I believe that ensuring that my empirical findings are translated into improved policy via direct and sustained engagement with policymakers and key policy stakeholders is as important as conducting the research in the first place.
At the institutional level, I am the ethicist on the Michigan Medicine Human Data and Biospecimen Release Committee. We developed and implemented a new Michigan Medicine commercial data-sharing policy based in part on best practices identified through my research. I then presented our model to the Leadership Consortium of the National Academies of Medicine (NAM). The NAM CEO responded that he was “energized and inspired” by our work and published the U-M model as a “best practice” study for their report on “Sharing Health Data.” The U-M model was also described in the World Health Organization Report “Ethics and Governance of Artificial Intelligence for Health.”
Because of this expertise, in 2022, I was asked to Chair the American Heart Association’s Data Privacy and Security Committee and led the development of its new data collection and use policy for its $462M portfolio. I continue to work closely with the National Academies in data sharing and research, including most recently serving on the congressionally mandated committee to examine the current landscape of newborn screening systems, processes, and research in the U.S. to recommend future improvements.
Because of the symbiotic relationship between my research on data sharing and demographic diversity with artificial intelligence/machine learning technologies, I also represented the medical school on the U-M 2023 Provost’s Generative AI Advisory Committee which developed a comprehensive report to assess the opportunities and challenges posed by Generative AI to make recommendations on how to ensure the technology is used responsibly, ethically, and equitably across U-M. I am currently on the ongoing campus and Michigan Medicine Generative AI committee and gave input to President Biden’s 2023 Executive Order on AI and Health.
I began my career as legal counsel for medical drug and device companies designing direct-to-consumer advertising and training sales representatives to sell their products in a compliant fashion. But when does a genetic testing ad—promising that consumers will be able to “do things a little differently” for their health—imply the test is a diagnostic device in violation of FDA law? I quickly learned about the sometimes sizable “gap” between vague health laws and how they are interpreted and applied by the rapidly evolving health technology market. We often relied on industry “best practice” recommendations to fill that gap.
During this time, I also became interested in how the way industry fills these gaps affects access for patients. Does the genetic testing advertisement educate patients about their options? Or does it dissuade them from going to see a doctor about health concerns? At the time, President Obama was also devoted to issues of enhancing health access, so I transitioned to a career where I could focus on these issues, serving as Associate Director for the Presidential Commission for the Study of Bioethical Issues (2010-2015).
The same gap was now apparent from the other side. But this time, I realized it was caused by governance structures perennially out of sync with regulated industry. Policymakers in the legislative branch are often required to translate scientific research into recommendations quickly; the pace of politics does not follow the academic calendar. There is often insufficient time to assimilate the literature, and potential impacts, before deadlines. Moreover, policymakers generally lack the knowledge to understand the science behind the policy.
By contrast, agency regulation in the executive branch generally happens slowly. The government often has to apply outdated regulations to new technologies. Therefore, legislatures passing laws are often moving too fast, and agencies promulgating regulations too slowly, to effectively govern the rapidly evolving health technology market. This is why industry has the flexibility to fill in those gaps itself.
But for-profit entities are primarily interested in what drives the market—and sells their product. What industry chooses to fill governance gaps with will often primarily be focused on self-interest and profit. Reliable models for flexible governance mechanisms are therefore critical to ensuring access issues remain at the forefront.
The science of genetics has time and again been promised as the basis for much health improvement. The private genetic testing industry is also growing rapidly. As a result, I began to focus on the effective governance of the direct-to-consumer genetic testing industry, as well as the increasing privatization of genetic data. But I realized that we need ethical, legal, and social implication (ELSI) researchers fluent in both the science of genetics and empirical methods to design the research necessary for enabling best practice governance models that will fill the gap between regulation of, and the market for, genetic data. As the Obama administration ended, I decided academia would provide me with the freedom necessary to approach this complex topic. Since then, I became the first faculty member with a JD as a terminal degree to make tenure in the medical school.
I won the Kennedy Center American College Theater Festival “One- Act” Play competition in 2004