By: Howard of Travis, Gonzales, England, H.B. No. 1896

King of Taylor, et al.

Substitute the following for H.B. No. 1896:

By: Delisi C.S.H.B. No. 1896

A BILL TO BE ENTITLED

AN ACT

relating to information submitted to and maintained in the immunization registry.

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

SECTION 1. Section 161.0001, Health and Safety Code, is amended to read as follows:

Sec. 161.0001. DEFINITIONS. In this subchapter:

(1) "Data elements" means the information:

(A) a health care provider who administers a vaccine is required to record in a medical record under 42 U.S.C. Section 300aa-25, as amended, including:

(i) [(A)] the date the vaccine is administered;

(ii) [(B)] the vaccine manufacturer and lot number of the vaccine;

(iii) any adverse or unexpected events for a vaccine; and

(iv) [(C)] the name, the address, and if appropriate, the title of the health care provider administering the vaccine; and

(B) specified in rules adopted to implement Section 161.0078.

(1-a) "Patient's legally authorized representative" means:

(A) a parent, managing conservator, or guardian of a patient, if the patient is a minor;

(B) a guardian of the patient, if the patient has been adjudicated incompetent to manage the patient's personal affairs; or

(C) an agent of the patient authorized under a durable power of attorney for health care.

(2) "Payor" means an insurance company, a health maintenance organization, or another organization that pays a health care provider to provide health care benefits, including providing immunizations [to a person younger than 18 years of age].

SECTION 2. Sections 161.007(a), (a-1), (b), (c), (d), (e), (f), and (j), Health and Safety Code, are amended to read as follows:

(a) The department, for purposes of establishing and maintaining a single repository of accurate, complete, and current immunization records to be used in aiding, coordinating, and promoting efficient and cost-effective [childhood] communicable disease prevention and control efforts, shall establish and maintain an [a childhood] immunization registry. The department by rule shall develop guidelines to:

(1) protect the confidentiality of patients in accordance with Section 159.002, Occupations Code;

(2) inform the patient or the patient's legally authorized representative [a parent, managing conservator, or guardian of each patient] about the registry;

(3) require the written consent of the patient or the patient's legally authorized representative [a parent, managing conservator, or guardian of a patient] before any information relating to the patient is included in the registry; [and]

(4) permit the patient or the patient's legally authorized representative [a parent, managing conservator, or guardian] to withdraw consent for the patient to be included in the registry; and

(5) determine the process by which consent is verified, including affirmation by a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained.

(a-1) The written consent required by Subsection (a)(3) is required to be obtained only one time. The written consent is valid until the patient or the patient's legally authorized representative withdraws [child becomes 18 years of age unless] the consent [is withdrawn] in writing. A parent, managing conservator, or guardian of a child may provide the written consent by using an electronic signature on the child's birth certificate.

(b) Except as provided by Section 161.0071, the [The childhood] immunization registry must contain information on the immunization history that is obtained by the department under this section of each person [who is younger than 18 years of age and] for whom consent has been obtained in accordance with guidelines adopted under Subsection (a). The department shall retain the information until the person's death. The department shall remove from the registry information for any person for whom consent has been withdrawn. The department may not retain individually identifiable information about any person for whom consent has been withdrawn.

(c) A payor that receives data elements from a health care provider who administers an immunization to a person [younger than 18 years of age] shall provide the data elements to the department. A payor is required to provide the department with only the data elements the payor receives from a health care provider. The data elements shall be submitted in a format prescribed by the department. The department shall verify consent before disclosing [including] the reported information to other users of [in] the immunization registry. The department may [not] retain individually identifiable information about a person for whom consent cannot be verified but may not disclose the information to other users of the registry until consent is verified.

