85R673 LED-F     By: Howard H.B. No. 243       A BILL TO BE ENTITLED   AN ACT   relating to the immunization data included in and excluded from the   immunization registry.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Section 161.007, Health and Safety Code, is   amended by amending Subsections (a), (a-2), (b), (b-1), (c), (d),   and (e) and adding Subsections (e-1), (l), and (m) to read as   follows:          (a)  The department, for the primary purpose 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 communicable disease   prevention and control efforts, shall establish and maintain an   immunization registry.  The executive commissioner by rule shall   develop guidelines to:                (1)  protect the confidentiality of patients in   accordance with Section 159.002, Occupations Code;                (2)  inform the individual or the individual's legally   authorized representative about the registry and that registry   information may be released under Section 161.00735;                (3)  [require the written or electronic consent of the   individual or the individual's legally authorized representative   before any information relating to the individual is included in   the registry;                [(4)]  permit the individual or the individual's   legally authorized representative to request that the individual's   information be removed from [withdraw consent for the individual to   be included in] the registry;                (4)  provide opportunities for the individual or the   individual's legally authorized representative to request removal   at any time, including:                      (A)  at the time of the individual's birth if   attended by a health care provider who administers immunizations;                      (B)  each time the individual receives any   immunization administered by a health care provider in this state;                      (C)  through electronic submission of a request   for removal using a request for removal procedure available on the   department's Internet website;                      (D)  through submission to the department of a   written request for removal; and                      (E)  following a natural or man-made disaster;   [and]                (5)  ensure that an individual or the individual's   legally authorized representative is not required to request   removal from the registry more than one time and that, after a   request for removal is made, the individual's immunization   information will not be included in the registry unless the   individual or the individual's legally authorized representative   submits to the department a written request for inclusion of the   individual's information in the registry; and                (6)  include on each immunization record generated by   the registry the procedures for requesting removal from the   registry [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-2)  [The written or electronic consent required by   Subsection (a)(3) for an individual who is 18 years of age or older   is required to be obtained only one time and must be received from   the individual before the information may be released.]  An   individual's legally authorized representative or the individual,   after the individual has attained 18 years of age, may submit a   request [consent] in writing or electronically for the individual's   information to be removed from [remain in] the registry.  [The   consent of the representative or individual is valid until the   individual or the individual's legally authorized representative   withdraws consent in writing or electronically.     The department   may not include in the registry the immunization information of an   individual who is 26 years of age or older until written or   electronic consent has been obtained as provided by this   subsection.]  The department shall coordinate with the Texas   Education Agency to distribute materials described in Section   161.0095(a)(2) to students and parents through local school   districts.          (b)  Except as provided by Section 161.0071, the   immunization registry must contain information on the immunization   history that is obtained by the department under:                (1)  this section of each individual for whom   immunization information [consent] has been obtained, unless the   individual or the individual's legally authorized representative   has requested that the individual's information be removed from the   registry in accordance with guidelines adopted under Subsection   (a);                (2)  Section 161.00705 of persons immunized to prepare   for or in response to a declared disaster, public health emergency,   terrorist attack, hostile military or paramilitary action, or   extraordinary law enforcement emergency;                (3)  Section 161.00706 of first responders or their   immediate family members; and                (4)  Section 161.00735 of persons evacuated or   relocated to this state because of a disaster.          (b-1)  The department shall remove from the registry   information for any individual for whom [consent has been   withdrawn.   The department may not retain individually identifiable   information about any individual:                [(1)  for whom consent has been withdrawn;                [(2)     for whom a consent for continued inclusion in the   registry following the end of the declared disaster, public health   emergency, terrorist attack, hostile military or paramilitary   action, or extraordinary law enforcement emergency has not been   received under Section 161.00705(f);                [(3)     for whom a request to be removed from the registry   has been received under Section 161.00706(e);                [(4)     for whom consent for continued inclusion in the   registry following the end of a disaster has not been received under   Section 161.00735(f); or                [(5)  for whom] a request to remove information from   the registry has been received under this subchapter [Section   161.00735(g)].          (c)  A payor that receives data elements from a health care   provider who administers an immunization to an individual 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.  A   payor that receives data elements from a health care provider who   administers an immunization to an individual 18 years of age or   older may provide the data elements to the department.  The data   elements shall be submitted in a format prescribed by the   department.  [The department shall verify consent before including   the reported information in the immunization registry.     The   department may not retain individually identifiable information   about an individual for whom consent cannot be verified.]          (d)  A health care provider who administers an immunization   to an individual 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 an individual 18   years of age or older may submit data elements regarding an   immunization to the department.  At the request and with the   authorization of the health care provider, the data elements may be   submitted through a health information exchange as defined by   Section 182.151.  The data elements shall be submitted in a format   prescribed by the department.  A health care provider who   administers an immunization to any individual and provides data   elements to the department shall notify the individual or the   individual's legally authorized representative:                (1)  that the individual's immunization information   will be included in the registry unless removal from the registry is   requested in accordance with the guidelines adopted under   Subsection (a); and                (2)  of the procedures for requesting removal from the   registry.  [The department shall verify consent before including   the information in the immunization registry.     The department may   not retain individually identifiable information about an   individual for whom consent cannot be verified.]          (e)  The department shall:                (1)  make available on the department's Internet   website a printable form that states an individual's immunization   information will be included in the registry unless removal from   the registry is requested and that details the procedures for   submitting an electronic or written request for removal from the   registry [provide notice to a health care provider that submits an   immunization history for an individual for whom consent cannot be   verified.   The notice shall contain instructions for obtaining   consent] in accordance with guidelines adopted under Subsection   (a); and                (2)  make the form described by Subdivision (1)   available for distribution to health care providers [and   resubmitting the immunization history to the department].          (e-1)  A health care provider may use the printable form   described by Subsection (e) to provide the notification required   under Subsection (d).          (l)  Registry information may not be used to exclude any   individual from the receipt of any service during a natural or   man-made disaster unless the service is withheld because of a   medical contraindication.          (m)  The department may not sell registry information to any   public or private entity.          SECTION 2.  Section 161.00705(f), Health and Safety Code, is   amended to read as follows:          (f)  Unless an individual or the individual's legally   authorized representative [consents] in writing or electronically   requests that [to continued inclusion of] the individual's   information be removed from [in] the registry, the department shall   include [remove] the immunization records collected under this   section in [from] the registry [on expiration of the period   prescribed under Subsection (e)].          SECTION 3.  Sections 161.0071(a) and (b), Health and Safety   Code, are amended to read as follows:          (a)  The first time the department receives registry data for   an individual [for whom the department has received consent] to be   included in the registry, the department shall send notice to the   individual or the individual's legally authorized representative   disclosing:                (1)  that providers and payors may be sending the   individual'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 Sections 161.00735(b) and 161.008(d);                (4)  the purpose and use of the registry;                (5)  the procedure to exclude an individual from the   registry; and                (6)  the procedure to report a violation if an   individual's information is included in the registry after   exclusion has been requested [or consent has been withdrawn].          (b)  The [On discovering that consent to be included in the   registry has not been granted or has been withdrawn, the]   department shall exclude [the individual's immunization records]   from the registry and any other registry-related department record   that individually identifies the individual the immunization   record of any individual from whom a request for exclusion has been   received by the department.          SECTION 4.  Section 161.0073, Health and Safety Code, is   amended by amending Subsection (a) and adding Subsections (e), (f),   (g), and (h) to read as follows:          (a)  Except as provided by this section and Sections 161.007,    161.00705, 161.00706, [and] 161.00735, and 161.008, information   that individually identifies an individual that is received by the   department for the immunization registry is confidential and may be   used by the department for registry purposes only.          (e)  The department may use registry information for   internal public health research on approval of the department's   institutional review board.          (f)  The department may release registry information for   external public health research if:                (1)  the individual or the individual's legally   authorized representative submits a written authorization to the   department for release of the individual's registry data;                (2)  the department does not disclose individually   identifiable information; or                (3)  the department's institutional review board   approves the release of individually identifiable information   subject to Subsection (g).          (g)  The department's institutional review board may not   approve the release of individually identifiable information for a   research proposal unless the proposal includes a provision   requiring the proposal's researchers to obtain informed consent   from each individual or the individual's legally authorized   representative before the department releases the individual's   registry data to the researchers.          (h)  The executive commissioner shall adopt rules to ensure   that the use or release of registry information under this   subchapter complies with all state and federal laws relating to the   privacy, protection, confidentiality, and transmission of health   information, including the Health Insurance Portability and   Accountability Act of 1996 (Pub. L. No. 104-191) and rules adopted   under that Act.          