This document defines the medical and health-related disclaimers that govern all Omniwo products, services, communications, and user-facing content. It establishes the legal and regulatory boundaries within which Omniwo operates as a UK direct-to-consumer (D2C) wellness platform. All product teams, copywriters, designers, and developers must treat this document as a binding reference when creating any content that touches on health, biomarkers, wearable data, or predictive insights.
Omniwo combines at-home blood testing (fulfilled by our CQC-registered laboratory partner) with consumer wearable device data to provide users with educational wellness information. Omniwo does not diagnose, treat, cure, or prevent any disease or medical condition.
1.1. All information provided by Omniwo, including but not limited to biomarker results, wearable data summaries, trend projections, traffic-light statuses, health scores, and personalised recommendations, is for educational and informational purposes only.
1.2. Omniwo content does not constitute medical advice, clinical diagnosis, or a recommendation for any specific treatment, medication, or course of action.
1.3. Nothing presented within the Omniwo platform should be interpreted as a substitute for professional medical advice from a qualified healthcare provider. Users should always consult their GP or an appropriate medical professional before making decisions about their health, altering medication, or beginning or discontinuing any treatment.
1.4. Omniwo does not establish a doctor-patient, clinician-patient, or any other therapeutic relationship with its users. Use of the platform does not create such a relationship.
1.5. Individual health circumstances vary. Information that appears within a normal or optimal range for one individual may not be appropriate or applicable to another. Omniwo results must always be considered in the context of a user's full medical history, which only their healthcare provider can assess.
2.1. Omniwo is not a diagnostic service. The platform does not diagnose any disease, disorder, deficiency, or medical condition.
2.2. The traffic-light statuses (Green, Amber, Red, Urgent Red) assigned to biomarker results are informational wellness indicators. They reflect where a result falls relative to published reference ranges and are not clinical diagnoses or medical opinions.
2.3. A result flagged as Red or Urgent Red does not confirm the presence of a disease. Equally, a result flagged as Green does not guarantee the absence of a disease. Many conditions cannot be identified or excluded by a single biomarker test.
2.4. Omniwo does not interpret results in the context of a user's symptoms, medical history, concurrent medications, or other clinical factors. Only a qualified healthcare professional can perform such contextual interpretation.
2.5. No Omniwo output, whether textual, graphical, or numerical, should be treated as a clinical finding. Users must not self-diagnose or self-treat based on any information provided by the platform.
3.1. Omniwo is not a regulated medical device as defined by the Medicines and Healthcare products Regulatory Agency (MHRA) under the Medical Devices Regulations 2002 (as amended) or the forthcoming UK regulatory framework for medical devices.
3.2. The Omniwo platform, including its mobile application, web dashboard, algorithms, scoring systems, and any associated software, has not been registered, approved, or certified by the MHRA as a medical device, in vitro diagnostic device, or software as a medical device (SaMD).
3.3. Omniwo does not make any claims of clinical efficacy, diagnostic accuracy, or therapeutic benefit that would bring it within the scope of medical device regulation.
3.4. The Overall Status indicator and Health Score are wellness tools designed to summarise a user's biomarker profile in an accessible format. They are not clinical assessment instruments and must not be relied upon for medical decision-making.
3.5. Should the regulatory classification of wellness platforms change under future MHRA guidance, Omniwo will review and update its compliance position accordingly.
4.1. All blood sample analysis is performed by our independent CQC-registered and UKAS-accredited laboratory partner. Blood test results are processed and validated by qualified laboratory professionals operating under our laboratory partner's clinical governance framework.
4.2. Omniwo does not operate a laboratory, does not analyse blood samples, and does not employ laboratory scientists or pathologists for the purposes of result validation. Omniwo receives finalised results from its laboratory partner and presents them to users within the Omniwo platform.
4.3. The accuracy, precision, and reliability of blood test results are the responsibility of the laboratory partner under its CQC registration and UKAS accreditation. Omniwo relies on the accuracy of data provided by the laboratory and does not independently verify individual test results.
4.4. Reference ranges displayed within Omniwo are sourced from our laboratory partner's validated reference ranges unless otherwise stated. These ranges represent the values typically observed in a healthy population and may differ from ranges used by other laboratories or NHS services. Minor discrepancies between Omniwo-displayed ranges and those used by a user's GP do not indicate an error.
