Risks and capability
Four neurotechnology risk objects open the portfolio. Order carries no rank. Each is read across driver, exposure, vulnerability, capacity, cascade and consequence.
Contents
- ·Edition home
- ·Executive summary
- 1Neurotechnology is clinical hardware and a new class of personal data
- 2Key findings
- 3Systems and sectors at baseline
- 4Risks and capability
- 5Consumer neural data outside medical rules
- 6Readings from the other desks
- 7The 2027 agenda
- 8Systems in depth
- AMethodology
- BData appendix
- CReferences and record
- ·Complete edition, for print
4.1Risk objects
Each risk is read across the chain from hazard to consequence, with its status and evidence-quality level.
InferredEQL 3RSK-XT20-DAT-001
Neural data outside medical and privacy rules
- Driver
- consumer headsets and decoders that infer mental states518
- Exposure
- users of consumer devices; participants in speech trials
- Vulnerability
- inferred data fall in a grey zone in Chile18; US rules differ by state1412
- Capacity
- UNESCO Recommendation; state laws; a Senate study bill101411
- Cascade
- DAT → FIN, HLT, GOV
- Horizon
- 1 to 5 years
InferredEQL 3RSK-XT20-INF-002
Long-term signal loss and device failure
InferredEQL 3RSK-XT20-GOV-003
Fragmented rules and uneven access
Expert inputEQL 2RSK-XT20-FIN-004
Company claims ahead of peer-reviewed evidence
4.2Capability ladder
Existence is not readiness. Each of the fifteen capability functions is placed on the ladder by the strongest public evidence for neurotechnology at the global level.
| Function | Rung | Level | Strongest public evidence at baseline |
|---|---|---|---|
| Prevention and mitigation | EXISTS | FDA guidance on testing implanted interfaces; UNESCO Recommendation910 | |
| Monitoring and observation | LISTED | no common tracker of device failure or neural data practices | |
| Early warning | LISTED | no consolidated signal system | |
| Preparedness and planning | EXISTS | registry entries, policy targets and a Senate study bill111316 | |
| Redundancy and reserves | LISTED | support continuity if a device company ceases is not documented | |
| Response | LISTED | no tested response to a data incident or device recall at scale | |
| Continuity of critical services | LISTED | long-term follow-up and device support not reported | |
| Recovery | LISTED | not applicable at baseline | |
| Adaptation | EXISTS | decoder recalibration and drift-correction methods studied22 | |
| Social protection | LISTED | access to implants for those who need them is not documented | |
| Finance and insurance | LISTED | reimbursement not reviewed; private rounds large20 | |
| Institutional coordination | EXISTS | UNESCO, OECD and national policies101631 | |
| Technical infrastructure | EXISTS | clinical trial sites and a cleared cortical-surface array815 | |
| Workforce | LISTED | surgeons and programming staff; no figure bound | |
| Research capacity | ADEQUATE | strong peer-reviewed base1257 | |
| A capability listed in policy is not a tested one; each rung is the strongest public evidence at baseline. | |||
Notes
Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references
- 5Kunz, E.M. et al., Inner speech in motor cortex and implications for speech neuroprostheses, Cell 188(17), 4658 to 4673, published online 14 August 2025 (reference record read: four participants). Cell Press, Cambridge MA. Observation year 2025. Accessed 2026-11-03.back
- 18Lee, B.H., Even Chile neurorights leave inferred mental data in a gray zone, Stanford Law School Law and Biosciences Blog, 27 April 2026 (blog page read; commentary, not a legal text). Stanford University, Stanford. Observation year 2026. Accessed 2026-11-03.back
- 14Colorado General Assembly (ed.), HB24-1058 Protect Privacy of Biological Data (bill page read: signed 17 April 2024; effective 7 August 2024). Colorado General Assembly, Denver. Observation year 2024. Accessed 2026-11-03.back
- 12US Senate Committee on Commerce, Science, and Transportation (ed.), release on the introduction of the MIND Act, 24 September 2025 (release read: names Colorado, California, Montana and Connecticut as states with neural data laws). US Senate, Washington. Observation year 2025. Accessed 2026-11-03.back
- 10UNESCO (ed.), Recommendation on the Ethics of Neurotechnology (page read: adopted November 2025 at the 43rd session of the General Conference; mandate entrusted by 194 Member States in 2023; the page states no neural data provisions). United Nations Educational, Scientific and Cultural Organization, Paris. Observation year 2025. Accessed 2026-11-03.back
- 11United States Senate (ed.), Management of Individuals Neural Data Act of 2025 (MIND Act), S. 2925, 119th Congress, introduced text (text read: FTC study and report within one year of enactment; USD 10 million authorised; referred to committee). US Government Publishing Office, Washington. Observation year 2025. Accessed 2026-11-03.back
