Sec. 502. Development
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The Secretary shall ensure that, to the extent practicable, the development of clinical practice guidelines are guided by the Standards for Developing Trustworthy Clinical Practice Guidelines of the Institute of Medicine and— are developed through a transparent process that minimizes conflicts of interest; are developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups; take into consideration important patient subgroups and patient preferences, as appropriate; are based on a systematic review of the existing evidence; provide a clear explanation of the relationship between care options and health outcomes; provide ratings of both the quality of evidence and strength of recommendation; are reconsidered and revised when new evidence emerges; and clearly identify any exceptions to the application of the clinical practice guideline.
Any person who is affiliated with an eligible professional organization and who directly participated in the creation of a clinical practice guideline shall disclose any conflicts of interest pertaining to the development of the clinical practice guideline, including any conflict of interest pertaining to any instrument, medicine, drug, or any other substance, device, or means included in the clinical practice guideline. Disclosures to the Secretary by eligible professional organizations shall be made promptly, upon submission of the guidelines, and during every review of the guidelines.
Disclosures shall include the following: Scientific methodology and evidence that supports clinical practice guidelines. Outside collaborators. Endorsements.