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<!DOCTYPE html>
<html lang="en">
<head>
<meta charset="utf-8" />
<title>B1MG MLM Framework</title>
<meta name="description" content="">
<meta name="author" content="">
<meta name="HandheldFriendly" content="true">
<meta http-equiv="X-UA-Compatible" content="IE=edge,chrome=1">
<meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1">
<link href='http://fonts.googleapis.com/css?family=Montserrat:400,700|Open+Sans:400,300,700' rel='stylesheet' type='text/css'>
<!-- Import CSS -->
<link rel="stylesheet" href="css/base.css">
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<link href= "css/ie.css" rel= "stylesheet" media= "all" />
<![endif]-->
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<script src="http://html5shiv.googlecode.com/svn/trunk/html5.js"></script>
<![endif]-->
</head>
<body>
<!-- Start Header -->
<header>
<div class="header-bg"></div>
<div class="container">
<div class="row">
<div class="span3">
<br><br>
<a href="https://b1mg-project.eu/"><img src="img/logo1.png" class="logo" alt="B1MG logo" padding="50px"></a>
</div>
<div class="span9">
<div class="title" align="left">
<span font-size="20px"> B1MG</span><br>
<strong>Maturity Level Model</strong><br>
Framework
</div>
</div>
</div>
</div>
</header>
<!-- End Header -->
<!-- Website body -->
<section class="page">
<div class="container">
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<h1>The vision</h1>
</div>
<div class="span9">
<p>The B1MG Maturity level model (MLM) aims to promote and facilitate the adoption of genomics by healthcare systems for making personalised medicine accessible to citizens and patients across Europe.<br>
Experts from the B1MG project developed the MLM framework to enable all interested countries to self evaluate the level of maturity of national genomic medicine practices following a common matrix.</p>
</div>
</div>
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<div class="span12">
<div class="alert alert-info margin">
<button type="button" class="close" data-dismiss="alert">×</button>
<strong>Heads up!</strong> This site is a draft open to reviewers and, as such, subject to changes. A final version will be available end of 2021
</div>
</div>
</div>
</div>
<div class="container">
<!-- Start Info Block -->
<div class="info-block">
<div class="ib-text">
<h3>Information for evaluators</h3>
<p></strong> Browse the MLM framwework by using the <strong>tabs</strong>. Click on the <strong>➕</strong> to reveal more information.<br>
Hover over <span class="tooltip">pink underlined terms<span class="tooltiptext">This is a tooltip to quickly read definitions</span></span> to read the definition without disturbing your reading. For more information about other terms, switch to the <strong>Glossary tab</strong>.</p>
<p><strong>Round 1 and 2</strong> display the updated text of the MLM based on the first and second round of analysis to validate, reformulate or reevaluate the MLM.<br>
</p>
<p>Each subdomain, indicator and maturity level has been coloured according to the classification criteria that defines the current level of decision:</p>
<div class="row">
<div class="span10">
<div class="validated"><strong>Validated</strong>: items with an agreement rate ≥86% were accepted in the final version</div>
<div class="validated"><strong>Validated</strong>: items with an agreement rate ≥79% and no disagremeents (corresponding to a rate of neither agree or disagree ≥21%) were accepted in the final version</div>
<div class="validated"><strong>Validated with rewording</strong>: a few items with an agreement rate ≥ 86% were slightly changed to accommodate very relevant comments and were accepted in the final version</div>
<div class="reformulated"><strong>Reformulated</strong>: items with an agreement rate <86% and cumulatively with a disagreement rate ≥7% were reformulated according to comments for validation in the Delphi round 2</div>
<div class="reevaluate"><strong>Reevaluate</strong>: items with an agreement rate <86% without suggestions for improvement were deemed inconclusive, and included for reevaluation in the Delphi round 2 with the original wording</div>
</div>
</div>
</div>
</div>
<!-- End Info Block -->
</div>
<br> <br>
<!-- Start Tabs -->
<div class="container">
<div class="row">
<div class="span14">
<div class="tabs">
<ul>
<li id="tab1" class="current">B1MG MLM</li>
<li id="tab2">Round 2</li>
<li id="tab3">Round 1</li>
<li id="tab4">Glossary</li>
</ul>
<div class="tab-content-wrp">
<!-- Start Round 3 Tab -->
<div id="tab1-content" class="tab-content active">
<div class="container">
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<div class="span12">
<div class="toggle">
<div class="toggle-wrp">
<h2>I. Governance and strategy</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Governance</h4>
</div>
<div class="span3">
<p>Country/region has a <span class="tooltip">dedicated governance<span class="tooltiptext">The process by which decisions are made and implemented. Governance is the process by which public institutions conduct public affairs and manage public resources.</span></span> for genomics in healthcare</p>
