1 | 1 | | |
---|
2 | 2 | | Introduced Version |
---|
3 | 3 | | HOUSE BILL No. 1335 |
---|
4 | 4 | | _____ |
---|
5 | 5 | | DIGEST OF INTRODUCED BILL |
---|
6 | 6 | | Citations Affected: IC 16-18-2; IC 16-38-7; IC 35-52-16-33.5. |
---|
7 | 7 | | Synopsis: Indiana vaccination adverse event reporting system. |
---|
8 | 8 | | Requires the Indiana department of health (department) to establish an |
---|
9 | 9 | | Indiana vaccination adverse event reporting system (IVAERS) for |
---|
10 | 10 | | reporting the occurrence of adverse events relating to childhood |
---|
11 | 11 | | vaccines. Provides that IVAERS must enable a health care provider to |
---|
12 | 12 | | report the occurrence of an adverse event experienced by a child |
---|
13 | 13 | | residing in Indiana who is under the care of the health care provider. |
---|
14 | 14 | | Requires the department to create a searchable Internet data base for |
---|
15 | 15 | | publishing information reported through IVAERS. Provides that the |
---|
16 | 16 | | health information of a particular individual is confidential. Specifies |
---|
17 | 17 | | to whom and the requirements for releasing health information of a |
---|
18 | 18 | | particular individual. Provides that a person who knowingly, |
---|
19 | 19 | | intentionally, or recklessly discloses confidential information received |
---|
20 | 20 | | through IVAERS in violation of the statute commits a Class A |
---|
21 | 21 | | misdemeanor. Authorizes the department to adopt rules concerning |
---|
22 | 22 | | IVAERS. Makes an appropriation. |
---|
23 | 23 | | Effective: July 1, 2024. |
---|
24 | 24 | | Borders |
---|
25 | 25 | | January 10, 2024, read first time and referred to Committee on Public Health. |
---|
26 | 26 | | 2024 IN 1335—LS 6434/DI 104 Introduced |
---|
27 | 27 | | Second Regular Session of the 123rd General Assembly (2024) |
---|
28 | 28 | | PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana |
---|
29 | 29 | | Constitution) is being amended, the text of the existing provision will appear in this style type, |
---|
30 | 30 | | additions will appear in this style type, and deletions will appear in this style type. |
---|
31 | 31 | | Additions: Whenever a new statutory provision is being enacted (or a new constitutional |
---|
32 | 32 | | provision adopted), the text of the new provision will appear in this style type. Also, the |
---|
33 | 33 | | word NEW will appear in that style type in the introductory clause of each SECTION that adds |
---|
34 | 34 | | a new provision to the Indiana Code or the Indiana Constitution. |
---|
35 | 35 | | Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts |
---|
36 | 36 | | between statutes enacted by the 2023 Regular Session of the General Assembly. |
---|
37 | 37 | | HOUSE BILL No. 1335 |
---|
38 | 38 | | A BILL FOR AN ACT to amend the Indiana Code concerning |
---|
39 | 39 | | health and to make an appropriation. |
---|
40 | 40 | | Be it enacted by the General Assembly of the State of Indiana: |
---|
41 | 41 | | 1 SECTION 1. IC 16-18-2-7.5 IS ADDED TO THE INDIANA CODE |
---|
42 | 42 | | 2 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY |
---|
43 | 43 | | 3 1, 2024]: Sec. 7.5. "Adverse event", for purposes of IC 16-38-7, has |
---|
44 | 44 | | 4 the meaning set forth in IC 16-38-7-1. |
---|
45 | 45 | | 5 SECTION 2. IC 16-18-2-54.6 IS ADDED TO THE INDIANA |
---|
46 | 46 | | 6 CODE AS A NEW SECTION TO READ AS FOLLOWS |
---|
47 | 47 | | 7 [EFFECTIVE JULY 1, 2024]: Sec. 54.6. "Childhood vaccine", for |
---|
