Intended Use Statement

1. Manufacturer

2. Device Identification

3. Intended Purpose

The Aryash Patient Health Explainer is patient general health self-management software (GMDN 64275) that provides plain-English explanations of health information encountered by UK adults — including investigations and test results, prescribed medicines, common health conditions, and cardiovascular risk factors.

The device supports non-pregnant adults aged 18 years and over in the UK to understand health information they have received from, or will discuss with, their GP, NHS Health Check, pharmacist, hospital, or another registered healthcare professional.

The device is delivered as a modular platform: each module covers a distinct area of health information (blood tests, cardiovascular risk, heart health, men's health, prescribed medicines, non-laboratory investigations) and is released and versioned under the single intended purpose set out in this document. Adding a new module is a version update of the same device, not a new device.

The intended purpose is delivered through the following functions, applied by each module where relevant to its content:

1. Comparison of patient-entered clinical data (where the module accepts it — currently Module 1 only) against UK reference information such as NICE, NHS, royal-college, or BNF guidance.
2. Plain-English explanation of what a test, medicine, investigation, condition, or risk factor is and what a result, effect, or finding can mean.
3. Visual displays (UK reference scales, guideline thresholds, condition overviews, or comparable visualisations) with source attribution.
4. Fictional worked patient examples illustrating representative scenarios and their usual UK primary-care management context.
5. Suggested questions the patient can raise at their next GP or clinical appointment.
6. Optional audio guides and downloadable infographics reinforcing the same content.

3.1 What the device does

• Provides plain-English information about investigations, results, prescribed medicines, common health conditions, and cardiovascular risk encountered by UK adults.
• Where a module accepts patient-entered clinical data (currently Module 1 — Blood Test Explainer), compares that data against UK reference information and presents a status or plain-language summary (e.g. below range / within range / above range).
• Displays UK-anchored reference information with source attribution (NICE, NHS, royal college, BNF, as applicable).
• Offers suggested questions for the patient to discuss with their GP or other clinician.
• Provides supporting audio guides and downloadable infographics.

3.2 What the device does not do

• Does not diagnose any medical condition.
• Does not compute cardiovascular risk or other risk scores — Module 2 (Cardiovascular Risk Explainer) signposts users to NHS-validated external calculators (e.g. qrisk.org) for actual score computation.
• Does not recommend specific medicines, dosages, or treatments.
• Does not analyse biological samples (it is not an in-vitro diagnostic device).
• Does not perform an investigation itself — it explains investigations, results, and medications the patient has already received from, or will discuss with, a registered healthcare professional.
• Does not store, transmit, or process patient-identifiable information.
• Does not create, contribute to, or integrate with any medical record.
• Does not replace consultation with, or assessment by, a registered healthcare professional.
• Does not interpret paediatric or pregnancy-specific data.

3.3 Current modules

Each module is released as a version update of the Aryash Patient Health Explainer under this intended purpose. Future modules will be added under the same intended purpose when they are developed and released. Module-level scope and step-by-step user instructions are recorded in the Instructions for Use (AHL-TOOLS-DOC-005) and, where relevant, in the Clinical Evaluation Report (AHL-TOOLS-DOC-007).

4. Intended Users and Use Environment

4.1 Intended users

Non-pregnant adult patients (aged 18 years and over) resident in the UK who have received or will discuss health information (e.g. a blood test result, a cardiovascular risk discussion, a cardiac condition, or a men's-health concern) with their GP, NHS Health Check, pharmacist, hospital, or another registered healthcare professional and wish to understand that information better before, during, or after their appointment.

Family members or informal carers supporting a patient, and clinicians who wish to direct patients to a patient-facing explainer, are also expected to encounter the device. Clinical decision-making remains the responsibility of the treating clinician.

4.2 User profile

4.3 Use environment

5. Clinical Benefits

• Improves patient health literacy across investigations, results, medications, common conditions, and cardiovascular risk encountered by UK adults.
• Reduces anxiety between receipt of clinical information and follow-up consultation by providing context in plain language.
• Helps patients prepare informed questions for their GP, improving the quality of the consultation.
• Supports equitable access to health information — free at the point of use, accessible on any web-enabled device, no account required.

