2021-09-22 19:39:44 +00:00
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<!DOCTYPE html>
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<html>
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<head>
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<meta charset="utf-8" />
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<meta name="generator" content="pandoc" />
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<meta http-equiv="X-UA-Compatible" content="IE=EDGE" />
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<title>Preserving Privacy in an OMOP CDM Implementation</title>
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2023-10-26 18:13:30 +00:00
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<script src="site_libs/header-attrs-2.25/header-attrs.js"></script>
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2022-01-13 18:59:03 +00:00
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<script src="site_libs/jquery-3.6.0/jquery-3.6.0.min.js"></script>
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2021-09-22 19:39:44 +00:00
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<meta name="viewport" content="width=device-width, initial-scale=1" />
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<link href="site_libs/bootstrap-3.3.5/css/cosmo.min.css" rel="stylesheet" />
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<script src="site_libs/bootstrap-3.3.5/js/bootstrap.min.js"></script>
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<script src="site_libs/bootstrap-3.3.5/shim/html5shiv.min.js"></script>
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<script src="site_libs/bootstrap-3.3.5/shim/respond.min.js"></script>
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2022-01-13 18:59:03 +00:00
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<style>h1 {font-size: 34px;}
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h1.title {font-size: 38px;}
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h2 {font-size: 30px;}
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h3 {font-size: 24px;}
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h4 {font-size: 18px;}
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h5 {font-size: 16px;}
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h6 {font-size: 12px;}
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code {color: inherit; background-color: rgba(0, 0, 0, 0.04);}
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pre:not([class]) { background-color: white }</style>
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2023-10-26 18:13:30 +00:00
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<script src="site_libs/jqueryui-1.13.2/jquery-ui.min.js"></script>
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2021-09-22 19:39:44 +00:00
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<link href="site_libs/tocify-1.9.1/jquery.tocify.css" rel="stylesheet" />
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<script src="site_libs/tocify-1.9.1/jquery.tocify.js"></script>
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<script src="site_libs/navigation-1.1/tabsets.js"></script>
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<link href="site_libs/highlightjs-9.12.0/default.css" rel="stylesheet" />
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<script src="site_libs/highlightjs-9.12.0/highlight.js"></script>
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2023-10-26 18:13:30 +00:00
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<link href="site_libs/font-awesome-6.4.2/css/all.min.css" rel="stylesheet" />
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<link href="site_libs/font-awesome-6.4.2/css/v4-shims.min.css" rel="stylesheet" />
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2021-09-22 19:39:44 +00:00
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<link rel='shortcut icon' type='image/x-icon' href='favicon.ico' />
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<style type="text/css">
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code{white-space: pre-wrap;}
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span.smallcaps{font-variant: small-caps;}
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span.underline{text-decoration: underline;}
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div.column{display: inline-block; vertical-align: top; width: 50%;}
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div.hanging-indent{margin-left: 1.5em; text-indent: -1.5em;}
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ul.task-list{list-style: none;}
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</style>
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<style type="text/css">code{white-space: pre;}</style>
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<script type="text/javascript">
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if (window.hljs) {
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hljs.configure({languages: []});
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hljs.initHighlightingOnLoad();
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if (document.readyState && document.readyState === "complete") {
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window.setTimeout(function() { hljs.initHighlighting(); }, 0);
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}
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}
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</script>
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2022-07-27 01:48:28 +00:00
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2021-09-22 19:39:44 +00:00
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<link rel="stylesheet" href="style.css" type="text/css" />
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<style type = "text/css">
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.main-container {
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max-width: 940px;
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margin-left: auto;
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margin-right: auto;
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}
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img {
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max-width:100%;
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}
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.tabbed-pane {
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padding-top: 12px;
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}
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.html-widget {
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margin-bottom: 20px;
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}
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button.code-folding-btn:focus {
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outline: none;
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}
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summary {
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display: list-item;
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}
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2022-07-27 01:48:28 +00:00
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details > summary > p:only-child {
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display: inline;
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}
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2022-01-13 18:59:03 +00:00
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pre code {
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padding: 0;
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}
