REGULATING FOR THE FUTURE OF MEDICINE: TIME FOR A NEW TECHNOLOGY IN A BRAVE NEW WORLD?

Can we-should we-regulate health Big Tech? If so, how? In the age of CRISPR, Big Data analytics, robotics and AI, how can law keep up? Can regulation foster innovation and support individual and societal flourishing? Has the technology irrevocably outpaced regulation, as Big Tech lobbyists would have us believe, leaving us in some kind of anarchic dystopia where regulators are irrelevant and clinicians are subservient to the owners of the brave new tools? Notwithstanding recent high-profile examples of regulatory failure-an inability or unwillingness to effectively regulate medical technologies, in the face of conflicting patient, practitioner and corporate interests-empirical evidence indicates that regulation often does get it right but could do better. This paper proposes a new approach to technology-competent regulation, based on co-design principles that promote public and industry engagement, build trust and foster sufficient flexibility to accommodate rapid technological development across global markets.