Amy P. Abernethy

Jan 8, 2025 | jamanetwork.com | Derek C. Angus |Alison J. Huang |Roger Lewis |Amy P. Abernethy

Collaborator Corrected The Integration of Clinical Trials With the Practice of Medicine Derek C. Angus, MD, MPH; Alison J. Huang, MD, MAS; Roger J. Lewis, MD, PhD; Amy P. Abernethy, MD, PhD; Robert M. Califf, MD; Martin Landray, PhD; Nancy Kass, ScD; Kirsten Bibbins-Domingo, PhD, MD, MAS; JAMA Summit on Clinical Trials Participants; Ali B Abbasi; Kaleab Z Abebe; Amy P Abernethy; Stacey J.

Oct 25, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

Medicare has recently endorsed the concept of “fit-for-purpose” (FFP) studies to support ongoing evidence generation as a condition of coverage for selected emerging medical products.

Oct 24, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

When Medicare coverage for a drug, device, or other medical technology is conditioned on additional evidence development, several important policy questions arise: What will be the utility of the evidence generated for informing coverage decisions and, ultimately, the care of Medicare beneficiaries? What will be the burden of conducting the study? And how will the evidence development affect access to the technology by patients?

Feb 27, 2024 | podcasts.apple.com | Amy P. Abernethy |Jacob Effron

Jacob sits down with Dr. Amy Abernethy, whose health tech career spans from clinician and researcher to CMO at Flatiron Health to Principal Deputy Commissioner and Chief Innovation Officer at the FDA to CMO and President of Product Development at Verily to co-founder of her own non-profit to accelerate evidence generation.

Nov 15, 2023 | nam.edu | Jenna Ogilvie |Debra Mathews |Amy P. Abernethy |Atul J. Butte

IntroductionThis case study was developed as one of a set of three studies, focusing on somewhat mature but rapidly evolving technologies. These case studies are intended to draw out lessons for the development of a cross-sectoral governance framework for emerging technologies in health and medicine. The focus of the case studies is the governance ecosystem in the United States, though where appropriate, the international landscape is included to provide context.