918 lines
33 KiB
HTML
918 lines
33 KiB
HTML
<!DOCTYPE html>
|
||
|
||
<html>
|
||
|
||
<head>
|
||
|
||
<meta charset="utf-8" />
|
||
<meta name="generator" content="pandoc" />
|
||
<meta http-equiv="X-UA-Compatible" content="IE=EDGE" />
|
||
|
||
|
||
|
||
|
||
<title>Preserving Privacy in an OMOP CDM Implementation</title>
|
||
|
||
<script src="site_libs/header-attrs-2.25/header-attrs.js"></script>
|
||
<script src="site_libs/jquery-3.6.0/jquery-3.6.0.min.js"></script>
|
||
<meta name="viewport" content="width=device-width, initial-scale=1" />
|
||
<link href="site_libs/bootstrap-3.3.5/css/cosmo.min.css" rel="stylesheet" />
|
||
<script src="site_libs/bootstrap-3.3.5/js/bootstrap.min.js"></script>
|
||
<script src="site_libs/bootstrap-3.3.5/shim/html5shiv.min.js"></script>
|
||
<script src="site_libs/bootstrap-3.3.5/shim/respond.min.js"></script>
|
||
<style>h1 {font-size: 34px;}
|
||
h1.title {font-size: 38px;}
|
||
h2 {font-size: 30px;}
|
||
h3 {font-size: 24px;}
|
||
h4 {font-size: 18px;}
|
||
h5 {font-size: 16px;}
|
||
h6 {font-size: 12px;}
|
||
code {color: inherit; background-color: rgba(0, 0, 0, 0.04);}
|
||
pre:not([class]) { background-color: white }</style>
|
||
<script src="site_libs/jqueryui-1.13.2/jquery-ui.min.js"></script>
|
||
<link href="site_libs/tocify-1.9.1/jquery.tocify.css" rel="stylesheet" />
|
||
<script src="site_libs/tocify-1.9.1/jquery.tocify.js"></script>
|
||
<script src="site_libs/navigation-1.1/tabsets.js"></script>
|
||
<link href="site_libs/highlightjs-9.12.0/default.css" rel="stylesheet" />
|
||
<script src="site_libs/highlightjs-9.12.0/highlight.js"></script>
|
||
<link href="site_libs/font-awesome-6.4.2/css/all.min.css" rel="stylesheet" />
|
||
<link href="site_libs/font-awesome-6.4.2/css/v4-shims.min.css" rel="stylesheet" />
|
||
<link rel='shortcut icon' type='image/x-icon' href='favicon.ico' />
|
||
|
||
<style type="text/css">
|
||
code{white-space: pre-wrap;}
|
||
span.smallcaps{font-variant: small-caps;}
|
||
span.underline{text-decoration: underline;}
|
||
div.column{display: inline-block; vertical-align: top; width: 50%;}
|
||
div.hanging-indent{margin-left: 1.5em; text-indent: -1.5em;}
|
||
ul.task-list{list-style: none;}
|
||
</style>
|
||
|
||
<style type="text/css">code{white-space: pre;}</style>
|
||
<script type="text/javascript">
|
||
if (window.hljs) {
|
||
hljs.configure({languages: []});
|
||
hljs.initHighlightingOnLoad();
|
||
if (document.readyState && document.readyState === "complete") {
|
||
window.setTimeout(function() { hljs.initHighlighting(); }, 0);
|
||
}
|
||
}
|
||
</script>
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<link rel="stylesheet" href="style.css" type="text/css" />
|
||
|
||
|
||
|
||
<style type = "text/css">
|
||
.main-container {
|
||
max-width: 940px;
|
||
margin-left: auto;
|
||
margin-right: auto;
|
||
}
|
||
img {
|
||
max-width:100%;
|
||
}
|
||
.tabbed-pane {
|
||
padding-top: 12px;
|
||
}
|
||
.html-widget {
|
||
margin-bottom: 20px;
|
||
}
|
||
button.code-folding-btn:focus {
|
||
outline: none;
|
||
}
|
||
summary {
|
||
display: list-item;
|
||
}
|
||
details > summary > p:only-child {
|
||
display: inline;
|
||
}
|
||
pre code {
|
||
padding: 0;
|
||
}
|
||
</style>
|
||
|
||
|
||
<style type="text/css">
|
||
.dropdown-submenu {
|
||
position: relative;
|
||
}
|
||
.dropdown-submenu>.dropdown-menu {
|
||
top: 0;
|
||
left: 100%;
|
||
margin-top: -6px;
|
||
margin-left: -1px;
|
||
border-radius: 0 6px 6px 6px;
|
||
}
|
||
.dropdown-submenu:hover>.dropdown-menu {
|
||
display: block;
|
||
}
|
||
.dropdown-submenu>a:after {
|
||
display: block;
|
||
content: " ";
|
||
float: right;
|
||
width: 0;
|
||
height: 0;
|
||
border-color: transparent;
|
||
border-style: solid;
|
||
border-width: 5px 0 5px 5px;
|
||
border-left-color: #cccccc;
|
||
margin-top: 5px;
|
||
margin-right: -10px;
|
||
}
|
||
.dropdown-submenu:hover>a:after {
|
||
border-left-color: #adb5bd;
|
||
}
|
||
.dropdown-submenu.pull-left {
|
||
float: none;
|
||
}
|
||
.dropdown-submenu.pull-left>.dropdown-menu {
|
||
left: -100%;
|
||
margin-left: 10px;
|
||
border-radius: 6px 0 6px 6px;
|
||
}
|
||
</style>
|
||
|
||
<script type="text/javascript">
|
||
// manage active state of menu based on current page
|
||
$(document).ready(function () {
