<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.44.30.02" title_num="10" subtitle_num="44" chapter_num="30" heading="General Provisions for Handwritten, Typed, and Electronic Health Records.">
  <paragraph num="A.">
    <text>A dentist shall create and maintain a separate dental record for each patient.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Dental records shall include:</text>
    <paragraph num="(1)">
      <text>A patient’s clinical chart as described in Regulation .03 of this chapter; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Financial records as described in Regulation .04 of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Dental records may be:</text>
    <paragraph num="(1)">
      <text>Handwritten in ink;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Typed; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Generated on a computer or other electronic device.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Dental records may not be created or maintained in pencil.</text>
  </paragraph>
  <paragraph num="E.">
    <text>If treatment is rendered, dental records shall be made contemporaneously with the treatment rendered.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Dental records shall be created and maintained for each individual seeking or receiving dental services, regardless of whether:</text>
    <paragraph num="(1)">
      <text>Any treatment is actually rendered; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Any fee is charged.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>All entries shall be dated.</text>
  </paragraph>
  <paragraph num="H.">
    <text>Electronic Health Records.</text>
    <paragraph num="(1)">
      <text>A dentist who creates and maintains electronic health records shall utilize best practices related to:</text>
      <paragraph num="(a)">
        <text>Hazard and risk analysis and mitigation;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Software development;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Validation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Maintenance;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Security measures; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>System integration and operation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A dentist who creates and maintains electronic health records shall maintain a back-up copy of the records and, if feasible, a back-up copy off site.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The initials and signatures in electronic health records required by this chapter may be produced electronically.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Electronic health record systems shall include an audit-trail function that details all interactions between systems and their users and all interactions among systems.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The audit-trail identified in §H(4) of this regulation shall include:</text>
      <paragraph num="(a)">
        <text>Attempted or successful unauthorized access to the electronic health records where the determination is feasible;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Attempted or successful unauthorized modification or destruction of any records where the determination is feasible;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Interference with application operations of the electronic records;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Any setting of or change to logical access controls related to the dispensing of controlled substance prescriptions; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Attempted or successful interference with audit trail functions.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Electronic health record systems shall provide the capability to produce a hard copy business version of each treatment or progress note and shall indicate:</text>
      <paragraph num="(a)">
        <text>The date and time of each entry;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The identity of each individual who made the entry;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The method used in the creation of each entry, which shall include but not be limited to:</text>
        <paragraph num="(i)">
          <text>Direct entry via keyboard or mouse;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Speech recognition;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Automation;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Machine-entered default information;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Pre-created documentation via form or template;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Copy or import of an object including the date and time of the entry and the identity of the original author;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Copy forward previous note contents including the date and time of the entry and the identity of the original author; and</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Dictation and transcription from an external system.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>A dental record shall contain:</text>
    <paragraph num="(1)">
      <text>The patient’s name or other patient identifier;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If the patient is a minor, the name and address of the patient’s parents or guardian;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The patient’s address and telephone number;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The patient’s date of birth;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The patient’s place of employment if the patient wishes to provide the information;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Emergency contact information;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Medical and dental histories which shall be updated at each visit; and</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Insurance information.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>To the extent practicable, each document in the dental records shall contain one or more patient identifiers.</text>
  </paragraph>
  <paragraph num="K.">
    <text>Dental records shall:</text>
    <paragraph num="(1)">
      <text>Be accurate;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Be detailed;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be legible;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Be well organized; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Document all data in the dentist’s possession pertaining to the patient's dental health status;</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>Entries shall be signed or initialed by the individual who provided the treatment.</text>
  </paragraph>
  <paragraph num="M.">
    <text>With the exception of dental hygienists, entries made by auxiliary personnel shall be:</text>
    <paragraph num="(1)">
      <text>Reviewed by the treating dentist; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Signed or initialed by the treating dentist.</text>
    </paragraph>
  </paragraph>
  <paragraph num="N.">
    <text>Entries made by individuals other than the individual who provided the treatment shall:</text>
    <paragraph num="(1)">
      <text>Identify the individual who made the entry;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identify the individual who provided the treatment;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be signed or initialed by the individual who provided the treatment; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Be signed or initialed by the treating dentist.</text>
    </paragraph>
  </paragraph>
  <paragraph num="O.">
    <text>Exception. Entries made by an individual other than the individual who provided the treatment may not require the signature or initials of the treating dentist if the treatment was provided by a dental hygienist.</text>
  </paragraph>
  <paragraph num="P.">
    <text>A dentist and auxiliary personnel may not erase, alter, obliterate, or “white out” dental records.</text>
  </paragraph>
  <paragraph num="Q.">
    <text>Blank spaces may not be left between entries.</text>
  </paragraph>
  <paragraph num="R.">
    <text>Changes to handwritten and typed dental records shall:</text>
    <paragraph num="(1)">
      <text>Be made by a single line strike-through of the incorrect entry so that the incorrect entry may be read;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Contain changes in the corresponding margin or in close proximity to the incorrect entry;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be dated;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Be signed or initialed by the treating dentist; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>If the change was made by auxiliary personnel:</text>
      <paragraph num="(a)">
        <text>Be reviewed;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Be approved; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Be signed or initialed by the treating dentist.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="S.">
    <text>The dental records shall contain only those abbreviations that are commonly acceptable within the profession and comprehensible to other dentists.</text>
  </paragraph>
  <paragraph num="T.">
    <text>Except for notations of payment or failure to make payment, financial records may not be maintained in the clinical chart.</text>
  </paragraph>
  <paragraph num="U.">
    <text>Dentists are responsible for the content of the dental records.</text>
  </paragraph>
  <paragraph num="V.">
    <text>A dentist who has been issued a dispensing permit by the Board shall maintain dispensing records in accordance with Regulation .03J of this chapter.</text>
  </paragraph>
</regulation>