6. Module Scopes

Thresholds, reference ranges, and content in each module follow UK guidance (NICE, NHS, royal college, BNF) and are attributed to source within the module where appropriate. Step-by-step user instructions for each module are set out in the Instructions for Use (AHL-TOOLS-DOC-005).

6.1 Module 1 — Blood Test Explainer

50 routine UK blood tests across the following domains. The unit shown in each test page is the unit expected on a UK NHS lab report.

6.2 Module 2 — Cardiovascular Risk Explainer

Plain-English explanations of the QRISK3 cardiovascular-risk score, cholesterol components (LDL, HDL, TC:HDL ratio, triglycerides), and lifestyle-based risk modification. The module explains what the score and its input factors mean, what risk bands imply for primary-prevention decisions, and what conversations to have with a GP. The module does not calculate a risk score — it signposts the user to the NHS-validated external calculator at qrisk.org for actual score computation.

6.3 Module 3 — Heart Health Explainer

Plain-English explanations of common cardiac conditions (hypertension, atrial fibrillation, heart failure, coronary heart disease, angina), routine cardiac investigations (ECG, echocardiogram, stress testing, angiogram, Holter monitoring), cardiac blood tests (BNP, troponin), and cardiac medication classes (statins, beta-blockers, ACE inhibitors, anticoagulants, diuretics). Content is framed for patients who have received a diagnosis or been referred for investigation and wish to understand what it means.

6.4 Module 4 — Men's Health Explainer

Plain-English explanations of prostate health (PSA testing, enlarged prostate, prostate cancer awareness), testicular health and self-examination, erectile dysfunction (including the cardiovascular link), testosterone deficiency, men's mental health, and UK screening guidance relevant to men. Content is framed for adult men and those supporting them.

7. Contraindications and Excluded Populations

8. Responsibility Statement

8.1 The user is responsible for

• Using the device only for themselves, or to support another adult, and not for children under 18 or in pregnancy.
• Where a module accepts data (Module 1): entering data accurately from their own NHS or registered-provider report, in the correct UK units.
• Following any different target or instruction set by their own GP in preference to the general UK reference information shown.
• Calling 999 in an emergency and contacting their GP or NHS 111 for urgent but non-emergency concerns.
• Reporting any concern about the safety or accuracy of the device (see section 11).

8.2 The manufacturer is responsible for

• Ensuring content aligns with current UK NICE / NHS / royal college / BNF guidance (as applicable to each module) and is reviewed on a defined cycle.
• Maintaining clinical accuracy and the quality of the reference information, threshold bands, condition content, risk-factor content, and worked examples presented.
• Operating a post-market surveillance process, including a user feedback route and Yellow Card reporting pathway.
• Responding to reports of clinical inaccuracy or safety concern and, where indicated, issuing corrections and field safety notices.
• Maintaining the supporting technical file, risk management file, clinical evaluation report, and declaration of conformity for inspection by the MHRA.

9. Regulatory Basis and Applicable Standards

9.1 Supporting governance documents

10. Acceptance by Users

By using the Aryash Patient Health Explainer, users acknowledge that:

• The device provides general information about UK investigations, results, medications, common conditions, and cardiovascular risk, and is not a substitute for consultation with a registered healthcare professional.
• Interpretation of their specific situation is a clinical judgement reserved to their GP or treating clinician.
• The device does not calculate cardiovascular risk.
• The device is not intended for use in pregnancy or in children or young people under 18.
• Reference information shown is UK-general and individual laboratories, prescribers, or clinicians may use different targets or instructions.
• The device does not collect, store, or transmit any personal or identifiable information about the user.

11. Reporting Concerns

Users, clinicians, and members of the public can report concerns about the safety or accuracy of the Aryash Patient Health Explainer by either of the following routes:

12. Declaration

12.1 Version history