|
||
// active menu anchor
|
||
href = window.location.pathname
|
||
href = href.substr(href.lastIndexOf('/') + 1)
|
||
if (href === "")
|
||
href = "index.html";
|
||
var menuAnchor = $('a[href="' + href + '"]');
|
||
|
||
// mark the anchor link active (and if it's in a dropdown, also mark that active)
|
||
var dropdown = menuAnchor.closest('li.dropdown');
|
||
if (window.bootstrap) { // Bootstrap 4+
|
||
menuAnchor.addClass('active');
|
||
dropdown.find('> .dropdown-toggle').addClass('active');
|
||
} else { // Bootstrap 3
|
||
menuAnchor.parent().addClass('active');
|
||
dropdown.addClass('active');
|
||
}
|
||
|
||
// Navbar adjustments
|
||
var navHeight = $(".navbar").first().height() + 15;
|
||
var style = document.createElement('style');
|
||
var pt = "padding-top: " + navHeight + "px; ";
|
||
var mt = "margin-top: -" + navHeight + "px; ";
|
||
var css = "";
|
||
// offset scroll position for anchor links (for fixed navbar)
|
||
for (var i = 1; i <= 6; i++) {
|
||
css += ".section h" + i + "{ " + pt + mt + "}\n";
|
||
}
|
||
style.innerHTML = "body {" + pt + "padding-bottom: 40px; }\n" + css;
|
||
document.head.appendChild(style);
|
||
});
|
||
</script>
|
||
|
||
<!-- tabsets -->
|
||
|
||
<style type="text/css">
|
||
.tabset-dropdown > .nav-tabs {
|
||
display: inline-table;
|
||
max-height: 500px;
|
||
min-height: 44px;
|
||
overflow-y: auto;
|
||
border: 1px solid #ddd;
|
||
border-radius: 4px;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs > li.active:before, .tabset-dropdown > .nav-tabs.nav-tabs-open:before {
|
||
content: "\e259";
|
||
font-family: 'Glyphicons Halflings';
|
||
display: inline-block;
|
||
padding: 10px;
|
||
border-right: 1px solid #ddd;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs.nav-tabs-open > li.active:before {
|
||
content: "\e258";
|
||
font-family: 'Glyphicons Halflings';
|
||
border: none;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs > li.active {
|
||
display: block;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs > li > a,
|
||
.tabset-dropdown > .nav-tabs > li > a:focus,
|
||
.tabset-dropdown > .nav-tabs > li > a:hover {
|
||
border: none;
|
||
display: inline-block;
|
||
border-radius: 4px;
|
||
background-color: transparent;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs.nav-tabs-open > li {
|
||
display: block;
|
||
float: none;
|
||
}
|
||
|
||
.tabset-dropdown > .nav-tabs > li {
|
||
display: none;
|
||
}
|
||
</style>
|
||
|
||
<!-- code folding -->
|
||
|
||
|
||
|
||
<style type="text/css">
|
||
|
||
#TOC {
|
||
margin: 25px 0px 20px 0px;
|
||
}
|
||
@media (max-width: 768px) {
|
||
#TOC {
|
||
position: relative;
|
||
width: 100%;
|
||
}
|
||
}
|
||
|
||
@media print {
|
||
.toc-content {
|
||
/* see https://github.com/w3c/csswg-drafts/issues/4434 */
|
||
float: right;
|
||
}
|
||
}
|
||
|
||
.toc-content {
|
||
padding-left: 30px;
|
||
padding-right: 40px;
|
||
}
|
||
|
||
div.main-container {
|
||
max-width: 1200px;
|
||
}
|
||
|
||
div.tocify {
|
||
width: 20%;
|
||
max-width: 260px;
|
||
max-height: 85%;
|
||
}
|
||
|
||
@media (min-width: 768px) and (max-width: 991px) {
|
||
div.tocify {
|
||
width: 25%;
|
||
}
|
||
}
|
||
|
||
@media (max-width: 767px) {
|
||
div.tocify {
|
||
width: 100%;
|
||
max-width: none;
|
||
}
|
||
}
|
||
|
||
.tocify ul, .tocify li {
|
||
line-height: 20px;
|
||
}
|
||
|
||
.tocify-subheader .tocify-item {
|
||
font-size: 0.90em;
|
||
}
|
||
|
||
.tocify .list-group-item {
|
||
border-radius: 0px;
|
||
}
|
||
|
||
|
||
</style>
|
||
|
||
|
||
|
||
</head>
|
||
|
||
<body>
|
||
|
||
|
||
<div class="container-fluid main-container">
|
||
|
||
|
||
<!-- setup 3col/9col grid for toc_float and main content -->
|
||
<div class="row">
|
||
<div class="col-xs-12 col-sm-4 col-md-3">
|
||
<div id="TOC" class="tocify">
|
||
</div>
|
||
</div>
|
||
|
||
<div class="toc-content col-xs-12 col-sm-8 col-md-9">
|
||
|
||
|
||
|
||
|
||
<div class="navbar navbar-default navbar-fixed-top" role="navigation">
|
||
<div class="container">
|
||
<div class="navbar-header">
|
||
<button type="button" class="navbar-toggle collapsed" data-toggle="collapse" data-bs-toggle="collapse" data-target="#navbar" data-bs-target="#navbar">
|
||
<span class="icon-bar"></span>
|
||
<span class="icon-bar"></span>