(d) A health care provider who administers an immunization to a person younger than 18 years of age shall provide data elements regarding an immunization to the department. A health care provider who administers an immunization to a person 18 years of age or older may submit data elements regarding an immunization to the department. The data elements shall be submitted in a format prescribed by the department. The department shall verify consent before disclosing [including] the information to other users of [in] the immunization registry. The department may [not] retain individually identifiable information about a person for whom consent cannot be verified but may not disclose the information to other users of the registry until consent is verified.

(e) The department shall provide notice to a health care provider that submits an immunization history for a patient [person] for whom consent cannot be verified. The notice shall contain instructions for obtaining consent in accordance with guidelines adopted under Subsection (a) and resubmitting the immunization history to the department.

(f) The department and health care providers may use the registry to provide notices by mail, telephone, personal contact, or other means to a patient or the patient's legally authorized representative [parent, managing conservator, or guardian] regarding a patient [his or her child or ward] who is due or overdue for a particular type of immunization according to the department's immunization schedule. The department shall consult with health care providers to determine the most efficient and cost-effective manner of using the registry to provide those notices.

(j) Except as provided by Section 161.008, information obtained by the department for the immunization registry is confidential and may be disclosed only with the written consent of the patient or the patient's legally authorized representative [child's parent, managing conservator, or guardian].

SECTION 3. Section 161.0071, Health and Safety Code, is amended to read as follows:

Sec. 161.0071. NOTICE OF RECEIPT OF REGISTRY DATA; EXCLUSION FROM REGISTRY. (a) The first time the department receives registry data for a patient [child] for whom the department has received consent to be included in the registry, [from a person other than the child's parent, managing conservator, or guardian,] the department shall send a written notice to the patient or the patient's legally authorized representative [child's parent, managing conservator, or guardian] disclosing:

(1) that providers and payors may be sending the patient's [child's] immunization information to the department;

(2) the information that is included in the registry;

(3) the persons to whom the information may be released under Section 161.008(d);

(4) the purpose and use of the registry;

(5) the procedure to exclude a patient [child] from the registry; and

(6) the procedure to report a violation if a patient [parent, managing conservator, or guardian discovers a child] is included in the registry after exclusion has been requested.

(b) On discovering that consent to be included in the registry has not been granted, the department shall exclude the patient's [child's] immunization records from the registry and any other registry-related department record that individually identifies the patient [child].

(c) On receipt of a written request to exclude a patient's [child's] immunization records from the registry, the department shall send to the patient or the patient's legally authorized representative [a parent, managing conservator, or guardian] who makes the request a written confirmation of receipt of the request for exclusion and shall exclude the patient's [child's] records from the registry.

(d) The department commits a violation if the department fails to exclude a patient's [child's] immunization information from the registry as required by Subsection (b) or (c).

(e) The department shall accept a written statement from a patient or the patient's legally authorized representative [parent, managing conservator, or guardian] communicating to the department that a patient [child] should be excluded from the registry, including a statement on the patient's [child's] birth certificate, as a request for exclusion under Subsection (c). The written statement may include the electronic signature on the patient's [child's] birth certificate.

SECTION 4. Section 161.0072, Health and Safety Code, is amended to read as follows:

Sec. 161.0072. PROVIDING IMMUNIZATION INFORMATION TO DEPARTMENT. (a) If the patient or the patient's legally authorized representative [parent, managing conservator, or guardian of a child] has reasonable concern that the patient's [child's] health care provider is not submitting the immunization history to the department [and the parent, managing conservator, or guardian wants the child included in the registry], the patient or the patient's legally authorized representative [parent, managing conservator, or guardian] may provide the patient's [child's] immunization history directly to the department to be included in the immunization registry.

(b) The patient or the patient's legally authorized representative [parent, managing conservator, or guardian of a child] may send evidence of the patient's [child's] immunization history to the department by facsimile transmission or by mail. The evidence may include a copy of:

(1) the patient's [child's] medical record indicating the immunization history;

(2) an invoice from a health care provider for the immunization; or

(3) documentation showing that a claim for the immunization was paid by a payor.