SECTION 5.  Sections 161.00735(c) and (h), Health and Safety   Code, are amended to read as follows:          (c)  The department may receive immunization information   from a health authority of another state or from a local health   authority in another state if the department determines that   residents of that state have evacuated or relocated to this state in   response to a disaster.  The department shall include information   received under this subsection in the registry.  [Notwithstanding   Section 161.007, the department is not required to obtain written   consent for the inclusion in the registry of information received   under this subsection.]          (h)  The executive commissioner shall make every effort to   enter into a memorandum of agreement with each state to which   residents of this state are likely to evacuate in a disaster on:                (1)  the release to and use by [of registry information   under this section to] the appropriate health authority or local   health authority of that state of registry information under this   section[, including the length of time the information may be   retained by that state]; and                (2)  the receipt and use of information submitted by   the health authority or local health authority of that state for   inclusion in the registry under this section.          SECTION 6.  Sections 161.008(c) and (e), Health and Safety   Code, are amended to read as follows:          (c)  The department may obtain the data constituting an   immunization record for an individual from a public health   district, a local health department, the individual or the   individual's legally authorized representative, a physician to the   individual, 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 an individual for whom consent   cannot be verified.]          (e)  An individual or the individual's legally authorized   representative may obtain and on request to the department shall be   provided with all individually identifiable immunization registry   information concerning the individual and information on the   procedure for requesting removal from the registry.          SECTION 7.  Section 161.0095(a), Health and Safety Code, is   amended to read as follows:          (a)  The department shall develop:                (1)  continuing education programs for health care   providers relating to immunizations and the vaccines for children   program operated by the department under authority of 42 U.S.C.   Section 1396s; and                (2)  educational information, for health care   providers, health care clinics, hospitals, and any other health   care facility that provides health care to children 14 to 18 years   of age, relating to the immunization registry and the option for an   individual or the individual's legally authorized representative   to request removal [who is 18 years of age or older to consent to   submission and retention] of the individual's information from [in]   the immunization registry.          SECTION 8.  Section 161.0107(c), Health and Safety Code, is   amended to read as follows:          (c)  The executive commissioner by rule shall specify:                (1)  the fields necessary to populate the immunization   registry[, including a field that indicates the patient's consent   to be listed in the immunization registry has been obtained]; and                (2)  the data standards that must be used for   electronic submission of immunization information.          SECTION 9.  The following provisions of the Health and   Safety Code are repealed:                (1)  Sections 161.007(a-1), (a-3), (a-4), (a-5), and   (a-6);                (2)  Sections 161.00705(e) and (h); and                (3)  Sections 161.00735(e) and (f).          SECTION 10.  (a)  The changes in law made by this Act to   Subchapter A, Chapter 161, Health and Safety Code, apply to   immunization information received by the Department of State Health   Services before, on, or after January 1, 2019. An individual whose   immunization information was included immediately before January   1, 2019, in the immunization registry established under Subchapter   A, Chapter 161, Health and Safety Code, is subject to the changes in   law made by this Act to that subchapter, including the procedures   established by that subchapter as amended by this Act.          (b)  The changes in law made by this Act do not authorize the   Department of State Health Services to include in the immunization   registry established under Subchapter A, Chapter 161, Health and   Safety Code, immunization information of an individual who is 18   years of age or older and whose immunization information was not   included in the registry on or before January 1, 2019, unless the   department receives immunization data from a health care provider   who:                (1)  administers an immunization to the individual   after that date and elects to provide the individual's immunization   information to the department; and                (2)  notifies the individual before submission of the   information to the department:                      (A)  that the health care provider is providing   the information to the department for inclusion in the registry;                      (B)  that the information will remain in the   registry until removal is requested by the individual or the   individual's legally authorized representative; and                      (C)  of the procedures for requesting removal from   the registry under Subchapter A, Chapter 161, Health and Safety   Code, as amended by this Act.          SECTION 11.  (a)  As soon as practicable after the effective   date of this section, the Department of State Health Services shall   conduct a public awareness campaign to educate health care   providers, parents, payors, schools, and the public about the   changes in law made by this Act.          (b)  As soon as practicable after the effective date of this   section, the executive commissioner of the Health and Human   Services Commission shall adopt the rules required by Section   161.0073(h), Health and Safety Code, as added by this Act.          SECTION 12.  (a) Except as provided by Subsection (b) of this   section, this Act takes effect January 1, 2019.          (b)  Section 11 of this Act takes effect September 1, 2017.