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A BILL TO BE ENTITLED
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AN ACT
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relating to the establishment of the undiagnosed disease registry. |
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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 82B to read as follows: |
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CHAPTER 82B. UNDIAGNOSED DISEASE REGISTRY |
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Sec. 82B.001. SHORT TITLE. This chapter may be cited as the |
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Undiagnosed Disease Reporting Act. |
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Sec. 82B.002. DEFINITIONS. In this chapter: |
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(1) "Clinical laboratory" means an accredited |
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facility in which: |
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(A) tests are performed identifying findings of |
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anatomical changes; and |
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(B) specimens are interpreted and pathological |
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diagnoses are made. |
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(2) "Executive commissioner" means the executive |
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commissioner of the Health and Human Services Commission. |
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(3) "Health care facility" means: |
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(A) a general or special hospital as defined by |
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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, including an outpatient |
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clinic, that provides diagnosis or treatment services to patients |
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with an undiagnosed disease that results in death. |
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(4) "Physician" has the meaning assigned by Section |
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151.002, Occupations Code. |
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Sec. 82B.003. APPLICABILITY OF CHAPTER. This chapter |
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applies to records of cases of undiagnosed diseases that result in |
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death on or after January 1, 2010. |
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Sec. 82B.004. REGISTRY REQUIRED. The department shall |
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maintain for this state an undiagnosed disease registry for |
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undiagnosed diseases that result in death or other cases the |
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executive commissioner by rule requires to be included in the |
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registry. |
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Sec. 82B.005. CONTENT OF REGISTRY; SAMPLES. (a) The |
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undiagnosed disease registry must be a central data bank of |
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accurate, precise, and current information that medical |
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authorities agree serves as an invaluable tool in the early |
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recognition, prevention, cure, and control of undiagnosed |
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diseases. |
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(b) The undiagnosed disease registry must include: |
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(1) a record of the cases of undiagnosed diseases that |
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result in death in this state; and |
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(2) information concerning undiagnosed disease cases |
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the department considers necessary and appropriate for the |
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recognition, prevention, cure, or control of undiagnosed diseases. |
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(c) The undiagnosed disease registry may include cases of |
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undiagnosed diseases that do not result in death. |
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(d) The department shall store samples of tissues |
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corresponding to individual registry records that may be of future |
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benefit to medical professionals. |
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Sec. 82B.006. EXECUTIVE COMMISSIONER POWERS. To implement |
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this chapter, the executive commissioner may: |
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(1) adopt rules the executive commissioner considers |
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necessary; |
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(2) execute contracts the executive commissioner |
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considers necessary; |
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(3) receive the data from medical records of cases of |
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undiagnosed diseases that are in the custody or under the control of |
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clinical laboratories, health care facilities, and physicians to |
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record and analyze the data directly related to the diseases; |
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(4) compile and publish statistical and other studies |
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derived from the patient data obtained under this chapter to |
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provide, in an accessible form, information that is useful to |
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physicians, other medical personnel, and the general public; |
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(5) comply with requirements as necessary to obtain |
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federal funds in the maximum amounts and most advantageous |
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proportions possible; |
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(6) receive and use gifts made for the purpose of this |
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chapter; and |
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(7) limit undiagnosed disease reporting activities |
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under this chapter to specified geographic areas of this state to |
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ensure optimal use of funds available for obtaining the data. |
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Sec. 82B.007. REPORTS. (a) The department shall submit an |
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annual report to the legislature on the information obtained under |
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this chapter. |
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(b) The department, in cooperation with other undiagnosed |
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disease reporting organizations and research institutions, may |
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publish reports the department determines are necessary or |
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desirable to carry out the purpose of this chapter. |
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Sec. 82B.008. DATA FROM MEDICAL RECORDS; TISSUE SAMPLES. |
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(a) To ensure an accurate and continuing source of data concerning |
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undiagnosed disease, each clinical laboratory, health care |
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facility, and physician shall furnish to the department or its |
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representative, on request, data that the executive commissioner |
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considers necessary and appropriate and that is derived from each |
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medical record pertaining to a case of an undiagnosed disease that |
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is in the custody or under the control of the clinical laboratory, |
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health care facility, or physician. The department may not request |
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data that is more than three years old unless the department is |
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investigating a possible undiagnosed disease cluster. |
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(b) A clinical laboratory, health care facility, or |
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physician shall furnish the data requested under Subsection (a) in |
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a reasonable format prescribed by the department and within six |