|
||
<span class="icon-bar"></span>
|
||
</button>
|
||
<a class="navbar-brand" href="index.html"><div><img src="ohdsi16x16.png"></img> OMOP Common Data Model </div></a>
|
||
</div>
|
||
<div id="navbar" class="navbar-collapse collapse">
|
||
<ul class="nav navbar-nav">
|
||
<li>
|
||
<a href="index.html">
|
||
<span class="fa fa-house"></span>
|
||
|
||
</a>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-landmark"></span>
|
||
|
||
Background
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="background.html">Model Background</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdmRefreshProcess.html">CDM Refresh Process</a>
|
||
</li>
|
||
<li>
|
||
<a href="vocabulary.html">How the Vocabulary is Built</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-list-alt"></span>
|
||
|
||
Conventions
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="https://ohdsi.github.io/Themis">THEMIS Convention Library</a>
|
||
</li>
|
||
<li>
|
||
<a href="dataModelConventions.html">General Conventions</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdmPrivacy.html">Patient Privacy and OMOP</a>
|
||
</li>
|
||
<li>
|
||
<a href="customConcepts.html">Custom Concepts</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-history"></span>
|
||
|
||
CDM Versions
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="cdm30.html">CDM v3.0</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdm53.html">CDM v5.3</a>
|
||
</li>
|
||
<li class="dropdown-submenu">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">CDM v5.4</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="cdm54.html">CDM v5.4</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdm54Changes.html">Changes from CDM v5.3</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdm54erd.html">Entity Relationships</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdm54ToolingSupport.html">Detailed tooling support per CDM field</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-plus-square"></span>
|
||
|
||
CDM Additions
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="typesOfAdditions.html">Types of CDM Additions</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdmRequestProcess.html">How to Propose Changes to the CDM</a>
|
||
</li>
|
||
<li class="dropdown-submenu">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">Accepted Changes</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="https://github.com/OHDSI/CommonDataModel/tree/develop">CDM version in development</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-question"></span>
|
||
|
||
How to
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="download.html">Download the DDL</a>
|
||
</li>
|
||
<li>
|
||
<a href="cdmRPackage.html">Use the CDM R Package</a>
|
||
</li>
|
||
<li>
|
||
<a href="drug_dose.html">Calculate Drug Dose</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
<li class="dropdown">
|
||
<a href="#" class="dropdown-toggle" data-toggle="dropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">
|
||
<span class="fa fa-life-ring"></span>
|
||
|
||
Support
|
||
|
||
<span class="caret"></span>
|
||
</a>
|
||
<ul class="dropdown-menu" role="menu">
|
||
<li>
|
||
<a href="cdmDecisionTree.html">Help! My Data Doesn't Fit!</a>
|
||
</li>
|
||
<li>
|
||
<a href="faq.html">FAQ</a>
|
||
</li>
|
||
<li>
|
||
<a href="sqlScripts.html">SQL Scripts</a>
|
||
</li>
|
||
<li>
|
||
<a href="contribute.html">Ask a Question</a>
|
||
</li>
|
||
</ul>
|
||
</li>
|
||
</ul>
|
||
<ul class="nav navbar-nav navbar-right">
|
||
<li>
|
||
<a href="https://github.com/OHDSI/CommonDataModel">
|
||
<span class="fa fa-github"></span>
|
||
|
||
</a>
|
||
</li>
|
||
</ul>
|
||
</div><!--/.nav-collapse -->
|
||
</div><!--/.container -->
|
||
</div><!--/.navbar -->
|
||
|
||
<div id="header">
|
||
|
||
|
||
|
||
<h1 class="title toc-ignore"><strong>Preserving Privacy in an OMOP CDM
|
||
Implementation</strong></h1>
|
||
|
||
</div>
|
||
|
||
|
||
<p><em>By Kristin Kostka</em></p>
|
||
<div id="background" class="section level1">
|
||
<h1>Background</h1>
|
||
<p>The OMOP CDM is a person-centric model. Being person-centric means
|
||
the model can retain attributes that may be considered personal
|
||
identified information (PII) or protected health information (PHI).
