SB-0467, As Passed Senate, April 27, 2006
SUBSTITUTE FOR
SENATE BILL NO. 467
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 16221, 17020, and 17520 (MCL 333.16221,
333.17020, and 333.17520), section 16221 as amended by 2004 PA
214 and sections 17020 and 17520 as added by 2000 PA 29, and by
adding sections 17020a, 17520a, and 20170a.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 16221. The department may investigate activities
2 related to the practice of a health profession by a licensee, a
3 registrant, or an applicant for licensure or registration. The
4 department may hold hearings, administer oaths, and order
5 relevant testimony to be taken and shall report its findings to
6 the appropriate disciplinary subcommittee. The disciplinary
1 subcommittee shall proceed under section 16226 if it finds that 1
2 or more of the following grounds exist:
3 (a) A violation of general duty, consisting of negligence or
4 failure to exercise due care, including negligent delegation to
5 or supervision of employees or other individuals, whether or not
6 injury results, or any conduct, practice, or condition that
7 impairs, or may impair, the ability to safely and skillfully
8 practice the health profession.
9 (b) Personal disqualifications, consisting of 1 or more of
10 the following:
11 (i) Incompetence.
12 (ii) Subject to sections 16165 to 16170a, substance abuse as
13 defined in section 6107.
14 (iii) Mental or physical inability reasonably related to and
15 adversely affecting the licensee's ability to practice in a safe
16 and competent manner.
17 (iv) Declaration of mental incompetence by a court of
18 competent jurisdiction.
19 (v) Conviction of a misdemeanor punishable by imprisonment
20 for a maximum term of 2 years; a misdemeanor involving the
21 illegal delivery, possession, or use of a controlled substance;
22 or a felony. A certified copy of the court record is conclusive
23 evidence of the conviction.
24 (vi) Lack of good moral character.
25 (vii) Conviction of a criminal offense under sections 520b to
26 520g of the Michigan penal code, 1931 PA 328, MCL 750.520b to
27 750.520g. A certified copy of the court record is conclusive
1 evidence of the conviction.
2 (viii) Conviction of a violation of section 492a of the
3 Michigan penal code, 1931 PA 328, MCL 750.492a. A certified copy
4 of the court record is conclusive evidence of the conviction.
5 (ix) Conviction of a misdemeanor or felony involving fraud in
6 obtaining or attempting to obtain fees related to the practice of
7 a health profession. A certified copy of the court record is
8 conclusive evidence of the conviction.
9 (x) Final adverse administrative action by a licensure,
10 registration, disciplinary, or certification board involving the
11 holder of, or an applicant for, a license or registration
12 regulated by another state or a territory of the United States,
13 by the United States military, by the federal government, or by
14 another country. A certified copy of the record of the board is
15 conclusive evidence of the final action.
16 (xi) Conviction of a misdemeanor that is reasonably related
17 to or that adversely affects the licensee's ability to practice
18 in a safe and competent manner. A certified copy of the court
19 record is conclusive evidence of the conviction.
20 (xii) Conviction of a violation of section 430 of the
21 Michigan penal code, 1931 PA 328, MCL 750.430. A certified copy
22 of the court record is conclusive evidence of the conviction.
23 (c) Prohibited acts, consisting of 1 or more of the
24 following:
25 (i) Fraud or deceit in obtaining or renewing a license or
26 registration.
27 (ii) Permitting the license or registration to be used by an
1 unauthorized person.
2 (iii) Practice outside the scope of a license.
3 (iv) Obtaining, possessing, or attempting to obtain or
4 possess a controlled substance as defined in section 7104 or a
5 drug as defined in section 7105 without lawful authority; or
6 selling, prescribing, giving away, or administering drugs for
7 other than lawful diagnostic or therapeutic purposes.
8 (d) Unethical business practices, consisting of 1 or more of
9 the following:
10 (i) False or misleading advertising.
11 (ii) Dividing fees for referral of patients or accepting
12 kickbacks on medical or surgical services, appliances, or
13 medications purchased by or in behalf of patients.
14 (iii) Fraud or deceit in obtaining or attempting to obtain
15 third party reimbursement.
