I generally focus my research on health policy, thinking about how regulation & the law impact new medical technologies (e.g., drugs, devices, digital health).

Prior to this, I researched computational genomics during the first half of medical school and chemical physics in college.

This page describes my health policy research highlighted by subtopic and includes a list of select publications at the bottom.

Regulation & payment policies for medical devices

How can government agencies ensure that medical device innovation is based on strong and representative clinical evidence?

Our JAMA Cardiology Special Communication explores the processes of FDA market authorization and Medicare coverage for new cardiovascular devices. Highlighting the Breakthrough Device Program, we proposed policy recommendations for FDA and CMS to promote rigorous evidence generation and proper use of Medicare funds [10].

Evidence standards for medical products

We were curious if it was possible to rely on real-world evidence to answer clinical questions in pandemics.

To answer this, we compared results from observational studies for Covid-19 drugs to results from randomized clinical trials (the gold standard) looking at the same exact treatments. We published our findings in The BMJ showing that observational studies and RCTs frequently agreed in their conclusions [7] [8]. This work informed the 2022 update of the Agency on Healthcare Research and Quality guidance for inclusion of nonrandomized studies in systematic reviews.

Genetic testing: data privacy, innovation policy

Health data is governed weirdly in the United States, and consumers often have to rely on company goodwill versus solid regulation. For Nature Medicine, we explored risks posed by the genetic testing industry (e.g., 23andMe) and proposed solutions for how consumers may be safeguarded [5]. The National Society of Genetic Counselors referenced our regulatory analysis in their practice resource on elective genomic testing.

In separate work, we considered the testing industry from an innovation policy perspective [2]. Bad regulation allowed for the development of a Covid-19 testing monopoly, a phenomenon sharing parallels to the history of genetic testing. We argued aginst relying on exclusivity-creating patents to promote innovation and instead outlined a more effective reimbursement model.

Postmarket regulation of medical products

This series of work evaluated the performance of FDA postmarket studies [3] [4] [6] [9]. These studies happen after a drug is already on the market and are increasingly important nowadays, as new drugs undergo less testing before approval.

We found that postmarket studies can lead to worthwhile outcomes, but often are delayed and not completed on time. We proposed increasing the FDA's authority to enforce evidence generation after drug approval.

Select publications

[10] Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program

[9] Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016

[8] Generating evidence during a pandemic: what’s reliable?

[7] Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study.

[6] New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

[5] Direct-to-consumer personal genomic tests need better regulation.

[4] Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020.

[3] An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.

[2] Covid-19, single-sourced diagnostic tests, and innovation policy.

[1] Electrostatic screening of charged defects in monolayer MoS2.