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<regulation prefix="Regulation" num=".12" citation="COMAR 10.25.18.12" title_num="10" subtitle_num="25" chapter_num="18" heading="Requirements for Providing Health Care Consumers Electronic Access to Their Health Information.">
  <paragraph num="A.">
    <text>An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their health information shall:</text>
    <paragraph num="(1)">
      <text>Appropriately verify the identity of the health care consumer requesting electronic access or proposing an addition or change to the patient’s information available through the HIE prior to disclosing or accepting changes to the information;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Follow, at a minimum, the National Institute of Standards and Technology (NIST) Level 2 registration and identity proofing requirements as outlined in the most recent version of Special Publication 800-63: Electronic Authentication Guideline or its comparable industry best practices and may perform remote identity proofing;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Implement the health care consumer’s authorization for access within a maximum of 5 business days of receipt of all necessary information for identity proofing;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Adopt and implement authentication processes for health care consumer electronic access that is in accordance with Regulation .05D(3) and (4) of this chapter;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Establish individual unique user names and passwords in accordance with the most recent applicable standards issued by NIST, or other comparable standards generally adopted by the health care and HIE industry;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Implement processes for auditing health care consumer access that are in compliance with applicable requirements of Regulation .06 of this chapter;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Implement a process for suspending and reinstating a health care consumer’s access in compliance with applicable requirements in Regulation .07 of this chapter;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Establish processes and procedures to allow a patient to authorize an individual to have electronic access to their information;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Establish processes and procedures that allow an individual to electronically access health information for a patient or patients:</text>
      <paragraph num="(a)">
        <text>For whom the individual has legal authorization for such access (e.g., guardian, person with a medical power of attorney, etc.); or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For whom the patient has authorized such access;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>Establish processes and procedures to confirm the authority of a person in interest, if not directly authorized by a patient, which must be satisfied as a condition to providing access to that person in interest; and</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Comply with applicable federal and State laws and regulations related to sensitive health information when disclosing such information to a health care consumer.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their information may:</text>
    <paragraph num="(1)">
      <text>Charge a reasonable cost-based published fee for healthcare consumer electronic access consistent with applicable federal and State laws; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Deny a health care consumer’s electronic access in accordance with:</text>
      <paragraph num="(a)">
        <text>Applicable law or regulation, including 45 CFR §164.524, in coordination with applicable participating organizations; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The HIE’s reasonable policies, procedures, or agreements with a participating organization and shall provide notice to the health care consumer of their right to request access to the patient’s health information from the covered entity.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>An HIE or its third party that offers health care consumer electronic access to view the patient’s health information available through the HIE shall, in accordance with federal and State law:</text>
    <paragraph num="(1)">
      <text>Provide the patient’s health information that is equivalent to what is made available to authorized users that are health care providers, which may include:</text>
      <paragraph num="(a)">
        <text>Demographic information, such as name, address, and date of birth;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Provider encounters or procedures performed (e.g., hospital, ambulatory, post-acute care, etc.);</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Immunizations;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Visit summaries;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Care plan(s);</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Clinical test results; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Prescriptions;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>At a minimum, and if made available through the HIE, make the following data attributes for the patient’s health information electronically available to the health care consumer:</text>
      <paragraph num="(a)">
        <text>Date of the encounter, procedure, test, prescription, or immunization;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Results or summary of the encounter, procedure, test, prescription, or immunization; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Source of the health information, including provider name and organization name;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Inform health care consumers regarding:</text>
      <paragraph num="(a)">
        <text>Contacting their health care provider to discuss the health information they may be viewing if they have any concerns or questions; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Translation services and resources that may be available, through the HIE or another entity, to help assist the health care consumer in understanding their health information; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Allow the health care consumer to view the patient’s health information in an electronic format that meets the following criteria:</text>
      <paragraph num="(a)">
        <text>The information is presented in substantially the same form and format as presented to an authorized user that is a health care provider;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The form and format presented to a health care consumer is easy for the health care consumer to navigate;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The information can be easily printed; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>If supplemental information is made available along with the patient’s health information, such as educational resources, the supplemental information meets the criteria specified in Regulation .03B(2)(c)—(e) of this chapter.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>An HIE or its third party that offers health care consumers the ability to electronically control the patient’s health information being made available through the HIE shall:</text>
    <paragraph num="(1)">
      <text>Implement technology processes that meet industry standards and best practices and are in compliance with State and federal privacy and security laws; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide an electronic process by which a health care consumer can control the patient’s health information that is in accordance with §C(4)(b)—(d) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>An HIE or its third party that offers health care consumers the ability to download the patient’s health information being made available through the HIE shall provide the patient’s health information that is:</text>
    <paragraph num="(1)">
      <text>In accordance with §C(3) and (4)(b)—(d) of this regulation;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Requested by the health care consumer; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>In a readily available industry standard format.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>An HIE or its third party that offers health care consumers the ability to submit information to the HIE:</text>
    <paragraph num="(1)">
      <text>Shall identify the source of the information, such as patient, payor, or health care provider, when presented to an authorized user of the HIE; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>May not use patient submitted health information to override or replace health information submitted from other sources.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>An HIE or its third party that offers health care consumers the ability to transmit the patients’ health information being made available through the HIE to a third party of the health care consumer’s designation shall comply with the requirements as detailed in:</text>
    <paragraph num="(1)">
      <text>§C(3) of this regulation;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>§C(4)(b) and (d) of this regulation; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>§E(2) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Health Care Consumer Education About Electronic Access.</text>
    <paragraph num="(1)">
      <text>An HIE shall provide needed information, as part of its health care consumer education plan (as detailed in .03B(1) of this chapter and meeting the characteristics as detailed in Regulation .03B(2) of this chapter), about the services or features offered by the HIE or its third party that allows the health care consumer to electronically view, download, submit, or control the patient’s information that is available through the HIE.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The health care consumer education plan shall outline the process which, if available, allows a health care consumer to electronically view, download, transmit, submit, or control the patient’s information that is available through the HIE, including:</text>
      <paragraph num="(a)">
        <text>The information the health care consumer must provide as part of patient identity proofing;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The patient’s rights to:</text>
        <paragraph num="(i)">
          <text>Authorize a person in interest or individual to also have access to the patient’s health information; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Request a review of a denial of access;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The extent to which the health care consumer has control of the patient’s health information being made available through the HIE; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The need to safeguard information obtained from the HIE to the same extent they safeguard other sensitive personal information.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>