Bill Text: MN HF589 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Genetic information provisions changed.
Sponsorship: Moderate Partisan Bill (Democrat 4-1)
Status: (Introduced - Dead) 2013-03-13 - Second reading [HF589 Detail]
Download: Minnesota-2013-HF589-Engrossed.html
1.2relating to health; making changes to genetic information provisions;amending
1.3Minnesota Statutes 2012, sections 13.386, subdivision 3; 144.966, subdivision 3,
1.4by adding a subdivision; proposing coding for new law in Minnesota Statutes,
1.5chapter 144.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2012, section 13.386, subdivision 3, is amended to read:
1.8 Subd. 3. Collection, storage, use, and dissemination of genetic information. (a)
1.9Unless otherwise expressly provided by law, genetic information about an individual:
1.10(1) may be collected by a government entity, as defined in section13.02 , subdivision
1.117a, or any other person only with the written informed consent of the individual;
1.12(2) may be used only for purposes to which the individual has given written
1.13informed consent;
1.14(3) may be stored only for a period of time to which the individual has given written
1.15informed consent; and
1.16(4) may be disseminated only:
1.17(i) with the individual's written informed consent; or
1.18(ii) if necessary in order to accomplish purposes described by clause (2). A consent
1.19to disseminate genetic information under item (i) must be signed and dated. Unless
1.20otherwise provided by law, such a consent is valid for one year or for a lesser period
1.21specified in the consent.
1.22(b) Newborn screening activities conducted under sections 144.125 to 144.128 are
1.23subject to paragraph (a). Other programs and activities governed under section 144.192
1.24are not subject to paragraph (a).
2.1 Sec. 2. [144.192] TREATMENT OF BIOLOGICAL SPECIMENS AND HEALTH
2.2DATA HELD BY THE DEPARTMENT OF HEALTH AND HEALTH BOARDS.
2.3 Subdivision 1. Definitions. (a) For purposes of this section, the following terms
2.4have the meanings given.
2.5(b) "Biological specimen" means tissue, fluids, excretions, or secretions that contain
2.6human DNA originating from an identifiable individual, either living or deceased.
2.7Biological specimen does not include infectious agents or chemicals that are isolated from a
2.8specimen. Nothing in this section or section 13.386 is intended to limit the commissioner's
2.9ability to collect, use, store, or disseminate such isolated infectious agents or chemicals.
2.10(c) "Health data" has the meaning given in section 13.3805, subdivision 1, paragraph
2.11(a), clause (2).
2.12(d) "Health oversight" means oversight of the health care system for activities
2.13authorized by law, limited to the following:
2.14(1) audits;
2.15(2) civil, administrative, or criminal investigations;
2.16(3) inspections;
2.17(4) licensure or disciplinary actions;
2.18(5) civil, administrative, or criminal proceedings or actions; and
2.19(6) other activities necessary for appropriate oversight of the health care system and
2.20persons subject to such governmental regulatory programs for which biological specimens
2.21or health data are necessary for determining compliance with program standards.
2.22(e) "Individual" has the meaning given in section 13.02, subdivision 8. In addition,
2.23for a deceased individual, individual also means the representative of the decedent.
2.24(f) "Person" has the meaning given in section 13.02, subdivision 10.
2.25(g) "Program operations" means actions, testing, and procedures directly related to
2.26the operation of department programs, limited to the following:
2.27(1) diagnostic and confirmatory testing;
2.28(2) laboratory quality control assurance and improvement;
2.29(3) calibration of equipment;
2.30(4) evaluation and improvement of test accuracy;
2.31(5) method development and validation;
2.32(6) compliance with regulatory requirements; and
2.33(7) continuity of operations to ensure that testing continues in the event of an
2.34emergency.
2.35(h) "Public health practice" means actions related to disease, conditions, injuries,
2.36risk factors, or exposures taken to protect public health, limited to the following:
3.1(1) monitoring the health status of a population;
3.2(2) investigating occurrences and outbreaks;
3.3(3) comparing patterns and trends;
3.4(4) implementing prevention and control measures;
3.5(5) conducting program evaluations and making program improvements;
3.6(6) making recommendations concerning health for a population;
3.7(7) preventing or controlling known or suspected diseases and injuries; and
3.8(8) conducting other activities necessary to protect or improve the health of
3.9individuals and populations for which biological specimens or health data are necessary.
3.10(i) "Representative of the decedent" has the meaning given in section 13.10,
3.11subdivision 1, paragraph (c).
3.12(j) "Research" means activities that are not program operations, public health
3.13practice, or health oversight and is otherwise defined in Code of Federal Regulations, title
3.1445, part 46, subpart A, section 46.102(d).