16 (e) Unprofessional conduct, consisting of 1 or more of the
17 following:
18 (i) Misrepresentation to a consumer or patient or in
19 obtaining or attempting to obtain third party reimbursement in
20 the course of professional practice.
21 (ii) Betrayal of a professional confidence.
22 (iii) Promotion for personal gain of an unnecessary drug,
23 device, treatment, procedure, or service.
24 (iv) Either of the following:
25 (A) A requirement by a licensee other than a physician that
26 an individual purchase or secure a drug, device, treatment,
27 procedure, or service from another person, place, facility, or
1 business in which the licensee has a financial interest.
2 (B) A referral by a physician for a designated health
3 service that violates section 1877 of part D of title XVIII of
4 the social security act, 42 USC 1395nn, or a regulation
5 promulgated under that section. Section 1877 of part D of title
6 XVIII of the social security act, 42 USC 1395nn, and the
7 regulations promulgated under that section, as they exist on June
8 3, 2002, are incorporated by reference for purposes of this
9 subparagraph. A disciplinary subcommittee shall apply section
10 1877 of part D of title XVIII of the social security act, 42 USC
11 1395nn, and the regulations promulgated under that section
12 regardless of the source of payment for the designated health
13 service referred and rendered. If section 1877 of part D of title
14 XVIII of the social security act, 42 USC 1395nn, or a regulation
15 promulgated under that section is revised after June 3, 2002, the
16 department shall officially take notice of the revision. Within
17 30 days after taking notice of the revision, the department shall
18 decide whether or not the revision pertains to referral by
19 physicians for designated health services and continues to
20 protect the public from inappropriate referrals by physicians. If
21 the department decides that the revision does both of those
22 things, the department may promulgate rules to incorporate the
23 revision by reference. If the department does promulgate rules to
24 incorporate the revision by reference, the department shall not
25 make any changes to the revision. As used in this subparagraph,
26 "designated health service" means that term as defined in section
27 1877 of part D of title XVIII of the social security act, 42 USC
1 1395nn, and the regulations promulgated under that section and
2 "physician" means that term as defined in sections 17001 and
3 17501.
4 (v) For a physician who makes referrals pursuant to section
5 1877 of part D of title XVIII of the social security act, 42 USC
6 1395nn, or a regulation promulgated under that section, refusing
7 to accept a reasonable proportion of patients eligible for
8 medicaid and refusing to accept payment from medicaid or medicare
9 as payment in full for a treatment, procedure, or service for
10 which the physician refers the individual and in which the
11 physician has a financial interest. A physician who owns all or
12 part of a facility in which he or she provides surgical services
13 is not subject to this subparagraph if a referred surgical
14 procedure he or she performs in the facility is not reimbursed at
15 a minimum of the appropriate medicaid or medicare outpatient fee
16 schedule, including the combined technical and professional
17 components.
18 (f) Beginning June 3,
2003, the department of
consumer and
19 industry services shall prepare the first of 3 annual reports on
20 the effect of this amendatory act on access to care for the
21 uninsured and medicaid patients. The department shall report on
22 the number of referrals by licensees of uninsured and medicaid
23 patients to purchase or secure a drug, device, treatment,
24 procedure, or service from another person, place, facility, or
25 business in which the licensee has a financial interest.
26 (g) Failure to report a change of name or mailing address
27 within 30 days after the change occurs.
1 (h) A violation, or aiding or abetting in a violation, of
2 this article or of a rule promulgated under this article.
3 (i) Failure to comply with a subpoena issued pursuant to
4 this part, failure to respond to a complaint issued under this
5 article or article 7, failure to appear at a compliance
6 conference or an administrative hearing, or failure to report
7 under section 16222 or 16223.
8 (j) Failure to pay an installment of an assessment levied
9 pursuant to the insurance code of 1956, 1956 PA 218, MCL 500.100
10 to 500.8302, within 60 days after notice by the appropriate
11 board.
12 (k) A violation of section 17013 or 17513.
13 (l) Failure to meet 1 or more of the requirements for
14 licensure or registration under section 16174.
