Florida Senate - 2025 CS for SB 1356
By the Committee on Education Postsecondary; and Senator Burton
589-02481-25 20251356c1
1 A bill to be entitled
2 An act relating to the Florida Institute for Pediatric
3 Rare Diseases; creating s. 1004.4211, F.S.;
4 establishing the Florida Institute for Pediatric Rare
5 Diseases within the Florida State University College
6 of Medicine; providing the goals of the institute;
7 requiring the institute to establish and administer
8 the Sunshine Genetics Pilot Program for a specified
9 period; providing the purpose of the pilot program;
10 providing institute responsibilities and duties
11 relating to the pilot program; providing requirements
12 for participation in the pilot program and data
13 collection and release in the pilot program; defining
14 the term “health care practitioner”; providing
15 reporting requirements for the pilot program;
16 establishing the Sunshine Genetics Consortium for
17 specified purposes; requiring the consortium to be
18 administered at the institute by an oversight board;
19 providing for the membership and terms of the board;
20 providing meeting and reporting requirements for the
21 consortium; providing appropriations; providing an
22 effective date.
23
24 Be It Enacted by the Legislature of the State of Florida:
25
26 Section 1. Section 1004.4211, Florida Statutes, is created
27 to read:
28 1004.4211 The Florida Institute for Pediatric Rare
29 Diseases; the Sunshine Genetics Pilot Program; the Sunshine
30 Genetics Consortium.—
31 (1) The Florida Institute for Pediatric Rare Diseases is
32 established within the Florida State University College of
33 Medicine as a statewide resource for pediatric rare disease
34 research and clinical care. The purpose of the institute is to
35 improve the quality of life and health outcomes for children and
36 families affected by rare diseases by advancing knowledge,
37 diagnosis, and treatment of pediatric rare diseases through
38 research, clinical care, education, and advocacy.
39 (2) The goals of the institute are to:
40 (a) Conduct research to better understand the causes,
41 mechanisms, and potential treatments for pediatric rare
42 diseases, including leveraging emerging research methods.
43 (b) Develop advanced diagnostic and genetic screening tools
44 and techniques to enable health care providers to identify rare
45 diseases in newborns and children more rapidly, accurately, and
46 economically.
47 (c) Provide comprehensive multidisciplinary clinical
48 services and care for children with rare diseases. Such care may
49 include, but is not limited to, patient, family, and caregiver
50 support and resources to help navigate the challenges associated
51 with these conditions, support groups, and patient advocacy.
52 (d) Educate and train health care professionals, including,
53 but not limited to, genetic counselors, pediatricians,
54 scientists, and other specialists in the field of pediatric rare
55 diseases.
56 (e) Establish collaborations with other research
57 institutions, medical centers, patient and family advocacy
58 organizations, and government agencies whenever deemed
59 appropriate by the institute director to share expertise, raise
60 awareness, and promote a collective effort to tackle pediatric
61 rare diseases.
62 (3)(a) The institute shall establish and administer the
63 Sunshine Genetics Pilot Program to be administered for a period
64 of 5 years. The pilot program shall provide newborn genetic
65 screening, including, but not limited to, whole genome
66 sequencing. Genetic screening shall be performed by the
67 institute and institutional members of the oversight board upon
68 approval of the oversight board.
69 (b) The institute may establish partnerships with Florida
70 universities and colleges and health care service providers to
71 promote and assist in the implementation of the pilot program.
72 (c) The pilot program shall be an opt-in program and a
73 parent of a newborn must provide consent to participate in the
74 pilot program.
75 (d) The institute and institutional members of the
76 oversight board shall release clinical findings of a newborn’s
77 screening to the newborn’s health care practitioner and the
78 newborn’s parent. As used in this paragraph, the term “health
79 care practitioner” means a physician or physician assistant
80 licensed under chapter 458; an osteopathic physician or
81 physician assistant licensed under chapter 459; an advanced
82 practice registered nurse, registered nurse, or licensed
83 practical nurse licensed under part I of chapter 464; a midwife
84 licensed under chapter 467; a speech-language pathologist or
85 audiologist licensed under part I of chapter 468; a dietitian or
86 nutritionist licensed under part X of chapter 468; or a genetic
87 counselor licensed under part III of chapter 483.
