Safely balancing a double-edged blade: identifying and mitigating emerging biosecurity risks in precision medicine
Authors: Dr. Dianne DiEuliis (National Defense University) & Dr. James Giordano (Georgetown University Medical Center)
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Tools and methods of precision medicine are developing rapidly, through both iterative discoveries enabled by innovations in biomedical research (e.g., genome editing, synthetic biology, bioengineered devices). These are strengthened by advancements in information technology and the increasing body of data—as assimilated, analyzed, and made accessible—and affectable—through current and emerging cyber—and systems- technologies. Taken together, these approaches afford ever greater volume and availability of individual and collective human data. Machine learning and/or artificial intelligence approaches are broadening this dual use risk; and in the aftermath of COVID-19, there is growing incentive and impetus to gather more biological data from individuals and their environments on a routine basis. By engaging these data—and the interventions that are based upon them, precision medicine offer promise of highly individualized treatments for disease and injury, optimization of structure and function, and concomitantly, the potential for (mis) using data to incur harm. This double-edged blade of benefit and risk obligates the need to safeguard human data from purloinment, through systems, guidelines and policies of a novel discipline, cyberbiosecurity, which, as coupled to ethical precepts, aims to protect human privacy, agency, and safety in ways that remain apace with scientific and technological advances in biomedicine. Herein, current capabilities and trajectories precision medicine are described as relevant to their dual use potential, and approaches to biodata security (viz.-cyberbiosecurity) are proposed and discussed.
The author(s) declare financial support was received for the research, authorship, and/or publication of this article. James Giordano was supported by federal funds from Award UL1TR001409 from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through the Clinical and Translational Science Awards Program (CTSA), a trademark of the Department of Health and Human Services, part of the Roadmap Initiative, “Re-Engineering the Clinical Research Enterprise”; National Sciences Foundation Award 2113811—Amendment ID 001; the Henry Jackson Foundation for Military Medicine; the Strategic Multilayer Assessment Branch of the Joint Staff, J-39, and US Strategic Command, Pentagon; the Institute for Biodefense Research; and Leadership Initiatives; and is currently serving as a Non-Resident Senior Fellow of the Simon Center for the Professional Military Ethic, United States Military Academy, West Point, NY, United States.
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