15 (m) A violation of section 17015 or 17515.
16 (n) A violation of section 17016 or 17516.
17 (o) Failure to comply with section 9206(3).
18 (p) A violation of section 5654 or 5655.
19 (q) A violation of section 16274.
20 (r) A violation of section 17020, or 17020a, 17520, or
21 17520a.
22 (s) A violation of the medical records access act, 2004 PA
23 47, MCL 333.26261 to 333.26271.
24 (t) A violation of section 17764(2).
25 Sec. 17020. (1) Except as otherwise provided for a test
26 performed under section 5431 and except as otherwise provided by
27 law, beginning upon the expiration of 6 months after the
1 effective date of the amendatory act that added this section
2 September 15, 2000, a physician or an individual to whom the
3 physician has delegated authority to perform a selected act,
4 task, or function under section 16215 shall not order a
5 presymptomatic or predictive genetic test without first obtaining
6 the written, informed consent of the test subject, pursuant to
7 this section.
8 (2) For purposes of subsection (1), written, informed
9 consent consists of a signed writing executed by the test subject
10 or the legally authorized representative of the test subject that
11 confirms that the physician or the individual acting under the
12 delegatory authority of the physician has explained, and the test
13 subject or the legally authorized representative of the test
14 subject understands, at a minimum, all of the following:
15 (a) The nature and purpose of the presymptomatic or
16 predictive genetic test.
17 (b) The effectiveness and limitations of the presymptomatic
18 or predictive genetic test.
19 (c) The implications of taking the presymptomatic or
20 predictive genetic test, including, but not limited to, the
21 medical risks and benefits.
22 (d) The future uses of the sample taken from the test
23 subject in order to conduct the presymptomatic or predictive
24 genetic test and the information obtained from the presymptomatic
25 or predictive genetic test.
26 (e) The meaning of the presymptomatic or predictive genetic
27 test results and the procedure for providing notice of the
1 results to the test subject.
2 (f) Who will have access to the sample taken from the test
3 subject in order to conduct the presymptomatic or predictive
4 genetic test and the information obtained from the presymptomatic
5 or predictive genetic test, and the test subject's right to
6 confidential treatment of the sample and the information.
7 (3) Within 6 months after the effective date of the
8 amendatory act that added this section Before September 15,
9 2000, the department of community health, in consultation with
10 the Michigan board of medicine, the Michigan board of osteopathic
11 medicine and surgery, at least 1 physician who is board certified
12 by the American board of medical genetics, and appropriate
13 professional organizations, shall develop and distribute a model
14 informed consent form for purposes of this section that
15 practitioners may adopt. The department of community health shall
16 include in the model form at least all of the information
17 required under subsection (2). The department of community health
18 shall distribute the model form to physicians and other
19 individuals subject to this section upon request and at no
20 charge. The department of community health shall review the model
21 form at least annually for 5 years after the first model form is
22 distributed, and shall revise the model form if necessary to make
23 the form reflect the latest developments in medical genetics.
24 (4) The department of community health, in consultation with
25 the entities described in subsection (3), may also develop and
26 distribute a pamphlet that provides further explanation of the
27 information included in the model informed consent form.
1 (5) If a test subject or his or her legally authorized
2 representative signs a copy of the model informed consent form
3 developed and distributed under subsection (3), the physician or
4 individual acting under the delegatory authority of the physician
5 shall give the test subject a copy of the signed informed consent
6 form and shall include the original signed informed consent form
7 in the test subject's medical record.
8 (6) If a test subject or his or her legally authorized
9 representative signs a copy of the model informed consent form
10 developed and distributed under subsection (3), the test subject
11 is barred from subsequently bringing a civil action for damages
12 against the physician, or an individual to whom the physician
13 delegated the authority to perform a selected act, task, or
14 function under section 16215, who ordered the presymptomatic or
15 predictive genetic test, based on failure to obtain informed
16 consent for the presymptomatic or predictive genetic test.
17 (7) A physician's duty to inform a patient under this
18 section does not require disclosure of information beyond what a
19 reasonably well-qualified physician licensed under this article
20 would know.
