Medical Disclaimer | Important Compliance Information

1. Platform Purpose

RxSure© is a software platform designed to assist UK pharmacies and healthcare professionals in managing private clinical services, appointments, documentation, and compliance tracking.

RxSure is a workflow management tool only. It is not a medical device, does not provide medical advice, and is not intended to replace professional clinical judgement.

2. Clinical Responsibility Disclaimer

2.1 Professional Responsibility

All clinical decisions, prescribing, dispensing, and patient care remain the sole responsibility of the registered healthcare professional using the platform. This includes but is not limited to:

Patient assessment and diagnosis
Treatment selection and prescribing decisions
Drug interactions and contraindication checks
Dosage calculations and verification
Patient counselling and follow-up care
Adverse event monitoring and reporting

2.2 Clinical Judgement

While RxSure provides guided workflows based on clinical protocols and Summary of Product Characteristics (SmPC), these are decision-support tools only. Healthcare professionals must:

Exercise independent professional judgement in all clinical matters
Verify all information against current clinical guidelines
Consider individual patient circumstances
Override system suggestions when clinically appropriate
Maintain competency in all services delivered

2.3 No Medical Advice

RxSure does not provide medical, pharmaceutical, or clinical advice. The platform:

Does not diagnose medical conditions
Does not recommend specific treatments
Does not guarantee clinical outcomes
Cannot replace proper clinical training and expertise

3. Questionnaire and Template Disclaimer

3.1 Pre-Screening Questionnaires

Our consultation questionnaires and templates are designed based on:

Summary of Product Characteristics (SmPC)
NICE guidelines and clinical best practices
GPhC standards and requirements

However, these questionnaires:

May not capture all relevant clinical information
Should be supplemented by professional clinical assessment
May require customisation for specific patient populations
Are not substitutes for comprehensive patient history taking

3.2 Template Updates

While we strive to keep templates current with guidelines, there may be delays between guideline updates and template revisions. Healthcare professionals should:

Verify templates against current guidelines
Report any discrepancies to our team
Not rely solely on templates for clinical compliance

4. Documentation Disclaimer

4.1 Auto-Generated Documents

Documents generated by RxSure (prescriptions, certificates, GP notifications) are based on information entered into the system. The healthcare professional is responsible for:

Accuracy of all information entered
Reviewing documents before issuing
Ensuring appropriateness for each patient
Legal validity of prescriptions issued
Proper signing and authorisation

4.2 Record Keeping

While RxSure maintains digital records, pharmacy owners should:

Maintain backup records as per GPhC requirements
Verify record accuracy regularly
Not rely solely on digital records for legal purposes

5. Compliance Disclaimer

5.1 Regulatory Compliance

RxSure is designed to support GPhC compliance, but the platform:

Does not guarantee regulatory compliance
Cannot ensure all legal requirements are met
Is not a substitute for professional legal advice
May not cover all regulatory requirements for all services

5.2 Pharmacy Owner Responsibility

Pharmacy owners remain fully responsible for:

GPhC registration and compliance
Staff training and competency verification
Premises standards and equipment
Standard Operating Procedures (SOPs)
Responding to GPhC inspections
Maintaining appropriate insurance

6. Third-Party Services

RxSure integrates with third-party services including payment processors, email providers, and SMS services. We are not responsible for:

Third-party service availability or reliability
Payment processing errors or disputes
Communication delivery failures
Data handling by third-party providers

Payment transactions go directly to your own Stripe, PayPal, or bank accounts. We do not handle or process patient payments.

7. Limitation of Liability

To the maximum extent permitted by law, RxSure accepts no liability for:

Clinical outcomes or patient harm
Prescribing errors or adverse drug events
Regulatory penalties or sanctions
Loss of revenue or business
Data loss beyond our control
Actions taken based on platform information

This disclaimer does not exclude liability for death or personal injury caused by our negligence, fraud, or other matters where liability cannot be excluded by law.

8. Professional Indemnity Insurance

All healthcare professionals using RxSure must maintain appropriate professional indemnity insurance that covers:

All private services offered through the platform
Prescribing activities (where applicable)
Clinical advice and consultations

RxSure's insurance does not cover individual healthcare professional liability.

9. Information Accuracy

While we make reasonable efforts to ensure information on this platform is accurate and up-to-date:

We do not warrant the accuracy of all information
Clinical guidelines and regulations change frequently
Drug information may become outdated
Users should verify critical information from authoritative sources

10. Service Availability

We aim for high availability but cannot guarantee uninterrupted service. Healthcare professionals should:

Have contingency plans for system unavailability
Maintain offline access to critical patient information
Not solely rely on the platform for emergency situations

11. Clinical Safety & Risk Management

RxSure maintains a clinical safety framework compliant with DCB0129 (Clinical Risk Management: its Application in the Manufacture of Health IT Systems):

Clinical Safety Officer: Navid-Ul-Khurram Kaleem, Pharmacist Independent Prescriber (GPhC: 2064676), is the appointed Clinical Safety Officer responsible for overseeing the safety of the platform and its clinical workflows
Hazard Log: A clinical hazard log is maintained, identifying potential clinical risks associated with platform use and the mitigations in place
Risk Assessment: Clinical risks are assessed using a standardised risk matrix considering likelihood and severity of harm
Safety Case: A clinical safety case is maintained documenting the argument that the platform is safe for its intended use
Incident Reporting: Clinical safety incidents can be reported to contact@rxsure.co.uk and are investigated in accordance with our clinical risk management process

The clinical safety documentation is available for review by NHS organisations and regulatory bodies upon request.

12. Medical Device Classification

RxSure has been assessed against the UK Medical Devices Regulations 2002 (as amended) and the MHRA guidance on software as a medical device.

RxSure is not classified as a medical device.

The rationale for this classification is:

RxSure does not diagnose, prevent, monitor, treat, or alleviate any disease or medical condition
The platform does not perform any clinical calculation that could directly affect patient treatment
SmPC-guided workflows present published reference information but do not interpret, analyse, or recommend — the prescriber applies their own clinical judgement
The AI Consultation Assistant provides supplementary information only and does not make or influence clinical decisions
The platform functions as a practice management, record-keeping, and workflow tool — equivalent to an electronic patient record system
All clinical decision-making authority remains with the qualified healthcare professional

This classification is reviewed whenever new features are added that may change the platform's intended purpose. If the platform's functionality changes such that it meets the definition of a medical device, appropriate UKCA/CE marking and MHRA registration will be pursued.

13. Automated Decision-Making & AI Disclaimer

The RxSure AI Consultation Assistant:

Is a supplementary clinical support tool only
Does not make, override, or influence clinical decisions
Does not produce legally binding outcomes
May produce inaccurate or incomplete information — all output must be verified by the prescriber
Is not a substitute for clinical training, experience, or professional judgement
Does not process data for purposes of automated individual decision-making under Article 22 of UK GDPR

Healthcare professionals must independently verify all information provided by the AI assistant before acting on it.

14. Changes to This Disclaimer

We may update this disclaimer periodically to reflect changes in our services or legal requirements. Continued use of the platform after changes constitutes acceptance of the updated disclaimer.

15. Contact Us

If you have questions about this disclaimer or require clarification:

Email: contact@rxsure.co.uk
Phone: +441613830950
Address: 934 Stockport Rd, Manchester M19 3AB, UK

Disclaimer