Florida Senate - 2025 COMMITTEE AMENDMENT
Bill No. SB 1356
Ì758458WÎ758458
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/19/2025 .
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The Committee on Education Postsecondary (Burton) recommended
the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 1004.4211, Florida Statutes, is created
6 to read:
7 1004.4211 The Florida Institute for Pediatric Rare
8 Diseases; the Sunshine Genetics Pilot Program; the Sunshine
9 Genetics Consortium.—
10 (1) The Florida Institute for Pediatric Rare Diseases is
11 established within the Florida State University College of
12 Medicine as a statewide resource for pediatric rare disease
13 research and clinical care. The purpose of the institute is to
14 improve the quality of life and health outcomes for children and
15 families affected by rare diseases by advancing knowledge,
16 diagnosis, and treatment of pediatric rare diseases through
17 research, clinical care, education, and advocacy.
18 (2) The goals of the institute are to:
19 (a) Conduct research to better understand the causes,
20 mechanisms, and potential treatments for pediatric rare
21 diseases, including leveraging emerging research methods.
22 (b) Develop advanced diagnostic and genetic screening tools
23 and techniques to enable health care providers to identify rare
24 diseases in newborns and children more rapidly, accurately, and
25 economically.
26 (c) Provide comprehensive multidisciplinary clinical
27 services and care for children with rare diseases. Such care may
28 include, but is not limited to, patient, family, and caregiver
29 support and resources to help navigate the challenges associated
30 with these conditions, support groups, and patient advocacy.
31 (d) Educate and train health care professionals, including,
32 but not limited to, genetic counselors, pediatricians,
33 scientists, and other specialists in the field of pediatric rare
34 diseases.
35 (e) Establish collaborations with other research
36 institutions, medical centers, patient and family advocacy
37 organizations, and government agencies whenever deemed
38 appropriate by the institute director to share expertise, raise
39 awareness, and promote a collective effort to tackle pediatric
40 rare diseases.
41 (3)(a) The institute shall establish and administer the
42 Sunshine Genetics Pilot Program to be administered for a period
43 of 5 years. The pilot program shall provide newborn genetic
44 screening, including, but not limited to, whole genome
45 sequencing. Genetic screening shall be performed by the
46 institute and institutional members of the oversight board upon
47 approval of the oversight board.
48 (b) The institute may establish partnerships with Florida
49 universities and colleges and health care service providers to
50 promote and assist in the implementation of the pilot program.
51 (c) The pilot program shall be an opt-in program and a
52 parent of a newborn must provide consent to participate in the
53 pilot program.
54 (d) The institute and institutional members of the
55 oversight board shall release clinical findings of a newborn’s
56 screening to the newborn’s health care practitioner and the
57 newborn’s parent. As used in this paragraph, the term “health
58 care practitioner” means a physician or physician assistant
59 licensed under chapter 458; an osteopathic physician or
60 physician assistant licensed under chapter 459; an advanced
61 practice registered nurse, registered nurse, or licensed
62 practical nurse licensed under part I of chapter 464; a midwife
63 licensed under chapter 467; a speech-language pathologist or
64 audiologist licensed under part I of chapter 468; a dietitian or
65 nutritionist licensed under part X of chapter 468; or a genetic
66 counselor licensed under part III of chapter 483.
67 (e) The institute shall:
68 1. Maintain a secure database to collect and store all
69 pilot program data, including, but not limited to, newborn
70 genomics sequence data and deidentified newborn data.
71 2. Provide deidentified newborn data to members of the
72 consortium pursuant to a data sharing agreement to support
73 ongoing and future research.
74 (f) By December 1, 2030, the institute shall provide a
75 report on the Sunshine Genetics Pilot Program to the Governor,
76 the President of the Senate, and the Speaker of the House of
77 Representatives. The report must include, at a minimum:
78 1. Study population and enrollment metrics.
79 2. Whole genome sequencing metrics.
80 3. Clinical and public health impact.
81 4. Cost effectiveness and economic benefits.