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2021-09-22 19:39:44 +00:00
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</style>
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<style type="text/css">
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.dropdown-submenu {
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position: relative;
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}
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.dropdown-submenu>.dropdown-menu {
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top: 0;
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left: 100%;
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margin-top: -6px;
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margin-left: -1px;
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border-radius: 0 6px 6px 6px;
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}
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.dropdown-submenu:hover>.dropdown-menu {
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display: block;
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}
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.dropdown-submenu>a:after {
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display: block;
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content: " ";
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float: right;
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width: 0;
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height: 0;
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border-color: transparent;
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border-style: solid;
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border-width: 5px 0 5px 5px;
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border-left-color: #cccccc;
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margin-top: 5px;
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margin-right: -10px;
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}
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.dropdown-submenu:hover>a:after {
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2022-01-13 18:59:03 +00:00
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border-left-color: #adb5bd;
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2021-09-22 19:39:44 +00:00
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}
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.dropdown-submenu.pull-left {
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float: none;
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}
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.dropdown-submenu.pull-left>.dropdown-menu {
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left: -100%;
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margin-left: 10px;
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border-radius: 6px 0 6px 6px;
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}
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</style>
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2022-01-13 18:59:03 +00:00
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<script type="text/javascript">
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2021-09-22 19:39:44 +00:00
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// manage active state of menu based on current page
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$(document).ready(function () {
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// active menu anchor
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href = window.location.pathname
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href = href.substr(href.lastIndexOf('/') + 1)
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if (href === "")
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href = "index.html";
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var menuAnchor = $('a[href="' + href + '"]');
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2023-02-08 20:04:22 +00:00
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// mark the anchor link active (and if it's in a dropdown, also mark that active)
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var dropdown = menuAnchor.closest('li.dropdown');
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if (window.bootstrap) { // Bootstrap 4+
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menuAnchor.addClass('active');
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dropdown.find('> .dropdown-toggle').addClass('active');
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} else { // Bootstrap 3
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menuAnchor.parent().addClass('active');
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dropdown.addClass('active');
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}
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2022-01-13 18:59:03 +00:00
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// Navbar adjustments
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var navHeight = $(".navbar").first().height() + 15;
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var style = document.createElement('style');
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var pt = "padding-top: " + navHeight + "px; ";
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var mt = "margin-top: -" + navHeight + "px; ";
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var css = "";
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// offset scroll position for anchor links (for fixed navbar)
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for (var i = 1; i <= 6; i++) {
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css += ".section h" + i + "{ " + pt + mt + "}\n";
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}
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style.innerHTML = "body {" + pt + "padding-bottom: 40px; }\n" + css;
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document.head.appendChild(style);
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2021-09-22 19:39:44 +00:00
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});
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</script>
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<!-- tabsets -->
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<style type="text/css">
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.tabset-dropdown > .nav-tabs {
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display: inline-table;
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max-height: 500px;
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min-height: 44px;
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overflow-y: auto;
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border: 1px solid #ddd;
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border-radius: 4px;
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}
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2023-10-26 18:13:30 +00:00
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.tabset-dropdown > .nav-tabs > li.active:before, .tabset-dropdown > .nav-tabs.nav-tabs-open:before {
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content: "\e259";
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2021-09-22 19:39:44 +00:00
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font-family: 'Glyphicons Halflings';
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display: inline-block;
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padding: 10px;
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border-right: 1px solid #ddd;