</div>
<div class="span6 ">
<ol>
<li>No dedicated governance for genomics in healthcare</li>
<li>Elements of governance exist but they are not fully functional</li>
<li>Scope of governance for genomics has been defined but elements are still under development</li>
<li>There is a governance body that is fully operating, led <span class="tooltip">centrally<span class="tooltiptext">Based within a national or regional node.</span></span>, and activities are monitored based on a work plan</li>
<li>Governance body is institutionalised, recognised as the lead for genomics in healthcare, and is open to novel developments and supportive of international cooperation</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Priority</h4>
</div>
<div class="span3 ">
<p>Genomics in healthcare is established as a priority at national/regional level</p>
</div>
<div class="span6 " padding-left="3px">
<ol><li>Genomics in healthcare is not included in national/regional health plans</li>
<li>Inclusion of genomics in healthcare in relevant national/regional health plans is under discussion</li>
<li>Genomics in healthcare is included in relevant national/regional health plans</li>
<li>Genomics in healthcare is implemented as part of national/regional health and other relevant plans (e.g. education, research)</li>
<li>Genomics in healthcare is implemented in health and other relevant plans, and is periodically evaluated for optimisation, taking into account novel developments at the international level</li></ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Strategy</h4>
</div>
<div class="span3 ">
<p>There is a national/regional strategy for genomics in healthcare with a <span class="tooltip">costed implementation plan<span class="tooltiptext">A multi-year roadmap that enables governments to prioritise interventions, engage stakeholders around one strategy, forecast costs and mobilise resources to meet identified gaps, namely to implement genomics in healthcare systems.</span></span></p>
</div>
<div class="span6 ">
<ol><li>No genomics in healthcare strategy with costed implementation plan</li>
<li>A strategy for genomics in healthcare with costed implementation plan under discussion</li>
<li>A costed implementation plan for genomics in healthcare is developed and approved</li>
<li>The national/regional strategy for genomics in healthcare is under implementation</li>
<li>The national/regional strategy for genomics in healthcare is implemented, with monitoring and long term resources and aligned with European and international strategies</li></ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>II. Investment and economic model</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span2">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Investment</h4>
</div>
<div class="span3 ">
<p>There is an investment plan at the national and/or regional levels for genomics in healthcare, with public or mixed public-private funding models</p>
</div>
<div class="span6 ">
<ol>
<li>There is no established investment plan at the national or regional level for genomics in healthcare</li>
<li>An investment plan for genomics in healthcare at the national and/or regional levels is under development</li>
<li>There is a national and/or regional investment plan for genomics in healthcare that is mostly dedicated to setting up infrastructure </li>
<li>There is a national and/or regional investment plan for the regular operational costs of genomics in healthcare (for specific tests e.g. for rare diseases diagnostics or specific cancer treatments)</li>
<li>There is a national and/or regional investment plan for genomics in healthcare that incorporates innovation according to opportunities and international developments</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Access and reimbursement</h4>
</div>
<div class="span3 ">
<p>There is a framework for reimbursement or <span class="tooltip">no-cost access plans<span class="tooltiptext">Detailed set of rules that determines rights, duties and procedures to benefit from access to genomic tests at no cost</span></span> for genomic tests, at the national or regional levels</p>
</div>
<div class="span6 ">
<ol>
<li>No framework for reimbursement or no-cost access plans for genomic tests</li>
<li>A framework for reimbursement or no-cost access plans for specific genomic tests is under development</li>
<li>A reimbursement framework or no-cost access plans for specific genomic tests are developed, approved and operationalised, with disease or patient-specific models</li>
<li>A reimbursement framework or no-cost access plans for specific genomic tests are fully implemented in national and/or regional healthcare systems</li>
<li>A reimbursement framework or no-cost access plans for specific genomic tests are fully implemented, periodically evaluated and optimised, with plan for adoption of novel tools and technologies</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Health Economics</h4>
</div>
<div class="span3 ">