(c) The board shall develop rules to ensure that the immunization history submitted by a patient or the patient's legally authorized representative [parent, managing conservator, or guardian] is medically verified immunization information.

SECTION 5. Sections 161.0073(a), (b), and (c), Health and Safety Code, are amended to read as follows:

(a) The information that individually identifies a patient [child] received by the department for the immunization registry is confidential and may be used by the department for registry purposes only.

(b) Unless specifically authorized under this subchapter, the department may not release registry information to any individual or entity without the consent of the patient or the patient's legally authorized representative [person or, if a minor, the parent, managing conservator, or guardian of the child].

(c) A person required to report information to the department for registry purposes or authorized to receive information from the registry may not disclose the individually identifiable information to any other person without written consent of the patient or the patient's legally authorized representative [parent, managing conservator, or guardian of the child], except as provided by Chapter 159, Occupations Code, or Section 602.053, Insurance Code.

SECTION 6. Section 161.0075, Health and Safety Code, is amended to read as follows:

Sec. 161.0075. IMMUNITY FROM LIABILITY. Except as provided by Section 161.009, the following persons subject to this subchapter that act in compliance with Sections 161.007, 161.0071, 161.0073, 161.0074, 161.0078, and 161.008 are not civilly or criminally liable for furnishing the information required under this subchapter:

(1) a payor;

(2) a health care provider who administers immunizations; and

(3) an employee of the department.

SECTION 7. Subchapter A, Chapter 161, Health and Safety Code, is amended by adding Section 161.0077 to read as follows:

Sec. 161.0077. FIRST RESPONDERS. (a) In this section, "first responder" has the meaning assigned by Section 421.095, Government Code.

(b) The department shall develop a program for informing first responders about the immunization registry and educating first responders about the benefits of being included in the immunization registry, including:

(1) ensuring that first responders receive necessary immunizations to prevent the spread of communicable diseases to which a first responder may be exposed during a public health emergency; and

(2) preventing duplication of vaccinations.

SECTION 8. Subchapter A, Chapter 161, Health and Safety Code, is amended by adding Section 161.0078 to read as follows:

Sec. 161.0078. RECORDING ADMINISTRATION OF IMMUNIZATION AND MEDICATION FOR DISASTERS AND EMERGENCIES. (a) The department shall maintain a registry of persons who receive an immunization, antiviral, and other medication administered to prepare for a potential disaster or public health emergency or in response to a declared disaster or public health emergency. A health care provider who administers an immunization, antiviral, or other medication may provide the data elements to the department except that to the extent that reporting is required by Section 161.007, the health care provider shall provide the data elements to the department.

(b) The department shall maintain the registry as part of the immunization registry required by Section 161.007.

(c) The department shall track adverse reactions to an immunization, antiviral, and other medication administered to prepare for a potential disaster or public health emergency or in response to a declared disaster or public health emergency. A health care provider who administers an immunization, antiviral, or other medication may provide data related to adverse reactions to the department.

(d) Sections 161.007, 161.0071, 161.0072, 161.0073, and 161.0074 apply to the data elements submitted to the department under this section, unless a provision in those sections conflicts with a requirement in this section.

(e) The executive commissioner of the Health and Human Services Commission may adopt rules necessary to implement this section.

SECTION 9. Sections 161.008(b), (c), (d), (e), (f), and (g), Health and Safety Code, are amended to read as follows:

(b) An immunization record contains [the]:

(1) the name and date of birth of the person immunized;

(2) the dates of immunization;

(3) the types of immunization administered; [and]

(4) any adverse or unexpected events for a vaccine;

(5) the name and address of the health care provider administering the immunization; and

(6) any additional information specified in rules adopted to implement Section 161.0078.

