Sec. 101. Developing a common lexicon to facilitate progress on diagnostics
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Not later than 180 days after the date of enactment of this Act, the Secretary shall establish within the Department of Health and Human Services the Advanced Diagnostics Education Council (in this section referred to as the ). Council The Council shall promote an improved understanding of key concepts related to innovative diagnostics by recommending standard terms and definitions for use by patients, physicians, health care providers, payers, and policymakers. The Secretary shall publish and disseminate a guide regarding such recommended terms and definitions for patients, physicians, health care providers, payers, and policymakers.
Not later than 12 months after the establishment of the Council, the Secretary shall prepare and submit a report to the Congress and to the public on the Council’s deliberations, activities, and determinations with respect to meeting its duties described in paragraphs
(1)and (2). The Secretary, or the Secretary’s designee, shall serve as chairperson of the Council. In addition to the Secretary, the Council shall consist of the following: The head of each the following agencies (or a designee thereof): The National Institutes of Health. The Centers for Disease Control and Prevention. The Food and Drug Administration. The Agency for Healthcare Research and Quality. The Centers for Medicare & Medicaid Services. The Department of Defense. The Department of Veterans Affairs. The Health Resources and Services Administration. The Substance Abuse and Mental Health Services Administration. The Indian Health Service. Seven members appointed by the Secretary from among individuals who collectively— represent a broad range of perspectives; and have expertise in— basic and translational research, including with respect to molecular biology and genetics; bioinformatics; the discovery, development, and commercialization of in vitro diagnostics; and law and ethics. Four members appointed by the Secretary who are each a chief medical or scientific officer of a patient advocacy organization. In carrying out its duties, the Council shall solicit input from relevant stakeholders and the public. The Council shall terminate after publishing the guide required by subsection (b)(2) and submitting the report required by subsection (b)(3), or later at the discretion of the Secretary.