Bioethicists call for Oversight of poorly regulated, consumer-grade neurotechnology products (Medical News):

“The marketing of direct-to-consumer “neurotechnologies” can be enticing: apps that diagnose a mental state, and Brain devices that improve cognition or “read” one’s emotional state. However, many of these increasingly popular products aren’t fully supported by science and have little to no regulatory oversight, which poses potential health risks to the public. In a new piece published in the journal Science this week, two bioethicists from Penn Medicine and the University of British Columbia suggest the creation of a working group that would further study, monitor, and provide guidance for this growing industry — which is expected to top $3 billion by 2020.

“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,” said lead author Anna Wexler, PhD, an instructor in the department of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania. “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.”

The Paper

Oversight of direct-to-consumer neurotechnologies (Science):

Summary: Marketed for the purpose of modulating cognition or a variety of affective and mental states, a growing ecosystem of neurotechnology products is being sold direct to consumers (DTC) without necessitating the physician as intermediary. Offering individuals the prospect of monitoring and manipulating a range of brain functions from memory to mental health, the major product categories are neuromonitoring devices, cognitive training applications, neurostimulation devices, and mental health apps. The market for these products is predicted to top $3 billion by 2020 (1). Yet there are good reasons to conclude that regulatory oversight of DTC neurotechnologies is insufficient. We suggest ways to provide systematic support for regulatory agencies, funding bodies, and a public that is thirsty for knowledge about the efficacy of DTC neurotechnology products.

News in Context

• Guidance by the National Institute for Health and Care Excellence (NICE) on the use of transcranial direct current stimulation (tdcs) for depression
  
• FDA clears first CBT-based digital therapeutic to treat substance abuse disorders
  
• The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation
• Important insights on the growing home use of tDCS brain stimulation
• 10 Neurotechnologies About to Transform Brain Enhancement and Brain Health