HB1431ham001 99TH GENERAL ASSEMBLY

Rep. La Shawn K. Ford

Filed: 3/23/2015

09900HB1431ham001 LRB099 07179 JLK 32896 a

AMENDMENT TO HOUSE BILL 1431

AMENDMENT NO. ______. Amend House Bill 1431 by replacing everything after the enacting clause with the following:

"Section 5. The AIDS Confidentiality Act is amended by changing Sections 3 and 4 as follows:

(410 ILCS 305/3) (from Ch. 111 1/2, par. 7303)

Sec. 3. Definitions. 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 physician assistant to whom the physician assistant's supervising physician has delegated the provision of AIDS and HIV-related health services, (iii) an advanced practice registered nurse who has a written collaborative agreement with a collaborating physician which authorizes the provision of AIDS and HIV-related health services, (iv) an advanced practice nurse or physician assistant who practices in a hospital or ambulatory surgical treatment center and possesses appropriate clinical privileges, (v) a licensed dentist, (vi) (v) a licensed podiatric physician, or (vii) (vi) an individual certified to provide HIV testing and counseling by a state or local public health department.

(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 Act.

(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) 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; or

(2) where a health facility has implemented opt-out testing, the individual or their legal representative has received pre-test information and been given the opportunity to ask questions and the opportunity to decline testing, and has not declined testing. a written or verbal agreement by the subject of a test or the subject's legally authorized representative without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, which entails at least the following pre-test information:

(1) a fair explanation of the test, including its purpose, potential uses, limitations, and the meaning of its results;

(2) a fair explanation of the procedures to be followed, including the voluntary nature of the test, 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; and

In addition, (3) 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.

Consent must occur without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

A Pre-test information may be provided in writing, verbally, or by video, electronic, or other means. The subject must be offered an opportunity to ask questions about the HIV test and decline testing. Nothing in this Act shall prohibit a health care provider, or health care professional, or health facility may combine from combining 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 medical procedures without being required to consent to HIV testing and clearly explain how the subject may opt out of HIV testing. Health facility clerical 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).

(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 an appropriate 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.

The pre-test information required as part of the informed consent 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 and Section 5 of this Act, an appropriate person to answer questions is someone determined to be sufficiently knowledgeable in the professional judgment of a supervising health care professional or as designated by a health 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. 98-214, eff. 8-9-13; 98-1046, eff. 1-1-15.)

(410 ILCS 305/4) (from Ch. 111 1/2, par. 7304)

Sec. 4. Informed consent. No person may order an HIV test without first receiving the documented informed consent of the subject of the test or the subject's legally authorized representative. A health care facility or provider may provide offer opt-out HIV testing where the subject or the subject's legally authorized representative is informed that the subject may will be tested for HIV unless he or she refuses. The subject's or the subject's legally authorized representative's verbal or written consent, or declination of opt-out HIV testing, must be documented by the health facility or provider in the general consent for medical care, a separate consent form, or elsewhere in the medical record. The health care facility or provider must document the provision of informed consent, including pre-test information, and whether the subject or the subject's legally authorized representative declined the offer of HIV testing.

(Source: P.A. 95-7, eff. 6-1-08.)

(410 ILCS 305/5 rep.)

Section 10. The AIDS Confidentiality Act is amended by repealing Section 5.".