The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Direct-to-Consumer Neurotechnology: Ethical Applications Today and Tomorrow

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) heard this morning from a panel of experts representing the neurotechnology sector and regulatory agencies on the ethical considerations in direct-to-consumer (DTC) sales of neurotechnologies. The Bioethics Commission is reviewing the ethical issues associated with the application of neuroscience research in response to President Obama’s request as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.

Starting off the conversation, John Reppas, M.D., Ph.D., the Director of Public Policy at the Neurotechnology Industry Organization, discussed the current state of the DTC neurotechnology market. Breaking direct-to-consumer neurotechnologies into two categories, Reppas discussed technologies that measure data and have back-end technologies to analyze data, as well as devices that send artificially generated signals into the brain or body.

“Measurement devices are considered quite safe,” said Reppas. “For this product class, the major real-world concern would center on data privacy and ownership, as well as how that data ends up being presented back to the consumer,” said Reppas.

For products that aim to change ongoing brain function to produce specific behaviors, like relaxation or more efficient learning, Reppas said that “the ethical imperative is to make sure that these products don’t have unanticipated long-term effects on user behavior or health.”

On the question of how these technologies should be regulated, Reppas argued that the neurotechnology sector has been safe and use of these technologies often changes once they’ve reached the market.

Carlos Peña, Ph.D., M.S., the Director of the Division of Neurological and Physical Medicine Devices in the Office of Device Evaluation at the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) focused on the steps that the FDA takes to regulate new products, including past efforts to regulate neurological devices such as deep brain stimulators, neurodiagnostic devices, and therapeutic devices for migraines.

Picking up the conversation of FDA regulation, Freddie Ann Hoffman, M.D., CEO of the consulting firm, HeteroGeneity LLC and Former Deputy Director of the Medicine Staff in the Office of the Commissioner at the U.S. FDA, shared her expertise on past FDA regulatory requirements, specifically with regard to the Dietary and Supplement Health and Education Act. Hoffman focused primarily on the regulatory standards that exist for dietary supplements and drugs to help establish the framework into which neurotechnologies must fit.

“There are specific legal assumptions that surround these two categories,” explained Hoffman. “Dietary supplements are intended to supplement the diet of healthy, normal individuals for which no risk is really tolerable, versus drugs which are intended for use by a population for which the benefit has been proven to outweigh the risks.”

Wrapping up the panelist’s presentations, Deven McGraw, J.D., M.P.H., LL.M., focused on privacy issues. McGraw is a partner at Manatt, Phelps & Phillips, LLP and Former Director of the Health Privacy Project at the Center for Democracy and Technology. Discussing existing regulations to protect privacy, McGraw explained that DTC neurotechnology is not clearly regulated under the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

“HIPAA generally is not going to apply in the context of DTC technology; it has very limited coverage,” said McGraw. “The DTC space is collecting a lot of health data…and is not going to be covered. Most medical devices are not covered, as well.”

McGraw went on to explain where there is currently authority to regulate these types of devices within the Federal Trade Commission (FTC). “It isn’t the case that this is a completely unregulated space. The data and the use of it are regulated to some extent by the FTC,” said McGraw. “The FTC has authority to prevent and seek redress for unfair acts or practices. They have very broad authority and they’ve used it to penalize some consumer-facing for-profit companies for failing to abide by a privacy policy.”

However, McGraw explained, “[the FTC] doesn’t set a comprehensive set of guardrails and rules on the data being collected on these devices.”

Following lunch, the Bioethics Commission will return to hear about clinical innovations through neuroscience research.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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