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}
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.tabset-dropdown > .nav-tabs.nav-tabs-open > li.active:before {
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2023-10-26 18:13:30 +00:00
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content: "\e258";
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2021-09-22 19:39:44 +00:00
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font-family: 'Glyphicons Halflings';
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2023-10-26 18:13:30 +00:00
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border: none;
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2021-09-22 19:39:44 +00:00
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}
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.tabset-dropdown > .nav-tabs > li.active {
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display: block;
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}
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.tabset-dropdown > .nav-tabs > li > a,
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.tabset-dropdown > .nav-tabs > li > a:focus,
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.tabset-dropdown > .nav-tabs > li > a:hover {
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border: none;
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display: inline-block;
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border-radius: 4px;
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background-color: transparent;
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}
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.tabset-dropdown > .nav-tabs.nav-tabs-open > li {
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display: block;
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float: none;
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}
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.tabset-dropdown > .nav-tabs > li {
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display: none;
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}
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</style>
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<!-- code folding -->
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<style type="text/css">
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#TOC {
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margin: 25px 0px 20px 0px;
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}
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@media (max-width: 768px) {
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#TOC {
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position: relative;
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width: 100%;
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}
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}
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@media print {
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.toc-content {
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/* see https://github.com/w3c/csswg-drafts/issues/4434 */
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float: right;
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}
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}
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.toc-content {
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padding-left: 30px;
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padding-right: 40px;
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}
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div.main-container {
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max-width: 1200px;
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}
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div.tocify {
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width: 20%;
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max-width: 260px;
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max-height: 85%;
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}
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@media (min-width: 768px) and (max-width: 991px) {
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div.tocify {
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width: 25%;
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}
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}
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@media (max-width: 767px) {
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div.tocify {
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width: 100%;
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max-width: none;
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}
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}
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.tocify ul, .tocify li {
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line-height: 20px;
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}
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.tocify-subheader .tocify-item {
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font-size: 0.90em;
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}
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.tocify .list-group-item {
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border-radius: 0px;
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}
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</style>
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<a href="cdmRequestProcess.html">How to Propose Changes to the CDM</a>
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How to
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<a href="cdmRPackage.html">Use the CDM R Package</a>
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<a href="drug_dose.html">Calculate Drug Dose</a>
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<a href="cdmDecisionTree.html">Help! My Data Doesn't Fit!</a>
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2021-09-22 19:39:44 +00:00
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<a href="https://github.com/OHDSI/CommonDataModel">
|
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<span class="fa fa-github"></span>
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2021-09-22 19:39:44 +00:00
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</a>
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</div><!--/.nav-collapse -->
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</div><!--/.container -->
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</div><!--/.navbar -->
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2022-01-13 18:59:03 +00:00
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<div id="header">
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2021-09-22 19:39:44 +00:00
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2023-02-08 20:04:22 +00:00
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<h1 class="title toc-ignore"><strong>Preserving Privacy in an OMOP CDM
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Implementation</strong></h1>
|
2021-09-22 19:39:44 +00:00
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</div>
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<p><em>By Kristin Kostka</em></p>
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<div id="background" class="section level1">
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<h1>Background</h1>
|
2023-02-08 20:04:22 +00:00
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<p>The OMOP CDM is a person-centric model. Being person-centric means
