Regulatory Information
Last updated: 22 Aug 2026
Note for review — remove before publication. Changes in this version: intended purpose and Platform description added; clinical safety section expanded with the design controls and ongoing audit processes; document upload, voice transcription and the Clinical Assistant chat noted; clinical records position stated; MHRA guidance of 29 July 2026 referenced. Items marked [TO CONFIRM] require verification before publication.
Body Navigator is developed and operated by Andrew Jackson Physiotherapy and is committed to the highest standards of clinical safety, data protection, and regulatory compliance. This page provides the information physiotherapists and procuring organisations need to assess Body Navigator against their clinical governance and procurement requirements.
Medical Device Registration
Body Navigator is a Class I medical device registered with the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Devices Regulations 2002 (as amended). It is UKCA marked and self-certified by the manufacturer.
| MHRA registration number | 0000038522 |
| MHRA registration date | 8 June 2026 |
| Device classification | Class I (software as a medical device) |
| Classification rule | Rule 12, Annex IX — all other active devices |
| GMDN code | 61087 — Clinical management support software |
| Regulatory standard | UK Medical Devices Regulations 2002 (as amended) |
| UKCA marking | Self-certified by Andrew Jackson Physiotherapy |
| Manufacturer | Andrew Jackson Physiotherapy, UNTIL, 1 Orchard Street, London W1H 6HJ |
| Clinical Safety Officer | Andrew Jackson, MCSP SRP MSc BSc |
| Regulatory enquiries | office@thebodynavigator.com |
Body Navigator is available to registered physiotherapists and allied health professionals in Great Britain (England, Scotland, and Wales) only. It is not available in Northern Ireland, which is subject to a different regulatory framework.
Intended purpose
Body Navigator is a clinical reasoning support and knowledge organisation tool for HCPC-registered physiotherapists and other suitably qualified allied health professionals practising within their scope of practice in Great Britain.
The Platform retrieves relevant considerations, associations, relationships and specialist links from a curated clinical knowledge base in response to case information entered by the clinician, and — at the clinician’s direction — structures the clinician’s own ruled-in considerations into written outputs.
The Platform does not diagnose, does not determine management, and does not triage. Diagnostic conclusions, treatment decisions, prognostic judgements, referral decisions and red flag determinations are made by the registered clinician.
The Platform is not intended for use by, or provision to, students in pre-registration training, members of the public, or patients.
The full Intended Purpose Statement is available on request.
How the Platform works
Case information may be entered by typed text, by voice recording with transcription, or by document upload. The Platform then:
- retrieves relevant content from a private, curated clinical knowledge base and verifies its relevance to the specific case before any report is generated;
- produces category reports across nine clinical domains;
- surfaces clinical flags and high-priority considerations for the clinician to evaluate;
- structures the clinician’s ruled-in considerations into a working hypothesis, treatment effect and approach considerations, prognostic considerations, and supporting documents; and
- maintains a chronological case record to which the clinician may add notes from subsequent sessions.
An interactive Clinical Assistant chat operates on the case and the curated knowledge base. Where a response draws on the underlying model’s general clinical knowledge rather than the curated knowledge base, it is explicitly labelled as such.
Clinical safety
Body Navigator has undergone formal clinical risk assessment in accordance with the principles of DCB0129 (Clinical Risk Management for Manufacturers of Health IT).
Design controls
Clinical safety is addressed by design rather than by disclaimer. The principal controls are:
Progressive clinician affirmation. No consideration surfaced by the Platform carries forward to any subsequent stage unless the clinician affirmatively rules it in. Nothing arrives pre-selected — inaction excludes rather than includes. Clinicians may add considerations the Platform has not surfaced. Considerations ruled out are retained and may be returned to.
Reasoning presented for evaluation. Outputs present the reasoning and the findings on which a consideration rests, rather than a conclusion alone, so that the clinician evaluates the basis rather than receiving a verdict. Confidence ratings are not used; where a consideration is weakly supported, the output states what the available evidence does and does not cover.
Anchoring resistance. Named diagnoses, imaging findings and clinician labels present in the case notes are treated as claims to be evaluated rather than as steers. Each high-priority consideration is presented alongside the strongest competing explanation, with equal engagement, and a weighing of the two. Each report additionally carries a section of considerations that the presenting framing has pushed down the list, presented at equal depth.
Non-directive register. Outputs do not instruct the clinician or the patient. Management, monitoring and next-step content is framed as considerations to weigh.
