(a) Purpose. (1) This section provides for the certification of mammography systems and mammography machines used for interventional breast radiography. No person shall use radiation machines for mammography of humans or for interventional breast radiography except as authorized in a certification issued by the agency in accordance with the requirements of this section. Certification by this agency includes certification of mammography systems and facilities that have received accreditation by the agency accreditation body or by another United States Food and Drug Administration (FDA)-approved accreditation body and certification of mammography machines used for interventional breast radiography. (2) The use of all mammography machines certified in accordance with this section shall be by or under the supervision of a physician licensed by the Texas Medical Board. (b) Scope. (1) In addition to the requirements of this section, all registrants are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). Mammography facilities choosing to be accredited by the agency accreditation body will be subject to §289.234 of this title (relating to Mammography Accreditation). (2) The procedures found in §289.205 of this title for modifications, suspensions, revocations, denials, and hearings regarding certificates of registration are applicable to certifications issued by the agency. (3) This section does not apply to an entity under the jurisdiction of the federal government. (4) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, 45 Code of Federal Regulations (CFR), Parts 160 and 164) may be subject to privacy standards governing how information that identifies a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department making a referral of a potential violation to the United States Department of Health and Human Services. (c) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise. (1) Accreditation--An approval of a mammography machine within a mammography facility by an accreditation body. A facility may be accredited by the agency accreditation body or another FDA-approved accreditation body. (2) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401. (3) Action limit--The minimum or maximum value of a quality assurance measurement representing acceptable performance. Values less than the minimum or greater than the maximum action limit indicate that corrective action must be taken by the facility. (4) Additional mammography review (includes targeted clinical image reviews)--At the request of the agency certification body or an FDA-approved accreditation body, a review by the FDA-approved accreditation body of clinical images and other relevant facility information necessary to assess conformation with the accreditation standards. The reviews include the following: (A) clinical image review with interpretation; or (B) clinical image review without interpretation. (5) Adverse event--An undesirable experience associated with mammography activities within the scope of this section. Adverse events include but are not limited to: (A) poor image quality; (B) failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and (C) use of personnel who do not meet the applicable requirements of subsection (r) of this section. (6) Agency accreditation body--For the purpose of this section, the agency as approved by the FDA under