Clear Intended Purpose, Responsibilities and Evidence Boundaries
Governance and Compliance
Neuromap™ uses a governance-led approach in which the intended research use, delegated responsibilities, data handling, quality controls, evidence status and regulatory boundaries are defined before production work begins.
Last reviewed: 17 July 2026
Research-use scope
The Neuromap™ website describes analytical and scientific-support services for research. Unless a separate, documented pathway states otherwise, the service is not presented as a clinical diagnostic service, a replacement for clinical EEG interpretation, a medical decision system or regulatory advice. Every project defines the intended use, users, population, outputs, review level and prohibited interpretations.
UK clinical trials and Good Clinical Practice
The amended UK Clinical Trials Regulations took full effect on 28 April 2026, alongside UK implementation of ICH E6(R3) Good Clinical Practice. For a clinical trial of an investigational medicinal product, the sponsor retains responsibility for oversight and for ensuring that delegated activities are appropriately qualified and controlled. Neuromap™’s tasks, records, access, quality controls, data flows, issue management, audit support, escalation routes and release authority are documented in the applicable agreements and study materials.
Software and AI medical-device boundary
Whether software is a medical device depends on its intended purpose and claims. Neuromap™ does not use this website to claim MHRA approval, medical-device status, diagnostic performance or clinical decision authority. Where a proposed use could fall within the UK medical-device framework, classification, conformity assessment, clinical evidence, registration, post-market obligations and change management must be addressed before that use is offered or deployed.
NHS use and digital assurance
The website does not claim NHS approval or automatic suitability for NHS deployment. Any NHS use is subject to the receiving organisation’s procurement and assurance process. Depending on intended use and deployment, this can include Digital Technology Assessment Criteria, DCB0129 and DCB0160 clinical-safety standards, Data Security and Protection Toolkit expectations, accessibility, cyber security, information governance, interoperability and local contractual requirements.
Data protection and research information governance
EEG and associated health information can be special-category personal data. Controller and processor roles, lawful basis, Article 9 condition, transparency information, data minimisation, pseudonymisation, access, retention, security, sub-processing, international transfer and data-subject rights are defined for each project. A data-protection impact assessment is completed by the responsible organisation where required.
Responsible AI and human oversight
- AI or computational methods are used only for defined purposes within the approved workflow.
- Input requirements, limitations, uncertainty and version are documented.
- Data are minimised and protected according to the project’s governance model.
- Human review is applied at the contracted level and does not remove all uncertainty.
- Neuromap™ research outputs are not used for solely automated clinical decisions about individuals through the website service.
- Material algorithm or configuration changes are controlled and assessed before use in an active study.
Quality and data integrity
- Study-specific critical-to-quality factors.
- Documented roles, training and review authority.
- Controlled configurations, versions and change records.
- Traceable source files, processing status and deliverables.
- Predefined inclusion, exclusion and exception rules.
- Issue, deviation and corrective-action pathways.
- Retention and archival arrangements agreed with the sponsor or contracting party.
Evidence and claims governance
Analytical features, candidate biomarkers, internal benchmarks, peer-reviewed evidence and regulatory claims are distinct. Website and project wording must identify the evidence level and intended use. A statistical association, reference deviation or exploratory model does not independently establish disease, causation, efficacy, safety or clinical utility.
Partner responsibilities
| Party | Responsibility |
|---|---|
| Sponsor or research organisation | Defines the protocol, approvals, participant protection, oversight, intended use, data roles and decisions supported by the research. |
| CRO or operational partner | Manages delegated activities according to the sponsor agreement and maintains oversight of subcontracted work. |
| Neuromap™ | Delivers the contracted analytical and scientific-support activities within the approved specification and escalates limitations or deviations. |
| Clinical professionals | Provide any separately required clinical EEG interpretation, medical assessment, safety monitoring or treatment decisions. |
No implied certification
References to MHRA, HRA, ICH GCP, NHS England, DTAC, DCB standards, DSPT, UK GDPR or other frameworks describe relevant governance considerations. They do not imply certification, endorsement or approval of Neuromap™ unless a current, specific and verifiable status is explicitly published.
Frequently asked questions
Common questions about Neuromap™ governance and compliance.
Is Neuromap™ MHRA approved?
This website does not claim MHRA approval. Regulatory status depends on intended purpose and the specific function or deployment.
Is Neuromap™ NHS approved or NHS compliant?
No such claim is made. NHS use requires the receiving organisation’s applicable procurement, clinical-safety, DTAC, information-governance, cyber-security and contractual assurance.
Does GCP apply to every Neuromap™ project?
GCP applies according to the type and jurisdiction of the research. For UK CTIMPs, delegated Neuromap™ activities must sit within the sponsor’s applicable GCP and regulatory framework.
Who is responsible for participant safety?
Responsibilities are defined by the protocol and applicable law. Neuromap™’s research analytics service does not replace sponsor, investigator, medical-monitor or clinical-team responsibilities.