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A BILL TO BE ENTITLED
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AN ACT
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relating to the creation of a youth diabetes registry; providing |
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penalties. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle D, Title 2, Health and Safety Code, is |
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amended by adding Chapter 98 to read as follows: |
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CHAPTER 98. DIABETES IN YOUTH REGISTRY |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 98.001. DEFINITIONS. In this chapter: |
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(1) "Advanced practice nurse" has the meaning assigned |
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by Section 301.152, Occupations Code. |
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(2) "Clinical laboratory" means an accredited |
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facility in which tests are performed to identify abnormal blood |
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sugars. |
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(3) "Department" means the Department of State Health |
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Services. |
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(4) "Diabetes" includes all types of diabetes. |
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(5) "Executive commissioner" means the executive |
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commissioner of the Health and Human Services Commission. |
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(6) "Health care facility" means: |
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(A) a hospital licensed under Chapter 241; |
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(B) an ambulatory surgical center licensed under |
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Chapter 243; |
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(C) an institution licensed under Chapter 242; or |
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(D) any other facility licensed by this state |
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that provides diagnosis or treatment services to patients with |
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diabetes. |
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(7) "Patient" means a person younger than 18 years of |
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age who has been diagnosed by a physician as having diabetes. |
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(8) "Physician" means a person licensed to practice |
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medicine in this state. |
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(9) "Physician assistant" means a person who holds a |
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license under Chapter 204, Occupations Code. |
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(10) "Registry" means the youth diabetes registry |
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established under this chapter. |
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[Sections 98.002-98.050 reserved for expansion] |
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SUBCHAPTER B. POWERS AND DUTIES OF EXECUTIVE COMMISSIONER AND |
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DEPARTMENT |
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Sec. 98.051. REGISTRY: ESTABLISHMENT AND CONTENT. (a) The |
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department shall maintain a youth diabetes registry of cases of |
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diabetes diagnosed in persons younger than 18 years of age. |
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(b) The registry must be an accurate, precise, and current |
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central information bank on the number of diabetes cases in this |
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state to help determine the impact of diabetes in youth. |
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(c) Each registered case must include: |
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(1) the type of diabetes diagnosed; |
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(2) the age of the patient; |
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(3) the region in which the patient resides; |
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(4) the results of a test of the patient's glycated |
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hemoglobin at the time of diagnosis; and |
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(5) any other appropriate information to assist in |
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determining the impact of diabetes in youth. |
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Sec. 98.052. REGISTRY GUIDELINES. The executive |
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commissioner, in consultation with the Texas Diabetes Council, |
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shall by rule develop guidelines to: |
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(1) determine appropriate information to include in |
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the registry under Section 98.051(b); |
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(2) protect the confidentiality of patients in |
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accordance with Section 98.057 and Section 159.002, Occupations |
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Code, to ensure that registry information is considered both |
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confidential and privileged; |
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(3) create a means to inform a patient and the |
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patient's parent or legal guardian about the existence, structure, |
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and intent of the registry and of the option to be excluded from the |
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registry before any personal information about the patient is |
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transferred to the department; |
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(4) collect necessary information from clinical |
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laboratories, health care facilities, and physicians; |
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(5) compile and analyze collected information; |
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(6) publish studies based on information collected |
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under this chapter; and |
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(7) provide information based on registry information |
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relating to youth diabetes that is useful to physicians, other |
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medical personnel, and the public. |
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Sec. 98.053. RULES; CONTRACTS; GIFTS AND GRANTS. (a) The |
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executive commissioner may adopt the rules necessary to administer |
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this chapter. |
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(b) The department may enter into contracts as necessary for |
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the purposes of this chapter. |
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(c) The department may accept and administer gifts and |
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grants for the purposes of this chapter. |
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Sec. 98.054. ANNUAL REPORT; REPORT TO LEGISLATURE. |
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(a) The department shall publish an annual youth diabetes report |
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based on registry information. The report may include: |
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(1) a summary of the statistical information compiled |
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in the registry, including a specific discussion of any clusters, |
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high or low incidences, or trends encountered; and |
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(2) any policy, research, educational, or other |
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recommendations the department considers appropriate. |
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(b) The department shall present the annual youth diabetes |
