HF 589

1st Engrossment - 88th Legislature (2013 - 2014) Posted on 03/13/2013 08:14pm

A bill for an act
relating to health; making changes to genetic information provisions; amending
Minnesota Statutes 2012, sections 13.386, subdivision 3; 144.966, subdivision 3,
by adding a subdivision; proposing coding for new law in Minnesota Statutes,
chapter 144.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2012, section 13.386, subdivision 3, is amended to read:

Subd. 3.

Collection, storage, use, and dissemination of genetic information.

(a)
Unless otherwise expressly provided by law, genetic information about an individual:

(1) may be collected by a government entity, as defined in section 13.02, subdivision
7a, or any other person only with the written informed consent of the individual;

(2) may be used only for purposes to which the individual has given written
informed consent;

(3) may be stored only for a period of time to which the individual has given written
informed consent; and

(4) may be disseminated only:

(i) with the individual's written informed consent; or

(ii) if necessary in order to accomplish purposes described by clause (2). A consent
to disseminate genetic information under item (i) must be signed and dated. Unless
otherwise provided by law, such a consent is valid for one year or for a lesser period
specified in the consent.

(b) Newborn screening activities conducted under sections 144.125 to 144.128 are
subject to paragraph (a). Other programs and activities governed under section 144.192
are not subject to paragraph (a).

Sec. 2.

[144.192] TREATMENT OF BIOLOGICAL SPECIMENS AND HEALTH
DATA HELD BY THE DEPARTMENT OF HEALTH AND HEALTH BOARDS.

Subdivision 1.

Definitions.

(a) For purposes of this section, the following terms
have the meanings given.

(b) "Biological specimen" means tissue, fluids, excretions, or secretions that contain
human DNA originating from an identifiable individual, either living or deceased.
Biological specimen does not include infectious agents or chemicals that are isolated from a
specimen. Nothing in this section or section 13.386 is intended to limit the commissioner's
ability to collect, use, store, or disseminate such isolated infectious agents or chemicals.

(c) "Health data" has the meaning given in section 13.3805, subdivision 1, paragraph
(a), clause (2).

(d) "Health oversight" means oversight of the health care system for activities
authorized by law, limited to the following:

(1) audits;

(2) civil, administrative, or criminal investigations;

(3) inspections;

(4) licensure or disciplinary actions;

(5) civil, administrative, or criminal proceedings or actions; and

(6) other activities necessary for appropriate oversight of the health care system and
persons subject to such governmental regulatory programs for which biological specimens
or health data are necessary for determining compliance with program standards.

(e) "Individual" has the meaning given in section 13.02, subdivision 8. In addition,
for a deceased individual, individual also means the representative of the decedent.

(f) "Person" has the meaning given in section 13.02, subdivision 10.

(g) "Program operations" means actions, testing, and procedures directly related to
the operation of department programs, limited to the following:

(1) diagnostic and confirmatory testing;

(2) laboratory quality control assurance and improvement;

(3) calibration of equipment;

(4) evaluation and improvement of test accuracy;

(5) method development and validation;

(6) compliance with regulatory requirements; and

(7) continuity of operations to ensure that testing continues in the event of an
emergency.

(h) "Public health practice" means actions related to disease, conditions, injuries,
risk factors, or exposures taken to protect public health, limited to the following:

(1) monitoring the health status of a population;

(2) investigating occurrences and outbreaks;

(3) comparing patterns and trends;

(4) implementing prevention and control measures;

(5) conducting program evaluations and making program improvements;

(6) making recommendations concerning health for a population;

(7) preventing or controlling known or suspected diseases and injuries; and

(8) conducting other activities necessary to protect or improve the health of
individuals and populations for which biological specimens or health data are necessary.

(i) "Representative of the decedent" has the meaning given in section 13.10,
subdivision 1, paragraph (c).

(j) "Research" means activities that are not program operations, public health
practice, or health oversight and is otherwise defined in Code of Federal Regulations, title
45, part 46, subpart A, section 46.102(d).

Subd. 2.

Collection, use, storage, and dissemination.

(a) The commissioner may
collect, use, store, and disseminate biological specimens and health data, genetic or other,
as provided in this section and as authorized under any other provision of applicable law,
including any rules adopted on or before June 30, 2013. Any rules adopted after June 30,
2013, must be consistent with the requirements of this section.