<p>There is a <span class="tooltip">HTA framework<span class="tooltiptext">A multidisciplinary process that uses explicit methods to determine the value of health technology at different points in its lifecycle to help decision-makers make informed decisions.</span></span> to assess genomic tests in healthcare</p>
</div>
<div class="span6 ">
<ol>
<li>No HTA framework for genomic testing</li>
<li>HTA framework for genomic testing is under development</li>
<li>HTA framework for genomic testing is developed and approved</li>
<li>HTA framework for genomic testing is implemented in healthcare system</li>
<li>HTA framework is implemented, periodically evaluated and optimised, with plan for adoption of novel tools and technologies</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>There is a framework for <span class="tooltip">cost-effectiveness assessment<span class="tooltiptext">Cost-effectiveness analysis is a form of economic analysis that compares the relative costs and outcomes of different courses of action.</span></span> of genomic tests</p>
</div>
<div class="span6 ">
<ol>
<li>There is no framework for cost-effectiveness assessment of genomic tests</li>
<li>A framework for cost-effectiveness assessment of genomic tests is under development</li>
<li>A framework for cost-effectiveness assessment of specific genomic tests in the healthcare context are under implementation as pilots</li>
<li>A framework for cost-effectiveness assessment of specific genomic tests is implemented in healthcare systems at the national and/or regional levels</li>
<li>A framework for cost-effectiveness assessment of genomic tests is implemented, periodically evaluated and optimised, with plan for adoption of novel tools and technologies</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p><span class="tooltip">Societal benefits<span class="tooltiptext">Any advantages, gains or improvements as a result of employing a genomic approach to a group of people (e.g. patients, citizens).</span></span> are considered in <span class="tooltip">economic modelling<span class="tooltiptext">Structured approaches to help decision-makers choose between alternative ways of using resources, by weighting the cost of an action against the benefits that it provides. It is frequently used to anticipate the costs and benefits of new health care technologies, policies and regulations.</span></span> for genomic medicine</p>
</div>
<div class="span6 ">
<ol>
<li>Societal benefits are not considered in economic models for genomics in healthcare</li>
<li>Societal benefits are quantified in economic models for genomics in healthcare</li>
<li>Societal benefits are integrated in economic models for specific genomic tests</li>
<li>Societal benefits are integrated in global genomics economic models for regional or national healthcare systems</li>
<li>Societal benefits are integrated in global genomics economic models for regional or national healthcare systems and optimised for novel tools and technologies</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>III. Ethics, legislation and policy</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4><span class="tooltip">Data protection<span class="tooltiptext">Certainity that personal data is used fairly, lawfully and transparently – for specified, explicit purposes – in a way that is adequate, relevant and limited to only what is necessary, accurate and, where necessary, kept up-to-date, for no longer than is necessary, and handled in a way that ensures appropriate security, including protection against unlawful or unauthorised processing, access, loss, destruction or damage.</span></span> and privacy</h4>
</div>
<div class="span3 ">
<p>There are <span class="tooltip">norms<span class="tooltiptext">A set of principles of right action binding upon group members and serving to guide, control or regulate appropriate and acceptable behaviour. E.g. legislation, policies, professional regulations, codes of conduct.</span></span> to protect and ensure the lawful, fair and transparent processing of <span class="tooltip">personal data<span class="tooltiptext">Data related to a living individual, who is likely to be identified by the data directly or combined with other data (e.g. through a pseudonym). [ref. Art. 4 GDPR]</span></span></p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li></ol>
</div>
</div>
<div class="row">
<div class="span2 "></div>
<div class="span3 ">
<p>There are norms protecting the confidentiality of patient genetic/genomic test results, and specifically clarifying where family members may have rights to access these results</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li></ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>There are norms limiting genetic/genomic testing to legitimate purposes and preventing mis-use (e.g. no employer/insurer discrimination)</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Consent to genetic/genomic testing</h4></div>
<div class="span3 ">
<p>There are norms to ensure appropriate consent is obtained and counselling is provided in relation to genetic/genomic testing</p>
</div>
<div class="span6 ">
<ol>
<li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 "> </div>
<div class="span3 ">
