US Core Testing Guide
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US Core Testing Guide - Local Development build (v3.1.1-1). See the Directory of published versions

: US Core 3.1.1 Requirements for US Core General Security Considerations - TTL Representation

Draft as of 2023-08-25

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Requirements ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "us-core-req-security"] ; #
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>These requirements reference <a href=\"http://hl7.org/fhir/us/core/STU3.1.1/security.html\">http://hl7.org/fhir/us/core/STU3.1.1/security.html</a></p><p>These requirements apply to the following actors:</p><ul><li><a href=\"ActorDefinition-us-core-requestor.html\">US Core Requestor</a></li><li><a href=\"ActorDefinition-us-core-responder.html\">US Core Responder</a></li></ul><h2>Statements</h2><table class=\"grid\"><tr><td><b><a href=\"#us-core-req-security-01\">us-core-req-security-01</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> establish a risk analysis and management regime that conforms with HIPAA security regulatory requirements.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-01-a\">us-core-req-security-01-a</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>In addition US Federal systems <strong>SHOULD</strong> conform with the risk management and mitigation requirements defined in NIST 800 series documents. This <strong>SHOULD</strong> include security category assignment in accordance with NIST 800-60 vol. 2 Appendix D.14. The coordination of risk management and the related security and privacy controls – policies, administrative practices, and technical controls – <strong>SHOULD</strong> be defined in the Business Associate Agreement when available.</p>\n</div><p>Links:</p><ul><li>Parent: <a href=\"Requirements-us-core-req-security.html#us-core-req-security-01\">US Core 3.1.1 Requirements for US Core General Security Considerations # us-core-req-security-01-a</a></li></ul></td></tr><tr><td><b><a href=\"#us-core-req-security-02\">us-core-req-security-02</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> reference a single time source to establish a common time base for security auditing, as well as clinical data records, among computing systems.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-02-a\">us-core-req-security-02-a</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>The selected time service <strong>SHOULD</strong> be documented in the Business Associate Agreement when available.</p>\n</div><p>Links:</p><ul><li>Parent: <a href=\"Requirements-us-core-req-security.html#us-core-req-security-02\">US Core 3.1.1 Requirements for US Core General Security Considerations # us-core-req-security-02-a</a></li></ul></td></tr><tr><td><b><a href=\"#us-core-req-security-03\">us-core-req-security-03</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> keep audit logs of the various transactions.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-04\">us-core-req-security-04</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> use TLS version 1.2 or higher for all transmissions not taking place over a secure network connection. (Using TLS even within a secured network environment is still encouraged to provide defense in depth.)</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-04-a\">us-core-req-security-04-a</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>US Federal systems <strong>SHOULD</strong> conform with FIPS PUB 140-2.</p>\n</div><p>Links:</p><ul><li>Parent: <a href=\"Requirements-us-core-req-security.html#us-core-req-security-04\">US Core 3.1.1 Requirements for US Core General Security Considerations # us-core-req-security-04-a</a></li></ul></td></tr><tr><td><b><a href=\"#us-core-req-security-05\">us-core-req-security-05</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> conform to <a href=\"http://hl7.org/fhir/R4/security.html#http\">FHIR</a> Communications Security requirements.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-06\">us-core-req-security-06</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>For Authentication and Authorization, Systems <strong>SHALL</strong> support the <a href=\"http://www.hl7.org/fhir/smart-app-launch/history.cfml\">SMART App Launch Framework</a> for client &lt;-&gt; server interactions. NOTE: The SMART on FHIR specifications include the required OAuth 2.0 scopes for enabling security decisions.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-07\">us-core-req-security-07</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHALL\">SHALL</a></td><td><div><p>Systems <strong>SHALL</strong> implement consent requirements per their state, local, and institutional policies.