By Debra J. H. Mathews, Rachel Fabi and Anaeze C. Offodile II
Robyn is a 67-year-old Australian woman whose major depression was well managed with transcranial direct current stimulation (tDCS), a novel neurotechnology being used clinically in some countries, under the close supervision of her psychiatrist in Sydney. The treatment, which is approved by Australia’s Therapeutic Goods Administration, was covered by her private insurance. However, when Robyn moved to the United States for work, she was dismayed to learn that the treatment is not approved here. Increasingly anxious about her worsening symptoms, she went online and ordered a “wellness aid” that looked something like the device she remembered from her doctor’s office. One week and $250 later, she began using the device at home, trying her best to replicate the way her psychiatrist placed it on her head and the settings she had used.
When his school day ends, Liam, a ninth grader, pops on the tDCS device that his parents got him for his birthday before he begins to play computer games. Although not regulated by the US Food and Drug Administration (FDA), the device he wears is marketed to adults as a way to improve attention and focus. Liam feels it helps him concentrate when he’s gaming, as well as with his schoolwork and violin practice—so he uses it once or twice a day to try to maintain his edge at his competitive high school. His little brother, who is in third grade and struggles with attention-deficit/hyperactivity disorder, uses it occasionally as well.
These vignettes about Robyn and Liam, although hypothetical, highlight some of the questions raised by new tDCS technology. Is self-administered tDCS an adequate substitute for the mental health care that Robyn needs? What effects will chronic use have for Liam and his little brother? What other issues might arise from widespread and unregulated use of this emerging technology?
Transcranial direct current stimulation is one of many rapidly developing health-related technologies that transcend today’s regulatory boundaries. As these technologies spread, they raise short-term questions like those embodied in these two vignettes, while also posing larger questions about how the technologies will affect society and how they should be governed. To begin to identify and address these questions for a range of new technologies, a new committee established by the National Academy of Medicine has developed a systematic methodology to inform a novel governance framework that considers not only the experiences of individuals like Robyn and Liam, but also anticipates larger social impacts.
This methodology is necessary because novel technologies developed to support and advance health and medicine that once stayed in the clinic are now making their way into workplaces, homes, entertainment, and beyond. Boundaries that once seemed clear—the difference between medical treatment and self-enhancement, for example, or the demarcation between therapy intended for adults and gaming devices intended for children—are blurring. Although neural technologies such as tDCS may someday have the potential to transform mental health care, their ease of use, low cost, and relatively low physical risk have led to broad availability and use with little oversight.
By expanding access to promising technologies and driving their rapid evolution, such sector-crossing diffusion could be beneficial. But it can also broaden and magnify complex social, legal, and ethical issues. And as these technologies evolve simultaneously in multiple settings, it will be nearly impossible to anticipate or attend to their impacts on individuals, groups, or society at large.
How should such technologies be regulated and governed? It is increasingly clear that past governance structures and strategies are not up to the task. What these technologies require is a new governance approach that accounts for their interdisciplinary impacts and potential for both good and ill at both the individual and societal level.
To help lay the groundwork for a novel governance framework that will enable policymakers to better understand these technologies’ cross-sectoral footprint and anticipate and address the social, legal, ethical, and governance issues they raise, our team worked under the auspices of the National Academy of Medicine’s Committee on Emerging Science, Technology, and Innovation in health and medicine (CESTI) to develop an analytical approach to technology impacts and governance. The approach is grounded in detailed case studies—including the vignettes about Robyn and Liam—which have informed the development of a set of guiding principles.
Based on careful analysis of past governance, these case studies also contain a plausible vision of what might happen in the future. They illuminate ethical issues and help reveal governance tools and choices that could be crucial to delivering social benefits and reducing or avoiding harms. We believe that the approach taken by the committee will be widely applicable to considering the governance of emerging health technologies. Our methodology and process, as we describe here, may also be useful to a range of stakeholders involved in governance issues like these.