<p>There are special rules to ensure that <span class="tooltip">vulnerable groups<span class="tooltiptext">Vulnerable groups of population include children, adults with diminished capacities, the elderly, racial or ethnic minorities, the socioeconomically disadvantaged, underinsured or those with certain medical conditions who are at risk for unequal healthcare access, outcomes and exploitation.</span></span> have access to genetic/genomic testing, with counselling and appropriate protections to fully respect their rights and avoid their exploitation</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li></ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Quality of patient care involving genetic/genomic testing</h4>
</div>
<div class="span3 ">
<p>There are norms ensuring the quality of genetic/genomic testing services (e.g. professional codes and self-regulatory bodies)</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li></ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Health data sharing and<span class="tooltip"> reuse<span class="tooltiptext">Reuse, or secondary use, of health data for purposes other than the primary reason for which they were originally saved. Other purposes may include scientific research, development and innovation activities, teaching and statistics.</span></span></h4>
</div>
<div class="span3 ">
<p>There are norms addressing the accreditation, registration, supervision, secure storage, and responsible use (including exchange and sharing) of human biological samples</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li></ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>There is a national strategy for promoting health research and innovation, and associated <span class="tooltip">data protection<span class="tooltiptext">Certainity that personal data is used fairly, lawfully and transparently – for specified, explicit purposes – in a way that is adequate, relevant and limited to only what is necessary, accurate and, where necessary, kept up-to-date, for no longer than is necessary, and handled in a way that ensures appropriate security, including protection against unlawful or unauthorised processing, access, loss, destruction or damage.</span></span> rules allowing sharing and <span class="tooltip">further processing<span class="tooltiptext">The processing of personal data for a different purpose(s) than the initially collected.</span></span> of <span class="tooltip">health/genetic data<span class="tooltiptext"><strong>Genetic data</strong>.<br>Personal data related to the inherited or acquired genetic characteristics of an individual, which give unique information about his/her physiology or health, that result from an analysis of a biological sample from the individual in question.<br> <strong> Personal data</strong>.<br>Related to the physical or mental health of an individual independent of its origin (e.g. healthcare context, research, clinical trials, the data subject directly, smart devices).<br>[ref. Art. 4 GDPR]</span></span> for research or treating other patients</p>
</div>
<div class="span6 ">
<ol><li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>There are norms facilitating genomic data sharing by researchers and/or healthcare providers, at the national and international levels
</p>
</div>
<div class="span6 ">
<ol>
<li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Research ethics</h4>
</div>
<div class="span3 ">
<p>There are norms and processes ensuring the ethical practice and scientific integrity of genomic research</p>
</div>
<div class="span6 ">
<ol>
<li>Norms (e.g. legislation, policies, professional regulations, codes of conduct) do not exist</li>
<li>Norms are implemented but insufficient in scope</li>
<li>Norms are implemented but not yet consistently enforced</li>
<li>Norms are implemented and consistently enforced</li>
<li>Norms are implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>There is a national (or regional if appropriate) research ethics committee or network to effectively and efficiently oversee the conduct of multicentre genetic/genomic studies</p>
</div>
<div class="span6 ">
<ol>
<li>A framework for national or regional research ethics committee to oversee multicentre genetic/genomic studies does not exist</li>
<li>A framework for national or regional research ethics committee to oversee multicentre genetic/genomic studies is under development</li>
<li>A framework for national or regional research ethics committee to oversee multicentre genetic/genomic studies exists, but is not consistently enforced</li>
<li>A framework for national or regional research ethics committee to oversee multicentre genetic/genomic studies is implemented and consistently enforced</li>
<li>A framework for national or regional research ethics committee to oversee multicentre genetic/genomic studies is implemented, enforced and fit-for-purpose</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>IV. Public awareness and acceptance</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>
<span class="tooltip">Awareness
<span class="tooltiptext">Public's level of understanding about the importance and implications of genomic medicine.