|
||
There are many different ways a site may treat their OMOP CDM to uphold
|
||
their privacy protocols. In this article we provide guidance on overall
|
||
process and the potential fields that should be monitored to adhere to
|
||
these various privacy preserving protocols.</p>
|
||
<div id="defining-pii-and-phi" class="section level3">
|
||
<h3>Defining PII and PHI</h3>
|
||
<ul>
|
||
<li>PII is defined as any representation of information that permits the
|
||
identity of an individual to whom the information applies to be
|
||
reasonably inferred to either direct or indirect means [1].</li>
|
||
<li>The United States Department of Health & Human Services´ Office
|
||
for Civil Rights has defined PHI as any Personal Identifying Information
|
||
(PII) that – individually or combined – could potentially identify a
|
||
specific individual, their past, present or future healthcare, or the
|
||
method of payment. There are eighteen unique identifiers considered to
|
||
be PHI: 1) names, 2) geographic data, 3) all elements of dates, 4)
|
||
telephone numbers, 5) FAX numbers, 6) email addresses, 7) Social
|
||
Security numbers (SSN), 8) medical record numbers (MRN), 9) health plan
|
||
beneficiary numbers, 10) account numbers, 11) certificate/license
|
||
numbers, 12) vehicle identifiers and serial numbers including license
|
||
places, 13) device identifiers and serial numbers, 14) web URLs, 15)
|
||
internet protocol addresses, 16) biometric identifiers (i.e. retinal
|
||
scan, fingerprints), 17) full face photos and comparable images, and 18)
|
||
any unique identifying number, characteristic or code. PHI is no longer
|
||
considered PHI when it de-identified of these unique attributes. PHI is
|
||
commonly referred to in relation to the Health Insurance Portability and
|
||
Accountability Act (HIPAA) and associated legislation such as the Health
|
||
Information Technology for Economic and Clinical Health Act (HITECH)
|
||
[2].</li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
<div id="the-data-holders-responsibility" class="section level1">
|
||
<h1>The Data Holder’s Responsibility</h1>
|
||
<p>In OHDSI, it is the responsibility of each data holder to know,
|
||
understand and follow local data governance processes related to use of
|
||
the OMOP CDM. In the United States, these processes will follow your
|
||
organization’s local interpretation for maintaining compliance to PII
|
||
and PHI protection. In OMOP CDM implementations containing European
|
||
Union citizen data, local governance processes will include measures to
|
||
comply with General Data Protection Regulation (GDPR) [3]. As a
|
||
community, the OHDSI data network covers more than 330 databases from 34
|
||
countries. There is extensive community knowledge on the interpretation
|
||
of rule sets and exemplar IRB and local governance workflows that can be
|
||
made available to institutions navigating these processes for the first
|
||
time. If your organization does not have an established data governance
|
||
process, please reach out on the <a href="forums.ohdsi.org">OHDSI
|
||
Forums</a> under “Implementers” and the community can respond with
|
||
shared guidance from their own deployments. As a community, we aim to
|
||
conduct research that keeps patient-level data local and share only
|
||
aggregate results.</p>
|
||
</div>
|
||
<div id="complying-with-privacy-preservation" class="section level1">
|
||
<h1>Complying with Privacy Preservation</h1>
|
||
<p>Complying with local governance processes depends on the rule set
|
||
being used. There may be allowable times when data use agreements and
|
||
data transfer agreements exist between collaborating institutions to
|
||
facilitate sharing of PII and PHI. In this section we will discuss
|
||
common rule sets that organizations adhere to.</p>
|
||
<div id="limited-data-sets" class="section level2">
|
||
<h2>Limited Data Sets</h2>
|
||
<p>A limited data set (LDS) is defined as protected health information
|
||
that excludes certain direct identifiers of an individual or of
|
||
relatives, employers or household members of the individual — but may
|
||
include city, state, ZIP code and elements of dates. A LDS can be
|
||
disclosed only for purposes of research, public health or health care
|
||
operations. LDS requirements are dictated by the HIPAA Privacy Rule.</p>
|
||
</div>
|
||
<div id="de-identified-data-sets" class="section level2">
|
||
<h2>De-identified Data Sets</h2>
|
||
<p>A de-identified data, as defined by Section 164.514(a) of the HIPAA