- 22Ma, X. et al., Using adversarial networks to extend brain computer interface decoding accuracy over time, eLife 12, e84296, 2023 (reference record read). eLife Sciences, Cambridge. Observation year 2023. Accessed 2026-11-03.back
- 24Feng, Y. et al., Brain-computer interfaces: the dawn of a new era in disease treatment, Exploration 6(3), 2026 (reference record read: electrode biocompatibility and signal resolution named as challenges). Wiley, Beijing. Observation year 2026. Accessed 2026-11-03.back
- 7Lorach, H. et al., Walking naturally after spinal cord injury using a brain-spine interface, Nature 618(7963), 126 to 133, published online 24 May 2023 (reference record read: fully implanted; stable for over one year; one man with chronic tetraplegia). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
- 8Chetty, N. et al., Signal properties and stability of a chronically implanted endovascular brain computer interface, medRxiv preprint, 25 September 2025 (preprint record read: five participants; 16-channel array; one year; not peer reviewed). Cold Spring Harbor Laboratory, New York. Observation year 2025. Accessed 2026-11-03.back
- 9US Food and Drug Administration (ed.), Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation: Non-clinical Testing and Clinical Considerations, final guidance, May 2021 (guidance page read). Center for Devices and Radiological Health, Silver Spring. Observation year 2021. Accessed 2026-11-03.back
- 15Precision Neuroscience (ed.), company release on FDA 510(k) clearance of the Layer 7 Cortical Interface, 17 April 2025 (release read; vendor announcement, weak evidence: up to 30 days of implantation; 37 patients tested). Precision Neuroscience, New York. Observation year 2025. Accessed 2026-11-03.back
- 16Ministry of Industry and Information Technology and six other bodies (eds.), Implementation Opinions on Promoting the Innovation and Development of the Brain-Computer Interface Industry, MIIT (2025) No. 164, 23 July 2025, English translation by the Center for Security and Emerging Technology, 18 December 2025 (translation page read). Georgetown University, Washington. Observation year 2025. Accessed 2026-11-03.back
- 40UNVERIFIED, not opened: ISO (ed.), ISO 14708-3, Implants for surgery: active implantable medical devices, part 3, implantable neurostimulators, cited from memory without figures. International Organization for Standardization, Geneva. Observation year 2017. Accessed 2026-11-03.back
- 20Zeff, M., Elon Musk Neuralink closes a USD 650 million Series E (trade report, 2 June 2025; page read; vendor statement as reported: five people implanted; valuation of about USD 9 billion pre-money from an earlier press report). TechCrunch, San Francisco. Observation year 2025. Accessed 2026-11-03.back
- 27UNVERIFIED, not opened: Paradromics (ed.), company statements on an FDA investigational device exemption for the Connect-One early feasibility study (November 2025, two initial participants) and a first implant at a university hospital, taken from search-result summaries of vendor announcements; weak evidence. Paradromics, Austin. Observation year 2025. Accessed 2026-11-03.back
- 30UNVERIFIED, not opened: trade reports of other company funding rounds in 2025 including a Series D for an endovascular interface company and a seed round for a new interface company, taken from search-result summaries; weak evidence and no figure used. Observation year 2025. Accessed 2026-11-03.back
- 13ClinicalTrials.gov (ed.), PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices, NCT06429735 (record read: recruiting; start 9 January 2024; estimated enrolment 15; updated January 2026; sponsor-supplied entry). National Library of Medicine, Bethesda. Observation year 2026. Accessed 2026-11-03.back
- 31UNVERIFIED, not opened: OECD (ed.), Recommendation of the Council on Responsible Innovation in Neurotechnology, 2019, cited from memory. Organisation for Economic Co-operation and Development, Paris. Observation year 2019. Accessed 2026-11-03.back
- 1Willett, F.R. et al., A high-performance speech neuroprosthesis, Nature 620(7976), 1031 to 1036, published online 23 August 2023 (reference record read: 62 words per minute; 23.8% word error rate on 125,000 words; 9.1% on 50 words). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
- 2Metzger, S.L. et al., A high-performance neuroprosthesis for speech decoding and avatar control, Nature 620(7976), 1037 to 1046, published online 23 August 2023 (reference record read: median 78 words per minute; median word error rate 25%). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