</span>
</span>
</h4>
</div>
<div class="span3 ">
<p>There are literacy programmes or campaigns on genomic medicine with monitored impact on awareness</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Literacy programmes or campaigns are available <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span> as a bottom up initiative, on particular topics</li>
<li>Strategy for literacy programmes or campaigns targeting specific audiences is defined, based on genomic literacy surveys, and under implementation</li>
<li>Strategy for literacy programmes or campaigns targeting specific audiences is defined, and widely implemented with dedicated funds</li>
<li>Strategy for literacy programmes or campaigns is widely implemented, with regular evaluation and monitoring of impact on awareness, update of topics to include innovation, and with dedicated funds</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4><span class="tooltip">Acceptance<span class="tooltiptext">Perceived usefulness of genomic medicine to patients. Recognition from citizens, patients and patients' associations of a positive impact of the use of genomic medicine on patients levels of satisfaction.</span></span></h4>
</div>
<div class="span3 ">
<p>Synergies with patient associations are well established</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Available <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span> as a bottom up initiative with specific associations</li>
<li>Strategy for engaging patient associations in genomic medicine issues is defined and under implementation</li>
<li>Strategy for engaging patient associations in genomic medicine issues is widely implemented at national level, with dedicated funds</li>
<li>Strategy for engaging patient associations in genomic medicine issues is widely implemented at national level, with dedicated funds, regular monitoring and updates to include innovation</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Communication to the general public</h4>
</div>
<div class="span3 ">
<p>There is a communication strategy for genomic medicine </p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Available <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span> as a bottom up initiative with specific target audiences</li>
<li>A global strategy for communication with the public is under development</li>
<li> A global strategy for communication with the public is widely implemented, with dedicated funds</li>
<li>A global strategy for communication with the public is widely implemented, with dedicated funds and regular monitoring, and includes tools for active involvement of the public in general, minorities and youth in particular</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>V. Workforce skills and organisation</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Education</h4>
</div>
<div class="span3 ">
<p>Genomics is integrated in general university <em>curricula</em> for medical doctors</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Needs assessed, gaps identified, training options under development</li>
<li>Training available, under implementation</li>
<li>Training available and widely implemented</li>
<li>Training <em>curricula</em> regularly updated to incorporate novel technologies and tools</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>Genomics is integrated in general <em>curricula</em> for nurses</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Needs assessed, gaps identified, training options under development</li>
<li>Training available, under implementation</li>
<li>Training available and widely implemented</li>
<li>Training <em>curricula</em> regularly updated to incorporate novel technologies and tools</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2 ">
</div>
<div class="span3 ">
<p>Genomics is integrated in general <em>curricula</em> for pharmacists</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Needs assessed, gaps identified, training options under development</li>
<li>Training available, under implementation</li>
<li>Training available and widely implemented</li>
<li>Training <em>curricula</em> regularly updated to incorporate novel technologies and tools</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Careers in genomic medicine</h4>
</div>
<div class="span3 ">
<p>There are officially recognised professional titles and career paths for genomic medicine </p>
</div>
<div class="span6 ">
<ol><li>No workforce strategy or policy that recognises genomic medicine professionals, and distribution of professionals is <em>ad hoc</em></li>
<li>Strategy or policy for genomic medicine professionals is proposed and under review</li>
<li>Strategy or policy for genomic medicine professionals is approved and under implementation</li>
<li>Strategy or policy for genomic medicine professionals is implemented, with full recognition and acceptance of career paths</li>
<li>Professional titles and career paths for genomic medicine professionals are flexible and regularly updated to incorporate needs from novel technologies and tools
</li></ol>
</div>
</div>
<div class="row">
<div class="span2"></div>
<div class="span3 ">
<p>There are training programmes for genetic counselling</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Needs assessed, gaps identified, training options under development</li>
<li>Training graduates are available but not yet deployed</li>
<li>Training graduates are deployed, but essential personnel gaps remain</li>
<li>Sufficient numbers of training graduates are available to support evolving national/regional needs</li>
</ol>
</div>
</div>
<div class="row">
<div class="span2"></div>
<div class="span3 ">
<p>There are life-long or continuing education programmes in genomic medicine for different healthcare professionals</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad ho</em>c</li>
<li>Needs assessed, gaps identified, training options under development</li>