|
||
Privacy rule, is health information that does not identify an individual
|
||
and with respect to which there is no reasonable basis to believe that
|
||
the information can be used to identify an individual is not
|
||
individually identifiable health information. There are two methods for
|
||
achieving de-identification in accordance with HIPAA [4].</p>
|
||
<ol style="list-style-type: decimal">
|
||
<li>Expert Determination (§164.514(a))- Implementation specifications:
|
||
requirements for de-identification of protected health information. A
|
||
covered entity may determine that health information is not individually
|
||
identifiable health information only if:</li>
|
||
</ol>
|
||
<ol style="list-style-type: decimal">
|
||
<li>A person with appropriate knowledge of and experience with generally
|
||
accepted statistical and scientific principles and methods for rendering
|
||
information not individually identifiable:</li>
|
||
</ol>
|
||
<ol style="list-style-type: lower-roman">
|
||
<li>Applying such principles and methods, determines that the risk is
|
||
very small that the information could be used, alone or in combination
|
||
with other reasonably available information, by an anticipated recipient
|
||
to identify an individual who is a subject of the information; and</li>
|
||
<li>Documents the methods and results of the analysis that justify such
|
||
determination.</li>
|
||
</ol>
|
||
<ol start="2" style="list-style-type: decimal">
|
||
<li>Safe Harbor (§164.514(b)) The eighteen unique identifiers are
|
||
obfuscated. This includes processes such as:</li>
|
||
</ol>
|
||
<ol style="list-style-type: upper-alpha">
|
||
<li>Dates of service are algorithmically shifted to protect patient
|
||
privacy.</li>
|
||
<li>Patient ZIP codes are truncated to the first three digits or removed
|
||
entirely if the ZIP code represents fewer than 20,000 individuals.</li>
|
||
<li>Removing and, when necessary, replacing unique identifiers AND The
|
||
entity does not have actual knowledge that the information could be used
|
||
alone or in combination with other information to identify an individual
|
||
who is a subject of the information.</li>
|
||
</ol>
|
||
</div>
|
||
<div id="field-level-implications-of-de-identification-processes"
|
||
class="section level2">
|
||
<h2>Field-level Implications of De-identification Processes</h2>
|
||
<div id="person-table-attributes" class="section level3">
|
||
<h3>PERSON Table Attributes</h3>
|
||
<p>In the OMOP CDM, the PERSON table serves as the central identity
|
||
management for all Persons in the database. It contains records that
|
||
uniquely identify each person or patient, and some demographic
|
||
information. It is a table that has a number of field-level implications
|
||
for privacy preserving protocols.</p>
|
||
<p>Considerations include: - PERSON.person_id should never contain
|
||
Medical Record Number, Social Security Number or similar uniquely
|
||
identifiable number. This should be a number that is essentially
|
||
meaningless but has the ability to be a primary key across tables. -
|
||
PERSON.year_of_birth, PERSON.month_of_birth and PERSON.date_of_birth,
|
||
PERSON.birth_datetime may require some redaction or modification
|
||
depending on interpretation of rule set. Consult local guidance on the
|
||
need to modify these fields when creating compliant views of
|
||
de-identified data. - PERSON.person_source_value may contain sensitive
|
||
information used to generate the person_id field. It is advised to
|
||
practice caution when creating views of these data. It would be wise to
|
||
obfuscate or redact this field if you are not sure what is contained in
|
||
the raw information being extracted, transformed and loaded into the
|
||
CDM.</p>
|
||
</div>
|
||
</div>
|
||
<div id="date-fields-across-domains" class="section level2">
|
||
<h2>Date Fields Across Domains</h2>
|
||
<p>Date fields are used across many OMOP domains including:
|
||
OBSERVATION_PERIOD, VISIT_OCCURRENCE, VISIT_DETAIL,
|
||
CONDITION_OCCURRENCE, DRUG_EXPOSURE, PROCEDURE_OCCURRENCE,
|
||
DEVICE_EXPOSURE, MEASUREMENT, OBSERVATION, DEATH, NOTE, NOTE_NLP,
|
||
SPECIMEN, PAYER_PLAN_PERIOD, DRUG_ERA, DOSE_ERA, and CONDITION_ERA.</p>
|
||
<p>As discussed previously, some rule sets may require algorithmically
|
||
shifting dates. It is advised that when date shifting is applied, it is
|
||
done holistically. This means that when shifting dates, you should not
|
||
treat each record independently. Instead, a robust date shifting