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-07-a\">us-core-req-security-07-a</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>The Business Associate Agreements <strong>SHOULD</strong> document systems mutual consent requirements.</p>\n</div><p>Links:</p><ul><li>Parent: <a href=\"Requirements-us-core-req-security.html#us-core-req-security-07\">US Core 3.1.1 Requirements for US Core General Security Considerations # us-core-req-security-07-a</a></li></ul></td></tr><tr><td><b><a href=\"#us-core-req-security-08\">us-core-req-security-08</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-SHOULD\">SHOULD</a></td><td><div><p>Systems <strong>SHOULD</strong> provide Provenance statements using the <a href=\"http://hl7.org/fhir/us/core/STU3.1.1/StructureDefinition-us-core-provenance.html\">US Core Provenance Profile</a> resource and associated requirements.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-09\">us-core-req-security-09</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-MAY\">MAY</a></td><td><div><p>Systems <strong>MAY</strong> implement the <a href=\"http://hl7.org/fhir/R4/security.html#digital%20signatures\">FHIR Digital Signatures</a> and provide feedback on its appropriateness for US Core transactions.</p>\n</div></td></tr><tr><td><b><a href=\"#us-core-req-security-10\">us-core-req-security-10</a></b></td><td><a href=\"http://hl7.org/fhir/R5/codesystem-conformance-expectation.html#conformance-expectation-MAY\">MAY</a></td><td><div><p>Systems <strong>MAY</strong> protect the confidentiality of data at rest via encryption and associated access controls. The policies and methods used are outside the scope of this specification.</p>\n</div></td></tr></table></div>"
  ] ; #
  fhir:url [ fhir:v "http://hl7.org/fhir/us/core-tg/Requirements/us-core-req-security"^^xsd:anyURI] ; #
  fhir:version [ fhir:v "3.1.1-1"] ; #
  fhir:name [ fhir:v "USCoreReqSecurity"] ; #
  fhir:title [ fhir:v "US Core 3.1.1 Requirements for US Core General Security Considerations"] ; #
  fhir:status [ fhir:v "draft"] ; #
  fhir:date [ fhir:v "2023-08-25"^^xsd:date] ; #
  fhir:publisher [ fhir:v "HL7 FHIR Infrastructure WG"] ; #
  fhir:contact ( [
fhir:name [ fhir:v "HL7 FHIR Infrastructure WG" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://hl7.org/Special/committees/fiwg" ]     ] )
  ] [
fhir:name [ fhir:v "Richard Ettema" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "mailto:richard.ettema@aegis.net" ]     ] )
  ] ) ; #
  fhir:description [ fhir:v "**Patient Privacy and Security**<br/><br/>US Core transactions often use patient-specific information, which could be exploited by malicious actors resulting in the exposure of patient data. For this reason, all US Core transactions must be secured appropriately with access to limited authorized individuals, data protected in transit, and appropriate audit measures taken.<br/><br/>Implementers **SHOULD** be aware of these [security considerations](http://hl7.org/fhir/R4/security.html) associated with FHIR transactions, particularly those related to:<br/><br/>* [Communications](http://hl7.org/fhir/R4/security.html#http)<br/>* [Authentication](http://hl7.org/fhir/R4/security.html#authentication)<br/>* [Authorization/Access Control](http://hl7.org/fhir/R4/security.html#authorization/access%20control)<br/>* [Audit Logging](http://hl7.org/fhir/R4/security.html#audit%20logging)<br/>* [Digital Signatures](http://hl7.org/fhir/R4/security.html#digital%20signatures)<br/>* [Security Labels](http://hl7.org/fhir/R4/security-labels.html)<br/>* [Narrative](http://hl7.org/fhir/R4/security.html#narrative)"] ; #
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ]     ] )
  ] ) ; #
  fhir:reference ( [ fhir:v "http://hl7.org/fhir/us/core/STU3.1.1/security.html"^^xsd:anyURI] ) ; #
  fhir:actor ( [
fhir:v "http://hl7.org/fhir/us/core-tg/ActorDefinition/us-core-requestor"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/core-tg/ActorDefinition/us-core-requestor>
  ] [
fhir:v "http://hl7.org/fhir/us/core-tg/ActorDefinition/us-core-responder"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/core-tg/ActorDefinition/us-core-responder>
  ] ) ; #
  fhir:statement ( [
fhir:key [ fhir:v "us-core-req-security-01" ] ;
fhir:label [ fhir:v "us-core-req-security-01" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** establish a risk analysis and management regime that conforms with HIPAA security regulatory requirements." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-01-a" ] ;