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the model can retain attributes that may be considered personal
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identified information (PII) or protected health information (PHI).
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There are many different ways a site may treat their OMOP CDM to uphold
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their privacy protocols. In this article we provide guidance on overall
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process and the potential fields that should be monitored to adhere to
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these various privacy preserving protocols.</p>
|
2021-09-22 19:39:44 +00:00
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<div id="defining-pii-and-phi" class="section level3">
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<h3>Defining PII and PHI</h3>
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<ul>
|
2023-02-08 20:04:22 +00:00
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<li>PII is defined as any representation of information that permits the
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identity of an individual to whom the information applies to be
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reasonably inferred to either direct or indirect means [1].</li>
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<li>The United States Department of Health & Human Services´ Office
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for Civil Rights has defined PHI as any Personal Identifying Information
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(PII) that – individually or combined – could potentially identify a
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specific individual, their past, present or future healthcare, or the
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method of payment. There are eighteen unique identifiers considered to
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be PHI: 1) names, 2) geographic data, 3) all elements of dates, 4)
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telephone numbers, 5) FAX numbers, 6) email addresses, 7) Social
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Security numbers (SSN), 8) medical record numbers (MRN), 9) health plan
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beneficiary numbers, 10) account numbers, 11) certificate/license
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numbers, 12) vehicle identifiers and serial numbers including license
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places, 13) device identifiers and serial numbers, 14) web URLs, 15)
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internet protocol addresses, 16) biometric identifiers (i.e. retinal
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scan, fingerprints), 17) full face photos and comparable images, and 18)
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any unique identifying number, characteristic or code. PHI is no longer
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considered PHI when it de-identified of these unique attributes. PHI is
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commonly referred to in relation to the Health Insurance Portability and
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Accountability Act (HIPAA) and associated legislation such as the Health
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Information Technology for Economic and Clinical Health Act (HITECH)
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[2].</li>
|
2021-09-22 19:39:44 +00:00
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</ul>
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</div>
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</div>
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<div id="the-data-holders-responsibility" class="section level1">
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<h1>The Data Holder’s Responsibility</h1>
|
2023-02-08 20:04:22 +00:00
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<p>In OHDSI, it is the responsibility of each data holder to know,
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understand and follow local data governance processes related to use of
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the OMOP CDM. In the United States, these processes will follow your
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organization’s local interpretation for maintaining compliance to PII
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and PHI protection. In OMOP CDM implementations containing European
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Union citizen data, local governance processes will include measures to
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comply with General Data Protection Regulation (GDPR) [3]. As a
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community, the OHDSI data network covers more than 330 databases from 34
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countries. There is extensive community knowledge on the interpretation
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|
|
of rule sets and exemplar IRB and local governance workflows that can be
|
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|
|
made available to institutions navigating these processes for the first
|
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|
|
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time. If your organization does not have an established data governance
|
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|
|
|
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
|
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|
|
|
conduct research that keeps patient-level data local and share only
|
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|
aggregate results.</p>
|
2021-09-22 19:39:44 +00:00
|
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</div>
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|
|
<div id="complying-with-privacy-preservation" class="section level1">
|
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|
<h1>Complying with Privacy Preservation</h1>
|
2023-02-08 20:04:22 +00:00
|
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<p>Complying with local governance processes depends on the rule set
|
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being used. There may be allowable times when data use agreements and
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data transfer agreements exist between collaborating institutions to
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facilitate sharing of PII and PHI. In this section we will discuss
|
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|
|
common rule sets that organizations adhere to.</p>
|
2021-09-22 19:39:44 +00:00
|
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|
|
<div id="limited-data-sets" class="section level2">
|
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|
|
<h2>Limited Data Sets</h2>
|
2023-02-08 20:04:22 +00:00
|
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<p>A limited data set (LDS) is defined as protected health information
|
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|
|
that excludes certain direct identifiers of an individual or of
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relatives, employers or household members of the individual — but may
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include city, state, ZIP code and elements of dates. A LDS can be
|
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|
