Guidelines developed by the Organisation for Economic Co-operation and Development (OECD).
Adopted on October 12, 2019.
The Need for an International Standard for Responsible Innovation in Neurotechnology
Novel neurotechnology offers significant potential for the promotion of health, well-being, and economic growth. Mental health is an increasingly important public health concern in OECD Member countries and beyond.Mental and neurological disorders (e.g. Alzheimer’s disease and other dementias) cause great human suffering and are increasingly recognised as major causes of death and disability worldwide. They often remain untreated and impose significant economic and social welfare costs, elevating their importance to the highest national and international policy levels.
Neurotechnology is redefining what is possible in terms of monitoring and intervention in clinical and non-clinical settings, with great promise for improving mental health, well-being and productivity. Spearheaded by large national and international flagship initiatives in brain science and fuelled by a clear medical need, research both in the public and private sector has made considerable advances. In particular, the convergence between neuroscience, engineering, digitalisation, and artificial intelligence (AI) is becoming a key driver of innovation and will disrupt existing practices as well as traditional boundaries between medical therapies and consumer markets.
At the same time, neurotechnology raises a range of unique ethical, legal, and societal questions that potential business models will have to address. These questions include issues of (brain) data privacy, the prospects of human enhancement, the regulation and marketing of direct-to-consumer devices, the vulnerability of cognitive patterns for commercial or political manipulation, and further inequalities in use and access. Governance issues surrounding neurotechnology affect the entire innovation pipeline, from fundamental brain research, cognitive neuroscience, and other brain-inspired sciences to questions of commercialisation and marketing.
In order to respond to these issues, the OECD, through its Working Party on Biotechnology, Nanotechnology and Converging Technologies (BNCT), has been pursuing a five-year project focusing on developing a set of principles for responsible innovation in neurotechnology. These aim to assist governments and innovators in addressing and anticipating the governance challenges raised by mental and neurological disorders and novel neurotechnologies. [ . . . ]