Last updated: May 2025
Please read this disclaimer carefully. It sets out important limitations on the nature and use of GeneAI's services and applies to all users of this platform in all jurisdictions.
1. Medical Disclaimer
IMPORTANT: GeneAI is not a medical device, clinical laboratory, or healthcare provider. Information provided by GeneAI's platform, including AI-assisted genomic interpretation reports, is for informational purposes only. It does not constitute a medical diagnosis, medical advice, or a treatment plan. You must consult a qualified, licensed healthcare professional before making any health-related decisions based on information from this platform.
GeneAI coordinates access to genomic analysis services and presents informational outputs derived from laboratory results. At no point in this process does GeneAI or any of its automated systems make a clinical determination about your health, your risk, or your recommended course of action.
Genomic information can be complex, nuanced, and deeply personal. The same genetic variant may have different clinical significance for different individuals depending on their personal and family medical history, environmental factors, and other clinical context that GeneAI does not have and does not claim to evaluate.
If anything in your GeneAI report causes you concern, please contact your doctor, a genetic counsellor, or another qualified healthcare professional without delay. If you are experiencing a medical emergency, call your local emergency services immediately.
2. AI Limitations Disclosure
What AI can do
GeneAI's AI system can identify patterns within genomic data, cross-reference known variants against published research databases, generate structured summaries of genomic findings, and flag areas that may warrant further clinical attention. This is a powerful tool for organising complex information and surfacing relevant context.
What AI cannot do
AI cannot replace clinical judgement. It does not know your full medical history unless you have provided it. It cannot physically examine you. It cannot account for environmental or lifestyle factors that may interact with genetic findings. It cannot interpret the emotional significance of a result, or communicate in the nuanced way that a skilled clinician can. It can produce errors, including errors that appear confident and detailed.
Current limitations of genomic AI
Genomic AI is an emerging field. The scientific understanding of most genetic variants — particularly rare variants — remains incomplete. AI models are trained on existing datasets, which may underrepresent certain populations, including populations in the GCC region. Variant classifications change over time as new research emerges. A variant classified as "of uncertain significance" today may be reclassified in future.
Confidence scoring
GeneAI reports include confidence indicators for AI-assisted interpretations. These scores reflect the degree to which an interpretation is supported by existing research literature — they do not measure clinical certainty. A high confidence score means there is substantial published research supporting an interpretation; it does not mean that interpretation is definitively correct for you as an individual.
Why human review exists
All AI-generated content in GeneAI reports is reviewed by a human reviewer before delivery. This review checks for coherence, ensures the report accurately reflects the laboratory data, and verifies that appropriate caveats are in place. Reviewers are not providing individual medical advice — they are quality-assuring the output. Human review reduces, but does not eliminate, the risk of errors in AI outputs.
3. Regulatory Status
GeneAI Ltd is registered as a company in England and Wales. We operate as an information and coordination service.
Medical Device Status
The GeneAI platform is not registered as a medical device under the UK Medical Devices Regulations 2002 (as amended) or the EU Medical Device Regulation (EU) 2017/745. This is because GeneAI does not meet the definition of a medical device: it does not perform diagnosis, does not make clinical determinations, and does not directly influence patient management decisions. GeneAI provides an information and coordination service — the clinical analysis is performed by our separately regulated partner laboratories, not by GeneAI.
Laboratory Services
Genomic analysis is performed by our partner UK laboratories, which hold appropriate accreditations (including UKAS accreditation under ISO 15189 where applicable) for the clinical laboratory services they provide. GeneAI does not perform clinical analysis and makes no representations about the regulatory status of specific partner laboratories beyond confirming their accreditation at the point of onboarding.
If the regulatory classification of GeneAI's service changes due to changes in applicable law or regulatory guidance, we will update this disclaimer and notify users promptly.
4. Accuracy Disclaimer
GeneAI works exclusively with accredited UK genomic laboratories and applies quality control processes to all reports. We take accuracy seriously. However:
No genomic analysis guarantees 100% accuracy. All laboratory techniques have limitations, including minimum detection thresholds, potential for artefacts, and boundaries in what can be analysed from a given sample type.
Variant interpretation evolves. Our scientific understanding of the human genome is advancing rapidly. A variant classified in a certain way today may be reclassified as new evidence emerges. GeneAI is not responsible for updating historical reports when scientific classifications change, although we may alert users to significant reclassifications where we become aware of them.
Sample quality affects results. The quality of your genomic report depends in part on the quality of the sample collected. Poor sample conditions, contamination, or insufficient sample volume may affect the completeness or accuracy of analysis. Our partner collection laboratories follow strict sample handling protocols to minimise this risk.
Reports reflect the information available at the time of analysis. GeneAI reports are a snapshot based on the data available at the time of laboratory analysis and report generation. They are not intended as a permanent, definitive, or comprehensive assessment of your genome.
5. Jurisdiction
This disclaimer applies to all users of the GeneAI platform in all jurisdictions. GeneAI's Terms of Service and Privacy Policy are governed by the law of England and Wales.
Notice to Users in GCC Countries
Users accessing GeneAI from countries in the Gulf Cooperation Council (Saudi Arabia, UAE, Qatar, Kuwait, Bahrain, Oman) should be aware that local health regulations may additionally apply to their use of this service. The regulation of genomic testing, the export of biological samples, and the use of health data may be subject to specific national requirements in your country of residence. It is your responsibility to ensure that your use of GeneAI complies with applicable local law. GeneAI does not provide legal advice on local regulatory compliance, and nothing in these documents should be construed as such.
Where local law in any jurisdiction imposes requirements on a service like GeneAI that are more stringent than those reflected in this disclaimer, GeneAI will endeavour to comply with those requirements to the extent it is aware of and able to do so. Users who are unsure about the regulatory framework in their jurisdiction should seek local legal advice before using the service.
GeneAI Ltd — Registered in England and Wales — For regulatory queries: legal@geneai.com