3.15 Subd. 2. Collection, use, storage, and dissemination. (a) The commissioner may
3.16collect, use, store, and disseminate biological specimens and health data, genetic or other,
3.17as provided in this section and as authorized under any other provision of applicable law,
3.18including any rules adopted on or before June 30, 2013. Any rules adopted after June 30,
3.192013, must be consistent with the requirements of this section.
3.20(b) The provisions in this section supplement other provisions of law and do not
3.21supersede or repeal other provisions of law applying to the collection, use, storage, or
3.22dissemination of biological specimens or health data.
3.23(c) For purposes of this section, genetic information is limited to biological
3.24specimens and health data.
3.25 Subd. 3. Biological specimens and health data for program operations, public
3.26health practice, and health oversight. (a) The commissioner may collect, use, store, and
3.27disseminate biological specimens and health data to conduct program operations activities,
3.28public health practice activities, and health oversight activities. Unless required under
3.29other applicable law, consent of an individual is not required under this subdivision.
3.30(b) With the approval of the commissioner, biological specimens may be
3.31disseminated to establish a diagnosis, to provide treatment, to identify persons at risk of
3.32illness, or to conduct an epidemiologic investigation to control or prevent the spread of
3.33serious disease, or to diminish an imminent threat to the public health.
3.34(c) For purposes of Clinical Laboratory Improvement Amendments proficiency
3.35testing, the commissioner may disseminate de-identified biological specimens to state
4.1public health laboratories that agree, pursuant to contract, not to attempt to re-identify
4.2the biological specimens.
4.3(d) Health data may be disseminated as provided in section 13.3805, subdivision 1,
4.4paragraph (b).
4.5 Subd. 4. Research. The commissioner may collect, use, store, and disseminate
4.6biological specimens and health data to conduct research in a manner that is consistent
4.7with the federal common rule for the protection of human subjects in Code of Federal
4.8Regulations, title 45, part 46.
4.9 Subd. 5. Storage of biological specimens and health data according to storage
4.10schedules. (a) The commissioner shall store health data according to section 138.17.
4.11(b) The commissioner shall store biological specimens according to a specimen
4.12storage schedule. The commissioner shall develop the storage schedule by July 1, 2013,
4.13and post it on the department's Web site.
4.14 Subd. 6. Secure storage of biological specimens. The commissioner shall establish
4.15appropriate security safeguards for the storage of biological specimens, with regard for
4.16the privacy of the individuals from whom the biological specimens originated, and store
4.17the biological specimens accordingly. When a biological specimen is disposed of, it
4.18must be destroyed in a way that prevents determining the identity of the individual from
4.19whom it originated.
4.20 Subd. 7. Applicability to health boards. The provisions of subdivisions 2; 3,
4.21paragraphs (a), (c), and (d); and 4 to 6 pertaining to the commissioner also apply to boards
4.22of health and community health boards organized under chapter 145A. These boards
4.23may also disseminate health data pursuant to section 13.3805, subdivision 1, paragraph
4.24(b), clause (2).
4.25 Sec. 3. Minnesota Statutes 2012, section 144.966, subdivision 3, is amended to read:
4.26 Subd. 3. Early hearing detection and intervention programs. All hospitals
4.27shall establish an early hearing detection and intervention (EHDI) program. Each EHDI
4.28program shall:
4.29 (1) in advance of any hearing screening testing, provide to the newborn's or infant's
4.30parents or parent information concerning the nature of the screening procedure, applicable
4.31costs of the screening procedure, the potential risks and effects of hearing loss, and the
4.32benefits of early detection and intervention;
4.33 (2) comply with parental consent under section144.125, subdivision 3 4 ;
4.34 (3) develop policies and procedures for screening and rescreening based on
4.35Department of Health recommendations;
5.1 (4) provide appropriate training and monitoring of individuals responsible for
5.2performing hearing screening tests as recommended by the Department of Health;
5.3 (5) test the newborn's hearing prior to discharge, or, if the newborn is expected to
5.4remain in the hospital for a prolonged period, testing shall be performed prior to three
5.5months of age or when medically feasible;
5.6 (6) develop and implement procedures for documenting the results of all hearing
5.7screening tests;
5.8 (7) inform the newborn's or infant's parents or parent, primary care physician, and
5.9the Department of Health according to recommendations of the Department of Health of
5.10the results of the hearing screening test or rescreening if conducted, or if the newborn or
5.11infant was not successfully tested. The hospital that discharges the newborn or infant to
5.12home is responsible for the screening; and
5.13 (8) collect performance data specified by the Department of Health.
5.14 Sec. 4. Minnesota Statutes 2012, section 144.966, is amended by adding a subdivision
5.15to read:
5.16 Subd. 8. Construction. Notwithstanding anything to the contrary, nothing in this
5.17section shall be construed as constituting newborn screening activities conducted under
5.18sections 144.125 to 144.128.