4.5. Omniwo's presentation layer (traffic-light statuses, summaries, educational content) is applied after results are received from our laboratory partner. The interpretive layer is educational, not clinical. The underlying laboratory result remains the definitive data point.
5.1.1. A single blood test provides a snapshot of a user's biomarker levels at one point in time. It does not represent a complete or longitudinal picture of health.
5.1.2. Biomarker levels fluctuate naturally due to factors including time of day, hydration status, recent food intake, exercise, stress, menstrual cycle phase, medication, and seasonal variation. A single result outside the optimal range does not necessarily indicate a health problem.
5.1.3. Trends observed across multiple tests over time are generally more informative than any single result. Users are encouraged to retest at recommended intervals and to discuss persistent trends with their GP.
The following principles govern the tone and content associated with each status level. These are not clinical grades but informational categories.
Green (Optimal)
5.2.1. A Green status indicates that a biomarker result falls within the optimal reference range. This is a positive indicator but does not guarantee good health or the absence of disease. Users are encouraged to maintain the behaviours that support their current levels.
5.2.2. Tone: Celebratory and encouraging. Reinforce positive habits.
Amber (Borderline)
5.2.3. An Amber status indicates that a biomarker result is approaching or has slightly exceeded the boundaries of the optimal range. This may warrant attention but is not cause for alarm.
5.2.4. Users with Amber results are encouraged to review lifestyle factors that may influence the relevant biomarker and to consider retesting in the recommended timeframe. If an Amber result persists across multiple tests, users should discuss it with their GP.
5.2.5. Tone: Calm, informative, and actionable. Provide practical context without causing unnecessary concern.
Red (Out of Range)
5.2.6. A Red status indicates that a biomarker result falls outside the standard reference range. This does not confirm a diagnosis, but it does suggest that a conversation with a GP is advisable.
5.2.7. Users with Red results should share their results with their GP for further evaluation. Omniwo provides a GP Share PDF for this purpose.
5.2.8. Tone: Serious and direct, but not alarming. Convey the importance of professional follow-up without using language that causes panic.
Urgent Red (Pulsing)
5.2.9. An Urgent Red status indicates that a biomarker result is significantly outside the reference range and may require prompt medical attention. Users must contact their GP as soon as possible. If their GP is unavailable, they should contact NHS 111.
5.2.10. Urgent Red messaging cannot be dismissed, suppressed, minimised, or hidden by the user. It must remain visible until the user acknowledges it, and the platform must log that acknowledgement.
5.2.11. Tone: Firm and safety-first. The language must convey urgency without using prohibited terms. The priority is to direct the user to professional medical care without delay.
Certain biomarkers require additional context due to their clinical complexity or potential for misinterpretation.
Lipoprotein(a) — Lp(a)
5.3.1. Lp(a) levels are primarily genetically determined and do not change significantly with diet or lifestyle modifications. An elevated Lp(a) result reflects a genetic predisposition, not a lifestyle failure. Users should discuss elevated Lp(a) with their GP, who may consider it alongside other cardiovascular risk factors.
Anti-Mullerian Hormone (AMH)
5.3.2. AMH provides an indication of ovarian reserve but does not determine fertility. A low AMH result does not mean a user cannot conceive, and a normal AMH result does not guarantee conception. Fertility is influenced by many factors beyond AMH. Users concerned about fertility should consult a reproductive health specialist.
Thyroid Stimulating Hormone (TSH)
5.3.3. TSH levels that fall slightly outside the reference range may indicate subclinical thyroid dysfunction, which is common and may not require treatment. Interpretation of borderline TSH results depends on the clinical context, including symptoms, other thyroid markers (Free T3, Free T4), and medical history. Users should discuss abnormal TSH results with their GP before drawing conclusions.
6.1. Omniwo may include cancer-associated markers such as Carcinoembryonic Antigen (CEA), Alpha-Fetoprotein (AFP), and Prostate-Specific Antigen (PSA) within certain test panels.
