<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.25.18.04" title_num="10" subtitle_num="25" chapter_num="18" heading="Access, Use, or Disclosure of Sensitive Health Information.">
  <paragraph num="A.">
    <text>Consistency with Disclosure Requirements Under Federal and State Law.</text>
    <paragraph num="(1)">
      <text>A person shall comply with all relevant State and federal laws, including 42 CFR Part 2, and Health-General Article, §4-302.5, Annotated Code of Maryland, concerning the access, use, or disclosure of sensitive health information through an HIE and maintenance of such information by an HIE.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If federal or State law requires written consent or authorization for access, use, or disclosure of sensitive health information, a person shall obtain consent or authorization consistent with the applicable law prior to the access, use, or disclosure of sensitive health information to and through an HIE to an authorized recipient.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>If federal or State law does not require written consent or authorization for access, use, or disclosure of sensitive health information, a person may not require consent or authorization prior to the access, use, or disclosure of the sensitive health information through an HIE.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>An HIE shall use only point-to-point transmission to allow access, use, or disclosure of the sensitive health information through an HIE, unless the HIE implements:</text>
      <paragraph num="(a)">
        <text>Nationally recognized standards that support control by the health care consumer over the electronic exchange of the patient's sensitive health information consistent with the privacy and consent directives made by the health care consumer;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Electronic exchange controls and processes that:</text>
        <paragraph num="(i)">
          <text>Support granular patient consent for the electronic transmission of sensitive health information consistent with applicable State and federal laws concerning the access, use, or disclosure of sensitive health information, including applicable standards and technical requirements in accordance with Part 2; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Assure that the health care consumer's granular consent controls remain associated with the sensitive health information and are adhered to as the information is transmitted through, maintained, or disclosed by the HIE; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Health care consumer educational content:</text>
        <paragraph num="(i)">
          <text>That is developed and established in coordination with the Commission and stakeholders;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>That is kept current; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>The receipt of which shall be acknowledged by the health care consumer as part of the granular consent process.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>In the case of the improper access, use, maintenance, or disclosure of sensitive health information, including an inadvertent release through an HIE, a participating organization shall take the following actions in addition to any other requirement imposed under federal or State law:</text>
      <paragraph num="(a)">
        <text>Take all steps necessary to immediately stop any further improper access, use, disclosure, or release of the patient's sensitive health information through the HIE and the improper maintenance of such information by the HIE; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In accordance with Regulation .08 of this chapter, notify each health care consumer whose sensitive health information has been accessed, used, maintained, or disclosed in violation of applicable State or federal laws, including a non-HIPAA violation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Procedure for Disclosing or Re-disclosing of Part 2 Health Information.</text>
    <paragraph num="(1)">
      <text>An HIE shall be in compliance with Part 2</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A participating organization that is a Part 2 program, as that term is defined by Part 2, shall identify itself as such and clearly indicate with all of its patient records any limits on use or disclosure required by Part 2.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>An HIE or participating organization that receives Part 2 information may not re-disclose such information without appropriate patient consent or authorization except as permitted by applicable federal and State laws and regulations.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Procedures for Disclosing or Re-Disclosing Legally Protected Health Information.</text>
    <paragraph num="(1)">
      <text>An HIE shall be in compliance with Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>By January 8, 2024, an HIE shall submit to the Commission:</text>
      <paragraph num="(a)">
        <text>An affirmation that it:</text>
        <paragraph num="(i)">
          <text>Possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Is parsing restricted codes and conveying all other information in the health record that is not prohibited by law to exchange; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Possesses the technological capacity to allow a consumer to request and consent to the exchange of legally protected health information to a specific treating provider; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>An implementation plan that includes:</text>
        <paragraph num="(i)">
          <text>An affirmation that, despite its best efforts, the HIE lacks the technological capability to fully comply with §C(1) of this regulation as of January 8, 2024, including a detailed explanation of the HIE’s limitations;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A detailed description of the steps the HIE is taking to ensure compliance with §C(1) of this regulation by June 1, 2024;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A timeline to implement the requirements of Health-General Article §4-302.5, Annotated Code of Maryland, by June 1, 2024; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>A description of the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>If an HIE submits an implementation plan in accordance with §C(2)(b) of this regulation, the HIE shall:</text>
      <paragraph num="(a)">
        <text>Notify all participating organizations by January 8, 2024, that the HIE is unable to comply with §C(1) of this regulation with a written notice that describes the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Provide a status report to the Commission by April 1, 2024, detailing the progress the HIE has made under its implementation plan; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Submit validation to the Commission by June 1, 2024, that it possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The Commission shall consider an HIE’s implementation plan and reported progress when assessing penalties for a violation of this section.</text>
    </paragraph>
  </paragraph>
</regulation>