Grounding and citation discipline. Content is retrieved from the curated knowledge base rather than generated from general model knowledge. Citations appear only where a retrieved source carries the claim. Where a named finding is inferred rather than tested, the output states what testing would have been required and that it is not documented.
Equity controls. Visually assessed signs are described using terms valid across skin tones, and a vasomotor, inflammatory or vascular consideration is not down-weighted because its classic visual cue is harder to detect in darker skin. Documented demographic factors are examined to a consistent standard rather than the most familiar factor being interrogated in greatest depth.
Demographic coherence check. Documented demographics are cross-checked against the clinical presentation before reasoning begins, and any incoherence is flagged explicitly rather than resolved silently.
Hazard management
Identified hazards and their controls are recorded in the Clinical Hazard Log, including hazards associated with generative AI such as hallucination, and the scope of the interactive Clinical Assistant chat.
Ongoing audit and post-market surveillance
| Process | Description |
|---|---|
| Regression testing | A fixed battery of standard cases is re-run whenever the model, the prompt suite or the knowledge base changes. Outputs are checked against expected clinical anchors to detect drift in reasoning quality. |
| Citation verification | A two-stage protocol — draft, then live verification of every reference — is applied to knowledge base content. |
| Change assessment | Every material change to the Platform is assessed for whether it alters the intended purpose or the device classification, and the assessment is recorded. |
| Promotional claims audit | Public-facing material is checked against the Intended Purpose Statement, since claims made about a product bear on its regulatory classification. |
| Post-market surveillance | User feedback and safety signals are monitored, with a duty to report serious incidents to the MHRA. |
| Periodic review | Classification and the compliance pack are reviewed at least annually, and sooner on publication of relevant regulatory guidance. |
Aggregated, de-identified metrics derived from Platform use may be applied to safety monitoring. Individual clinician records are not reviewed for the purpose of assessing professional performance.
Regulatory guidance
The Platform has been assessed against MHRA guidance published on 29 July 2026 concerning AI-enabled clinical software, including its interpretation of the boundary between reference information and clinical decision-making. The classification rationale is documented and is available to procuring organisations on request.
Documents available on request
- Intended Purpose Statement
- Clinical Hazard Log
- Classification rationale
- Declaration of Conformity
- Data Protection Impact Assessment
- Transfer Risk Assessment
To request any of these, email andrew@thebodynavigator.com.
Clinical records
Body Navigator supports clinical record-keeping; it does not replace it. Clinicians remain responsible for maintaining records in their own record-keeping system in accordance with HCPC and CSP requirements, including the retention periods applicable to those records. Data retention on the Platform is governed by the Privacy Policy and is not aligned to clinical record retention requirements.
Data protection
Body Navigator is operated in accordance with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018.
| ICO registration number | ZC164950 |
| Data controller (user and account data) | Andrew Jackson Physiotherapy |
| Data controller (patient data) | The treating clinician |
| Data protection contact | andrew@thebodynavigator.com |
Architecture. Patient identifier fields — patient name and age — are stored within the European Economic Area and are not transmitted to US-based AI sub-processors. Case notes content is processed by AI sub-processors in the United States under the UK Addendum to EU Standard Contractual Clauses.
Clinician responsibility. Clinicians are instructed not to enter direct patient identifiers into the case notes field. This applies equally to documents uploaded to the Platform, which routinely carry identifiers in headers and footers, and to voice recordings.
A Data Protection Impact Assessment and Transfer Risk Assessment are maintained and available on request.
Professional standards
Body Navigator does not alter the professional obligations of the clinicians who use it. Users remain accountable under HCPC standards and, where applicable, CSP guidance — including CSP principles on the use of artificial intelligence in practice, under which patients should be informed where AI tools have informed their care and any preference not to have such tools used should be respected.
Reporting a safety concern
If you become aware of any output that has caused, or could reasonably have caused, harm — or of any defect, deficiency or near-miss relevant to the safe operation of the Platform — please report it to andrew@thebodynavigator.com without delay.
Users may also report adverse incidents involving medical devices directly to the MHRA through the Yellow Card scheme.
Contact
For any regulatory, clinical safety, or data protection enquiries:
Andrew Jackson Physiotherapy — office@thebodynavigator.com
Legal Documents
Contact
For any regulatory, clinical safety, or data protection enquiries:
Andrew Jackson Physiotherapy – office@thebodynavigator.com