Clinical Safety Case Report
DCB0160 Compliance Document
Health IT System Deployment and Use
| Field | Details |
|---|
| Document Title | Clinical Safety Case Report |
| System Name | Aryash Health Patient Education Platform v1.0 |
| Organisation | Aryash Health |
| Clinical Safety Officer | Dr Krishnan Pasupathi |
| Document Date | 4 January 2026 |
| Review Date | 4 January 2027 |
| Version | 1.0 |
| Classification | Public |
1. Executive Summary
This Clinical Safety Case documents the hazard identification, risk assessment, and mitigation measures for the deployment of the Aryash Health patient education platform.
Overall Risk Assessment: ACCEPTABLE
The platform has been assessed as safe for public use as a patient education resource. It does not provide diagnosis, treatment recommendations, or medical advice.
2. System Description
2.1 System Overview
| Attribute | Description |
|---|
| System Name | Aryash Health Patient Education Platform |
| Version | 1.0 |
| Type | Patient Education Resource |
| Technology | Static web applications (HTML, CSS, JavaScript) |
| Deployment | Vercel cloud hosting |
| Connectivity | Works offline after initial load; no external data dependencies |
2.2 Platform Components
| Site | URL | Content |
|---|
| Landing Page | aryash.health | Overview and navigation to all resources |
| Health Tools Hub | tools.aryash.health | 35+ blood test explanations, 70 audio guides, 32 infographics |
| Heart Health Hub | heart.aryash.health | 5 cardiovascular conditions, medications, investigations, recovery |
| Men's Health Hub | mens.aryash.health | 6 men's health topics, PSA & testosterone test guides |
2.3 Clinical Context
The platform provides educational information to help patients:
- Understand what blood tests measure
- Learn about health conditions in plain English
- Prepare questions for GP appointments
- Access audio guides for those who prefer listening
The platform does NOT: Diagnose conditions, interpret individual results, recommend treatments, prescribe medications, or replace GP consultations.
3. Hazard Identification
3.1 Hazard Log
| ID | Hazard Description | Potential Cause | Potential Harm | Initial Severity |
|---|
| H01 | User self-diagnoses based on content | Misunderstanding educational content | Delayed medical assessment | Moderate (3) |
| H02 | Emergency symptoms not escalated | User reads content instead of seeking help | Delayed emergency treatment | Major (4) |
| H03 | Outdated clinical information | Guidelines updated, content not revised | Suboptimal patient understanding | Moderate (3) |
| H04 | Incorrect reference ranges displayed | Transcription error or guideline change | Misunderstanding of results | Moderate (3) |
| H05 | User avoids GP due to over-reliance | User feels informed enough to not consult | Missed diagnosis | Moderate (3) |
| H06 | Content misunderstood by low literacy users | Complex medical concepts | Confusion, anxiety, wrong conclusions | Minor (2) |
3.2 Severity Classification (NHS Digital Standard)
| Level | Severity | Description |
|---|
| 1 | Negligible | Inconvenience, no clinical impact |
| 2 | Minor | Short-term minor harm, full recovery |
| 3 | Moderate | Semi-permanent minor harm or temporary major harm |
| 4 | Major | Permanent major harm or long-term impairment |
| 5 | Catastrophic | Death or permanent catastrophic harm |
3.3 Likelihood Classification
| Level | Likelihood | Description |
|---|
| 1 | Very Low | Highly unlikely to occur |
| 2 | Low | May occur occasionally |
| 3 | Medium | Will probably occur at some point |
| 4 | High | Will occur frequently |
| 5 | Very High | Will occur repeatedly |
4. Risk Assessment and Mitigation
4.1 Risk Matrix
| Likelihood ↓ / Severity → | 1 Negligible | 2 Minor | 3 Moderate | 4 Major | 5 Catastrophic |
|---|
| 5 Very High | Low | Medium | High | Unacceptable | Unacceptable |