21 (8) Except as otherwise provided in subsection (9), as used
22 in this section and section 17020a:
23 (a) "Genetic information" means information about a gene,
24 gene product, or inherited characteristic which information is
25 derived from a genetic test.
26 (b) "Genetic test" means the analysis of human DNA, RNA,
27 chromosomes, and those proteins and metabolites used to detect
1 heritable or somatic disease-related genotypes or karyotypes for
2 clinical purposes. A genetic test must be generally accepted in
3 the scientific and medical communities as being specifically
4 determinative for the presence, absence, or mutation of a gene or
5 chromosome in order to qualify under this definition. Genetic
6 test does not include a routine physical examination or a routine
7 analysis, including, but not limited to, a chemical analysis, of
8 body fluids, unless conducted specifically to determine the
9 presence, absence, or mutation of a gene or chromosome.
10 (c) "Predictive genetic test" means a genetic test performed
11 for the purpose of predicting the future probability that the
12 test subject will develop a genetically related disease or
13 disability.
14 (d) "Presymptomatic genetic test" means a genetic test
15 performed before the onset of clinical symptoms or indications of
16 disease.
17 (9) For purposes of subsection (8)(b), the term "genetic
18 test" does not include a procedure performed as a component of
19 biomedical research that is conducted pursuant to federal common
20 rule under 21 C.F.R. CFR
parts 50 and 56 and 45 C.F.R.
CFR
21 part 46.
22 Sec. 17020a. (1) The fact that a presymptomatic or
23 predictive genetic test has been ordered and conducted under
24 section 17020 and the results of that test are privileged and
25 confidential. Except as otherwise provided by law, a person shall
26 not disclose that a test has been ordered or conducted or the
27 results of that test for purposes other than treatment, payment,
1 or health care operations as provided under the health insurance
2 portability and accountability act of 1996, Public Law 104-191,
3 and regulations promulgated under that act, 45 CFR parts 160 and
4 164, without first obtaining written authorization from the test
5 subject or his or her legally authorized representative as
6 provided under this section.
7 (2) For purposes of subsection (1), written authorization
8 shall be on a form that identifies to whom the information is to
9 be disclosed and includes the following notice:
10 NOTICE OF RIGHTS WITH REGARD TO
11 GENETIC TESTING AND INFORMATION
12 Michigan law restricts requests by health insurers, nonprofit
13 health care corporations, health maintenance organizations, and
14 employers for individuals to submit to genetic testing, to
15 disclose genetic information, or to disclose whether genetic
16 testing has been conducted or the results of that genetic
17 testing. Individuals who have questions about their rights may
18 seek legal advice.
19 (3) For purposes of subsection (1), a general consent or
20 authorization given for the release of medical records or other
21 medical information does not constitute written authorization for
22 disclosure under this section. The informed consent form required
23 under section 17020 for the performance of genetic testing shall
24 satisfy the written authorization requirements for disclosure
25 under this section if that informed consent form identifies to
26 whom the genetic information is being provided, includes the
1 notice described under subsection (2), and requires a separate
2 signature for disclosure than the signature required for the
3 performance of the genetic testing. If the test subject or his or
4 her legally authorized representative provides written
5 authorization under this section, the person shall do each of the
6 following:
7 (a) Provide the test subject with a copy of the signed
8 written authorization.
9 (b) Maintain the original signed written authorization in
10 the test subject's medical record.
11 (c) Provide the test subject and the person to whom the
12 information is being disclosed with the following notice:
13 RESTRICTIONS ON FURTHER DISCLOSURE OF
14 GENETIC TESTING AND INFORMATION
15 This information is privileged and confidential. This information
16 is being provided to you in accordance with Michigan law and
17 shall not be further disclosed without a separate written
18 authorization from the test subject or his or her legally
19 authorized representative. A general consent or authorization
20 for the release of medical records or other information is not
21 sufficient to authorize the disclosure of genetic testing and
22 information.
