Bioethicists say consumer neurotechnologies need more oversight

While direct-to-consumer neurotechnologies are popular, these products are not fully supported by science and have little regulatory oversight.

That’s the contention of two bioethicists from Penn Medicine and the University of British Columbia, writing this week in the journal Science. The authors propose the creation of an independent working group to study the poorly regulated market for these products—such as mental health apps—which is predicted to reach $3 billion by 2020.

“A growing ecosystem of neurotechnology products is being sold direct to consumers (DTC) without necessitating the physician as intermediary,” state the authors. “Yet there are good reasons to conclude that regulatory oversight of DTC neurotechnologies is insufficient.”

Part of the problem, contend the bioethicists, is that many of these products fall outside of the jurisdiction of the Food and Drug Administration because they are categorized as low risk. However, they point out that electroencephalography (EEG) devices—used to diagnose and treat epilepsy, among other conditions—can cause potential psychological harm in their attempt to determine the user’s emotional state.

“If a consumer EEG device erroneously shows that an individual is in a stressed state, this may cause him or her to become stressed or to enact this stressed state, resulting in unwarranted psychological harm,” according to the authors.

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Although most of the regulatory burden for consumer neurotechnologies falls under the auspices of the Federal Trade Commission, which has authority to act on false advertising claims, the authors make the case that the FTC cannot possible monitor and regulate the literally thousands of apps and devices on the market.

“There’s a real thirst for knowledge about the efficacy of these products from the public, which remains unclear because of this lack of oversight and gap in knowledge,” says Anna Wexler, lead author and an instructor in the Department of Medical Ethics and Health Policy at the University of Pennsylvania’s Perelman School of Medicine. “We believe a diverse, dedicated group would help back up or refute claims made by companies, determine what’s safe, better understand their use among consumers and address possible ethical concerns.”

Peter Reiner, professor in the Department of Psychiatry and the Neuroethics Collective at the University of British Columbia, is co-author of the article.

In their paper, Reiner and Wexler lay out their vision for the working group—composed of researchers, ethicists, funders and industry experts—that would serve as a clearinghouse for regulatory agencies by surveying the consumer neurotechnology market, providing appraisals of potential harms and probable efficacy as well as having the responsibility of publicly disseminating those assessments.

“Given that government agencies and private enterprises are actively funding research into new methods of modulating brain function,” the authors added, “the present generation of [direct-to-consumer] neurotechnologies may be only the tip of the iceberg—making it all the more imperative to create an independent body to monitor developments in this domain.”

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