Intended Use Statement

Aryash Health Patient Education Platform v1.0

Field	Details
System Name	Aryash Health Patient Education Platform
Version	1.0
Author	Dr Krishnan Pasupathi
Date	4 January 2026
Review Date	4 January 2027

1. Product Identification

Attribute	Details
Product Name	Aryash Health Patient Education Platform
Version	1.0
Type	Patient Education Resource
Regulatory Status	Not a Medical Device (general health education)
Deployment	Public internet access

1.1 Platform Components

Site	URL	Content Type
Landing Page	aryash.health	Navigation hub
Health Tools Hub	tools.aryash.health	Blood test education, audio guides, infographics
Heart Health Hub	heart.aryash.health	Cardiovascular health education
Men's Health Hub	mens.aryash.health	Men's health education

2. Intended Purpose

The Aryash Health platform is a patient education resource designed to help members of the public understand health topics in plain English.

2.1 The platform IS intended to:

Explain what common blood tests measure and why they are done
Describe health conditions in accessible, plain-English language
Provide audio guides for those who prefer listening to reading
Offer downloadable infographics for reference
Suggest questions patients can ask their GP
Help patients feel more informed before and after appointments
Signpost to emergency services (999, 111) where appropriate

2.2 The platform is NOT intended to:

Diagnose medical conditions
Interpret individual patient results
Recommend specific treatments or medications
Replace consultation with a healthcare professional
Provide personalised medical advice
Be used in clinical decision-making
Store or process patient health data
Create or contribute to medical records

3. Intended Users

3.1 Primary Users

User Type	Use Case
Patients	Understanding blood test results they have received
Patients	Learning about a condition they or family members have
Patients	Preparing questions for GP appointments
Carers	Understanding health information for those they care for
General public	Health education and awareness

3.2 Excluded Users / Use Cases

User Type	Reason
Clinicians (for clinical decisions)	Tool provides patient-level education, not clinical guidance
Users seeking diagnosis	Tool cannot diagnose; must see GP
Users in medical emergency	Must call 999, not use education tools
Users seeking prescriptions	Tool cannot prescribe; must see GP

4. Intended Environment

4.1 Access Environment

Setting	Suitability
Home	Primary intended setting
GP waiting room	Suitable (works offline)
Mobile/on the go	Suitable (responsive design)
Clinical consultation	May be used by patient to reference questions

4.2 Technical Environment

Requirement	Specification
Device	Any device with a web browser (phone, tablet, computer)
Browser	Modern browser (Chrome, Firefox, Edge, Safari)
Internet	Required for initial load; works offline thereafter
Account	Not required (no login, no registration)

5. Content Scope

5.1 Blood Test Education (tools.aryash.health)

Category	Tests Covered
Diabetes	HbA1c, fasting glucose, random glucose
Kidney	eGFR, creatinine, urea, potassium, sodium
Liver	ALT, AST, ALP, GGT, bilirubin, albumin
Thyroid	TSH, T4, T3
Heart/Cholesterol	Total cholesterol, LDL, HDL, triglycerides
Blood count	Haemoglobin, WBC, platelets, MCV
Iron	Ferritin, iron, TIBC, transferrin saturation
Vitamins	Vitamin D, B12, folate
Inflammation	CRP, ESR
Other	PSA, uric acid, calcium, and more

5.2 Heart Health Education (heart.aryash.health)

Section	Content
Conditions	High blood pressure, atrial fibrillation, heart failure, coronary heart disease, angina
Medications	Statins, ACE inhibitors, beta-blockers, anticoagulants
Investigations	ECG, echocardiogram, angiogram, blood tests
Lifestyle	Diet, exercise, smoking, alcohol, weight
Recovery	Post-heart attack care, cardiac rehabilitation

5.3 Men's Health Education (mens.aryash.health)

Topic	Content
Prostate Health	Enlarged prostate, PSA testing, cancer awareness
Testicular Health	Self-examination, lumps, cancer information
Erectile Dysfunction	Causes, treatments, cardiovascular link
Mental Health	Depression, anxiety, barriers to seeking help
Testosterone	Low testosterone symptoms, testing
Health Checks	Age-appropriate screening recommendations

6. Limitations and Contraindications

6.1 Known Limitations

Limitation	Mitigation
Cannot interpret individual results	Prominent "see your GP" messaging
Reference ranges are general	"Always compare to your report" disclaimer
Content may not cover rare conditions	GP consultation recommended for concerns
Guidelines may change	Annual review scheduled
English language only	Future translations may be considered

6.2 Contraindicated Uses

Use	Reason
As a diagnostic tool	Platform provides education, not diagnosis
To avoid GP consultation	Users should always consult GP for concerns
In medical emergencies	Call 999 immediately
To change medications	Discuss all medication changes with GP
To replace professional advice	Education complements, not replaces, care

7. Responsibility Statement

7.1 The User is responsible for:

Understanding this is educational content, not medical advice
Consulting their GP for personal health concerns
Comparing any reference ranges to their own lab report
Seeking emergency help (999/111) when needed
Not making health decisions based solely on this content

7.2 The Content Author is responsible for:

Ensuring content aligns with NHS/NICE guidelines
Writing in accessible, plain English
Reviewing and updating content annually
Maintaining clinical accuracy
Responding to reported errors or concerns

8. Regulatory Classification

8.1 Medical Device Status

This platform is NOT classified as a Medical Device under the UK Medical Devices Regulations 2002 (as amended) because:

It provides general health education, not individual diagnosis or treatment
It does not interpret patient-specific data
It does not make or inform clinical decisions
It is not intended to diagnose, treat, prevent, or monitor disease
Output is educational information available to the general public

8.2 Applicable Standards

Standard	Applicability
UK MDR 2002	Not applicable (not a medical device)
DCB0129	Not applicable (not a commercial manufacturer)
DCB0160	Applied voluntarily for best practice
UK GDPR	Applicable (DPIA screening confirms no personal data processed)
NHS DTAC	Not applicable (not an NHS-procured digital tool)

9. Acceptance

By using this platform, users acknowledge that:

The content is for educational purposes only
It does not replace professional medical advice
They should consult their GP for personal health concerns
Reference ranges may differ from their own lab results
They should call 999 in an emergency

10. Sign-Off

Role	Name	Signature	Date
Clinical Safety Officer	Dr Krishnan Pasupathi

Document ends