6.2. A single elevated cancer marker does NOT mean cancer. These markers can be raised for many reasons unrelated to cancer, including infection, inflammation, benign conditions, smoking, liver disease, and normal physiological variation.
6.3. Cancer markers are not screening tools when used in isolation. They are most useful when interpreted by a qualified clinician in conjunction with clinical examination, imaging, and medical history.
6.4. Omniwo does not screen for cancer, diagnose cancer, or rule out cancer. An elevated result should prompt a conversation with a GP, not a conclusion.
6.5. Users must not interpret a normal cancer marker result as confirmation that they are cancer-free. Equally, users must not interpret an elevated result as confirmation that they have cancer.
6.6. The following disclaimer must appear alongside every cancer marker result, without exception:
A single elevated marker does NOT mean cancer. Many non-cancerous conditions can cause elevated levels. Always discuss your results with your GP.
6.7. Cancer marker results must never be presented with language that implies a probability of cancer, a risk percentage, or a diagnostic conclusion.
7.1. Omniwo integrates data from consumer wearable devices. This data includes metrics such as heart rate variability (HRV), resting heart rate, sleep duration and quality, recovery scores, skin temperature trends, and activity levels.
7.2. Wearable devices are consumer-grade products, not clinical-grade medical instruments. The data they produce has not been validated to the same standards as medical monitoring equipment used in clinical settings.
7.3. Wearable data is subject to measurement variability, sensor limitations, fit quality, firmware differences, and environmental factors. It should be treated as an approximate indicator, not a precise clinical measurement.
7.4. When Omniwo presents correlations between wearable data and biomarker results, the following language rules apply:
7.5. Correlations drawn from wearable data and biomarker data are observational and educational. They do not establish causation and must never be presented as causal relationships.
7.6. Omniwo does not use wearable data to diagnose conditions, predict disease, or generate clinical recommendations. Wearable insights are contextual information designed to help users understand their wellness patterns.
7.7. Users should not make medical decisions based on wearable data alone. If wearable metrics suggest a concern (for example, a sustained elevation in resting heart rate), users should consult their GP.
8.1. Omniwo's features include trend projections based on a user's historical biomarker data. These projections use deterministic modelling only (linear regression applied to the individual user's own longitudinal data).
8.2. Projections are educational illustrations of where a biomarker trend may be heading if current patterns continue. They are not predictions of future health outcomes and they are not disease forecasts.
8.3. Projection language must follow this pattern:
8.4. Omniwo does not employ artificial intelligence or machine learning for health prediction, disease forecasting, or risk stratification. All trend calculations are transparent, deterministic, and based solely on the user's own historical data points.
8.5. Projections must not include probability percentages, confidence intervals presented as diagnostic certainty, or any language that implies clinical prognostication.
8.6. Projections are invalidated by changes in lifestyle, medication, diet, supplementation, or other factors. They assume a continuation of current patterns and do not account for future interventions.
8.7. Users must not rely on projections to make medical decisions. A projection suggesting a future suboptimal level is an invitation to take proactive steps and consult a healthcare professional, not a diagnosis of a future condition.
9.1.1. The Overall Status is a simple aggregate summary presented in the format "X of Y markers optimal" alongside a traffic-light colour indicator. It provides a high-level informational snapshot of a user's most recent test results.
9.1.2. The Overall Status is a wellness indicator, not a clinical assessment. It does not account for the relative clinical importance of individual markers, interactions between markers, or the user's medical history.
9.1.3. An Overall Status showing all markers as optimal does not constitute a clean bill of health. An Overall Status showing several markers outside optimal range does not constitute a medical diagnosis.
9.2.1. The Health Score is a weighted numerical score on a 0-100 scale. It is derived from biomarker results and, where available, wearable data. The weighting methodology reflects general wellness principles and is not a clinically validated scoring instrument.
9.2.2. The Health Score is an informational wellness tool, not a diagnostic instrument. It has not been validated in clinical trials, peer-reviewed studies, or regulatory submissions.
9.2.3. The Health Score must not be compared to clinical risk scores (such as QRISK, Framingham, or FRAX) or presented as equivalent to a clinician's assessment.