5.19 Sec. 5. EFFECTIVE DATE.
5.20Sections 1 to 4 are effective July 1, 2013.
1.3Minnesota Statutes 2012, sections 13.386, subdivision 3; 144.966, subdivision 3,
1.4by adding a subdivision; proposing coding for new law in Minnesota Statutes,
1.5chapter 144.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. Minnesota Statutes 2012, section 13.386, subdivision 3, is amended to read:
1.8 Subd. 3. Collection, storage, use, and dissemination of genetic information. (a)
1.9Unless otherwise expressly provided by law, genetic information about an individual:
1.10(1) may be collected by a government entity, as defined in section
1.117a, or any other person only with the written informed consent of the individual;
1.12(2) may be used only for purposes to which the individual has given written
1.13informed consent;
1.14(3) may be stored only for a period of time to which the individual has given written
1.15informed consent; and
1.16(4) may be disseminated only:
1.17(i) with the individual's written informed consent; or
1.18(ii) if necessary in order to accomplish purposes described by clause (2). A consent
1.19to disseminate genetic information under item (i) must be signed and dated. Unless
1.20otherwise provided by law, such a consent is valid for one year or for a lesser period
1.21specified in the consent.
1.22(b) Newborn screening activities conducted under sections 144.125 to 144.128 are
1.23subject to paragraph (a). Other programs and activities governed under section 144.192
1.24are not subject to paragraph (a).
2.1 Sec. 2. [144.192] TREATMENT OF BIOLOGICAL SPECIMENS AND HEALTH
2.2DATA HELD BY THE DEPARTMENT OF HEALTH AND HEALTH BOARDS.
2.3 Subdivision 1. Definitions. (a) For purposes of this section, the following terms
2.4have the meanings given.
2.5(b) "Biological specimen" means tissue, fluids, excretions, or secretions that contain
2.6human DNA originating from an identifiable individual, either living or deceased.
2.7Biological specimen does not include infectious agents or chemicals that are isolated from a
2.8specimen. Nothing in this section or section 13.386 is intended to limit the commissioner's
2.9ability to collect, use, store, or disseminate such isolated infectious agents or chemicals.
2.10(c) "Health data" has the meaning given in section 13.3805, subdivision 1, paragraph
2.11(a), clause (2).
2.12(d) "Health oversight" means oversight of the health care system for activities
2.13authorized by law, limited to the following:
2.14(1) audits;
2.15(2) civil, administrative, or criminal investigations;
2.16(3) inspections;
2.17(4) licensure or disciplinary actions;
2.18(5) civil, administrative, or criminal proceedings or actions; and
2.19(6) other activities necessary for appropriate oversight of the health care system and
2.20persons subject to such governmental regulatory programs for which biological specimens
2.21or health data are necessary for determining compliance with program standards.
2.22(e) "Individual" has the meaning given in section 13.02, subdivision 8. In addition,
2.23for a deceased individual, individual also means the representative of the decedent.
2.24(f) "Person" has the meaning given in section 13.02, subdivision 10.
2.25(g) "Program operations" means actions, testing, and procedures directly related to
2.26the operation of department programs, limited to the following:
2.27(1) diagnostic and confirmatory testing;
2.28(2) laboratory quality control assurance and improvement;
2.29(3) calibration of equipment;
2.30(4) evaluation and improvement of test accuracy;
2.31(5) method development and validation;
2.32(6) compliance with regulatory requirements; and
2.33(7) continuity of operations to ensure that testing continues in the event of an
2.34emergency.
2.35(h) "Public health practice" means actions related to disease, conditions, injuries,
2.36risk factors, or exposures taken to protect public health, limited to the following:
3.1(1) monitoring the health status of a population;
3.2(2) investigating occurrences and outbreaks;
3.3(3) comparing patterns and trends;
3.4(4) implementing prevention and control measures;
3.5(5) conducting program evaluations and making program improvements;
3.6(6) making recommendations concerning health for a population;
3.7(7) preventing or controlling known or suspected diseases and injuries; and
3.8(8) conducting other activities necessary to protect or improve the health of
3.9individuals and populations for which biological specimens or health data are necessary.
3.10(i) "Representative of the decedent" has the meaning given in section 13.10,
3.11subdivision 1, paragraph (c).
3.12(j) "Research" means activities that are not program operations, public health
3.13practice, or health oversight and is otherwise defined in Code of Federal Regulations, title
3.1445, part 46, subpart A, section 46.102(d).
3.15 Subd. 2. Collection, use, storage, and dissemination. (a) The commissioner may
3.16collect, use, store, and disseminate biological specimens and health data, genetic or other,
3.17as provided in this section and as authorized under any other provision of applicable law,
3.18including any rules adopted on or before June 30, 2013. Any rules adopted after June 30,
3.192013, must be consistent with the requirements of this section.