23 (4) If a test subject consents to the performance of a
24 genetic test for the sole purpose of assisting in the recovery or
25 identification of human remains from a disaster or assisting in
1 the identification of living or deceased missing persons by
2 matching forensic DNA profiles in the event of an emergency or
3 disaster, those results as well as the DNA profiles shall only be
4 disclosed and used for those identification purposes, are not
5 public records, are not subject to court subpoena, and are not
6 discoverable in a legal proceeding. Consent provided for testing
7 and DNA profiling under this subsection is not consent for
8 secondary research utilizing those results or DNA profiles or any
9 other use except for the identification of living or deceased
10 missing persons.
11 Sec. 17520. (1) Except as otherwise provided for a test
12 performed under section 5431 and except as otherwise provided by
13 law, beginning upon the expiration of 6 months after the
14 effective date of the amendatory act that added this section
15 September 15, 2000, a physician or an individual to whom the
16 physician has delegated authority to perform a selected act,
17 task, or function under section 16215 shall not order a
18 presymptomatic or predictive genetic test without first obtaining
19 the written, informed consent of the test subject, pursuant to
20 this section.
21 (2) For purposes of subsection (1), written, informed
22 consent consists of a signed writing executed by the test subject
23 or the legally authorized representative of the test subject that
24 confirms that the physician or the individual acting under the
25 delegatory authority of the physician has explained, and the test
26 subject or the legally authorized representative of the test
27 subject understands, at a minimum, all of the following:
1 (a) The nature and purpose of the presymptomatic or
2 predictive genetic test.
3 (b) The effectiveness and limitations of the presymptomatic
4 or predictive genetic test.
5 (c) The implications of taking the presymptomatic or
6 predictive genetic test, including, but not limited to, the
7 medical risks and benefits.
8 (d) The future uses of the sample taken from the test
9 subject in order to conduct the presymptomatic or predictive
10 genetic test and the information obtained from the presymptomatic
11 or predictive genetic test.
12 (e) The meaning of the presymptomatic or predictive genetic
13 test results and the procedure for providing notice of the
14 results to the test subject.
15 (f) Who will have access to the sample taken from the test
16 subject in order to conduct the presymptomatic or predictive
17 genetic test and the information obtained from the presymptomatic
18 or predictive genetic test, and the test subject's right to
19 confidential treatment of the sample and the information.
20 (3) Within 6 months after the effective date of the
21 amendatory act that added this section Before September 15,
22 2000, the department of community health, in consultation with
23 the Michigan board of medicine, the Michigan board of osteopathic
24 medicine and surgery, at least 1 physician who is board certified
25 by the American board of medical genetics, and appropriate
26 professional organizations, shall develop and distribute a model
27 informed consent form for purposes of this section that
1 practitioners may adopt. The department of community health shall
2 include in the model form at least all of the information
3 required under subsection (2). The department of community health
4 shall distribute the model form to physicians and other
5 individuals subject to this section upon request and at no
6 charge. The department of community health shall review the model
7 form at least annually for 5 years after the first model form is
8 distributed, and shall revise the model form if necessary to make
9 the form reflect the latest developments in medical genetics.
10 (4) The department of community health, in consultation with
11 the entities described in subsection (3), may also develop and
12 distribute a pamphlet that provides further explanation of the
13 information included in the model informed consent form.
14 (5) If a test subject or his or her legally authorized
15 representative signs a copy of the model informed consent form
16 developed and distributed under subsection (3), the physician or
17 individual acting under the delegatory authority of the physician
18 shall give the test subject a copy of the signed informed consent
19 form and shall include the original signed informed consent form
20 in the test subject's medical record.
21 (6) If a test subject or his or her legally authorized
22 representative signs a copy of the model informed consent form
23 developed and distributed under subsection (3), the test subject
24 is barred from subsequently bringing a civil action for damages
25 against the physician, or an individual to whom the physician
26 delegated the authority to perform a selected act, task, or
27 function under section 16215, who ordered the presymptomatic or
1 predictive genetic test, based on failure to obtain informed
2 consent for the presymptomatic or predictive genetic test.
3 (7) A physician's duty to inform a patient under this
4 section does not require disclosure of information beyond what a
5 reasonably well-qualified physician licensed under this article
6 would know.
