Trust and Safety
VitalMatrix™ is a clinical intelligence platform undergoing MHRA Software as a Medical Device classification assessment. This page states exactly what the platform does, what it does not do, and how it is governed.
Regulatory Status: As of April 2026
MHRA SaMD Assessment in Progress
VitalMatrix™ is currently undergoing formal MHRA Software as a Medical Device (SaMD) classification assessment. Until classification is formally confirmed and any required regulatory steps are completed, the platform operates under Phase 1 clinical governance.
Under Phase 1 governance, all VitalMatrix™ outputs carry mandatory T-series protective language. Every clinical output includes a practitioner review requirement header. The platform does not prescribe or replace clinical judgement in any context.
We will communicate MHRA classification status transparently to all practitioners as the assessment progresses. No change to platform language or clinical capability claims will be made before formal classification is received and reviewed.
What This Means for Practitioners
What the Platform Does
Terrain intelligence scoring, cascade mapping, zone activation analysis, governed documentation output. Support for practitioner clinical reasoning.
What the Platform Does Not Do
Prescribe. Replace clinical judgement. Generate regulatory-cleared medical device outputs before MHRA classification.
What Every Output Carries
A mandatory protective header: "This output is a terrain intelligence support document. All clinical interpretation, decisions, and patient communication are the responsibility of the treating practitioner."
T-Series Clinical Governance
T-series restrictions are temporary Phase 1 regulatory governance measures. They determine exactly what clinical language is used, what is suppressed, and what requires practitioner approval before any patient-facing use.
Output Title Governance
All clinical outputs are titled "Personalised Terrain Management Protocol": not "Protocol", "Plan", or "Treatment". This is a T-series requirement until MHRA classification confirms the appropriate clinical language.
DRD™ Language Governance
The Driver is referred to as "Driver" in all practitioner-visible materials. The full DRD™ designation language is used in educational and architectural contexts only.
Content Scope: Phase 1
Phase 1 clinical content covers: dietary recommendations, supplement protocols (Emerging and above tier), and lifestyle interventions. Medication-terrain interactions are Phase 2 only. CS09 and CS10 are currently gated.
Mandatory Practitioner Decision Block
Every clinical output contains a blank "Practitioner Clinical Decision" section. This section is intentionally empty: the practitioner fills it. This is a permanent governance requirement that does not revert regardless of MHRA outcome.
Data Governance
ICO Registration
VitalMatrix Ltd is registered with the Information Commissioner's Office. Registration number: ZC101813. This registration is current and confirmed.
GDPR Compliance
All patient data processed through VitalMatrix™ is handled in accordance with UK GDPR. No patient data is used for AI model training. No patient data is shared with third parties. Data processing purposes are specified in the data processing agreement provided to practitioners on enrolment.
Data Retention
Patient data is retained only for the period specified in the data processing agreement. Practitioners can request data deletion at any time. VitalMatrix Ltd will respond to data subject access requests within the statutory timeframe.
Practitioner Safeguards
VitalMatrix™ was designed with practitioner protection as an architectural constraint, not an afterthought.
Mandatory Review Headers
Every clinical output carries a mandatory protective header. This is a permanent governance requirement: it does not change, it does not get switched off, and it does not require the practitioner to opt in.
Blank Clinical Decision Section
Every output includes a section titled "Practitioner Clinical Decision" that is intentionally left blank. The practitioner's decision is the output. The platform supports it: it does not supply it.
Evidence Tier Transparency
Every clinical framework in VitalMatrix™ carries an explicit evidence tier. You always know whether the intelligence you are working with is Established, Emerging, Contested, Observed in Practice, or Theoretical.
No Prescription, No Diagnosis
VitalMatrix™ does not generate prescriptions or referral letters. It generates terrain intelligence. The clinical acts are yours. The governance record supports your decision-making: it does not replace it.
Formal Registrations and Confirmations
ICO ZC101813
ICO Registration (Confirmed)
MHRA SaMD
Classification Assessment (In Progress)
UK GDPR
Full Compliance (Confirmed)
Questions About Governance?
If you have a question about VitalMatrix™'s regulatory status, data practices, or clinical governance that this page does not answer: ask us. We respond to every governance question personally.
Ask a Governance Question Read Our Clinical Ethics FrameworkRelated