<li>Training available, under implementation</li>
<li>Training available and widely implemented</li>
<li>Training <em>curricula</em> regularly updated to incorporate novel technologies and tools</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Policy makers</h4>
</div>
<div class="span3 ">
<p>There are programmes for policy makers and healthcare managers to raise awareness on genomic medicine and its implications for healthcare</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Needs assessed, gaps identified, programme options under development</li>
<li>Programmes available, under implementation</li>
<li>Fully functional implementation of programmes at national level</li>
<li>Programmes are implemented and periodically evaluated for inclusion of novel tools and technologies</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>VI. Clinical organisation, infrastructure and tools</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Information and Communications Technology (ICT) tools for clinical decision</h4>
</div>
<div class="span3 ">
<p>There are <span class="tooltip">ICT tools<span class="tooltiptext">Information and communication technology, such as electronic health records, telehealth or online resources.</span></span> supporting clinical interpretation of genomic results, clinical decision-making and communication with the patient implemented in public hospitals and clinics</p>
</div>
<div class="span6 ">
<ol>
<li>ICT tools not available</li>
<li>ICT tools available in selected hospitals, frequently associated with research projects</li>
<li>ICT tools under wider implementation in healthcare systems following a strategy for genomic medicine</li>
<li>ICT tools implemented where needed as part of national/regional health systems strategies for genomic medicine</li>
<li>ICT tools implemented and periodically evaluated and optimised for novel tools and updates</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4><span class="tooltip">Multidisciplinary teams<span class="tooltiptext">Teams comprised of individuals who span across different areas of expertise to cover all knowledge areas required for genomic medicine.</span></span></h4>
</div>
<div class="span3 ">
<p> Clinical teams for genomic medicine are multidisciplinary and include ICT, biomedical and psychology experts</p>
</div>
<div class="span6 ">
<ol>
<li>Not available</li>
<li>Teams are assembled in some hospitals as a bottom up initiative, but not all areas are covered or necessary tools are available</li>
<li>Guidelines for assembling multidisciplinary teams exist, and there are referral networks at regional/local level</li>
<li>Guidelines for assembling multidisciplinary teams and referral networks are implemented at regional/national level, aligned with a strategy for genomics in healthcare and with dedicated funding</li>
<li>Multidisciplinary teams are the norm for implementation of national genomics in medicine strategy and the guidelines for their assembly and operation, and referral networks, are reviewed and optimised periodically</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Uptake of novel tools and technologies for genomics</h4>
</div>
<div class="span3 ">
<p>Adoption of novel technologies and software tools to support clinical decisions is fit-for-purpose</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Novel technologies and tools are selected and implemented locally (e.g. hospital, laboratory)</li>
<li>There are plans and processes for adoption of novel technologies and tools to support clinical decision making, but not widely implemented at regional/national levels</li>
<li>Plans and processes for adoption of novel technologies and tools to support clinical decision making are centralised at the regional/national levels, and aligned with a national strategy for genomics in healthcare</li>
<li>Plans and processes for adoption of novel technologies and tools to support clinical decision making are centralised at the regional/national levels, and aligned with a national strategy for genomics in healthcare and with international standards</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Synergies with research</h4>
</div>
<div class="span3 ">
<p>There are processes established for the integration of the clinics with research outcomes</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Implemented at a local level, depending on individual initiative</li>
<li>Implemented at local and regional level according to a local strategy for integrating stakeholders and partnerships</li>
<li>Implemented at national level with well established partnerships, support from public funds and dedicated budget</li>
<li>Implemented at national and international level with well established partnerships, periodically evaluated, support from public funds and dedicated budget</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Partnership with industry</h4>
</div>
<div class="span3 ">
<p>There are effective partnerships with stakeholders from the industry sector</p>
</div>
<div class="span6 ">
<ol>
<li>No or <em>ad hoc</em></li>
<li>Implemented at a local level, depending on individual initiative</li>
<li>Implemented at local and regional level according to a local strategy for integrating stakeholders and partnerships from the industry sector</li>
<li>Implemented at national level with well established partnerships, according to a national strategy for integration of industry stakeholders</li>
<li>Implemented with well established national and international partnerships, according to a national strategy for integration of industry stakeholders</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>VII. Clinical genomics guidelines and infrastructure</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Sequencing/ genotyping infrastructure</h4>
</div>
<div class="span3 ">
<p>Genomic centres are established</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Genomic centres are local (e.g. hospital, laboratory)</li>