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report to the governor, the lieutenant governor, the speaker of the |
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house of representatives, and the Legislative Budget Board. |
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(c) The department, in cooperation with other diabetes |
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reporting organizations and research institutions, may publish |
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reports the department determines necessary or desirable to |
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implement the purposes of this chapter. |
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Sec. 98.055. INFORMATION FROM MEDICAL RECORDS. (a) Except |
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as provided by Subsection (b), within six months of a new diagnosis |
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of diabetes in a patient, the health care facility, clinical |
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laboratory, or physician that makes the diagnosis, or the advanced |
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practice nurse or physician assistant that obtains information |
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related to the diagnosis, shall furnish to the department or the |
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department's representative information the department, in |
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accordance with rules adopted under Section 98.053, considers |
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necessary and appropriate that is derived from the patient's |
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medical record in the custody or under the control of the health |
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care facility, clinical laboratory, physician, advanced practice |
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nurse, or physician assistant. |
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(b) Before transferring any information, the health care |
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facility, clinical laboratory, physician, advanced practice nurse, |
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or physician assistant shall inform the patient and the patient's |
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parent or legal guardian of the existence, structure, and purpose |
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of the registry. |
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(c) The health care facility, clinical laboratory, |
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physician, advanced practice nurse, or physician assistant may not |
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transfer information about a patient if the patient or the |
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patient's parent or legal guardian chooses to exclude the |
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information from the registry. |
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(d) A health care facility, clinical laboratory, physician, |
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advanced practice nurse, or physician assistant shall furnish |
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information required under Subsection (a) in the format prescribed |
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by the department. |
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Sec. 98.056. FAILURE TO FURNISH INFORMATION; PENALTY. |
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(a) A health care facility, clinical laboratory, physician, |
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advanced practice nurse, or physician assistant that knowingly or |
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in bad faith fails to furnish information as required by this |
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chapter shall reimburse the department for the costs incurred by |
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the department in accessing and obtaining the information. Costs |
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reimbursed under this subsection must be reasonable based on the |
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actual costs incurred by the department in collecting the |
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information and may include salary and travel expenses. |
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(b) The department, after providing an opportunity for |
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hearing, may assess a late fee on an amount due under Subsection (a) |
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that is at least 60 days overdue. The late fee may not exceed one |
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and one-half percent of the total amount due for each month or |
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portion of a month the amount is not paid in full. |
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Sec. 98.057. CONFIDENTIALITY. (a) Reports, records, and |
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information obtained under this chapter are confidential and: |
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(1) are not subject to disclosure under Chapter 552, |
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Government Code; |
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(2) are not subject to subpoena; and |
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(3) may not otherwise be released or made public |
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except as provided by this chapter. |
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(b) Except as provided by Subsection (c), reports, records, |
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and information obtained under this chapter are for the |
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confidential use of the department and any person the department |
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determines necessary to carry out the intent of this chapter. |
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(c) Information obtained under this chapter may be released |
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to the health care facility, clinical laboratory, physician, |
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advanced practice nurse, or physician assistant that provided the |
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information to the department, but the release is limited to |
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information provided by that health care facility, clinical |
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laboratory, physician, advanced practice nurse, or physician |
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assistant. |
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(d) A state employee may not testify in a civil, criminal, |
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special, or other proceeding as to the existence or contents of |
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records, reports, or information concerning an individual whose |
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medical records have been used in submitting information required |
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under this chapter unless the individual consents in advance. |
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Sec. 98.058. RELEASE OF LIMITED INFORMATION. (a) Medical |
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or epidemiological information may be released: |
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(1) for statistical purposes in a manner that prevents |
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identification of a patient, health care facility, clinical |
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laboratory, physician, advanced practice nurse, physician |
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assistant, or other health care practitioner; |
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(2) with the consent of each person identified in the |
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information; or |
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(3) to promote diabetes research, including release of |
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information to other diabetes registries and appropriate state and |
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federal agencies, under rules adopted by the executive commissioner |
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to ensure confidentiality as required by state and federal laws. |
