Urges Direct Access to Diagnostic Medical Testing
RESOLVED, That the American Bar Association urges federal, state and territorial governments to assure that predictive and diagnostic medical genetic testing provided on-line, via the telephone, or by any other direct-to-consumer means complies, at a minimum, with the following requirements:
1. Test samples are received and tests are performed only in licensed laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform the category of tests requested and that comply with state and territorial requirements applicable to clinical laboratories;
2. Before test reports and interpretations of test results are issued to consumers, they are reviewed and authorized by qualified health personnel acting in accordance with relevant professional standards of care;
3. Consumers are fully informed of material information about the test and the test results, including but not limited to the following: the scientific evidence on which the test is based; the clinical utility of the test results, if any; the limits of the particular kind of genetic testing, including what it can and cannot tell the consumer; an explanation of what probabilities mean, in plain English; a statement that genes are not the only determinants of illness; a statement that genetic links to health conditions and diseases are the subject of ongoing research; and a statement that they are advised to discuss test results with a qualified health care professional before making medical decisions based upon the test results;
4. Consumers are advised regarding potential disclosure of their personal information;
5. Appropriate measures are in place to protect the security, privacy, and confidentiality of personal health information; and
6. Claims made and information provided by direct-to-consumer medical genetic testing companies are truthful, accurate, and not misleading.
FURTHER RESOLVED, That the American Bar Association urges federal, state and territorial governments to take action against companies that fail to meet applicable requirements or that make false or misleading claims about direct-to-consumer medical genetic testing.
RESOLVED, That the American Bar Association urges federal, state and territorial governments to assure that predictive and diagnostic medical genetic testing provided on-line, via the telephone, or by any other direct-to-consumer means complies, at a minimum, with the following requirements:
1. Test samples are received and tests are performed only in licensed laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform the category of tests requested and that comply with state and territorial requirements applicable to clinical laboratories;
2. Before test reports and interpretations of test results are issued to consumers, they are reviewed and authorized by qualified health personnel acting in accordance with relevant professional standards of care;
3. Consumers are fully informed of material information about the test and the test results, including but not limited to the following: the scientific evidence on which the test is based; the clinical utility of the test results, if any; the limits of the particular kind of genetic testing, including what it can and cannot tell the consumer; an explanation of what probabilities mean, in plain English; a statement that genes are not the only determinants of illness; a statement that genetic links to health conditions and diseases are the subject of ongoing research; and a statement that they are advised to discuss test results with a qualified health care professional before making medical decisions based upon the test results;
4. Consumers are advised regarding potential disclosure of their personal information;
5. Appropriate measures are in place to protect the security, privacy, and confidentiality of personal health information; and
6. Claims made and information provided by direct-to-consumer medical genetic testing companies are truthful, accurate, and not misleading.
FURTHER RESOLVED, That the American Bar Association urges federal, state and territorial governments to take action against companies that fail to meet applicable requirements or that make false or misleading claims about direct-to-consumer medical genetic testing.
Tags: HEALTH LAW SECTION
RESOLVED, That the American Bar Association urges federal, state and territorial governments to assure that predictive and diagnostic medical genetic testing provided on-line, via the telephone, or by any other direct-to-consumer means complies, at a minimum, with the following requirements:
1. Test samples are received and tests are performed only in licensed laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform the category of tests requested and that comply with state and territorial requirements applicable to clinical laboratories;
2. Before test reports and interpretations of test results are issued to consumers, they are reviewed and authorized by qualified health personnel acting in accordance with relevant professional standards of care;
3. Consumers are fully informed of material information about the test and the test results, including but not limited to the following: the scientific evidence on which the test is based; the clinical utility of the test results, if any; the limits of the particular kind of genetic testing, including what it can and cannot tell the consumer; an explanation of what probabilities mean, in plain English; a statement that genes are not the only determinants of illness; a statement that genetic links to health conditions and diseases are the subject of ongoing research; and a statement that they are advised to discuss test results with a qualified health care professional before making medical decisions based upon the test results;
4. Consumers are advised regarding potential disclosure of their personal information;
5. Appropriate measures are in place to protect the security, privacy, and confidentiality of personal health information; and
6. Claims made and information provided by direct-to-consumer medical genetic testing companies are truthful, accurate, and not misleading.
FURTHER RESOLVED, That the American Bar Association urges federal, state and territorial governments to take action against companies that fail to meet applicable requirements or that make false or misleading claims about direct-to-consumer medical genetic testing.
RESOLVED, That the American Bar Association urges federal, state and territorial governments to assure that predictive and diagnostic medical genetic testing provided on-line, via the telephone, or by any other direct-to-consumer means complies, at a minimum, with the following requirements:
1. Test samples are received and tests are performed only in licensed laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform the category of tests requested and that comply with state and territorial requirements applicable to clinical laboratories;
2. Before test reports and interpretations of test results are issued to consumers, they are reviewed and authorized by qualified health personnel acting in accordance with relevant professional standards of care;
3. Consumers are fully informed of material information about the test and the test results, including but not limited to the following: the scientific evidence on which the test is based; the clinical utility of the test results, if any; the limits of the particular kind of genetic testing, including what it can and cannot tell the consumer; an explanation of what probabilities mean, in plain English; a statement that genes are not the only determinants of illness; a statement that genetic links to health conditions and diseases are the subject of ongoing research; and a statement that they are advised to discuss test results with a qualified health care professional before making medical decisions based upon the test results;
4. Consumers are advised regarding potential disclosure of their personal information;
5. Appropriate measures are in place to protect the security, privacy, and confidentiality of personal health information; and
6. Claims made and information provided by direct-to-consumer medical genetic testing companies are truthful, accurate, and not misleading.
FURTHER RESOLVED, That the American Bar Association urges federal, state and territorial governments to take action against companies that fail to meet applicable requirements or that make false or misleading claims about direct-to-consumer medical genetic testing.
