(410 ILCS 305/3)
(from Ch. 111 1/2, par. 7303)
When used in this Act:
(a) "AIDS" means acquired immunodeficiency syndrome.
(b) "Authority" means the Illinois Health Information Exchange Authority established pursuant to the Illinois Health Information Exchange and Technology Act.
(c) "Business associate" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(d) "Covered entity" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(e) "De-identified information" means health information that is not individually identifiable as described under HIPAA, as specified in 45 CFR 164.514(b).
(f) "Department" means the Illinois Department of Public Health or its designated agents.
(g) "Disclosure" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(h) "Health care operations" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(i) "Health care professional" means (i) a licensed physician, (ii) a licensed
physician assistant, (iii) a licensed advanced practice registered nurse, (iv) an advanced practice registered nurse or physician assistant who practices in a hospital or ambulatory surgical treatment center and possesses appropriate clinical privileges, (v) a licensed dentist, (vi) a licensed podiatric physician, or (vii) an
individual certified to provide HIV testing and counseling by a state or local
(j) "Health care provider" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(k) "Health facility" means a hospital, nursing home, blood bank, blood
center, sperm bank, or other health care institution, including any "health
facility" as that term is defined in the Illinois Finance Authority
(l) "Health information exchange" or "HIE" means a health information exchange or health information organization that oversees and governs the electronic exchange of health information that (i) is established pursuant to the Illinois Health Information Exchange and Technology Act, or any subsequent amendments thereto, and any administrative rules adopted thereunder; (ii) has established a data sharing arrangement with the Authority; or (iii) as of August 16, 2013, was designated by the Authority Board as a member of, or was represented on, the Authority Board's Regional Health Information Exchange Workgroup; provided that such designation
shall not require the establishment of a data sharing arrangement or other participation with the Illinois Health
Information Exchange or the payment of any fee. In certain circumstances, in accordance with HIPAA, an HIE will be a business associate.
(m) "Health oversight agency" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(n) "HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, Public Law 111-05, and any subsequent amendments thereto and any regulations promulgated thereunder.
(o) "HIV" means the human immunodeficiency virus.
(p) "HIV-related information" means the identity of a person upon whom an HIV test is performed, the results of an HIV test, as well as diagnosis, treatment, and prescription information that reveals a patient is HIV-positive, including such information contained in a limited data set. "HIV-related information" does not include information that has been de-identified in accordance with HIPAA.
(q) "Informed consent" means:
(1) where a health care provider, health care
professional, or health facility has implemented opt-in testing, a process by which an individual or their legal representative receives pre-test information, has an opportunity to ask questions, and consents verbally or in writing to the test without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion; or
(2) where a health care provider, health care
professional, or health facility has implemented opt-out testing, the individual or their legal representative has been notified verbally or in writing that the test is planned, has received pre-test information, has been given the opportunity to ask questions and the opportunity to decline testing, and has not declined testing; where such notice is provided, consent for opt-out HIV testing may be incorporated into the patient's general consent for medical care on the same basis as are other screening or diagnostic tests; a separate consent for opt-out HIV testing is not required.
In addition, where the person providing informed consent is a participant in an HIE, informed consent requires a fair explanation that the results of the patient's HIV test will be accessible through an HIE and meaningful disclosure of the patient's opt-out right under Section 9.6 of this Act.
A health care provider, health care professional, or health facility undertaking an informed consent process for HIV testing under this subsection may combine a form used to obtain informed consent for HIV testing with forms used to obtain written consent for general medical care or any other medical test or procedure, provided that the forms make it clear that the subject may consent to general medical care, tests, or procedures without being required to consent to HIV testing, and clearly explain how the subject may decline HIV testing. Health facility clerical staff or other staff responsible for the consent form for general medical care may obtain consent for HIV testing through a general consent form.
(r) "Limited data set" has the meaning ascribed to it under HIPAA, as described in 45 CFR 164.514(e)(2).
(s) "Minimum necessary" means the HIPAA standard for using, disclosing, and requesting protected health information found in 45 CFR 164.502(b) and 164.514(d).
(s-1) "Opt-in testing" means an approach where an HIV test is presented by offering the test and the patient accepts or declines testing.
(s-3) "Opt-out testing" means an approach where an HIV test is presented such that a patient is notified that HIV testing may occur unless the patient declines.
(t) "Organized health care arrangement" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(u) "Patient safety activities" has the meaning ascribed to it under 42 CFR 3.20.
(v) "Payment" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(w) "Person" includes any natural person, partnership, association, joint venture, trust, governmental entity, public or private corporation, health facility, or other legal entity.
(w-5) "Pre-test information" means:
(1) a reasonable explanation of the test, including
its purpose, potential uses, limitations, and the meaning of its results; and
(2) a reasonable explanation of the procedures to be
followed, including the voluntary nature of the test, the availability of a qualified person to answer questions, the right to withdraw consent to the testing process at any time, the right to anonymity to the extent provided by law with respect to participation in the test and disclosure of test results, and the right to confidential treatment of information identifying the subject of the test and the results of the test, to the extent provided by law.
Pre-test information may be provided in writing, verbally, or by video, electronic, or other means and may be provided as designated by the supervising health care professional or the health facility.
For the purposes of this definition, a qualified person to answer questions is a health care professional or, when acting under the supervision of a health care professional, a registered nurse, medical assistant, or other person determined to be sufficiently knowledgeable about HIV testing, its purpose, potential uses, limitations, the meaning of the test results, and the testing procedures in the professional judgment of a supervising health care professional or as designated by a health care facility.
(x) "Protected health information" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103.
(y) "Research" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(z) "State agency" means an instrumentality of the State of Illinois and any instrumentality of another state that, pursuant to applicable law or a written undertaking with an instrumentality of the State of Illinois, is bound to protect the privacy of HIV-related information of Illinois persons.
(aa) "Test" or "HIV test" means a test to determine the presence of the
antibody or antigen to HIV, or of HIV infection.
(bb) "Treatment" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(cc) "Use" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 160.103, where context dictates.
(Source: P.A. 99-54, eff. 1-1-16; 99-173, eff. 7-29-15; 99-642, eff. 7-28-16; 100-513, eff. 1-1-18