Legislative and regulatory changes are allowing drugs, medical devices, and digital health technologies to gain approval based on low-quality evidence. The resulting uncertainty about risks and benefits for medical products may compromise bioethical principles including autonomy and non-maleficence. The team will assess if and how physicians convey this uncertainty to patients. A modified Delphi panel will identify consensus solutions to enhance patient protection and inform a regulatory framework that reconciles ethical principles with the need to generate new knowledge to inform care for patients.
A Bioethical Framework to Inform Use of Novel Drugs, Devices, and Digital Health Technologies Approved with Incomplete Evidence
University of California San Francisco
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