48 | 48 | | 8 purposes of IC 16-38-7, has the meaning set forth in IC 16-38-7-2. |
---|
49 | 49 | | 9 SECTION 3. IC 16-18-2-163, AS AMENDED BY |
---|
50 | 50 | | 10 P.L.179-2022(ss), SECTION 4, IS AMENDED TO READ AS |
---|
51 | 51 | | 11 FOLLOWS [EFFECTIVE JULY 1, 2024]: Sec. 163. (a) Except as |
---|
52 | 52 | | 12 provided in subsection (c), "health care provider", for purposes of |
---|
53 | 53 | | 13 IC 16-21, IC 16-38-7, and IC 16-41, means any of the following: |
---|
54 | 54 | | 14 (1) An individual, a partnership, a corporation, a professional |
---|
55 | 55 | | 15 corporation, a facility, or an institution licensed or legally |
---|
56 | 56 | | 16 authorized by this state to provide health care or professional |
---|
57 | 57 | | 17 services as a licensed physician, a psychiatric hospital, a hospital, |
---|
58 | 58 | | 2024 IN 1335—LS 6434/DI 104 2 |
---|
59 | 59 | | 1 a health facility, an emergency ambulance service (IC 16-31-3), |
---|
60 | 60 | | 2 a dentist, a registered or licensed practical nurse, a midwife, an |
---|
61 | 61 | | 3 optometrist, a pharmacist, a podiatrist, a chiropractor, a physical |
---|
62 | 62 | | 4 therapist, a respiratory care practitioner, an occupational therapist, |
---|
63 | 63 | | 5 a psychologist, a paramedic, an emergency medical technician, an |
---|
64 | 64 | | 6 advanced emergency medical technician, an athletic trainer, or a |
---|
65 | 65 | | 7 person who is an officer, employee, or agent of the individual, |
---|
66 | 66 | | 8 partnership, corporation, professional corporation, facility, or |
---|
67 | 67 | | 9 institution acting in the course and scope of the person's |
---|
68 | 68 | | 10 employment. |
---|
69 | 69 | | 11 (2) A college, university, or junior college that provides health |
---|
70 | 70 | | 12 care to a student, a faculty member, or an employee, and the |
---|
71 | 71 | | 13 governing board or a person who is an officer, employee, or agent |
---|
72 | 72 | | 14 of the college, university, or junior college acting in the course |
---|
73 | 73 | | 15 and scope of the person's employment. |
---|
74 | 74 | | 16 (3) A blood bank, community mental health center, community |
---|
75 | 75 | | 17 intellectual disability center, community health center, or migrant |
---|
76 | 76 | | 18 health center. |
---|
77 | 77 | | 19 (4) A home health agency (as defined in IC 16-27-1-2). |
---|
78 | 78 | | 20 (5) A health maintenance organization (as defined in |
---|
79 | 79 | | 21 IC 27-13-1-19). |
---|
80 | 80 | | 22 (6) A health care organization whose members, shareholders, or |
---|
81 | 81 | | 23 partners are health care providers under subdivision (1). |
---|
82 | 82 | | 24 (7) A corporation, partnership, or professional corporation not |
---|
83 | 83 | | 25 otherwise qualified under this subsection that: |
---|
84 | 84 | | 26 (A) provides health care as one (1) of the corporation's, |
---|
85 | 85 | | 27 partnership's, or professional corporation's functions; |
---|
86 | 86 | | 28 (B) is organized or registered under state law; and |
---|
87 | 87 | | 29 (C) is determined to be eligible for coverage as a health care |
---|
88 | 88 | | 30 provider under IC 34-18 for the corporation's, partnership's, or |
---|
89 | 89 | | 31 professional corporation's health care function. |
---|
90 | 90 | | 32 Coverage for a health care provider qualified under this subdivision is |
---|
91 | 91 | | 33 limited to the health care provider's health care functions and does not |
---|
92 | 92 | | 34 extend to other causes of action. |
---|
93 | 93 | | 35 (b) "Health care provider", for purposes of IC 16-35, has the |
