ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
0.16.0 - CI Build
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| Active as of 2024-08-12 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-TI.1.6"/>
<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>Secure all modes of EHR data exchange.</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>Whenever an exchange of EHR information occurs, it requires appropriate security and privacy considerations, including data obfuscation as well as both destination and source authentication when necessary. For example, it may be necessary to encrypt data sent to remote or external destinations.</p>
</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.1.6#01</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL secure all modes of EHR data exchange.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#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 conform to function [[TI.1.7]] (Secure Data Routing).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to de-identify data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL encrypt and decrypt EHR data that is exchanged over a non-secure link.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#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 encryption is used, THEN the system SHALL exchange data using recognized standards-based encryption mechanisms according to organizational policy, and/or jurisdictional law.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#06</span>
</td>
<td style="padding-left: 4px;">
<i>conditional</i>
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>IF the EHR-S is the recipient of a secure data exchange, THEN the system SHOULD provide the ability to transmit an acknowledgment of the receipt of the data.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>TI.1.6#07</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 determine static or dynamic addresses for known and authorized sources and destinations.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-TI.1.6"/>
<version value="0.16.0"/>
<name value="TI_1_6_Secure_Data_Exchange"/>
<title value="TI.1.6 Secure Data Exchange (Function)"/>
<status value="active"/>
<date value="2024-08-12T10:56:01+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description value="Secure all modes of EHR data exchange."/>
<purpose
value="Whenever an exchange of EHR information occurs, it requires appropriate security and privacy considerations, including data obfuscation as well as both destination and source authentication when necessary. For example, it may be necessary to encrypt data sent to remote or external destinations."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-01"/>
<label value="TI.1.6#01"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL secure all modes of EHR data exchange."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.6#1"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-02"/>
<label value="TI.1.6#02"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [[TI.1.7]] (Secure Data Routing)."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.6#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-03"/>
<label value="TI.1.6#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to de-identify data."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.6#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-04"/>
<label value="TI.1.6#04"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL encrypt and decrypt EHR data that is exchanged over a non-secure link."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.6#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="true"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-05"/>
<label value="TI.1.6#05"/>
<conformance value="SHALL"/>
<conditionality value="true"/>
<requirement
value="IF encryption is used, THEN the system SHALL exchange data using recognized standards-based encryption mechanisms according to organizational policy, and/or jurisdictional law."/>
<derivedFrom value="EHR-S_FM_R1.1 IN.1.6#5"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-06"/>
<label value="TI.1.6#06"/>
<conformance value="SHOULD"/>
<conditionality value="true"/>
<requirement
value="IF the EHR-S is the recipient of a secure data exchange, THEN the system SHOULD provide the ability to transmit an acknowledgment of the receipt of the data."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-TI.1.6-07"/>
<label value="TI.1.6#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL provide the ability to determine static or dynamic addresses for known and authorized sources and destinations."/>
</statement>
</Requirements>