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(b) Information furnished to a diabetes registry or a |
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diabetes researcher under Subsection (a)(3) is for the confidential |
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use of the diabetes registry or the diabetes researcher, as |
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applicable, and is subject to Section 98.057. |
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Sec. 98.059. REGISTRY ACCESS. Access to the registry is |
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limited to: |
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(1) authorized department employees; and |
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(2) other persons who are: |
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(A) qualified researchers who are approved by an |
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institutional review board and have a valid scientific interest; |
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(B) engaged in demographic, epidemiological, or |
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other studies related to health; and |
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(C) agree to maintain the confidentiality |
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requirements of this chapter. |
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Sec. 98.060. IMMUNITY FROM LIABILITY. The following |
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persons subject to this chapter that act in compliance with this |
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chapter are not civilly or criminally liable for furnishing the |
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information required under this chapter: |
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(1) a health care facility or clinical laboratory; |
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(2) an administrator, officer, or employee of a health |
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care facility or clinical laboratory; |
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(3) a physician or employee of a physician; |
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(4) an advanced practice nurse or physician assistant; |
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and |
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(5) an employee of the department. |
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Sec. 98.061. INJUNCTIVE RELIEF; CIVIL PENALTY. (a) The |
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attorney general may institute an action for injunctive relief to |
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restrain a release of information in violation of Section 98.057, |
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98.058, 98.059, or 98.064. |
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(b) In addition to the injunctive relief provided by |
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Subsection (a), the attorney general may institute an action for |
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civil penalties against a person for a release of information in |
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violation of Section 98.057, 98.058, 98.059, or 98.064. A civil |
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penalty assessed under this section may not exceed $3,000 for each |
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violation. |
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(c) If the court in which an action under Subsection (b) is |
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pending finds that the violations have occurred with a frequency as |
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to constitute a pattern or practice, the court may assess a civil |
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penalty not to exceed $250,000. |
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Sec. 98.062. DISCIPLINARY ACTION. In addition to the |
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penalties prescribed by this chapter, a release of information in |
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violation of Section 98.057, 98.058, 98.059, or 98.064 by an |
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individual or facility that is licensed by an agency of this state |
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is subject to investigation and disciplinary proceedings, |
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including probation or suspension by the licensing agency. If |
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there is evidence that the violations of this chapter constitute a |
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pattern or practice, the agency may revoke the individual's or |
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facility's license. |
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Sec. 98.063. EXCLUSION FROM STATE PROGRAMS. In addition to |
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the penalties prescribed by this chapter, a person shall be |
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excluded from participating in any state-funded health care program |
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if a court finds the person engaged in a pattern or practice of |
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releasing information in violation of Section 98.057, 98.058, |
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98.059, or 98.064. |
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Sec. 98.064. COMPLIANCE WITH FEDERAL LAW. (a) To the |
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extent that this chapter authorizes the disclosure of protected |
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health information by a covered entity, as those terms are defined |
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by the privacy rule of the Administrative Simplification subtitle |
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of the Health Insurance Portability and Accountability Act of 1996 |
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(Pub. L. No. 104-191) contained in 45 C.F.R. Part 160 and 45 C.F.R. |
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Part 164, Subparts A and E, the covered entity shall ensure that the |
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disclosure complies with all applicable requirements, standards, |
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and implementation specifications of the privacy rule. |
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(b) To the extent that the provisions of this chapter, and |
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the rules adopted under this chapter, relating to the use or |
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disclosure of information in the registry are more stringent than |
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the privacy rule described by Subsection (a), this chapter governs |
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the use or disclosure of information in the registry. |
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Sec. 98.065. EXAMINATION AND SUPERVISION NOT REQUIRED. |
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This chapter does not require an individual to submit to any medical |
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examination or supervision or to examination or supervision by the |
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department. |
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SECTION 2. (a) As soon as practicable after the effective |
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date of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt the rules necessary to implement |
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Chapter 98, Health and Safety Code, as added by this Act. |
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(b) The Department of State Health Services is not required |
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to collect and a health care facility, clinical laboratory, |
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physician, advanced practice nurse, or physician assistant is not |
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required to report information for the registry established under |
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Chapter 98, Health and Safety Code, as added by this Act, for a |
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patient who was diagnosed before January 1, 2007. |
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SECTION 3. This Act takes effect September 1, 2007. |
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* * * * * |