|
||
algorithm will link off the <em>.person_id (where </em> is the domain
|
||
name such as CONDITION_OCCURRENCE, etc) and apply the same offset to all
|
||
events. This allows researchers to have the ability to understand the
|
||
sequence of events while preserving patient privacy.</p>
|
||
<p>The implications of not holistically shifting all events together by
|
||
the same offset means that information may be out of sequence or
|
||
illogical. An example would be a death record that happens prior to
|
||
other event records (conditions, drugs, procedures, etc). When applying
|
||
an algorithmic shift of dates, it is important to educate your OMOP CDM
|
||
user group of the known offset. This is especially important in temporal
|
||
studies which may be looking to make statements about disease history
|
||
relative to the time when an event is observed.</p>
|
||
<p>Some rule sets do not require algorithmic shifting of dates, such as
|
||
Limited Data Sets. In these situations, a user of a LDS OMOP CDM would
|
||
not be expecting dates to the shifted. If a shift is applied, it should
|
||
be disclosed and the offset amount (e.g. +/- 7 days, +/- 30 days, etc)
|
||
should be made available to those who have received permission to use a
|
||
LDS dataset. Otherwise, these data are not upholding the assumptions of
|
||
the rule set applied.</p>
|
||
</div>
|
||
<div id="location-table-attributes" class="section level2">
|
||
<h2>LOCATION Table Attributes</h2>
|
||
<p>The LOCATION table represents a generic way to capture physical
|
||
location or address information of Persons and Care Sites. When applying
|
||
privacy preserving procedures, this table should be reviewed and
|
||
scrubbed relative to the rule set. The LOCATION.zip field should be
|
||
redacted relative to the type of process applied (e.g. 3-digit zip for
|
||
de-identified data). The LOCATION.location_source_value should be
|
||
reviewed for potential PII/PHI. It would be wise to obfuscate or redact
|
||
this field if you are not sure what is contained in the raw information
|
||
being extracted, transformed and loaded into the CDM.</p>
|
||
</div>
|
||
<div id="provider-table-attributes" class="section level2">
|
||
<h2>PROVIDER Table Attributes</h2>
|
||
<p>The PROVIDER table contains a list of uniquely identified healthcare
|
||
providers. These are individuals providing hands-on healthcare to
|
||
patients, such as physicians, nurses, midwives, physical therapists etc.
|
||
In some privacy preserving processes, the PROVIDER.npi and PROVIDER.dea
|
||
fields may be redacted. Please review this field and confirm that you
|
||
are adhering to privacy rule sets. The PROVIDER.year_of_birth field is
|
||
an optional field that may also require treatment in certain rule
|
||
sets.</p>
|
||
</div>
|
||
<div id="observation-table-attributes" class="section level2">
|
||
<h2>OBSERVATION Table Attributes</h2>
|
||
<p>The OBSERVATION table captures clinical facts about a Person obtained
|
||
in the context of examination, questioning or a procedure. Any data that
|
||
cannot be represented by any other domains, such as social and lifestyle
|
||
facts, medical history, family history, etc. are recorded here.</p>
|
||
<p>We strongly caution ETL teams to review the OBSERVATION table for
|
||
potential PII/PHI. In some source systems, there can be information
|
||
coming in these vocabularies that are not laboratory or clinical
|
||
observations but instead are patient identifiers. If you search in
|
||
ATHENA, you will find there are a number of standard terms in the SNOMED
|
||
and LOINC vocabularies that can represent phone numbers, emails, and
|
||
other PII information.</p>
|
||
<p>It is difficult to create an exhaustive list of terms because these
|
||
ontologies do not maintain or publish lists of terms that may contain
|
||
patient identifiers. It is, therefore, up to data holders to perform a
|
||
review of this domain with an eye for these potential privacy issues.
|
||
The National COVID Cohort Collaborative, a NIH consortium which uses the
|
||
OMOP CDM, has published a resource for sites needing assistance with
|
||
identifying these potentially problematic records. A “live” version of
|
||
this table that will track updates over time is hosted at <a
|
||
href="https://github.com/data2health/next-gen-data-sharing/blob/master/CodesWithPPIPotential.csv"
|
||
class="uri">https://github.com/data2health/next-gen-data-sharing/blob/master/CodesWithPPIPotential.csv</a>.
