Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law

Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law

Roger is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O’Connor College of Law at Arizona State University. He is also the Chief Medical Officer of Omniseq and Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.

Roger is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.

Contributions

Deep Dive Episode 117 – How to Approach Data Collection and Breaches in the Age of COVID-19

June 22, 2020

What are the data privacy and security implications for widespread data collection for COVID-19 contact tracing? Drew Bagley, Neil Chilson, and Roger Klein discuss.

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FDA Regulation of Diagnostic Testing and COVID-19

May 11, 2020

Did Food and Drug Administration (FDA) regulations hamper the fight against COVID-19 at a critical juncture? In this short video narrated by Roger Klein, we explore the relationship between the FDA and the CDC in regulating and conducting diagnostic tests.

In 2016, in response to the Zika virus, the FDA designated the Center for Disease Control and Prevention (CDC) as the country’s only diagnostic test manufacturer. In early February 2020, the CDC was ordered to distribute tests for COVID-19 which were faulty and had to have results verified by the CDC laboratory. Only in mid-March 2020, did the CDC loosen regulations which then allowed private hospitals and labs to develop and conduct their own tests.

Could more have been known about the disease at an earlier date if private testing and treatment had been allowed and encouraged? Should the COVID-19 emergency force us to reevaluate the purpose and use of public health regulations and policies?

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Deep Dive Episode 98 – Regulatory Reforms and the COVID Pandemic

March 30, 2020

In this episode, David Hyman, Roger Klein, and Shoshana Weissmann discuss potential regulatory reforms that could allow governments and private actors to be more responsive to public health threats.

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Deep Dive Episode 83 – Medicare for All

November 26, 2019

In this episode, Roger Klein and Adam Broad debate the merits of the increasingly prominent “Medicare for All” proposal for healthcare. The discussion is moderated by Courtney Hughes.

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E-Cigarettes: Smoke & Mirrors

August 26, 2019

In this Fourth Branch video, legal and healthcare experts debate how federal and state agencies should approach the regulation of e-cigarettes. Should vaping be encouraged as a harm-reduction strategy, with the aim of reducing cigarette-related deaths, or should regulators seek to restrict the availability of e-cigarettes, with the aim of preventing nicotine addiction? This video explores these questions and more.

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Fixing How FDA Regulates Diagnostic Lab Tests

Roger D. Klein

June 27, 2017

It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing

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