disclosed only for purposes of research, public health or health care
|
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operations. LDS requirements are dictated by the HIPAA Privacy Rule.</p>
|
2021-09-22 19:39:44 +00:00
|
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|
</div>
|
|
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|
|
<div id="de-identified-data-sets" class="section level2">
|
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|
<h2>De-identified Data Sets</h2>
|
2023-02-08 20:04:22 +00:00
|
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<p>A de-identified data, as defined by Section 164.514(a) of the HIPAA
|
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|
Privacy rule, is health information that does not identify an individual
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and with respect to which there is no reasonable basis to believe that
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the information can be used to identify an individual is not
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individually identifiable health information. There are two methods for
|
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achieving de-identification in accordance with HIPAA [4].</p>
|
2021-09-22 19:39:44 +00:00
|
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|
<ol style="list-style-type: decimal">
|
2023-02-08 20:04:22 +00:00
|
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|
|
<li>Expert Determination (§164.514(a))- Implementation specifications:
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|
requirements for de-identification of protected health information. A
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covered entity may determine that health information is not individually
|
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|
identifiable health information only if:</li>
|
2021-09-22 19:39:44 +00:00
|
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|
</ol>
|
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|
|
<ol style="list-style-type: decimal">
|
2023-02-08 20:04:22 +00:00
|
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|
<li>A person with appropriate knowledge of and experience with generally
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|
|
accepted statistical and scientific principles and methods for rendering
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information not individually identifiable:</li>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</ol>
|
|
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|
|
<ol style="list-style-type: lower-roman">
|
2023-02-08 20:04:22 +00:00
|
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|
<li>Applying such principles and methods, determines that the risk is
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very small that the information could be used, alone or in combination
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|
|
with other reasonably available information, by an anticipated recipient
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|
to identify an individual who is a subject of the information; and</li>
|
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|
<li>Documents the methods and results of the analysis that justify such
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|
determination.</li>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</ol>
|
|
|
|
|
|
<ol start="2" style="list-style-type: decimal">
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<li>Safe Harbor (§164.514(b)) The eighteen unique identifiers are
|
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|
|
obfuscated. This includes processes such as:</li>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</ol>
|
|
|
|
|
|
<ol style="list-style-type: upper-alpha">
|
2023-02-08 20:04:22 +00:00
|
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|
|
<li>Dates of service are algorithmically shifted to protect patient
|
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|
privacy.</li>
|
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|
<li>Patient ZIP codes are truncated to the first three digits or removed
|
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|
|
entirely if the ZIP code represents fewer than 20,000 individuals.</li>
|
|
|
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|
|
<li>Removing and, when necessary, replacing unique identifiers AND The
|
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|
entity does not have actual knowledge that the information could be used
|
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|
|
alone or in combination with other information to identify an individual
|
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|
|
who is a subject of the information.</li>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</ol>
|
|
|
|
|
|
</div>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<div id="field-level-implications-of-de-identification-processes"
|
|
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|
|
class="section level2">
|
2021-09-22 19:39:44 +00:00
|
|
|
|
<h2>Field-level Implications of De-identification Processes</h2>
|
|
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|
|
<div id="person-table-attributes" class="section level3">
|
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|
|
|
|
<h3>PERSON Table Attributes</h3>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<p>In the OMOP CDM, the PERSON table serves as the central identity
|
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|
|
management for all Persons in the database. It contains records that
|
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|
uniquely identify each person or patient, and some demographic
|
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|
information. It is a table that has a number of field-level implications
|
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|
|
for privacy preserving protocols.</p>
|
|
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|
<p>Considerations include: - PERSON.person_id should never contain
|
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|
|
Medical Record Number, Social Security Number or similar uniquely
|
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|
|
identifiable number. This should be a number that is essentially
|
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|
|
|
meaningless but has the ability to be a primary key across tables. -
|
|
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|
|
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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
</div>
|
|
|
|
|
|
<div id="date-fields-across-domains" class="section level2">
|
|
|
|
|
|
<h2>Date Fields Across Domains</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="location-table-attributes" class="section level2">
|
|
|
|
|
|
<h2>LOCATION Table Attributes</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="provider-table-attributes" class="section level2">
|
|
|
|
|
|
<h2>PROVIDER Table Attributes</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="observation-table-attributes" class="section level2">
|
|
|
|
|
|
<h2>OBSERVATION Table Attributes</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="scrutinizing-_source_value" class="section level2">
|
|
|
|
|
|
<h2>Scrutinizing *_source_value</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="scrutinizing-string-fields" class="section level2">
|
|
|
|
|
|
<h2>Scrutinizing String Fields</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="note-and-note_nlp-table-attributes" class="section level2">
|
|
|
|
|
|
<h2>NOTE and NOTE_NLP Table Attributes</h2>
|
2023-02-08 20:04:22 +00:00
|
|
|
|