9.2.4. Changes in the Health Score over time may reflect genuine improvements or deteriorations in measurable wellness markers, but they may also reflect measurement variability, lifestyle fluctuations, or changes in the scoring methodology. Users should focus on understanding individual markers rather than fixating on the aggregate number.
9.2.5. The Health Score must always be accompanied by the disclaimer that it is an informational tool and not a substitute for professional medical evaluation.
10.1. Omniwo is not an emergency service. The platform does not provide real-time monitoring, emergency alerts, or crisis intervention.
10.2. If a user is experiencing symptoms that they believe require urgent medical attention, they should:
10.3. Omniwo results, including Urgent Red statuses, are not delivered in real time and must not be relied upon in a medical situation that requires immediate intervention. There may be a delay between sample collection and result delivery.
10.4. No Omniwo result, regardless of its status, replaces the need to seek immediate medical help if a user feels unwell. If in doubt, users should always err on the side of contacting a medical professional.
10.5. Omniwo will never instruct a user to attend A&E or call 999 based on a biomarker result. The platform directs users to their GP or NHS 111 as the appropriate first point of contact for result-related concerns.
11.1. For all results flagged as Red or Urgent Red, Omniwo must include mandatory GP referral messaging. This messaging cannot be suppressed, dismissed, or hidden by the user or by any system process.
11.2. Red result GP referral language:
This result is outside the standard reference range. We recommend sharing this result with your GP for further evaluation. You can generate a GP Share PDF from your results page.
11.3. Urgent Red result GP referral language:
This result requires prompt attention. Please contact your GP as soon as possible to discuss this result. If your GP is unavailable, contact NHS 111. You can generate a GP Share PDF to take to your appointment.
11.4. GP referral messaging must appear:
11.5. GP referral language must never be conditional on user preferences, notification settings, or display configurations. It is a mandatory safety feature.
11.6. The GP Share PDF must include:
The following are the exact copy blocks to be implemented in the Omniwo user interface. These must not be altered without approval from both the legal and product teams.
Omniwo provides educational wellness information only and is not a medical service, diagnostic tool, or regulated medical device. Always consult your GP for medical advice.
This result is outside the standard reference range. This is not a diagnosis. Please share your results with your GP for professional evaluation.
A single elevated marker does NOT mean cancer. Many non-cancerous conditions can cause elevated levels. Always discuss your results with your GP.
Wearable data is from consumer-grade devices and correlations shown are observational, not causal. This is not clinical monitoring.
Projections are based on your historical data trends and assume current patterns continue. They are educational illustrations, not predictions of future health outcomes. Consult your GP before acting on any projection.
This report has been generated by Omniwo, a consumer wellness platform. It is not a clinical report. Blood test results were processed by our laboratory partner, a CQC-registered and UKAS-accredited laboratory. Results should be interpreted by a qualified healthcare professional in the context of the patient's full medical history, symptoms, and other clinical information.
For clarity and to support implementation, the following terms and phrases must never appear in any Omniwo user-facing content, including UI copy, notifications, emails, PDFs, marketing materials, and support communications:
| Category | Prohibited Terms |
|---|---|
| Alarmist language | "dangerous", "emergency", "critical", "life-threatening" |
| Diagnostic language | "you have [diagnosis]", "this confirms [condition]", "you are diagnosed with" |
| Prescriptive language | "you need [medication]", "stop [activity] immediately", "you must take [supplement]" |
| Probabilistic language | "risk: X%", "probability of", "your chance of [condition]" |
| AI/ML language | "AI predicts", "our algorithm", "machine learning", "artificial intelligence analysis" |
| Causal language (wearables) | "causes", "leads to", "results in", "proves", "is responsible for" |
| Field | Detail |
|---|---|
| Document reference | 05_LEGAL/03_Disclaimer (medical)/03_Medical_Disclaimer.md |
| Version | v1.1 |
| Last updated | March 2026 |
| Author | Omniwo Product & Legal Team |
| Status | v1.1 — Published |
02_PA/06_Interpretation_Rules.md — Biomarker interpretation logic, traffic-light thresholds, and status-level tone guidelines04_UX_UI/01_UX_Brief Section 11: Predictive Philosophy — Deterministic modelling principles, prohibited AI/ML claims, and projection language rules