This definition distinguished health selleck chemical checks from self-tests, which do not include service. The working group aimed to develop generic criteria that apply to all health checks, but acknowledges that certain health checks are already regulated. These include national screening programs, such as cancer screening programs and prenatal screening, and self-tests, which are already covered by national and European guidelines and

regulations. Also indicated testing, offered within the health care system as part of clinical care, is already covered by professional guidelines and falls outside the scope of the criteria proposed here. The working group specified criteria for the provision of information (domain 1), communication and informed consent (domain 2); the predictive ability and utility of the test (domains 3–7); and quality assurance (domain 8). Table 2 presents the domains as well as a summary of their items. The provision of information, communication and the informed consent (domain 1 and 2) aim to ensure that clients have access to all information they need to make informed decisions about undergoing the health check. This information needs to cover all relevant GSK2118436 aspects, and be understandable, timely, verifiable, accurate, complete, truthful and not misleading. The provider might outsource the provision

of such information, e.g., by referring to health websites, but remains fully responsible for the contents and quality. The provider has the responsibility to verify that the client has adequate understanding of what constitutes the health check and what the potential consequences of the test results are. To enable informed decisions, clients need to have access to information about what is tested, for whom the test is intended, including an assessment whether it Ergoloid is intended for them, and for what reasons they should use the test (domain 3). They need

access to information about what exactly will be done, how reliable and predictive the test is, and what possible adverse effects the test or the follow up procedure might have (domain 4 and 5). The client needs to receive a written report containing the results, the interpretation and (if available and necessary) further strategies to reduce or manage the risk of the condition that is tested for (domain 6 and 7). The interpretation of the results as well as the recommendations for follow-up strategies should follow established protocols or professional guidelines to ensure responsible care. Finally, the provider of the health check should ensure that the management of the service provision meets existing nationally and internationally accepted requirements as well as recognized quality, safety and information security requirements (domain 8).