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<regulation prefix="Regulation" num=".01" citation="COMAR 10.25.18.01" title_num="10" subtitle_num="25" chapter_num="18" heading="Scope and Purpose.">
  <paragraph num="A.">
    <text>This chapter addresses the privacy and security of protected health information maintained by a health information exchange, or obtained or released by any person through a health information exchange by adopting specific requirements:</text>
    <paragraph num="(1)">
      <text>To assure the privacy and security of protected health information accessed, used, or disclosed through a health information exchange, including protections for the secondary use of protected health information obtained, accessed, or released through a health information exchange;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To govern the access, use, maintenance, and disclosure of protected health information through or by a health information exchange;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>To improve access to clinical records by treating clinicians; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>To promote uses of a State-designated HIE that will assist public health agencies in reaching public health goals.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>This chapter applies to:</text>
    <paragraph num="(1)">
      <text>An HIE, as defined in Regulation .02B(38) of this chapter, including:</text>
      <paragraph num="(a)">
        <text>An individual or entity that determines, controls, or has discretion to administer any requirement, policy, or agreement that allows, enables, or requires the use of any technology or services for access, exchange, or use of electronic protected health information:</text>
        <paragraph num="(i)">
          <text>Among more than two unaffiliated individuals or entities that are enabled to exchange electronic protected health information with each other; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>That is for a treatment, payment, or health care operations purpose, as those terms are defined in 45 CFR §164.501, regardless of whether the individuals or entities are subject to the requirements of 45 CFR Parts 160 and 164; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>A health information technology developer of certified health information technology as that term is defined in Regulation .02B(39) of this chapter;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A person who accesses, uses, or discloses protected health information through an HIE;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Electronic health information stored in, or maintained by, an HIE; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A dispenser authorized by law to dispense noncontrolled prescription drugs to a patient or the patient’s agent in the State.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>This chapter does not apply to:</text>
    <paragraph num="(1)">
      <text>Protected health information exchanged, accessed, used, or disclosed:</text>
      <paragraph num="(a)">
        <text>Between a hospital and a credentialed professional;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Among credentialed professionals of a hospital’s medical staff;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Between a hospital and its affiliated ancillary clinical service provider who is affiliated with the hospital and who, if required by HIPAA, has entered into a business associate agreement with the hospital;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Among entities under common ownership as defined at Health-General Article, §4-301, Annotated Code of Maryland, for health care treatment, payment, or health care operations purposes, as those terms are defined in 45 CFR §164.501;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>By a carrier, as defined in Insurance Article, §15-301, Annotated Code of Maryland, exchanging information as required by 45 CFR §156.221; or</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Between a carrier and its business associate, as defined in 45 CFR §160.103, if the organizational and technical processes provided or governed by the business associate are transactions, as defined in 45 CFR §160.103; or</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The use, access, or disclosure of protected health information using point-to-point transmission unless an HIE is involved in the transmission of the data.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>In the event that an HIE is unable to meet a requirement of this chapter independently, it may do so by the execution of a written agreement or by requesting an exemption in accordance with Regulation .09G or H of this chapter.</text>
  </paragraph>
  <paragraph num="E.">
    <text>The requirements in this chapter are in addition to those set forth below:</text>
    <paragraph num="(1)">
      <text>The Health Insurance Portability and Accountability Act of 1996, and the pertinent regulations at 45 CFR Parts 160 and 164;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Maryland Consumer Protection Act, Commercial Law Article, Title 13, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The Maryland Personal Information Protection Act, Commercial Law Article, Title 14, Subtitle 35, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Health General Article, §4-307, Annotated Code of Maryland, Confidentiality of Mental Health Records;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>16 CFR Part 318, Health Breach Notification Rule, adopted by the Federal Trade Commission pursuant to the HITECH Act;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Titles IV and XI of the 21st Century Cures Act and the pertinent regulations, 45 CFR Part 171, and as defined at Regulation .02B(78) of this chapter; and</text>
    </paragraph>
    <paragraph num="(9)">
      <text>All other applicable State and federal laws and regulations governing the use, access, maintenance, and disclosure of health information.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Nothing in this chapter shall prohibit:</text>
    <paragraph num="(1)">
      <text>The Maryland Department of Health, the Commission, or the Health Services Cost Review Commission from using electronic health information, subject to federal and State law, for health regulatory and public health functions;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The sharing or disclosing of information that is required to be exchanged under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The sharing or disclosing of information that is required to be exchanged under federal law, including for the purposes of payment, as defined in 45 CFR § 164.501.</text>
    </paragraph>
  </paragraph>
</regulation>