than one year following completion of
such activity.
(k) For the purposes of notifying contacts under Public
Health Law section 2782(1)(d), blood transfusion and organ
and tissue transplantation present a risk of HIV
transmission. Notifying contacts potentially exposed to HIV
through tissues, organs, or transfused blood under a
federally mandated recipient notification program or
guidelines acceptable to the commissioner shall be
sufficient to meet the notification requirements of Article
21, Title III and Article 27-F. Blood banks, organ
procurement organizations, and tissue banks may disclose
the HIV status of a donation to a donor's provider for
the purposes of notifying known contacts of a donor.
(l) When contact notification is initiated by a physician
not related to reporting mandates or Article 21, Title III,
but based on authority to notify an identified spouse, sex
partner, hypodermic needle and syringe partner under Public
Health Law section 2782(4), physicians or their agents and
authorized public health officials may conduct contact
notification as follows:
(1) a physician or his/her agent may, without the protected
person's consent, notify such contact or report such
contact to the authorized public health official for the
purpose of notifying a contact when:
(i) the physician believes disclosure is medically
appropriate and a significant risk of infection may exist
to the contact; and
(ii) the protected person has been counseled to notify
his/her contacts or the physician has taken all reasonable
efforts to attempt to counsel the person; and
(iii) domestic violence screening in accordance with the
screening protocol has been applied;
(2) the physician must inform the protected person of the
physician's intent to notify such contacts and of their
responsibility to report the case and such contacts to the
commissioner, and inform the protected person that he/she
may express a preference whether contact notification shall
be made by the physician or authorized public health
official, and that the protected individual's name or
other information about them is not disclosed to any person
during the contact notification process;
(3) if the protected person's preference is for the
authorized public health official to notify contacts or if
the protected person's preference is for the physician
to notify contacts but the physician chooses not to do so,
he/she shall notify the protected person of his/her
decision to contact the authorized public health official
and shall forward names and addresses of the case and
contacts to the authorized public health official, who
shall take reasonable measures to notify such contacts. If
the protected person's preference is for the physician
to notify contacts and the physician elects to do so, the
physician or his/her agent may then notify contacts; and
(4) the physician must report to the authorized public
health official regarding the success or failure of such
efforts, including the names and addresses of the cases and
contacts. If contacts have not been notified or
notification cannot be verified by the physician or his/her
agent, public health officers shall take reasonable
measures to inform the contact as set forth in subdivisions
(b) through (g) of section 63.8.
(m) When the requirements of this section have been met,
physicians and other diagnostic providers may disclose
HIV-related information to physicians or other diagnostic
providers of persons whom the protected individual may have
exposed to HIV under the circumstances noted below that
present a risk of transmission of HIV, except that
disclosures related to exposures of emergency response
employees governed by federal law shall continue to be
governed by such law:
(1) the incident must involve exposure to blood, semen,
vaginal secretions, tissue or the following body fluids:
cerebrospinal, amniotic, peritoneal, synovial, pericardial
and pleural; and
(2) a person has contact with the body substances, as noted
in paragraph (1) above, of another to mucus membranes
(e.g., eyes, nose, mouth), non-intact skin (e.g., open
wound, skin with a dermatitis condition, abraded areas) or
to the vascular system. Examples of such contact may
include needlesticks, puncture wound injuries and direct
saturation or permeation of non-intact skin by potentially
infectious substances. These circumstances shall not
include those delineated in subdivision (d) of section
63.10; and
(3) the exposure incident occurred to staff, employees or
volunteers in the performance of employment or professional
duties:
(i) in a medical or dental office; or
(ii) in a facility regulated, authorized or supervised by
the Department of Health, Office of Mental Health, Office
of Mental Retardation and Developmental Disabilities,
Office of Children and Family Services, Office of
Alcoholism and Substance Abuse Services, Department of
Correctional Services; or
(iii) involved an emergency response employee, paid or
volunteer, including an emergency medical technician, a
firefighter, a law enforcement officer (e.g., police,
probation, parole officer) or local correctional officer or
medical staff; and
(4) an incident report documenting the details of the
exposure, including witnesses to the incident, if any, is
on record with supervisory staff; and
(5) a request for disclosure of HIV status is made to the
provider of the source or to the medical officer designated
by the facility by the exposed person or by the provider of
the exposed person as soon as possible after the alleged
exposure if a decision relating to the initiation or
continuation of post-exposure prophylactic treatment is
being considered; and
(6) the medical provider of the exposed person or the
medical officer designated by the facility reviews,
investigates and evaluates the incident and certifies that:
(i) the information is necessary for immediate decisions
regarding initiation or continuation of post-exposure
prophylactic treatment for the exposed person; and
(ii) the exposed person's status is either HIV negative
or unknown and that if the person's status is unknown,
the person has consented to an HIV test; and
(iii) if such test result becomes known as positive prior
to the receipt of the source's HIV status, no
disclosure of the source's HIV status will be made to
the person; and
(7) documentation of the request is placed in the medical
record of the exposed person; and
(8) if the provider of the source or the medical officer
designated by the facility determines that a risk of
transmission has occurred or is likely to have occurred in
the reasonable exercise of his/her professional judgment,
the provider or medical officer may release the HIV status
of the source, if known. The provider or medical officer
may consult with the municipal health commissioner or
district health officer to determine whether a risk of
transmission exists. If consultation occurs, both the
provider and the local health officer must be in agreement
if the HIV information is to be disclosed. In the
disclosure process the name of the source shall not be
provided to the exposed person. Redisclosure of the HIV
status of the source is prohibited except when made in
conformance with Public Health Law Article 21, Title III.