---|
94 | 94 | | 36 meaning set forth in subsection (a). However, for purposes of IC 16-35, |
---|
95 | 95 | | 37 the term also includes a health facility (as defined in section 167 of this |
---|
96 | 96 | | 38 chapter). |
---|
97 | 97 | | 39 (c) "Health care provider", for purposes of IC 16-32-5, IC 16-36-5, |
---|
98 | 98 | | 40 IC 16-36-6, and IC 16-41-10 means an individual licensed or |
---|
99 | 99 | | 41 authorized by this state to provide health care or professional services |
---|
100 | 100 | | 42 as: |
---|
101 | 101 | | 2024 IN 1335—LS 6434/DI 104 3 |
---|
102 | 102 | | 1 (1) a licensed physician; |
---|
103 | 103 | | 2 (2) a registered nurse; |
---|
104 | 104 | | 3 (3) a licensed practical nurse; |
---|
105 | 105 | | 4 (4) an advanced practice registered nurse; |
---|
106 | 106 | | 5 (5) a certified nurse midwife; |
---|
107 | 107 | | 6 (6) a paramedic; |
---|
108 | 108 | | 7 (7) an emergency medical technician; |
---|
109 | 109 | | 8 (8) an advanced emergency medical technician; |
---|
110 | 110 | | 9 (9) an emergency medical responder, as defined by section 109.8 |
---|
111 | 111 | | 10 of this chapter; |
---|
112 | 112 | | 11 (10) a licensed dentist; |
---|
113 | 113 | | 12 (11) a home health aide, as defined by section 174 of this chapter; |
---|
114 | 114 | | 13 or |
---|
115 | 115 | | 14 (12) a licensed physician assistant. |
---|
116 | 116 | | 15 The term includes an individual who is an employee or agent of a |
---|
117 | 117 | | 16 health care provider acting in the course and scope of the individual's |
---|
118 | 118 | | 17 employment. |
---|
119 | 119 | | 18 (d) "Health care provider", for purposes of IC 16-36-7, has the |
---|
120 | 120 | | 19 meaning set forth in IC 16-36-7-12. |
---|
121 | 121 | | 20 (e) "Health care provider", for purposes of IC 16-40-4, means any |
---|
122 | 122 | | 21 of the following: |
---|
123 | 123 | | 22 (1) An individual, a partnership, a corporation, a professional |
---|
124 | 124 | | 23 corporation, a facility, or an institution licensed or authorized by |
---|
125 | 125 | | 24 the state to provide health care or professional services as a |
---|
126 | 126 | | 25 licensed physician, a psychiatric hospital, a hospital, a health |
---|
127 | 127 | | 26 facility, an emergency ambulance service (IC 16-31-3), an |
---|
128 | 128 | | 27 ambulatory outpatient surgical center, a dentist, an optometrist, a |
---|
129 | 129 | | 28 pharmacist, a podiatrist, a chiropractor, a psychologist, or a |
---|
130 | 130 | | 29 person who is an officer, employee, or agent of the individual, |
---|
131 | 131 | | 30 partnership, corporation, professional corporation, facility, or |
---|
132 | 132 | | 31 institution acting in the course and scope of the person's |
---|
133 | 133 | | 32 employment. |
---|
134 | 134 | | 33 (2) A blood bank, laboratory, community mental health center, |
---|
135 | 135 | | 34 community intellectual disability center, community health |
---|
136 | 136 | | 35 center, or migrant health center. |
---|
137 | 137 | | 36 (3) A home health agency (as defined in IC 16-27-1-2). |
---|
138 | 138 | | 37 (4) A health maintenance organization (as defined in |
---|
139 | 139 | | 38 IC 27-13-1-19). |
---|
140 | 140 | | 39 (5) A health care organization whose members, shareholders, or |
---|
141 | 141 | | 40 partners are health care providers under subdivision (1). |
---|
142 | 142 | | 41 (6) A corporation, partnership, or professional corporation not |
---|
143 | 143 | | 42 otherwise specified in this subsection that: |
---|
