Introduced Version
HOUSE BILL No. 1335
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 16-18-2; IC 16-38-7; IC 35-52-16-33.5.
Synopsis: Indiana vaccination adverse event reporting system.
Requires the Indiana department of health (department) to establish an
Indiana vaccination adverse event reporting system (IVAERS) for
reporting the occurrence of adverse events relating to childhood
vaccines. Provides that IVAERS must enable a health care provider to
report the occurrence of an adverse event experienced by a child
residing in Indiana who is under the care of the health care provider.
Requires the department to create a searchable Internet data base for
publishing information reported through IVAERS. Provides that the
health information of a particular individual is confidential. Specifies
to whom and the requirements for releasing health information of a
particular individual. Provides that a person who knowingly,
intentionally, or recklessly discloses confidential information received
through IVAERS in violation of the statute commits a Class A
misdemeanor. Authorizes the department to adopt rules concerning
IVAERS. Makes an appropriation.
Effective: July 1, 2024.
Borders
January 10, 2024, read first time and referred to Committee on Public Health.
2024 IN 1335—LS 6434/DI 104 Introduced
Second Regular Session of the 123rd General Assembly (2024)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
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between statutes enacted by the 2023 Regular Session of the General Assembly.
HOUSE BILL No. 1335
A BILL FOR AN ACT to amend the Indiana Code concerning
health and to make an appropriation.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 16-18-2-7.5 IS ADDED TO THE INDIANA CODE
2 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
3 1, 2024]: Sec. 7.5. "Adverse event", for purposes of IC 16-38-7, has
4 the meaning set forth in IC 16-38-7-1.
5 SECTION 2. IC 16-18-2-54.6 IS ADDED TO THE INDIANA
6 CODE AS A NEW SECTION TO READ AS FOLLOWS
7 [EFFECTIVE JULY 1, 2024]: Sec. 54.6. "Childhood vaccine", for
8 purposes of IC 16-38-7, has the meaning set forth in IC 16-38-7-2.
9 SECTION 3. IC 16-18-2-163, AS AMENDED BY
10 P.L.179-2022(ss), SECTION 4, IS AMENDED TO READ AS
11 FOLLOWS [EFFECTIVE JULY 1, 2024]: Sec. 163. (a) Except as
12 provided in subsection (c), "health care provider", for purposes of
13 IC 16-21, IC 16-38-7, and IC 16-41, means any of the following:
14 (1) An individual, a partnership, a corporation, a professional
15 corporation, a facility, or an institution licensed or legally
16 authorized by this state to provide health care or professional
17 services as a licensed physician, a psychiatric hospital, a hospital,
2024 IN 1335—LS 6434/DI 104 2
1 a health facility, an emergency ambulance service (IC 16-31-3),
2 a dentist, a registered or licensed practical nurse, a midwife, an
3 optometrist, a pharmacist, a podiatrist, a chiropractor, a physical
4 therapist, a respiratory care practitioner, an occupational therapist,
5 a psychologist, a paramedic, an emergency medical technician, an
6 advanced emergency medical technician, an athletic trainer, or a
7 person who is an officer, employee, or agent of the individual,
8 partnership, corporation, professional corporation, facility, or
9 institution acting in the course and scope of the person's
10 employment.
11 (2) A college, university, or junior college that provides health
12 care to a student, a faculty member, or an employee, and the
13 governing board or a person who is an officer, employee, or agent
14 of the college, university, or junior college acting in the course
15 and scope of the person's employment.
16 (3) A blood bank, community mental health center, community
17 intellectual disability center, community health center, or migrant
18 health center.
19 (4) A home health agency (as defined in IC 16-27-1-2).
20 (5) A health maintenance organization (as defined in
21 IC 27-13-1-19).
22 (6) A health care organization whose members, shareholders, or
23 partners are health care providers under subdivision (1).
24 (7) A corporation, partnership, or professional corporation not
25 otherwise qualified under this subsection that:
26 (A) provides health care as one (1) of the corporation's,
27 partnership's, or professional corporation's functions;
28 (B) is organized or registered under state law; and
29 (C) is determined to be eligible for coverage as a health care
30 provider under IC 34-18 for the corporation's, partnership's, or
31 professional corporation's health care function.
32 Coverage for a health care provider qualified under this subdivision is
33 limited to the health care provider's health care functions and does not
34 extend to other causes of action.
35 (b) "Health care provider", for purposes of IC 16-35, has the
36 meaning set forth in subsection (a). However, for purposes of IC 16-35,
37 the term also includes a health facility (as defined in section 167 of this
38 chapter).
39 (c) "Health care provider", for purposes of IC 16-32-5, IC 16-36-5,
40 IC 16-36-6, and IC 16-41-10 means an individual licensed or
41 authorized by this state to provide health care or professional services
42 as:
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1 (1) a licensed physician;
2 (2) a registered nurse;
3 (3) a licensed practical nurse;
4 (4) an advanced practice registered nurse;
5 (5) a certified nurse midwife;
6 (6) a paramedic;
7 (7) an emergency medical technician;
8 (8) an advanced emergency medical technician;
9 (9) an emergency medical responder, as defined by section 109.8
10 of this chapter;
11 (10) a licensed dentist;
12 (11) a home health aide, as defined by section 174 of this chapter;
13 or
14 (12) a licensed physician assistant.
15 The term includes an individual who is an employee or agent of a
16 health care provider acting in the course and scope of the individual's
17 employment.
18 (d) "Health care provider", for purposes of IC 16-36-7, has the
19 meaning set forth in IC 16-36-7-12.