7 (8) Except as otherwise provided in subsection (9), as used
8 in this section and section 17520a:
9 (a) "Genetic information" means information about a gene,
10 gene product, or inherited characteristic which information is
11 derived from a genetic test.
12 (b) "Genetic test" means the analysis of human DNA, RNA,
13 chromosomes, and those proteins and metabolites used to detect
14 heritable or somatic disease-related genotypes or karyotypes for
15 clinical purposes. A genetic test must be generally accepted in
16 the scientific and medical communities as being specifically
17 determinative for the presence, absence, or mutation of a gene or
18 chromosome in order to qualify under this definition. Genetic
19 test does not include a routine physical examination or a routine
20 analysis, including, but not limited to, a chemical analysis, of
21 body fluids, unless conducted specifically to determine the
22 presence, absence, or mutation of a gene or chromosome.
23 (c) "Predictive genetic test" means a genetic test performed
24 for the purpose of predicting the future probability that the
25 test subject will develop a genetically related disease or
26 disability.
27 (d) "Presymptomatic genetic test" means a genetic test
1 performed before the onset of clinical symptoms or indications of
2 disease.
3 (9) For purposes of subsection (8)(b), the term "genetic
4 test" does not include a procedure performed as a component of
5 biomedical research that is conducted pursuant to federal common
6 rule under 21 C.F.R. CFR
parts 50 and 56 and 45 C.F.R.
CFR
7 part 46.
8 Sec. 17520a. (1) The fact that a presymptomatic or
9 predictive genetic test has been ordered and conducted under
10 section 17520 and the results of that test are privileged and
11 confidential. Except as otherwise provided by law, a person shall
12 not disclose that a test has been ordered or conducted or the
13 results of that test for purposes other than treatment, payment,
14 or health care operations as provided under the health insurance
15 portability and accountability act of 1996, Public Law 104-191,
16 and regulations promulgated under that act, 45 CFR parts 160 and
17 164, without first obtaining written authorization from the test
18 subject or his or her legally authorized representative as
19 provided under this section.
20 (2) For purposes of subsection (1), written authorization
21 shall be on a form that identifies to whom the information is to
22 be disclosed and includes the following notice:
23 NOTICE OF RIGHTS WITH REGARD TO
24 GENETIC TESTING AND INFORMATION
25 Michigan law restricts requests by health insurers, nonprofit
26 health care corporations, health maintenance organizations, and
1 employers for individuals to submit to genetic testing, to
2 disclose genetic information, or to disclose whether genetic
3 testing has been conducted or the results of that genetic
4 testing. Individuals who have questions about their rights may
5 seek legal advice.
6 (3) For purposes of subsection (1), a general consent or
7 authorization given for the release of medical records or other
8 medical information does not constitute written authorization for
9 disclosure under this section. The informed consent form required
10 under section 17020 for the performance of genetic testing shall
11 satisfy the written authorization requirements for disclosure
12 under this section if that informed consent form identifies to
13 whom the genetic information is being provided, includes the
14 notice described under subsection (2), and requires a separate
15 signature for disclosure than the signature required for the
16 performance of the genetic testing. If the test subject or his or
17 her legally authorized representative provides written
18 authorization under this section, the person shall do each of the
19 following:
20 (a) Provide the test subject with a copy of the signed
21 written authorization.
22 (b) Maintain the original signed written authorization in
23 the test subject's medical record.
24 (c) Provide the test subject and the person to whom the
25 information is being disclosed with the following notice:
26 RESTRICTIONS ON FURTHER DISCLOSURE OF
1 GENETIC TESTING AND INFORMATION
2 This information is privileged and confidential. This information
3 is being provided to you in accordance with Michigan law and
4 shall not be further disclosed without a separate written
5 authorization from the test subject or his or her legally
6 authorized representative. A general consent or authorization for
7 the release of medical records or other information is not
8 sufficient to authorize the disclosure of genetic testing and
9 information.