144 | 144 | | 2024 IN 1335—LS 6434/DI 104 4 |
---|
145 | 145 | | 1 (A) provides health care as one (1) of the corporation's, |
---|
146 | 146 | | 2 partnership's, or professional corporation's functions; |
---|
147 | 147 | | 3 (B) is organized or registered under state law; and |
---|
148 | 148 | | 4 (C) is determined to be eligible for coverage as a health care |
---|
149 | 149 | | 5 provider under IC 34-18 for the corporation's, partnership's, or |
---|
150 | 150 | | 6 professional corporation's health care function. |
---|
151 | 151 | | 7 (7) A person that is designated to maintain the records of a person |
---|
152 | 152 | | 8 described in subdivisions (1) through (6). |
---|
153 | 153 | | 9 (f) "Health care provider", for purposes of IC 16-45-4, has the |
---|
154 | 154 | | 10 meaning set forth in 47 CFR 54.601(a). |
---|
155 | 155 | | 11 SECTION 4. IC 16-18-2-194.9 IS ADDED TO THE INDIANA |
---|
156 | 156 | | 12 CODE AS A NEW SECTION TO READ AS FOLLOWS |
---|
157 | 157 | | 13 [EFFECTIVE JULY 1, 2024]: Sec. 194.9. "IVAERS", for purposes |
---|
158 | 158 | | 14 of IC 16-38-7, has the meaning set forth in IC 16-38-7-3. |
---|
159 | 159 | | 15 SECTION 5. IC 16-38-7 IS ADDED TO THE INDIANA CODE AS |
---|
160 | 160 | | 16 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY |
---|
161 | 161 | | 17 1, 2024]: |
---|
162 | 162 | | 18 Chapter 7. Indiana Vaccination Adverse Event Reporting |
---|
163 | 163 | | 19 System |
---|
164 | 164 | | 20 Sec. 1. As used in this chapter, "adverse event" means any of the |
---|
165 | 165 | | 21 following occurring after the administration of a childhood |
---|
166 | 166 | | 22 vaccine: |
---|
167 | 167 | | 23 (1) An event that is a reportable event for purposes of the |
---|
168 | 168 | | 24 administration of the federal vaccination adverse event |
---|
169 | 169 | | 25 reporting system as published by the United States |
---|
170 | 170 | | 26 Department of Health and Human Services in the Table of |
---|
171 | 171 | | 27 Reportable Events in effect on January 1, 2022. |
---|
172 | 172 | | 28 (2) A diagnosis that a child receiving the childhood vaccine |
---|
173 | 173 | | 29 has autism spectrum disorder. |
---|
174 | 174 | | 30 (3) Any other reaction or injury that a health care provider |
---|
175 | 175 | | 31 determines is proximately caused by the administration of the |
---|
176 | 176 | | 32 childhood vaccine. |
---|
177 | 177 | | 33 Sec. 2. As used in this chapter, "childhood vaccine" means an |
---|
178 | 178 | | 34 immunization described in IC 20-34-4-2(a). |
---|
179 | 179 | | 35 Sec. 3. As used in this chapter, "IVAERS" refers to the Indiana |
---|
180 | 180 | | 36 vaccination adverse event reporting system established under |
---|
181 | 181 | | 37 section 4 of this chapter. |
---|
182 | 182 | | 38 Sec. 4. (a) The state department shall develop the Indiana |
---|
183 | 183 | | 39 vaccination adverse event reporting system (IVAERS). |
---|
184 | 184 | | 40 (b) IVAERS must enable a health care provider to report the |
---|
185 | 185 | | 41 occurrence of an adverse event experienced by a child residing in |
---|
186 | 186 | | 42 Indiana who is under the care of the health care provider. |
---|
187 | 187 | | 2024 IN 1335—LS 6434/DI 104 5 |
---|
188 | 188 | | 1 Sec. 5. A health care provider shall, in the form and manner |
---|
189 | 189 | | 2 required by the rules adopted by the state department, report to |
---|
190 | 190 | | 3 the state department through IVAERS the occurrence of an |
---|
191 | 191 | | 4 adverse event experienced by a child residing in Indiana who is |