20 (e) "Health care provider", for purposes of IC 16-40-4, means any
21 of the following:
22 (1) An individual, a partnership, a corporation, a professional
23 corporation, a facility, or an institution licensed or authorized by
24 the state to provide health care or professional services as a
25 licensed physician, a psychiatric hospital, a hospital, a health
26 facility, an emergency ambulance service (IC 16-31-3), an
27 ambulatory outpatient surgical center, a dentist, an optometrist, a
28 pharmacist, a podiatrist, a chiropractor, a psychologist, or a
29 person who is an officer, employee, or agent of the individual,
30 partnership, corporation, professional corporation, facility, or
31 institution acting in the course and scope of the person's
32 employment.
33 (2) A blood bank, laboratory, community mental health center,
34 community intellectual disability center, community health
35 center, or migrant health center.
36 (3) A home health agency (as defined in IC 16-27-1-2).
37 (4) A health maintenance organization (as defined in
38 IC 27-13-1-19).
39 (5) A health care organization whose members, shareholders, or
40 partners are health care providers under subdivision (1).
41 (6) A corporation, partnership, or professional corporation not
42 otherwise specified in this subsection that:
2024 IN 1335—LS 6434/DI 104 4
1 (A) provides health care as one (1) of the corporation's,
2 partnership's, or professional corporation's functions;
3 (B) is organized or registered under state law; and
4 (C) is determined to be eligible for coverage as a health care
5 provider under IC 34-18 for the corporation's, partnership's, or
6 professional corporation's health care function.
7 (7) A person that is designated to maintain the records of a person
8 described in subdivisions (1) through (6).
9 (f) "Health care provider", for purposes of IC 16-45-4, has the
10 meaning set forth in 47 CFR 54.601(a).
11 SECTION 4. IC 16-18-2-194.9 IS ADDED TO THE INDIANA
12 CODE AS A NEW SECTION TO READ AS FOLLOWS
13 [EFFECTIVE JULY 1, 2024]: Sec. 194.9. "IVAERS", for purposes
14 of IC 16-38-7, has the meaning set forth in IC 16-38-7-3.
15 SECTION 5. IC 16-38-7 IS ADDED TO THE INDIANA CODE AS
16 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
17 1, 2024]:
18 Chapter 7. Indiana Vaccination Adverse Event Reporting
19 System
20 Sec. 1. As used in this chapter, "adverse event" means any of the
21 following occurring after the administration of a childhood
22 vaccine:
23 (1) An event that is a reportable event for purposes of the
24 administration of the federal vaccination adverse event
25 reporting system as published by the United States
26 Department of Health and Human Services in the Table of
27 Reportable Events in effect on January 1, 2022.
28 (2) A diagnosis that a child receiving the childhood vaccine
29 has autism spectrum disorder.
30 (3) Any other reaction or injury that a health care provider
31 determines is proximately caused by the administration of the
32 childhood vaccine.
33 Sec. 2. As used in this chapter, "childhood vaccine" means an
34 immunization described in IC 20-34-4-2(a).
35 Sec. 3. As used in this chapter, "IVAERS" refers to the Indiana
36 vaccination adverse event reporting system established under
37 section 4 of this chapter.
38 Sec. 4. (a) The state department shall develop the Indiana
39 vaccination adverse event reporting system (IVAERS).
40 (b) IVAERS must enable a health care provider to report the
41 occurrence of an adverse event experienced by a child residing in
42 Indiana who is under the care of the health care provider.
2024 IN 1335—LS 6434/DI 104 5
1 Sec. 5. A health care provider shall, in the form and manner
2 required by the rules adopted by the state department, report to
3 the state department through IVAERS the occurrence of an
4 adverse event experienced by a child residing in Indiana who is
5 under the care of the health care provider.
6 Sec. 6. The state department shall do the following:
7 (1) Create a searchable Internet data base for publishing
8 information reported through IVAERS under section 5 of this
9 chapter after removing any personal identifying information
10 of a child who experiences an adverse event.
11 (2) Provide continuing twenty-four (24) hour a day online
12 access to the data base.
13 (3) Secure the information collected under section 5 of this
14 chapter and the data base maintained under this chapter
15 against access by unauthorized persons.
16 Sec. 7. (a) Health information reported by a health care
17 provider through IVAERS is confidential.
18 (b) The state department may release information received
19 through IVAERS relating to a particular individual to the
20 individual or to the individual's parent or guardian if the
21 individual is less than eighteen (18) years of age.
22 (c) With the consent of the individual or of the individual's
23 parent or guardian if the individual is less than eighteen (18) years
24 of age, the state department may release information received
25 through IVAERS relating to a particular individual to a health
26 care provider.
27 (d) A person who knowingly, intentionally, or recklessly
28 discloses confidential information received through IVAERS in
29 violation of this chapter commits a Class A misdemeanor.
30 Sec. 8. The state department shall adopt rules under IC 4-22-2
31 to implement this chapter, including rules concerning the
32 following:
33 (1) The form and manner in which a health care provider
34 must submit information to IVAERS.
35 (2) Protecting the privacy and personal identifying
36 information of children who experience adverse events.
37 (3) The form and manner of publishing information relating
38 to adverse events without breaching the confidentiality of the
39 health information of particular individuals.
40 (4) The design of the data base required under section 6 of this
41 chapter.
42 Sec. 9. Money is annually appropriated to the state department
2024 IN 1335—LS 6434/DI 104 6
1 from the state general fund in an amount sufficient to establish and
2 maintain IVAERS established under section 4 of this chapter.
3 SECTION 6. IC 35-52-16-33.5 IS ADDED TO THE INDIANA
4 CODE AS A NEW CHAPTER TO READ AS FOLLOWS
5 [EFFECTIVE JULY 1, 2024]: Sec. 33.5. IC 16-38-7-7 defines a crime
6 concerning the release of confidential information maintained in
7 the Indiana vaccination adverse event reporting system.
2024 IN 1335—LS 6434/DI 104