(b) The provisions in this section supplement other provisions of law and do not
supersede or repeal other provisions of law applying to the collection, use, storage, or
dissemination of biological specimens or health data.

(c) For purposes of this section, genetic information is limited to biological
specimens and health data.

Subd. 3.

Biological specimens and health data for program operations, public
health practice, and health oversight.

(a) The commissioner may collect, use, store, and
disseminate biological specimens and health data to conduct program operations activities,
public health practice activities, and health oversight activities. Unless required under
other applicable law, consent of an individual is not required under this subdivision.

(b) With the approval of the commissioner, biological specimens may be
disseminated to establish a diagnosis, to provide treatment, to identify persons at risk of
illness, or to conduct an epidemiologic investigation to control or prevent the spread of
serious disease, or to diminish an imminent threat to the public health.

(c) For purposes of Clinical Laboratory Improvement Amendments proficiency
testing, the commissioner may disseminate de-identified biological specimens to state
public health laboratories that agree, pursuant to contract, not to attempt to re-identify
the biological specimens.

(d) Health data may be disseminated as provided in section 13.3805, subdivision 1,
paragraph (b).

Subd. 4.

Research.

The commissioner may collect, use, store, and disseminate
biological specimens and health data to conduct research in a manner that is consistent
with the federal common rule for the protection of human subjects in Code of Federal
Regulations, title 45, part 46.

Subd. 5.

Storage of biological specimens and health data according to storage
schedules.

(a) The commissioner shall store health data according to section 138.17.

(b) The commissioner shall store biological specimens according to a specimen
storage schedule. The commissioner shall develop the storage schedule by July 1, 2013,
and post it on the department's Web site.

Subd. 6.

Secure storage of biological specimens.

The commissioner shall establish
appropriate security safeguards for the storage of biological specimens, with regard for
the privacy of the individuals from whom the biological specimens originated, and store
the biological specimens accordingly. When a biological specimen is disposed of, it
must be destroyed in a way that prevents determining the identity of the individual from
whom it originated.

Subd. 7.

Applicability to health boards.

The provisions of subdivisions 2; 3,
paragraphs (a), (c), and (d); and 4 to 6 pertaining to the commissioner also apply to boards
of health and community health boards organized under chapter 145A. These boards
may also disseminate health data pursuant to section 13.3805, subdivision 1, paragraph
(b), clause (2).

Sec. 3.

Minnesota Statutes 2012, section 144.966, subdivision 3, is amended to read:

Subd. 3.

Early hearing detection and intervention programs.

All hospitals
shall establish an early hearing detection and intervention (EHDI) program. Each EHDI
program shall:

(1) in advance of any hearing screening testing, provide to the newborn's or infant's
parents or parent information concerning the nature of the screening procedure, applicable
costs of the screening procedure, the potential risks and effects of hearing loss, and the
benefits of early detection and intervention;

(2) comply with parental consent under section 144.125, subdivision 3 4;

(3) develop policies and procedures for screening and rescreening based on
Department of Health recommendations;

(4) provide appropriate training and monitoring of individuals responsible for
performing hearing screening tests as recommended by the Department of Health;

(5) test the newborn's hearing prior to discharge, or, if the newborn is expected to
remain in the hospital for a prolonged period, testing shall be performed prior to three
months of age or when medically feasible;

(6) develop and implement procedures for documenting the results of all hearing
screening tests;

(7) inform the newborn's or infant's parents or parent, primary care physician, and
the Department of Health according to recommendations of the Department of Health of
the results of the hearing screening test or rescreening if conducted, or if the newborn or
infant was not successfully tested. The hospital that discharges the newborn or infant to
home is responsible for the screening; and

(8) collect performance data specified by the Department of Health.

Sec. 4.

Minnesota Statutes 2012, section 144.966, is amended by adding a subdivision
to read:

Subd. 8.

Construction.

Notwithstanding anything to the contrary, nothing in this
section shall be construed as constituting newborn screening activities conducted under
sections 144.125 to 144.128.

Sec. 5. EFFECTIVE DATE.

Sections 1 to 4 are effective July 1, 2013.