---|
192 | 192 | | 5 under the care of the health care provider. |
---|
193 | 193 | | 6 Sec. 6. The state department shall do the following: |
---|
194 | 194 | | 7 (1) Create a searchable Internet data base for publishing |
---|
195 | 195 | | 8 information reported through IVAERS under section 5 of this |
---|
196 | 196 | | 9 chapter after removing any personal identifying information |
---|
197 | 197 | | 10 of a child who experiences an adverse event. |
---|
198 | 198 | | 11 (2) Provide continuing twenty-four (24) hour a day online |
---|
199 | 199 | | 12 access to the data base. |
---|
200 | 200 | | 13 (3) Secure the information collected under section 5 of this |
---|
201 | 201 | | 14 chapter and the data base maintained under this chapter |
---|
202 | 202 | | 15 against access by unauthorized persons. |
---|
203 | 203 | | 16 Sec. 7. (a) Health information reported by a health care |
---|
204 | 204 | | 17 provider through IVAERS is confidential. |
---|
205 | 205 | | 18 (b) The state department may release information received |
---|
206 | 206 | | 19 through IVAERS relating to a particular individual to the |
---|
207 | 207 | | 20 individual or to the individual's parent or guardian if the |
---|
208 | 208 | | 21 individual is less than eighteen (18) years of age. |
---|
209 | 209 | | 22 (c) With the consent of the individual or of the individual's |
---|
210 | 210 | | 23 parent or guardian if the individual is less than eighteen (18) years |
---|
211 | 211 | | 24 of age, the state department may release information received |
---|
212 | 212 | | 25 through IVAERS relating to a particular individual to a health |
---|
213 | 213 | | 26 care provider. |
---|
214 | 214 | | 27 (d) A person who knowingly, intentionally, or recklessly |
---|
215 | 215 | | 28 discloses confidential information received through IVAERS in |
---|
216 | 216 | | 29 violation of this chapter commits a Class A misdemeanor. |
---|
217 | 217 | | 30 Sec. 8. The state department shall adopt rules under IC 4-22-2 |
---|
218 | 218 | | 31 to implement this chapter, including rules concerning the |
---|
219 | 219 | | 32 following: |
---|
220 | 220 | | 33 (1) The form and manner in which a health care provider |
---|
221 | 221 | | 34 must submit information to IVAERS. |
---|
222 | 222 | | 35 (2) Protecting the privacy and personal identifying |
---|
223 | 223 | | 36 information of children who experience adverse events. |
---|
224 | 224 | | 37 (3) The form and manner of publishing information relating |
---|
225 | 225 | | 38 to adverse events without breaching the confidentiality of the |
---|
226 | 226 | | 39 health information of particular individuals. |
---|
227 | 227 | | 40 (4) The design of the data base required under section 6 of this |
---|
228 | 228 | | 41 chapter. |
---|
229 | 229 | | 42 Sec. 9. Money is annually appropriated to the state department |
---|
230 | 230 | | 2024 IN 1335—LS 6434/DI 104 6 |
---|
231 | 231 | | 1 from the state general fund in an amount sufficient to establish and |
---|
232 | 232 | | 2 maintain IVAERS established under section 4 of this chapter. |
---|
233 | 233 | | 3 SECTION 6. IC 35-52-16-33.5 IS ADDED TO THE INDIANA |
---|
234 | 234 | | 4 CODE AS A NEW CHAPTER TO READ AS FOLLOWS |
---|
235 | 235 | | 5 [EFFECTIVE JULY 1, 2024]: Sec. 33.5. IC 16-38-7-7 defines a crime |
---|
236 | 236 | | 6 concerning the release of confidential information maintained in |
---|
237 | 237 | | 7 the Indiana vaccination adverse event reporting system. |
---|
238 | 238 | | 2024 IN 1335—LS 6434/DI 104 |
---|