ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
Publish Box goes here
| Active as of 2024-11-26 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-TI.1.1"/>
<meta>
<profile value="http://hl7.org/ehrs/StructureDefinition/FMFunction"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<span id="description"><b>Statement <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b> <div><p>Authenticate EHR-S users, and/or entities before allowing access.</p>
</div></span>
<span id="purpose"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>All entities accessing the EHR-S are subject to authentication.</p>
<p>Examples of entity authentication, with varying levels of authentication rigor, include:</p>
<ul>
<li>username/password;</li>
<li>digital certificate;</li>
<li>secure token;</li>
<li>biometrics.</li>
</ul>
</div></span>
<span id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></span>
<table id="statements" class="grid dict">
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#01</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL authenticate entities (e.g., users, organizations, applications, components, objects, and/or devices) accessing EHR-S protected resources (e.g., functions and data) according to scope of practice, organizational policy, and/or jurisdictional law, using an authentication mechanism such as an accredited Standards Development Organization-approved authentication standard (e.g., SAML, WS-Trust, Kerberos), username/password, digital certificate, secure token, biometric, or hardware-specific addressing mechanism. (See also ISO 22600.)</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL manage authentication data/information securely (e.g., passwords or biometric data).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#03</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL maintain configurable conditions and rules which protect against invalid, possibly malicious, authentication attempts according to organizational policy, and/or jurisdictional law (e.g., consecutive invalid logon attempts).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#04</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF passwords are used to control access to the EHR-S, THEN the system SHALL provide the ability to maintain configurable timeframes (e.g., 180 days) for the reuse of passwords according to organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#05</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF passwords are used to control access to the EHR-S, THEN the system SHALL provide the ability to maintain a configurable limit on the reuse of recently used passwords (e.g., the last 5 passwords) according to organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#06</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF username/passwords are used to control access to the EHR-S, THEN the system SHALL maintain password strength rules (e.g., requiring a minimum number of characters and inclusion of alpha-numeric complexity).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#07</span>
</td>
<td style="padding-left: 4px;">
<i>dependent</i>
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF passwords are used to control access to the system, THEN the system SHALL capture the password using obfuscation techniques (e.g., during user password entry) according to scope of practice, organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#08</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF passwords are used to control access to the EHR-S, THEN the system SHALL manage password reset as an administrative function.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#09</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF user passwords are initially set or later reset by an administrator, THEN the system SHALL provide the ability to update password at the next successful logon.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#10</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL present limited feedback to the user during authentication.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#11</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL provide the ability to enter case-insensitive 'usernames' that contain typeable alpha-numeric characters in support of ISO-646/ECMA-6 (aka US ASCII).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.1#12</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF passwords are used, THEN the system SHALL provide the ability to enter case-sensitive passwords that contain typeable alpha-numeric characters in support of ISO-646/ECMA-6 (aka US ASCII).</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.1.1"/>
<version value="2.1.0"/>
<name value="TI_1_1_Entity_Authentication"/>
<title value="TI.1.1 Entity Authentication (Function)"/>
<status value="active"/>
<date value="2024-11-26T16:30:50+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description
value="Authenticate EHR-S users, and/or entities before allowing access."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="All entities accessing the EHR-S are subject to authentication.
Examples of entity authentication, with varying levels of authentication rigor, include:
- username/password;
- digital certificate;
- secure token;
- biometrics."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-01"/>
<label value="TI.1.1#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL authenticate entities (e.g., users, organizations, applications, components, objects, and/or devices) accessing EHR-S protected resources (e.g., functions and data) according to scope of practice, organizational policy, and/or jurisdictional law, using an authentication mechanism such as an accredited Standards Development Organization-approved authentication standard (e.g., SAML, WS-Trust, Kerberos), username/password, digital certificate, secure token, biometric, or hardware-specific addressing mechanism. (See also ISO 22600.)"/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.1#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-02"/>
<label value="TI.1.1#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL manage authentication data/information securely (e.g., passwords or biometric data)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-03"/>
<label value="TI.1.1#03"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL maintain configurable conditions and rules which protect against invalid, possibly malicious, authentication attempts according to organizational policy, and/or jurisdictional law (e.g., consecutive invalid logon attempts)."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.1#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-04"/>
<label value="TI.1.1#04"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF passwords are used to control access to the EHR-S, THEN the system SHALL provide the ability to maintain configurable timeframes (e.g., 180 days) for the reuse of passwords according to organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-05"/>
<label value="TI.1.1#05"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF passwords are used to control access to the EHR-S, THEN the system SHALL provide the ability to maintain a configurable limit on the reuse of recently used passwords (e.g., the last 5 passwords) according to organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-06"/>
<label value="TI.1.1#06"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF username/passwords are used to control access to the EHR-S, THEN the system SHALL maintain password strength rules (e.g., requiring a minimum number of characters and inclusion of alpha-numeric complexity)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-07"/>
<label value="TI.1.1#07"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF passwords are used to control access to the system, THEN the system SHALL capture the password using obfuscation techniques (e.g., during user password entry) according to scope of practice, organizational policy, and/or jurisdictional law."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-08"/>
<label value="TI.1.1#08"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF passwords are used to control access to the EHR-S, THEN the system SHALL manage password reset as an administrative function."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-09"/>
<label value="TI.1.1#09"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF user passwords are initially set or later reset by an administrator, THEN the system SHALL provide the ability to update password at the next successful logon."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-10"/>
<label value="TI.1.1#10"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL present limited feedback to the user during authentication."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-11"/>
<label value="TI.1.1#11"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to enter case-insensitive 'usernames' that contain typeable alpha-numeric characters in support of ISO-646/ECMA-6 (aka US ASCII)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.1-12"/>
<label value="TI.1.1#12"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF passwords are used, THEN the system SHALL provide the ability to enter case-sensitive passwords that contain typeable alpha-numeric characters in support of ISO-646/ECMA-6 (aka US ASCII)."/>
</statement>
</Requirements>