fhir:label [ fhir:v "us-core-req-security-01-a" ] ;
    ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:requirement [ fhir:v "In addition US Federal systems **SHOULD** conform with the risk management and mitigation requirements defined in NIST 800 series documents. This **SHOULD** include security category assignment in accordance with NIST 800-60 vol. 2 Appendix D.14. The coordination of risk management and the related security and privacy controls – policies, administrative practices, and technical controls – **SHOULD** be defined in the Business Associate Agreement when available." ] ;
fhir:parent [ fhir:v "#us-core-req-security-01" ]
  ] [
fhir:key [ fhir:v "us-core-req-security-02" ] ;
fhir:label [ fhir:v "us-core-req-security-02" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** reference a single time source to establish a common time base for security auditing, as well as clinical data records, among computing systems." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-02-a" ] ;
fhir:label [ fhir:v "us-core-req-security-02-a" ] ;
    ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:requirement [ fhir:v "The selected time service **SHOULD** be documented in the Business Associate Agreement when available." ] ;
fhir:parent [ fhir:v "#us-core-req-security-02" ]
  ] [
fhir:key [ fhir:v "us-core-req-security-03" ] ;
fhir:label [ fhir:v "us-core-req-security-03" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** keep audit logs of the various transactions." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-04" ] ;
fhir:label [ fhir:v "us-core-req-security-04" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** use TLS version 1.2 or higher for all transmissions not taking place over a secure network connection. (Using TLS even within a secured network environment is still encouraged to provide defense in depth.)" ]
  ] [
fhir:key [ fhir:v "us-core-req-security-04-a" ] ;
fhir:label [ fhir:v "us-core-req-security-04-a" ] ;
    ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:requirement [ fhir:v "US Federal systems **SHOULD** conform with FIPS PUB 140-2." ] ;
fhir:parent [ fhir:v "#us-core-req-security-04" ]
  ] [
fhir:key [ fhir:v "us-core-req-security-05" ] ;
fhir:label [ fhir:v "us-core-req-security-05" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** conform to [FHIR](http://hl7.org/fhir/R4/security.html#http) Communications Security requirements." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-06" ] ;
fhir:label [ fhir:v "us-core-req-security-06" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "For Authentication and Authorization, Systems **SHALL** support the [SMART App Launch Framework](http://www.hl7.org/fhir/smart-app-launch/history.cfml) for client <-> server interactions. NOTE: The SMART on FHIR specifications include the required OAuth 2.0 scopes for enabling security decisions." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-07" ] ;
fhir:label [ fhir:v "us-core-req-security-07" ] ;
    ( fhir:conformance [ fhir:v "SHALL" ] ) ;
fhir:requirement [ fhir:v "Systems **SHALL** implement consent requirements per their state, local, and institutional policies." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-07-a" ] ;
fhir:label [ fhir:v "us-core-req-security-07-a" ] ;
    ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:requirement [ fhir:v "The Business Associate Agreements **SHOULD** document systems mutual consent requirements." ] ;
fhir:parent [ fhir:v "#us-core-req-security-07" ]
  ] [
fhir:key [ fhir:v "us-core-req-security-08" ] ;
fhir:label [ fhir:v "us-core-req-security-08" ] ;
    ( fhir:conformance [ fhir:v "SHOULD" ] ) ;
fhir:requirement [ fhir:v "Systems **SHOULD** provide Provenance statements using the [US Core Provenance Profile](http://hl7.org/fhir/us/core/STU3.1.1/StructureDefinition-us-core-provenance.html) resource and associated requirements." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-09" ] ;
fhir:label [ fhir:v "us-core-req-security-09" ] ;
    ( fhir:conformance [ fhir:v "MAY" ] ) ;
fhir:requirement [ fhir:v "Systems **MAY** implement the [FHIR Digital Signatures](http://hl7.org/fhir/R4/security.html#digital%20signatures) and provide feedback on its appropriateness for US Core transactions." ]
  ] [
fhir:key [ fhir:v "us-core-req-security-10" ] ;
fhir:label [ fhir:v "us-core-req-security-10" ] ;
    ( fhir:conformance [ fhir:v "MAY" ] ) ;
fhir:requirement [ fhir:v "Systems **MAY** protect the confidentiality of data at rest via encryption and associated access controls. The policies and methods used are outside the scope of this specification." ]
  ] ) . #