| 4 High | Low | Medium | High | Unacceptable | Unacceptable |
| 3 Medium | Low | Low | Medium | High | Unacceptable |
| 2 Low | Low | Low | Low | Medium | High |
| 1 Very Low | Low | Low | Low | Low | Medium |
4.2 Risk Assessment with Mitigations
| ID | Hazard | Initial Risk | Mitigations | Residual Risk | Acceptable? |
|---|
| H01 | User self-diagnoses | Medium (3×2=6) | Prominent "educational only" disclaimers; "Always consult GP" messaging; No diagnostic language used; GP questions encourage consultation | Low (3×1=3) | Yes |
| H02 | Emergency not escalated | High (4×2=8) | Emergency banner on every page (999/111); Red flag symptoms signpost to emergency services; "Seek immediate help if..." warnings where relevant | Low (4×1=4) | Yes |
| H03 | Outdated information | Low (3×2=6) | Annual review scheduled; Content sourced from NHS/NICE guidelines; Version control via changelog; Review date displayed on footer | Low (3×1=3) | Yes |
| H04 | Incorrect reference ranges | Low (3×2=6) | Ranges verified against NHS standards; "Always compare to your report" disclaimer; Lab variation explained; Clinical review by practising GP | Low (3×1=3) | Yes |
| H05 | Over-reliance on content | Low (3×2=6) | Every page encourages GP consultation; "Questions for your GP" feature promotes dialogue; Tool named "education" not "advisor" | Low (3×1=3) | Yes |
| H06 | Content misunderstood | Low (2×2=4) | Written at reading age 12; Plain English used; Audio guides available; Definitions provided for medical terms | Very Low (2×1=2) | Yes |
5. Safety Requirements
5.1 Technical Safety Features Implemented
| Requirement | Implementation | Verified |
|---|
| Emergency signposting visible | 999/111 banner on every page | Yes |
| Disclaimers prominent | "Educational only" on every page and tool | Yes |
| No diagnostic language | Content reviewed to remove "you have" phrasing | Yes |
| GP consultation encouraged | Every test/condition includes "Questions for GP" | Yes |
| Reference range warnings | "Always compare to your report" displayed | Yes |
| Offline capability | Works without internet after first load | Yes |
| No data collection | No cookies, tracking, or analytics | Yes |
| Accessible design | Large text, high contrast, audio options | Yes |
5.2 Content Safety Features
| Requirement | Implementation | Verified |
|---|
| UK units used | mmol/L, µmol/L, g/L throughout | Yes |
| NHS/NICE aligned | Content sourced from authoritative UK guidelines | Yes |
| Clinically reviewed | All content reviewed by practising NHS GP | Yes |
| Reading age appropriate | Written for reading age 12 | Yes |
| Mental health signposting | Samaritans (116 123) included where relevant | Yes |
6. Training Requirements
6.1 User Training
Not required - The platform is designed for public use without training. Clear instructions and intuitive navigation are built in.
7. Incident Management
7.1 Review Triggers
The Clinical Safety Case must be reviewed if:
- A user reports harm or near-miss related to the content
- NICE/NHS guidelines referenced are updated
- Significant content changes are made
- Annual review date is reached
8. Clinical Safety Officer Statement
I confirm that:
- This Clinical Safety Case has been prepared in accordance with DCB0160 principles
- The hazards associated with this patient education platform have been identified and assessed
- Appropriate mitigations are in place to reduce risks to acceptable levels
- The residual risk is acceptable for public deployment
- Ongoing monitoring and review processes are established
The Aryash Health Patient Education Platform v1.0 is approved for public deployment.
9. Sign-Off
| Role | Name | Signature | Date |
|---|
| Clinical Safety Officer | Dr Krishnan Pasupathi | | |
10. Document History
| Version | Date | Author | Changes |
|---|
| 1.0 | 04/01/2026 | Dr K Pasupathi | Initial release |
Document ends