What if the United States regulated emerging quantum technology the way it regulates new medicines? That is the provocation at the center of Quantum Trials: An FDA for Quantum Technology, a Stanford Law School working paper by Alexandra Waldherr, I. Glenn Cohen, and Mauritz Kop, posted as a preprint and first presented at the 2023 Stanford Responsible Quantum Technology Conference. The paper proposes a phased, documentation-driven pipeline for second-generation quantum technology, modeled on the FDA's clinical-trials regime.
A phased pipeline for quantum
The framework maps the FDA's four stages onto quantum research and development. Phase I captures a theoretical idea or laboratory proof-of-concept in a concise technical one-pager; Phase II adds a proof-of-principle validation with an ethical checklist; Phase III is a confirmatory stage whose findings are condensed into a Summary of Quantum Characteristics for regulatory assessment; and Phase IV follows the authorized technology through its public lifecycle, with failure reports and audits. Throughout, "efficacy" is reread as technical innovation and "safety" as the absence of unresolved ethical and legal concerns. A binding registry ties the phases together, serving regulators, engineers, educators, and the public from one shared record.
SEA TURTLE and the registry-first first step
Over the phases sits the SEA TURTLE checklist—a six-point barometer distilling the Ten Principles for Responsible Quantum Innovation and the broader Responsible Quantum Technology paradigm into a quick test of whether a technology is both innovative and responsibly developed. Its "SEA" element names a commitment to Safeguarding, Engaging, and Advancing quantum technology, society, and humankind. The authors are realistic about the political capital a full "FDA for Quantum" would demand, so they single out one immediate, low-cost step: making the registration of quantum developments mandatory by law, in the spirit of the legislation that produced clinicaltrials.gov. A standardized registry, they argue, gives regulators the evidence they need to balance underregulation against overregulation.
Why the analogy matters for governance
The deeper argument is structural. A young, dual-use, exponentially developing field is better served by an evidence-generating, phased pipeline than by either premature prohibition or laissez-faire. The same logic animates the authors' work on law, ethics, and policy of quantum and AI in healthcare and the ethics of biomedical discovery in Hippocratic Quantum. The paper does not claim the drug-approval analogy is settled; it invites the physics community to test its feasibility and the legislative branch to adopt, evaluate, and refine it. As an opening move in the design of quantum-specific regulatory institutions, it is less a verdict than a carefully argued invitation.
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