63.9 Health care provider and health facility policy and procedures.
Each health care provider and health facility employing
persons or contracting with persons to perform any activity
related to such provider's or facility's rendering
of health services shall develop and implement policies and
procedures to maintain the confidentiality of confidential
HIV related information. Such policies and procedures shall
assure that such information is disclosed to employees or
contractors only when appropriate under this Part. Such
policies and procedures shall include:
(a) initial employee education and annual inservice
education of employees regarding the legal prohibition
against unauthorized disclosure in Public Health Law
Article 27-F and provisions of Article 21, Title III. A
list of all employees who have had such training must be
maintained by health care providers and health facilities.
Health care providers and health facilities contracting
with others for services in which HIV-related information
may be disclosed to such contractors, must document
evidence that such contractors have been informed of the
confidentiality and disclosure requirements of this Part;
(b) maintenance of a list of job titles and the specific
employee functions within those titles for which employees
are authorized to access such information. This list shall
describe the limits of such access to information and must
be provided to the employees during employee education
sessions;
(c) a requirement that only full-time or part-time
employees, contractors and medical, nursing or
health-related students who have received such education on
HIV confidentiality, or can document that they have
received such education or training, shall have access to
confidential HIV-related information while performing the
authorized functions listed under paragraph (2).
(d) protocols for ensuring that records, including records
which are stored electronically, are maintained securely
and used for the purpose intended;
(e) procedures for handling requests by other parties for
confidential HIV-related information;
(f) protocols prohibiting employees/agents/contractors from
discriminating against persons having or suspected of
having HIV infection; and
(g) review of the policies and procedures on at least an
annual basis.
Section 63.10 Significant risk.
(a) The three factors necessary to create a significant
risk of contracting or transmitting HIV infection are:
(1) the presence of a significant risk body substance;
(2) a circumstance which constitutes significant risk for
transmitting or contracting HIV infection; and
(3) the presence of an infectious source and a non-infected
person.
(b) "Significant risk body substances" are blood,
semen, vaginal secretions, breast milk, tissue and the
following body fluids: cerebrospinal, amniotic, peritoneal,
synovial, pericardial, and pleural.
(c) Circumstances which constitute "significant risk
of transmitting or contracting HIV infection" are:
(1) sexual intercourse (vaginal, anal, oral) which exposes
a non-infected individual to blood, semen or vaginal
secretions of an infected individual;
(2) sharing of needles and other paraphernalia used for
preparing and injecting drugs between infected and
non-infected individuals;
(3) the gestation, birthing or breast feeding of an infant
when the mother is infected with HIV;
(4) transfusion or transplantation of blood, organs, or
other tissues from an infected individual to an uninfected
individual, provided such blood, organs or other tissues
have not tested conclusively for antibody or antigen and
have not been rendered non-infective by heat or chemical
treatment;
(5) other circumstances not identified in paragraphs (1)
through (4) during which a significant risk body substance
(other than breast milk) of an infected individual contacts
mucous membranes (e.g., eyes, nose, mouth), non-intact skin
(e.g., open wound, skin with a dermatitis condition,
abraded areas) or the vascular system of a non-infected
person. Such circumstances include, but are not limited to
needlestick or puncture wound injuries and direct
saturation or permeation of these body surfaces by the
infectious body substance.
(d) Circumstances that involve "significant risk"
shall not include:
(1) exposure to urine, feces, sputum, nasal secretions,
saliva, sweat, tears or vomitus that does not contain blood
that is visible to the naked eye;
(2) human bites where there is no direct blood to blood, or
blood to mucous membrane contact;
(3) exposure of intact skin to blood or any other body
substance;
(4) occupational settings where individuals use
scientifically accepted barrier techniques and preventive
practices in circumstances which would otherwise pose a
significant risk and such barriers are not breached and
remain intact.
Section 63.11 Separability.
If any section, subsection, clause or provision of this
Part shall be deemed by any court of competent jurisdiction
to be unconstitutional, ineffective or otherwise legally
invalid or unenforceable, in whole or in part, to the
extent that it is not unconstitutional, ineffective or
otherwise legally invalid or unenforceable, it shall be
valid and effective and no other section, subsection,
clause or provision shall, on account thereof, be deemed
invalid or ineffective.