<li>Genomic centres infrastructure networks are under development, to include common working guidelines and shared policies</li>
<li>Genomic centres infrastructure networks are implemented at the regional/national levels, and operate under common guidelines and policies</li>
<li>Genomic centres infrastructure networks are implemented at the regional/national levels, and operate under common guidelines and policies and aligned with global standards</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Sequencing guidelines</h4>
</div>
<div class="span3 ">
<p>Guidelines for sequencing are defined</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Guidelines for sequencing data generation are available <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span>(e.g. hospital, laboratory, project)</li>
<li>Local level genomic sequence generation for clinical use is aligned with <span class="tooltip">ISO<span class="tooltiptext">The International Organisation for Standardisation</span></span> laboratory accreditation/protocols</li>
<li>Genomic sequence generation is co-ordinated at regional/national level and aligned with ISO laboratory accreditation/protocols</li>
<li>Genomic sequence generation at regional/national level is governed in alignment with ISO accreditation/protocols, reviewed periodically, and in line with international standards</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4><span class="tooltip">Primary bioinformatics analysis<span class="tooltiptext">The initial analysis that turns the machine output of genomic sequencing into genomic information for clinical/research interpretation or other contexts.</span></span></h4>
</div>
<div class="span3 ">
<p>Guidelines for genomic data analysis are defined</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Guidelines for genomic data analysis are available at local/organisation level</li>
<li>Guidelines for genomic data analysis are available at the regional/national level</li>
<li>Standardised genomic analysis guidelines are implemented at national level and reviewed periodically</li>
<li>Standardised genomic analysis guidelines are implemented at national level, reviewed periodically and aligned with global standards</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Structure of sequence-associated metadata</h4>
</div>
<div class="span3 ">
<p>Guidelines for <span class="tooltip">sequence-metadata<span class="tooltiptext">Data that provides information about other data, specifically about genomic-sequence data.</span></span> structure to support clinical interpretation are established</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Guidelines to structure metadata to meet clinical use cases are defined <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span> (e.g. at the hospital, laboratory level)</li>
<li>Guidelines to structure metadata to meet clinical use cases are defined regionally/nationally</li>
<li>Standardised guidelines to structure metadata to meet clinical use cases are implemented at the national level and are reviewed periodically</li>
<li>International guidelines to structure metadata to meet clinical use cases are followed, implemented at the national level and are reviewed periodically</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Clinical interpretation</h4>
</div>
<div class="span3 ">
<p><span class="tooltip">Guidelines for clinical interpretation of genomic results<span class="tooltiptext">Guidelines for translating the technical output of a genetic or genomic test into potentially clinically actionable information.</span></span> are defined.</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Guidelines for clinical interpretation of genomic results are defined <span class="tooltip">locally<span class="tooltiptext">Within a single institution, i.e. not beyond a lab, department or hospital.</span></span> (e.g. at the hospital, laboratory level)</li>
<li>Guidelines for clinical interpretation of genomic results are defined regionally/nationally (e.g. by national genetics societies)</li>
<li>Guidelines for clinical interpretation of genomic results from internationally recognised bodies (e.g. ACMG, ClinGen) are implemented nationally </li>
<li>Guidelines for clinical interpretation of genomic results from internationally recognised bodies are implemented nationally, and there are interactions with these international bodies for guideline definition for specific diseases (e.g. ACMG, ClinGen)</li>
</ol>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Clinical reporting</h4>
</div>
<div class="span3 ">
<p><span class="tooltip">Guidelines for clinical reporting of genomic results<span class="tooltiptext">Guidelines for reporting the actionable results of a genetic or genomic test to the attending clinician and/or patient.</span></span> are defined</p>
</div>
<div class="span6 ">
<ol>
<li>No</li>
<li>Consistent clinical reporting guidelines are developed at an organisational level</li>
<li>National best practices for clinical reporting are defined and monitored, but not consistently enforced</li>
<li>National best practices for clinical reporting are enforced and monitored</li>
<li>Guidelines for clinical reporting are enforced at the national levels, in alignment with international standards and regularly reviewed based on changes in technological, regulatory and ethical considerations</li>
</ol>
</div>
</div>
</div>
</div>
<div class="toggle-wrp">
<h2>VIII. Data management, standards and infrastructure</h2>
<div class="toggle-content">
<div class="row">
<div class="span2">
<h3>Subdomain</h3>
</div>
<div class="span3">
<h3>Indicators</h3>
</div>
<div class="span6">
<h3>Maturity levels</h3>
</div>
</div>
<hr>
<div class="row">
<div class="span2 ">
<h4>Data security</h4>
</div>
<div class="span3 ">
<p>Infrastructure and policies for data security are established</p>
</div>