|
||
We welcome additions to this list from the community.</p>
|
||
</div>
|
||
<div id="scrutinizing-_source_value" class="section level2">
|
||
<h2>Scrutinizing *_source_value</h2>
|
||
<p>The *_source_value (where * is the domain name such as
|
||
CONDITION_OCCURRENCE, etc) fields present an opportunity for sites to
|
||
carry forward potential PII/PHI in ETL processes. Because the convention
|
||
of the OMOP CDM has minimal boundaries on what are retained in these
|
||
fields, it is important to treat all source_value fields as potentially
|
||
containing PII/PHI. We highly advise all data holders to scrutinize
|
||
these fields when applying privacy preserving processes. It is not
|
||
uncommon for fields to be overloaded and contain potential patient
|
||
identifiers. Please use caution when transmitting or making views of
|
||
these fields available to users.</p>
|
||
</div>
|
||
<div id="scrutinizing-string-fields" class="section level2">
|
||
<h2>Scrutinizing String Fields</h2>
|
||
<p>Across OMOP Domains, there are many fields which permit the use of
|
||
strings (e.g. DRUG_EXPOSURE.sig, MEASUREMENT.value_as_string,
|
||
OBSERVATION.value_as_string, We’ve discussed some of these in prior
|
||
sections. It is advised that fields with strings often have the
|
||
potential to contain unintentional PII/PHI. Targeted regular expressions
|
||
can be built into ETL processes in order to “sniff” out any additional
|
||
PII (or potential PII)–such as any data in the format of a phone number,
|
||
or a person or place name. (E.g., the regular expression “Mr.|Mrs.|Dr.|,
|
||
M.?D.?” will find any string with an English name prefix.) Depending on
|
||
risk tolerance, the expressions could err toward sensitivity or
|
||
specificity, and could be tweaked over time to meet different rule
|
||
sets.</p>
|
||
<p>Extensive regular expression matching during ETL may add significant
|
||
processing time and should therefore not be relied upon as a sole
|
||
solution, but rather an extra protection against edge cases. Other
|
||
algorithmic rules may also prove useful, such as automatically
|
||
quarantining records with lengthy string values (which could signal the
|
||
presence of free text). If these approaches are implemented, records
|
||
that match the regular expressions or rules can be quarantined in a
|
||
separate table or staging area to be manually reviewed by a data broker.
|
||
Thus, in addition to adding another layer of PII protection, another
|
||
advantage of these approaches is the potential to uncover ways that
|
||
underlying vocabularies may be contributing to unintentional sharing of
|
||
PII and create awareness for future privacy preserving processes shared
|
||
across the community.</p>
|
||
</div>
|
||
<div id="note-and-note_nlp-table-attributes" class="section level2">
|
||
<h2>NOTE and NOTE_NLP Table Attributes</h2>
|
||
<p>The NOTE table captures unstructured information that was recorded by
|
||
a provider about a patient in free text (in ASCII, or preferably in UTF8
|
||
format) notes on a given date. The NOTE_NLP table encodes all output of
|
||
NLP on clinical notes. Each row represents a single extracted term from
|
||
a note. There is a high potential these tables may retain information
|
||
that is considered PII/PHI. In addition to overall string searching,
|
||
these tables are likely to be dropped altogether to adhere to the most
|
||
stringent rule sets.</p>
|
||
<p>It is highly advised that if you are conducting a study with NOTE and
|
||
NOTE_NLP table information, please consult with your local governance
|
||
and privacy officers to ensure compliance with local rule sets.</p>
|
||
</div>
|
||
<div id="conclusion" class="section level2">
|
||
<h2>Conclusion</h2>
|
||
<p>Privacy preserving processes are not one-size fits all. There are
|
||
many different rule sets that can be applied to datasets. Data holders
|
||
are recommended to consult with their local privacy officer(s) to ensure
|
||
all processes applied to a database are compliant with local
|
||
interpretation of the selected rule set.</p>
|
||
</div>
|
||
</div>
|
||
<div id="references" class="section level1">
|
||
<h1>References</h1>
|
||
<ol style="list-style-type: decimal">
|
||
<li>BibText version: <span
|
||
class="citation">@MISC</span>{noauthor_undated-mg, title = “Guidance on
|
||
the Protection of Personal Identifiable Information”, abstract =
|
||
“Personal Identifiable Information (PII) is defined as:”, howpublished =
|
||
“”, note = “Accessed: 2021-8-18” }</li>
|
||
</ol>
|
||
<p>Regular citation: Guidance on the Protection of Personal Identifiable
|
||
Information. [cited 18 Aug 2021]. Available: <a
|
||
href="https://www.dol.gov/general/ppii"
|
||
class="uri">https://www.dol.gov/general/ppii</a></p>
|
||
<ol start="2" style="list-style-type: decimal">
|
||
<li>BibText version: <span
|
||
class="citation">@MISC</span>{HIPAA_Journal2017-yo, title = “What Does
|
||
{PHI} Stand For?”, author = “{HIPAA Journal}”, abstract = “PHI is a term
|
||
used in connection with health data, but what does PHI stand for? What
|
||
information is included in the definition of PHI.”, month = dec, year =
|
||
2017, howpublished = “”, note = “Accessed: 2021-8-18”, language = “en”
|
||
}</li>
|
||
</ol>
|
||
<p>Regular citation: HIPAA Journal. What Does PHI Stand For? 23 Dec 2017
|
||
[cited 18 Aug 2021]. Available: <a
|
||
href="https://www.hipaajournal.com/what-does-phi-stand-for/"
|
||
class="uri">https://www.hipaajournal.com/what-does-phi-stand-for/</a></p>
|
||
<ol start="3" style="list-style-type: decimal">
|
||
<li>BibText version:</li>
|
||
</ol>
|
||
<p><span class="citation">@MISC</span>{noauthor_2018-mt, title =
|
||
“General Data Protection Regulation ({GDPR}) Compliance Guidelines”,
|
||
abstract = “The EU General Data Protection Regulation went into effect
|
||
on May 25, 2018, replacing the Data Protection Directive 95/46/EC.