<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>
|
2021-09-22 19:39:44 +00:00
|
|
|
|
</div>
|
|
|
|
|
|
<div id="conclusion" class="section level2">
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<h2>Conclusion</h2>
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2023-02-08 20:04:22 +00:00
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<p>Privacy preserving processes are not one-size fits all. There are
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many different rule sets that can be applied to datasets. Data holders
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are recommended to consult with their local privacy officer(s) to ensure
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all processes applied to a database are compliant with local
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interpretation of the selected rule set.</p>
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2021-09-22 19:39:44 +00:00
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</div>
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</div>
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<div id="references" class="section level1">
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<h1>References</h1>
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<ol style="list-style-type: decimal">
|
2023-02-08 20:04:22 +00:00
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<li>BibText version: <span
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class="citation">@MISC</span>{noauthor_undated-mg, title = “Guidance on
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the Protection of Personal Identifiable Information”, abstract =
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“Personal Identifiable Information (PII) is defined as:”, howpublished =
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“”, note = “Accessed: 2021-8-18” }</li>
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2021-09-22 19:39:44 +00:00
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</ol>
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2023-02-08 20:04:22 +00:00
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<p>Regular citation: Guidance on the Protection of Personal Identifiable
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Information. [cited 18 Aug 2021]. Available: <a
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href="https://www.dol.gov/general/ppii"
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class="uri">https://www.dol.gov/general/ppii</a></p>
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2021-09-22 19:39:44 +00:00
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<ol start="2" style="list-style-type: decimal">
|
2023-02-08 20:04:22 +00:00
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<li>BibText version: <span
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class="citation">@MISC</span>{HIPAA_Journal2017-yo, title = “What Does
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{PHI} Stand For?”, author = “{HIPAA Journal}”, abstract = “PHI is a term
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used in connection with health data, but what does PHI stand for? What
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information is included in the definition of PHI.”, month = dec, year =
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2017, howpublished = “”, note = “Accessed: 2021-8-18”, language = “en”
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}</li>
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2021-09-22 19:39:44 +00:00
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</ol>
|
2023-02-08 20:04:22 +00:00
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<p>Regular citation: HIPAA Journal. What Does PHI Stand For? 23 Dec 2017
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[cited 18 Aug 2021]. Available: <a
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href="https://www.hipaajournal.com/what-does-phi-stand-for/"
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class="uri">https://www.hipaajournal.com/what-does-phi-stand-for/</a></p>
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2021-09-22 19:39:44 +00:00
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<ol start="3" style="list-style-type: decimal">
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<li>BibText version:</li>
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</ol>
|
2023-02-08 20:04:22 +00:00
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<p><span class="citation">@MISC</span>{noauthor_2018-mt, title =
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“General Data Protection Regulation ({GDPR}) Compliance Guidelines”,
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abstract = “The EU General Data Protection Regulation went into effect
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on May 25, 2018, replacing the Data Protection Directive 95/46/EC.
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Designed to increase data privacy for EU citizens, the regulation levies
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steep fines on organizations that don’t follow the law.”, month = jun,
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year = 2018, howpublished = “”, note = “Accessed: 2021-8-18”, language =
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“en” }</p>
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<p>Regular citation: General Data Protection Regulation (GDPR)
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Compliance Guidelines. 18 Jun 2018 [cited 18 Aug 2021]. Available: <a
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href="https://gdpr.eu/" class="uri">https://gdpr.eu/</a></p>
|
2021-09-22 19:39:44 +00:00
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<ol start="4" style="list-style-type: decimal">
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<li>BibText version:</li>
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</ol>
|
2023-02-08 20:04:22 +00:00
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<p><span
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class="citation">@MISC</span>{Office_for_Civil_Rights_OCR_undated-zy,
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title = “Methods for De-identification of {PHI}”, author = “{Office for
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Civil Rights (OCR)}”, abstract = “Guidance about methods and approaches
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|
to achieve de-identification in accordance with the Health Insurance
|
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Portability and Accountability Act of 1996.”, howpublished = “”, note =
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“Accessed: 2021-8-19” }</p>
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<p>Regular citation: Office for Civil Rights (OCR). Methods for
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|
De-identification of PHI. [cited 19 Aug 2021]. Available: <a
|
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|
href="https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html"
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|
class="uri">https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html</a></p>
|
2021-09-22 19:39:44 +00:00
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</div>
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</div>
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</div>
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2022-01-13 18:59:03 +00:00
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2021-09-22 19:39:44 +00:00
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