10 (4) If a test subject consents to the performance of a
11 genetic test for the sole purpose of assisting in the recovery or
12 identification of human remains from a disaster or assisting in
13 the identification of living or deceased missing persons by
14 matching DNA profiles in the event of an emergency or disaster,
15 those results as well as the DNA profiles shall only be disclosed
16 and used for those identification purposes, are not public
17 records, are not subject to court subpoena, and are not
18 discoverable in a legal proceeding. Consent provided for testing
19 and DNA profiling under this subsection is not consent for
20 secondary research utilizing those results or DNA profiles or any
21 other use except for the identification of living or deceased
22 missing persons.
23 Sec. 20170a. (1) All reports, records, and data pertaining
24 to genetic testing or other genetic information are privileged
25 and confidential. Except as otherwise provided by law, a health
26 facility or agency shall not disclose the test results of a
1 presymptomatic or predictive genetic test or the fact that such a
2 test was ordered for purposes other than treatment, payment, or
3 health care operations as provided under the health insurance
4 portability and accountability act of 1996, Public Law 104-191,
5 and regulations promulgated under that act, 45 CFR parts 160 and
6 164, without first obtaining written authorization from the test
7 subject or his or her legally authorized representative as
8 required under section 17020a or 17520a.
9 (2) If the test subject or the legally authorized
10 representative agrees to the disclosure of information relating
11 to his or her genetics or the presymptomatic or predictive
12 genetic testing, or both, he or she shall provide the health
13 facility or agency with the requisite written authorization.
14 (3) If the test subject or his or her legally authorized
15 representative provides written authorization for disclosure
16 under this section, the health facility or agency shall do each
17 of the following:
18 (a) Provide the test subject with a copy of the signed
19 written authorization.
20 (b) Maintain the original signed written authorization in
21 the test subject's medical record.
22 (c) Provide the test subject and the person to whom the
23 information is being disclosed with the following notice:
24 RESTRICTIONS ON FURTHER DISCLOSURE OF
25 GENETIC TESTING AND INFORMATION
26 This information is privileged and confidential. This information
1 is being provided to you in accordance with Michigan law and
2 shall not be further disclosed without a separate written
3 authorization from the test subject or his or her legally
4 authorized representative. A general consent or authorization for
5 the release of medical records or other information is not
6 sufficient to authorize the disclosure of genetic testing and
7 information.
8 (4) If a test subject consents to the performance of a
9 genetic test for the sole purpose of assisting in the recovery or
10 identification of human remains from a disaster or assisting in
11 the identification of living or deceased missing persons by
12 matching DNA profiles in the event of an emergency or disaster,
13 those results as well as the DNA profiles shall only be disclosed
14 and used for those identification purposes, are not public
15 records, are not subject to court subpoena, and are not
16 discoverable in a legal proceeding. Consent provided for testing
17 and DNA profiling under this subsection is not consent for
18 secondary research utilizing those results or DNA profiles or any
19 other use except for the identification of living or deceased
20 missing persons.
21 (5) Except as otherwise provided in subsection (6), as used
22 in this section:
23 (a) "Genetic information" means information about a gene,
24 gene product, or inherited characteristic which information is
25 derived from a genetic test.
26 (b) "Genetic test" means the analysis of human DNA, RNA,
27 chromosomes, and those proteins and metabolites used to detect
1 heritable or somatic disease-related genotypes or karyotypes for
2 clinical purposes. A genetic test must be generally accepted in
3 the scientific and medical communities as being specifically
4 determinative for the presence, absence, or mutation of a gene or
5 chromosome in order to qualify under this definition. Genetic
6 test does not include a routine physical examination or a routine
7 analysis, including, but not limited to, a chemical analysis, of
8 body fluids, unless conducted specifically to determine the
9 presence, absence, or mutation of a gene or chromosome.
10 (c) "Predictive genetic test" means a genetic test performed
11 for the purpose of predicting the future probability that the
12 test subject will develop a genetically related disease or
13 disability.
14 (d) "Presymptomatic genetic test" means a genetic test
15 performed before the onset of clinical symptoms or indications of
16 disease.
17 (6) For purposes of subsection (5)(b), the term "genetic
18 test" does not include a procedure performed as a component of
19 biomedical research that is conducted pursuant to federal common
20 rule under 21 CFR parts 50 and 56 and 45 CFR part 46.