|
||
Designed to increase data privacy for EU citizens, the regulation levies
|
||
steep fines on organizations that don’t follow the law.”, month = jun,
|
||
year = 2018, howpublished = “”, note = “Accessed: 2021-8-18”, language =
|
||
“en” }</p>
|
||
<p>Regular citation: General Data Protection Regulation (GDPR)
|
||
Compliance Guidelines. 18 Jun 2018 [cited 18 Aug 2021]. Available: <a
|
||
href="https://gdpr.eu/" class="uri">https://gdpr.eu/</a></p>
|
||
<ol start="4" style="list-style-type: decimal">
|
||
<li>BibText version:</li>
|
||
</ol>
|
||
<p><span
|
||
class="citation">@MISC</span>{Office_for_Civil_Rights_OCR_undated-zy,
|
||
title = “Methods for De-identification of {PHI}”, author = “{Office for
|
||
Civil Rights (OCR)}”, abstract = “Guidance about methods and approaches
|
||
to achieve de-identification in accordance with the Health Insurance
|
||
Portability and Accountability Act of 1996.”, howpublished = “”, note =
|
||
“Accessed: 2021-8-19” }</p>
|
||
<p>Regular citation: Office for Civil Rights (OCR). Methods for
|
||
De-identification of PHI. [cited 19 Aug 2021]. Available: <a
|
||
href="https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html"
|
||
class="uri">https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html</a></p>
|
||
</div>
|
||
|
||
|
||
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
<script>
|
||
|
||
// add bootstrap table styles to pandoc tables
|
||
function bootstrapStylePandocTables() {
|
||
$('tr.odd').parent('tbody').parent('table').addClass('table table-condensed');
|
||
}
|
||
$(document).ready(function () {
|
||
bootstrapStylePandocTables();
|
||
});
|
||
|
||
|
||
</script>
|
||
|
||
<!-- tabsets -->
|
||
|
||
<script>
|
||
$(document).ready(function () {
|
||
window.buildTabsets("TOC");
|
||
});
|
||
|
||
$(document).ready(function () {
|
||
$('.tabset-dropdown > .nav-tabs > li').click(function () {
|
||
$(this).parent().toggleClass('nav-tabs-open');
|
||
});
|
||
});
|
||
</script>
|
||
|
||
<!-- code folding -->
|
||
|
||
<script>
|
||
$(document).ready(function () {
|
||
|
||
// temporarily add toc-ignore selector to headers for the consistency with Pandoc
|
||
$('.unlisted.unnumbered').addClass('toc-ignore')
|
||
|
||
// move toc-ignore selectors from section div to header
|
||
$('div.section.toc-ignore')
|
||
.removeClass('toc-ignore')
|
||
.children('h1,h2,h3,h4,h5').addClass('toc-ignore');
|
||
|
||
// establish options
|
||
var options = {
|
||
selectors: "h1,h2,h3",
|
||
theme: "bootstrap3",
|
||
context: '.toc-content',
|
||
hashGenerator: function (text) {
|
||
return text.replace(/[.\\/?&!#<>]/g, '').replace(/\s/g, '_');
|
||
},
|
||
ignoreSelector: ".toc-ignore",
|
||
scrollTo: 0
|
||
};
|
||
options.showAndHide = true;
|
||
options.smoothScroll = true;
|
||
|
||
// tocify
|
||
var toc = $("#TOC").tocify(options).data("toc-tocify");
|
||
});
|
||
</script>
|
||
|
||
<!-- dynamically load mathjax for compatibility with self-contained -->
|
||
<script>
|
||
(function () {
|
||
var script = document.createElement("script");
|
||
script.type = "text/javascript";
|
||
script.src = "https://mathjax.rstudio.com/latest/MathJax.js?config=TeX-AMS-MML_HTMLorMML";
|
||
document.getElementsByTagName("head")[0].appendChild(script);
|
||
})();
|
||
</script>
|
||
|
||
</body>
|
||
</html>
|