3.20(b) The provisions in this section supplement other provisions of law and do not
3.21supersede or repeal other provisions of law applying to the collection, use, storage, or
3.22dissemination of biological specimens or health data.
3.23(c) For purposes of this section, genetic information is limited to biological
3.24specimens and health data.
3.25 Subd. 3. Biological specimens and health data for program operations, public
3.26health practice, and health oversight. (a) The commissioner may collect, use, store, and
3.27disseminate biological specimens and health data to conduct program operations activities,
3.28public health practice activities, and health oversight activities. Unless required under
3.29other applicable law, consent of an individual is not required under this subdivision.
3.30(b) With the approval of the commissioner, biological specimens may be
3.31disseminated to establish a diagnosis, to provide treatment, to identify persons at risk of
3.32illness, or to conduct an epidemiologic investigation to control or prevent the spread of
3.33serious disease, or to diminish an imminent threat to the public health.
3.34(c) For purposes of Clinical Laboratory Improvement Amendments proficiency
3.35testing, the commissioner may disseminate de-identified biological specimens to state
4.1public health laboratories that agree, pursuant to contract, not to attempt to re-identify
4.2the biological specimens.
4.3(d) Health data may be disseminated as provided in section 13.3805, subdivision 1,
4.4paragraph (b).
4.5 Subd. 4. Research. The commissioner may collect, use, store, and disseminate
4.6biological specimens and health data to conduct research in a manner that is consistent
4.7with the federal common rule for the protection of human subjects in Code of Federal
4.8Regulations, title 45, part 46.
4.9 Subd. 5. Storage of biological specimens and health data according to storage
4.10schedules. (a) The commissioner shall store health data according to section 138.17.
4.11(b) The commissioner shall store biological specimens according to a specimen
4.12storage schedule. The commissioner shall develop the storage schedule by July 1, 2013,
4.13and post it on the department's Web site.
4.14 Subd. 6. Secure storage of biological specimens. The commissioner shall establish
4.15appropriate security safeguards for the storage of biological specimens, with regard for
4.16the privacy of the individuals from whom the biological specimens originated, and store
4.17the biological specimens accordingly. When a biological specimen is disposed of, it
4.18must be destroyed in a way that prevents determining the identity of the individual from
4.19whom it originated.
4.20 Subd. 7. Applicability to health boards. The provisions of subdivisions 2; 3,
4.21paragraphs (a), (c), and (d); and 4 to 6 pertaining to the commissioner also apply to boards
4.22of health and community health boards organized under chapter 145A. These boards
4.23may also disseminate health data pursuant to section 13.3805, subdivision 1, paragraph
4.24(b), clause (2).
4.25 Sec. 3. Minnesota Statutes 2012, section 144.966, subdivision 3, is amended to read:
4.26 Subd. 3. Early hearing detection and intervention programs. All hospitals
4.27shall establish an early hearing detection and intervention (EHDI) program. Each EHDI
4.28program shall:
4.29 (1) in advance of any hearing screening testing, provide to the newborn's or infant's
4.30parents or parent information concerning the nature of the screening procedure, applicable
4.31costs of the screening procedure, the potential risks and effects of hearing loss, and the
4.32benefits of early detection and intervention;
4.33 (2) comply with parental consent under section
4.34 (3) develop policies and procedures for screening and rescreening based on
4.35Department of Health recommendations;
5.1 (4) provide appropriate training and monitoring of individuals responsible for
5.2performing hearing screening tests as recommended by the Department of Health;
5.3 (5) test the newborn's hearing prior to discharge, or, if the newborn is expected to
5.4remain in the hospital for a prolonged period, testing shall be performed prior to three
5.5months of age or when medically feasible;
5.6 (6) develop and implement procedures for documenting the results of all hearing
5.7screening tests;
5.8 (7) inform the newborn's or infant's parents or parent, primary care physician, and
5.9the Department of Health according to recommendations of the Department of Health of
5.10the results of the hearing screening test or rescreening if conducted, or if the newborn or
5.11infant was not successfully tested. The hospital that discharges the newborn or infant to
5.12home is responsible for the screening; and
5.13 (8) collect performance data specified by the Department of Health.
5.14 Sec. 4. Minnesota Statutes 2012, section 144.966, is amended by adding a subdivision
5.15to read:
5.16 Subd. 8. Construction. Notwithstanding anything to the contrary, nothing in this
5.17section shall be construed as constituting newborn screening activities conducted under
5.18sections 144.125 to 144.128.
5.19 Sec. 5. EFFECTIVE DATE.
5.20Sections 1 to 4 are effective July 1, 2013.
