<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.52.15.08" title_num="10" subtitle_num="52" chapter_num="15" heading="Records.">
  <paragraph num="A.">
    <text>The screening of newborn infants pursuant to this chapter is a population-based public health surveillance program as defined under the Health Insurance Portability and Accountability Act of 1996.</text>
  </paragraph>
  <paragraph num="B.">
    <text>On request, a birthing facility or health care provider shall make available to the Newborn Screening Follow-Up Unit:</text>
    <paragraph num="(1)">
      <text>Medical records;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Records of laboratory tests; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Any other medical information the Newborn Screening Follow-Up Unit considers necessary to:</text>
      <paragraph num="(a)">
        <text>Determine final outcomes of abnormal screening results; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Evaluate CCHD Screening activities in the State, including:</text>
        <paragraph num="(i)">
          <text>Performance of follow-up evaluations and diagnostic tests;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Initiation of treatment when necessary; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Surveillance of the accuracy and efficacy of the screening.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Information that the Department receives under this chapter is confidential and may only be used or disclosed:</text>
    <paragraph num="(1)">
      <text>To provide services to the newborn infant and the infant's family;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To study the relationships of the various factors determining the frequency and distribution of CCHD;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>For State or federally mandated statistical reports; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>To ensure that the information received by the Department is accurate and reliable.</text>
    </paragraph>
  </paragraph>
</regulation>