82 (4)(a) The Sunshine Genetics Consortium is established to
83 create a network of clinical and academic research
84 professionals, geneticists, and physicians from state
85 universities and the state’s children’s hospitals to collaborate
86 with leaders in the genetic industry and build and support a
87 culture of collaborative research and the development of cutting
88 edge genetic and precision medicine in the state. The consortium
89 shall:
90 1. Integrate state-of-the-art genomic sequencing
91 technologies.
92 2. Advance research and the development of cutting edge
93 genetic and precision medicine.
94 3. Leverage advancements in artificial intelligence
95 utilization in genomics.
96 4. Develop educational opportunities for clinicians on
97 genomic tools.
98 5. Support the growth and education of geneticists to meet
99 demand.
100 6. Solicit and leverage funds from nonprofits, private
101 industry, and others for the purpose of expanding the Sunshine
102 Genetics Pilot Program and to support genetic screenings by
103 institutional members of the oversight board.
104 7. Promote patient care that supports families with
105 children diagnosed with genetic disorders.
106 8. Report on the use of deidentified newborn data by
107 members of the consortium.
108 (b)1. The consortium shall be administered at the institute
109 by an oversight board. The board shall convene at least once
110 every 6 months.
111 2. The oversight board for the consortium shall consist of
112 the director of the institute who shall serve as chair and the
113 following voting members who shall serve 2-year terms:
114 a. One member nominated by the dean of the University of
115 Florida’s College of Medicine and approved by the university’s
116 president.
117 b. One member nominated by the dean of the University of
118 South Florida’s College of Medicine and approved by the
119 university’s president.
120 c. One member nominated by the dean of the University of
121 Miami’s School of Medicine and approved by the university’s
122 president.
123 d. One member appointed by the Governor.
124 e. One member appointed by the President of the Senate.
125 f. One member appointed by the Speaker of the House of
126 Representatives.
127 3. The board shall be responsible for the promotion and
128 oversight of the consortium, including, but not limited to, the
129 nomination and appointment of members of the consortium.
130 (c) Beginning October 15, 2026, and annually thereafter,
131 the consortium shall provide a report to the Governor, the
132 President of the Senate, and the Speaker of the House of
133 Representatives on research projects, research findings,
134 community outreach initiatives, and future plans for the
135 consortium.
136 Section 2. For the 2025-2026 fiscal year, the sum of $5
137 million in recurring funds is appropriated from the General
138 Revenue Fund to the Florida Institute for Pediatric Rare
139 Diseases.
140 Section 3. For the 2025-2026 fiscal year, the sum of $20
141 million in nonrecurring funds is appropriated from the General
142 Revenue Fund to the Florida Institute for Pediatric Rare
143 Diseases for the implementation of the Sunshine Genetics Pilot
144 Program established in s. 1004.4211, Florida Statutes.
145 Section 4. This act shall take effect July 1, 2025.
146 ================= T I T L E A M E N D M E N T ================
147 And the title is amended as follows:
148 Delete everything before the enacting clause
149 and insert:
150 A bill to be entitled
151 An act relating to the Florida Institute for Pediatric
152 Rare Diseases; creating s. 1004.4211, F.S.;
153 establishing the Florida Institute for Pediatric Rare
154 Diseases within the Florida State University College
155 of Medicine; providing the goals of the institute;
156 requiring the institute to establish and administer
157 the Sunshine Genetics Pilot Program for a specified
158 period; providing the purpose of the pilot program;
159 providing institute responsibilities and duties
160 relating to the pilot program; providing requirements
161 for participation in the pilot program and data
162 collection and release in the pilot program; defining
163 the term “health care practitioner”; providing
164 reporting requirements for the pilot program;
165 establishing the Sunshine Genetics Consortium for
166 specified purposes; requiring the consortium to be
167 administered at the institute by an oversight board;
168 providing for the membership and terms of the board;
169 providing meeting and reporting requirements for the
170 consortium; providing appropriations; providing an
171 effective date.