(c) The department may obtain the data constituting an immunization record for a patient [child] from a public health district, a local health department, a regional health information exchange, a local immunization registry, the patient or the patient's legally authorized representative [child's parent, managing conservator, or guardian], a physician to the patient [child], a payor, or any health care provider licensed or otherwise authorized to administer vaccines. The department shall verify consent before including the reported information in the immunization registry. The department may [not] retain individually identifiable information about a person for whom consent cannot be verified but may not disclose the information to other users of the registry until consent is verified.

(d) The department may release the data constituting an immunization record for the patient [child] to any entity that is described by Subsection (c), to a school or child care facility in which the patient [child] is enrolled, or to a state agency having legal custody of the patient [child].

(e) A patient or the patient's legally authorized representative [parent, managing conservator, or legal guardian] may obtain and on request to the department shall be provided with all individually identifiable immunization registry information concerning the patient [his or her child or ward].

(f) A person, including a health care provider, a payor, or an employee of the department, that submits in good faith an immunization history, data elements, or data to or obtains in good faith an immunization history, data elements, or data from the department in compliance with the provisions of this section and any rules adopted under this section is not liable for any civil damages.

(g) The department may release nonidentifying summary statistics related to the registry that do not individually identify a patient [child].

SECTION 10. Section 161.009(a), Health and Safety Code, is amended to read as follows:

(a) A person commits an offense if the person:

(1) negligently releases or discloses immunization registry information in violation of Section 161.007, 161.0071, 161.0073, or 161.008;

(2) fails to exclude a patient's [child's] immunization information in violation of Section 161.0071; or

(3) negligently uses information in the immunization registry to solicit new patients or clients or for other purposes that are not associated with immunization or quality-of-care purposes, unless authorized under this section.

SECTION 11. Subchapter A, Chapter 161, Health and Safety Code, is amended by adding Section 161.0102 to read as follows:

Sec. 161.0102. DISASTER PREPARATION. The department shall consult with public health departments and appropriate health care providers to identify adult immunizations that may be necessary to respond to or prepare for a disaster or public health emergency.

SECTION 12. Subchapter A, Chapter 161, Health and Safety Code, is amended by adding Sections 161.0107 and 161.0108 to read as follows:

Sec. 161.0107. ELECTRONIC MEDICAL RECORDS SYSTEMS. (a) In this section:

(1) "Electronic medical records software package or system" means an electronic system for maintaining medical records in the clinical setting.

(2) "Medical records" has the meaning assigned by Section 151.002, Occupations Code.

(b) A person who sells, leases, or otherwise provides an electronic medical records software package or system to a person who administers immunizations in this state or to an entity that manages records for the person shall provide, as part of the electronic medical records software package or system, the ability to:

(1) electronically interface with the immunization registry created under this subchapter; and

(2) generate electronic reports that contain the fields necessary to populate the immunization registry.

(c) The executive commissioner of the Health and Human Services Commission by rule shall specify:

(1) the fields necessary to populate the immunization registry; and

(2) the data standards that must be used for electronic submission of immunization information.

(d) The data standards specified under Subsection (b) must be compatible with the standards for immunization information transmission adopted by the Healthcare Information Technology Standards Panel sponsored by the American National Standards Institute and included in certification criteria by the Certification Commission for Healthcare Information Technology.

Sec. 161.0108. INJUNCTION. (a) The attorney general may bring an action in the name of the state to enjoin a violation of Section 161.0107.

(b) If the state prevails in a suit under this section, the attorney general may recover on behalf of the state reasonable attorney's fees, court costs, and reasonable investigative costs incurred in relation to the proceeding.

SECTION 13. The change in law made by Section 161.0108, Health and Safety Code, as added by this Act, applies only to a cause of action that accrues on or after the effective date of rules adopted by the executive commissioner of the Health and Human Services Commission under Section 161.0107, Health and Safety Code, as added by this Act.

SECTION 14. This Act takes effect immediately if it receives a vote of two-thirds of all the members elected to each house, as provided by Section 39, Article III, Texas Constitution. If this Act does not receive the vote necessary for immediate effect, this Act takes effect September 1, 2007.