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months of the patient's death or treatment for an undiagnosed |
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disease unless a different period is prescribed by the United |
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States Department of Health and Human Services. |
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(c) The data required to be furnished under this section |
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must include patient identification, symptoms, tests conducted, |
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and any other information the department requires. |
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(d) The department may access medical records that would |
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identify cases of undiagnosed diseases, establish characteristics |
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or treatment of undiagnosed diseases, or determine the medical |
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status of any identified patient from the following sources: |
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(1) a health care facility or clinical laboratory |
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providing screening or therapeutic services to a patient related to |
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an undiagnosed disease; or |
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(2) a physician providing treatment to a patient with |
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an undiagnosed disease. |
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(e) The executive commissioner shall adopt procedures that |
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ensure adequate notice is given to the clinical laboratory, health |
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care facility, or physician before the department accesses data |
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under Subsection (d). |
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(f) The data required to be furnished under this section may |
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be shared with undiagnosed disease registries of clinical |
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laboratories or health care facilities subject to the |
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confidentiality provisions in Section 82B.010. |
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(g) Each clinical laboratory, health care facility, and |
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physician shall furnish to the department or its representative, on |
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request, any available tissue samples that the executive |
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commissioner considers necessary. |
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Sec. 82B.009. FAILURE TO FURNISH DATA OR TISSUE SAMPLES. |
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(a) A clinical laboratory, health care facility, or physician that |
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knowingly or in bad faith fails to furnish data or available tissue |
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samples as required by this chapter shall reimburse the department |
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or its authorized representative for the costs of accessing and |
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reporting the data or collecting the samples. |
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(b) The costs reimbursed under this section must be |
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reasonable, based on the actual costs incurred by the department or |
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by its authorized representative in the collection of data or |
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samples under Section 82B.008, and may include salary and travel |
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expenses. |
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(c) The department may assess a late fee on an account that |
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is 60 days or more overdue. The late fee may not exceed one and |
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one-half percent of the total amount due on the late account for |
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each month or portion of a month the account is not paid in full. A |
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clinical laboratory, health care facility, or physician may request |
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that the department conduct a hearing to determine whether |
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reimbursement to the department under this subsection is |
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appropriate. |
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Sec. 82B.010. CONFIDENTIALITY. (a) Reports, records, and |
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information obtained under this chapter are confidential and are |
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not subject to disclosure under Chapter 552, Government Code, are |
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not subject to subpoena, and may not otherwise be released or made |
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public except as provided by this section or Section 82B.008(f). |
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The reports, records, and information obtained under this chapter |
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are for the confidential use of the department and the persons or |
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public or private entities that the department determines are |
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necessary to carry out the intent of this chapter. |
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(b) Medical 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 individuals, clinical laboratories, health care |
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facilities, or physicians; |
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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 undiagnosed disease research, |
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including release of information to other undiagnosed disease |
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registries and appropriate state and federal agencies, under rules |
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adopted by the executive commissioner to ensure confidentiality as |
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required by state and federal laws. |
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(c) 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 data required under |
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this chapter unless the individual consents in advance. |
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(d) Data furnished to an undiagnosed disease registry or an |
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undiagnosed disease researcher under Subsection (b) or Section |
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82B.008(f) is for the confidential use of the undiagnosed disease |
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registry or the undiagnosed disease researcher, as applicable, and |
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is subject to Subsection (a). |
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Sec. 82B.011. 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; and |
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(4) an employee of the department. |
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Sec. 82B.012. 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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executive commissioner or the executive commissioner's |
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representatives. |
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SECTION 2. (a) Not later than December 1, 2009, the |
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executive commissioner of the Health and Human Services Commission |
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shall adopt the rules and procedures required to establish the |
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undiagnosed disease registry under Chapter 82B, Health and Safety |
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Code, as added by this Act. |
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(b) Not later than January 1, 2010, the Department of State |
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Health Services shall establish the undiagnosed disease registry |
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under Chapter 82B, Health and Safety Code, as added by this Act. |
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(c) Notwithstanding Chapter 82B, Health and Safety Code, as |
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added by this Act, a clinical laboratory, health care facility, or |
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physician is not required to report the data required under Chapter |
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82B until January 1, 2010. |
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SECTION 3. This Act takes effect September 1, 2009. |