A report from the Nuffield Council on Bioethics has called for all technology tapping into brain waves to be classed as a medical device

Games tapping into brain waves 'should be regulated'

Video games and educational aids that tap into brain waves should be classified as medical devices, a think-tank has claimed.

The games, which use a helmet or headband to pick up electrical signals, ought to be regulated in the same way as breast implants, pacemakers and heart valves, according to the influential Nuffield Council on Bioethics.

Although brain-computer interface (BCI) technology is in its infancy, it is undergoing rapid development according to a new report from Nuffield.

One example already on the market is the Swedish game Mindball, in which brain waves are used to control a ball's movement across a table, which as well as providing entertainment, is intended to train players to be more relaxed and focused.

More obviously aimed at children, the Uncle Milton Star Wars Force Trainer uses similar technology to move a ball up and down a vertical tube.

The player, adopting the role of a Jedi Master from the Star Wars films to harness the power of "The Force", wears a headset that is said to respond to electrical activity from the brain.

Chair of the Nuffield enquiry Tom Baldwin, Professor of Philisophy at the University of York, says "some big players" in the gaming world appeared to be waiting on the side lines for the technology to progress.

"At the moment, BCI technology is not making much impact on the gaming industry, but the sense we got from the Americans we talked to was that everybody was just watching," he adds.

In future, games like these should be subjected to medical device scrutiny under European Commission law, according to the report.

The recommendation is part of a wider call for "smarter" regulation to ensure technology that connects with the brain is used in ways that put the care and safety of patients first.

Medical devices currently cover items as wide ranging as sticking plaster, hospital beds, hip replacements, X-ray machines, heart valves and pacemakers, and breast implants but the report says games and training aids that employ BCI technology should be added to this list.

Professor Graeme Laurie, from the University of Edinburgh, a member of the working party that produced the report, says: "What we would like to see is action from the European Commission to classify neuro devices as medical devices for regulatory purposes, even when they're being used for non-health care ends, such as gaming and educational purposes.

"What this would mean is that appropriate attention could be given to the health impact of these devices, because we believe that is where the priority should lie."

Other technology assessed in the report included treatments that stimulated neurons either with probes inserted into the brain or magnetic fields.

Deep Brain Stimulation (DBS), which employs electrode probes, is already used to treat Parkinson's disease. Transcranial Brain Stimulation (TBS), which uses magnetic fields, is licensed to treat depression in the US but only has a research permit in the UK.

The report said the regulation of such technology should encourage innovation while recognising the complexity of the brain and prioritising the needs of patients.

One recommendation made by the Council was offering patients undergoing procedures such as DBS or TBS independent counselling.

Co-author Professor Ilina Singh, from King's College London, said the brain treatments offered no guarantees to patients and presented a "complex mix" of benefits and side effects.

"We feel strongly that counselling should be offered to patients who are considering treatment using invasive neurotechnologies," she says.

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