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Brain-Computer Interfaces (BCIs) measure brain activity and can be used to control digital devices. The focus of BCI development has been on using the technology to allow patients to control assistive equipment such as wheelchairs or prostheses. Beyond medicine they are under development for applications in entertainment, marketing and defence. This POSTnote looks at the underpinning technology, its applications and the associated ethical and regulatory challenges.

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BCIs are a type of Neural Interface (NI), a broader family of devices that interact with an individual’s brain and nervous system. The term BCIs was first used in 1973. Since then, development has mainly focused on researching brain function and medical applications, such as assisting a patient with paralysis to communicate or control a prosthetic such as a limb or a wheelchair. BCIs have been highlighted by the Chief Medical Officer as an emerging technology with therapeutic potential. Other sectors, such as entertainment and defence, are also developing BCIs, while companies and entrepreneurs are investing in heavily in BCIs and other NIs.

BCIs present ethical challenges, many of which also apply more widely to other types of NI. In September 2019, a report by the Royal Society suggested that the UK could lead in developing responsible regulation and new applications for NIs.

Key Points:

• BCIs collect data from the brain and can translate it into control commands for electronic devices.
• BCIs can be categorised as invasive or non-invasive depending on where the device’s sensors are placed. Invasive BCIs use sensors that are implanted during a surgical procedure and non-invasive BCIs use sensors that are located outside the skull.
• Since the 1970s BCI research and development has been centred on medical applications, mostly focused on restoring lost function in patients, for example, following paralysis.
• Due to a range of technical challenges, practical clinical use has not yet been achieved. However, investment in BCIs is increasing and innovative approaches are being developed to address these issues.
• BCIs are also being developed outside medicine for brain-controlled gaming and improvement of cognitive functions, for which some companies already market consumer products.
• Companies are developing non-invasive BCI headsets to play computer games. These would allow users to control actions within the game via thought.
• The MoD is investigating how BCIs can enhance different cognitive abilities, including decision-making and sensory processing. In the U.S, the Defence Advanced Research Project Agency has an extensive funding programme on developing NIs and BCIs for military use.
• Given the pivotal role of the brain to human functioning, the ethics of using BCIs has been the subject of recent debate. Issues include safety, privacy, fair access, assessing risks versus benefits and attributing responsibility for actions involving BCIs.
• In 2013, the Nuffield Council on Bioethics published an ethical framework for technologies that interface with the brain.
• In the UK, there is no regulation specific to BCI technology. However, BCI systems may fall within the scope of the EU Medical Devices Regulation (MDR) if they are intended for medical use. BCI devices that fall outside the scope of the MDR will still be governed by consumer protection laws.
• New regulatory approaches may be needed to help stimulate further innovation and to ensure privacy and safety of BCI devices.

Acknowledgements

POSTnotes are based on literature reviews and interviews with a range of stakeholders and are externally peer reviewed. POST would like to thank interviewees and peer reviewers for kindly giving up their time during the preparation of this briefing, including:

• Alberto Garcia-Mogollon, British Standards Institution*
• Carolyn Young, NHS England*
• Dr  Marcello Ienca, ETH Zurich*
• Dr Andrew Sims, Newcastle University
• Dr Emily Postan, University of Edinburgh*
• Dr Hannah Maslen, University of Oxford
• Dr Jinendra Ekanayake, University College London*
• Dr Matt Richins, Defence Science and Technology Laboratory*
• Dr Sarah Chan, University of Edinburgh
• Dr Stephen Rainey, University of Oxford*
• Dr Tim Constandinou, Imperial College London*
• Duncan McPherson, Medicines and Healthcare products Regulatory Agency*
• Gavia Taan, Medicines and Healthcare products Regulatory Agency*
• Hugh Whittall, Nuffield Council on Bioethics*
• Jack Pilkington, Royal Society*
• Martin Glasspool, GO-Science*
• Professor Anna Wexler, University of Pennsylvania*
• Professor Chris Toumazou, Imperial College London
• Professor Dimitri Kullmann, University College London*
• Professor Jonathan Cole, Poole Hospital NHS Foundation Trust*
• Professor Narender Ramnani, Royal Holloway University & Trustee for Research Policy at the BNA*
• Professor Neil Burgess, University College London*
• Professor Tim Dension, University of Oxford*
• Robert Turpin, British Standards Institution*
• Sana Ahmed, GO-Science
• Tre Azam, MyndPlay*

*denotes people and organisations who acted as external reviewers of the briefing.