Abstract: Biomedical devices are used in a variety of operational scenarios and application contexts. These include devices that are fitted on the body (wearables), those that are in-body (implantables), and those that are external to the body (e.g. remotely tethered). Implantable devices may monitor physiological characteristics known as vital signs, be diagnostic in nature (e.g. swallowable cameras), and may in some cases even facilitate drug delivery as medicine is required (e.g. insulin pumps). Biomedical innovation is heavily regulated given the health and medical focus of their application by government agencies like the Food and Drug Administration (FDA) in the USA, Conformité Européenne (CE) marking for devices by Notified Bodies in the European Union, the Therapeutic Goods Administration (TGA) in Australia, and the Medical Device License (MDL) in Canada. Contrarily, non-medical devices remain unregulated despite that some standards exist for human-computer interfaces. There is no oversight if a commercial entity offers a service that uses an animal injector kit to implant an RFID tag into the human body. Resellers of the non-medical technology in diverse applications claim that the risk and liability rests entirely with the consenting implantee. Increasingly the electromagnetic interference (EMI) by body area networks, personal area networks, commercial and public networks is being identified as a potential hazard to workable solutions, though public awareness is low, radio communications authorities are beginning to think about the long-term implications. Is it time to consider regulating non-medical implantables? What are the challenges and opportunities of doing so?
Biography: Katina Michael is the director for the Centre for Engineering, Policy and Society at Arizona State University. She holds a joint appointment in the School for the Future of Innovation in Society and the School of Computing, Informatics and Decisions Systems Engineering. Her PhD was on the technological trajectory of automatic identification technologies where she was a pioneer in investigating microchipping humans from a socio-technical systems perspective. Katina has worked previously as a senior network engineer and systems analyst for several transnational companies. She holds qualifications in information technology and the law with a research interest in national security and location-based services. Together with MG Michael she has introduced the term uberveillance into the bioethics literature. She is the founding editor in chief of the IEEE Transactions on Technology and Society.
Background: The annual GETS (Governance of Emerging Technologies and Science) conference has been running for 7 years and was the brain child of Professor Gary Marchant. An excellent initiative it brings together regulators, lawyers, governance experts, technologists, scientists and more. Information can be found here annually: http://events.asucollegeoflaw.com/gets/
The conference is hosted by Arizona State University’s Sandra Day O’Connor College of Law in the Beus Center for Law and Society.
The website notes: “This unique and innovative conference, now in its seventh year, addresses the ethical, legal, regulatory, and policy issues that surround the emergence of new technologies and scientific advances. Drawing on the combined expertise of leaders in academia, industry, and government, this conference focuses on finding governance solutions for rapidly changing technologies. The dual challenge of any governance system is to encourage research, investment, and development while guarding against potential risks to health, safety, environment, and society. We confront this challenge by creating a forum for radically cross-disciplinary discussion involving experts in law, engineering, science, business, medicine, ethics, and other fields.
In recent years, these discussions have covered the broadest possible range of technologies and scientific study, including nanotechnology, artificial intelligence, robotics, autonomous vehicles, the internet of things, human-machine interfaces, neuroscience, synthetic biology, genomics, personalized medicine, telemedicine, human enhancement, gene editing, surveillance, national security, virtual and augmented reality, blockchain, autonomous weapon systems, and so on. The value we have uncovered in combining such a variety of subjects is that governance strategies and lessons learned in one field can often be applied to others in ways that generate new breakthroughs. This conference has thus become a go-to event for forward-looking policy makers, technologists, and business leaders who are at the forefront of a changing world.”
Citation: Katina Michael, 2019, “Towards the Regulation of Non-medical Implantables: Challenges and Opportunities”, 7th Annual Conference on Governance of Emerging Technologies and Science (GETS), 22-23 May 2019, Phoenix, Arizona.