88 (e) The institute shall:
89 1. Maintain a secure database to collect and store all
90 pilot program data, including, but not limited to, newborn
91 genomics sequence data and deidentified newborn data.
92 2. Provide deidentified newborn data to members of the
93 consortium pursuant to a data sharing agreement to support
94 ongoing and future research.
95 (f) By December 1, 2030, the institute shall provide a
96 report on the Sunshine Genetics Pilot Program to the Governor,
97 the President of the Senate, and the Speaker of the House of
98 Representatives. The report must include, at a minimum:
99 1. Study population and enrollment metrics.
100 2. Whole genome sequencing metrics.
101 3. Clinical and public health impact.
102 4. Cost effectiveness and economic benefits.
103 (4)(a) The Sunshine Genetics Consortium is established to
104 create a network of clinical and academic research
105 professionals, geneticists, and physicians from state
106 universities and the state’s children’s hospitals to collaborate
107 with leaders in the genetic industry and build and support a
108 culture of collaborative research and the development of cutting
109 edge genetic and precision medicine in the state. The consortium
110 shall:
111 1. Integrate state-of-the-art genomic sequencing
112 technologies.
113 2. Advance research and the development of cutting edge
114 genetic and precision medicine.
115 3. Leverage advancements in artificial intelligence
116 utilization in genomics.
117 4. Develop educational opportunities for clinicians on
118 genomic tools.
119 5. Support the growth and education of geneticists to meet
120 demand.
121 6. Solicit and leverage funds from nonprofits, private
122 industry, and others for the purpose of expanding the Sunshine
123 Genetics Pilot Program and to support genetic screenings by
124 institutional members of the oversight board.
125 7. Promote patient care that supports families with
126 children diagnosed with genetic disorders.
127 8. Report on the use of deidentified newborn data by
128 members of the consortium.
129 (b)1. The consortium shall be administered at the institute
130 by an oversight board. The board shall convene at least once
131 every 6 months.
132 2. The oversight board for the consortium shall consist of
133 the director of the institute who shall serve as chair and the
134 following voting members who shall serve 2-year terms:
135 a. One member nominated by the dean of the University of
136 Florida’s College of Medicine and approved by the university’s
137 president.
138 b. One member nominated by the dean of the University of
139 South Florida’s College of Medicine and approved by the
140 university’s president.
141 c. One member nominated by the dean of the University of
142 Miami’s School of Medicine and approved by the university’s
143 president.
144 d. One member appointed by the Governor.
145 e. One member appointed by the President of the Senate.
146 f. One member appointed by the Speaker of the House of
147 Representatives.
148 3. The board shall be responsible for the promotion and
149 oversight of the consortium, including, but not limited to, the
150 nomination and appointment of members of the consortium.
151 (c) Beginning October 15, 2026, and annually thereafter,
152 the consortium shall provide a report to the Governor, the
153 President of the Senate, and the Speaker of the House of
154 Representatives on research projects, research findings,
155 community outreach initiatives, and future plans for the
156 consortium.
157 Section 2. For the 2025-2026 fiscal year, the sum of $5
158 million in recurring funds is appropriated from the General
159 Revenue Fund to the Florida Institute for Pediatric Rare
160 Diseases.
161 Section 3. For the 2025-2026 fiscal year, the sum of $20
162 million in nonrecurring funds is appropriated from the General
163 Revenue Fund to the Florida Institute for Pediatric Rare
164 Diseases for the implementation of the Sunshine Genetics Pilot
165 Program established in s. 1004.4211, Florida Statutes.
166 Section 4. This act shall take effect July 1, 2025.