Quantum Trials: An FDA for Quantum Technology


Publish Date:
May 7, 2024
Publication Title:
Stanford Center for RQT Research Series
Stanford Law School
Journal Article Volume 1
  • Alexandra Waldherr, I. Glenn Cohen & Mauritz Kop, Quantum Trials: An FDA for Quantum Technology, 1 Stanford Center for RQT Research Series (2024).
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Quantum technology (QT) development and adoption by the markets promises high innovational rewards but is not yet sufficiently guarded by legal and ethical guidelines. Educational barriers remain high, while risk/benefit curves need to be optimized. In this article, we propose a phased regulatory framework for regulators to incentivize (or mandate) responsible development of novel QTs. Inspired by the way how policy makers and legislators have approached the problem of market approval in the pharmaceutical space, we draw parallels to stages in QT research and development: The FDA Clinical Trial model – three phases that precede market authorization, followed by a fourth post-approval stage – can be translated into an analogous structure to assess quantum developments. We propose the instatement of a federal agency which can guide, structure and market-authorize second generation (2G) QT. Our proposal, inspired by the clinical registry, hopes to set the table for regulating emerging quantum technologies.