2026-SaMTelem

h1. Structure

h2. 1.Requirement Gathering

h3. 1.1 Stakeholders

Identify who will use or benefit from your app:

* Patients with epilepsy

* Caregivers / family

* Doctors / neurologists

p=. !{width:50%}Stakeholders.png!

??Figure 3: App Users/Operators??

h3. 1.2 Functional Requirements

What the App should do???

*a).User registration and Login*

Create your private account and sign in securely to keep all your personal health information safe.

*b).Patient Profile Management*

A simple place to save your basic info, like your type of epilepsy and your doctor’s contact details.

*c).Seizure Monitoring* 

Easily record when a seizure happens, how long it lasted, and what might have caused it.

*d).Mood Monitoring*

A quick daily check-in to track how you’re feeling, helping you and your doctor see if your mood is linked to your seizures or meds.

*e).Medication Diary*

Set reminders to take your pills on time and keep a log so you know you’ve stayed on track.

*f).Telehealth Consultation*

Talk to a doctor through a private video call right inside the app, saving a trip to the clinic.

*g).Alert ang Emergency Support*

A quick way to notify your family or emergency services and share your location if you need help fast.

*h).Reports* 

Automatically turn your logs into a simple summary that you can show your doctor during your next visit.

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??Figure 4: Key Features??

h3. 1.3 Regulatory Requirements

Since the App deals with the patient health and diagnosis  it is classified as SaMD software as Medical Device and has to follow the standards

* EU Medical Device Regulation (MDR 2017/745)

* GDPR (General Data Protection Regulation)

* IEC 62366-1 — Usability Engineering for Medical Devices

* IEC 62304 – Medical Device Software Lifecycle

* ISO 14971 – Risk Management

* IEC 82304-1 – Health Software Product Safety

* ISO 13485 – Quality Management System

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??Figure 5: Regulatory Requirments??

h2. 2. Final Features and Specification

* *2.1 Patient Module*

The Patient Module is designed to help epileptic patients monitor seizures, emotional well-being, and medication adherence.

*_Feature_*

** Seizure Diary

** Mood Tracker

** Medication Diary

** Reports

*_Specifications_*

** Secure login and authentication

** User-friendly dashboard

** Offline data entry with cloud synchronization

** Push notifications for reminders

* *2.2 Doctor Module*

The Doctor Module enables healthcare professionals to monitor patient conditions remotely and make informed treatment decisions.

*_Feature_*

** Patient Overview Dashboard

** Seizure & Mood Trend Analysis

** Medication Adherence Monitoring

** Secure Communication

*_Specifications_*

** Role-based access control

** Real-time patient monitoring

** Data analytics dashboard

** HIPAA/GDPR compliant data access

* *2.3 Caregiver Module*

The Caregiver Module supports family members or guardians in monitoring and assisting patients.

*_Feature_*

** Patient Summary Access

** Medication Reminder Notifications

** Emergency Alerts

** Event Tracking

*_Specifications_*

** Shared access with patient consent

** Real-time alerts

** Notification management settings

** Limited access permissions

* *2.4 Admin Module*

The Admin Module manages system operations, user accounts, and application security.

*_Feature_*

** User Management

** Data Management

** System Settings

** Security & Privacy Management

** Support & Maintenance

*_Specifications_*

** Multi-level authentication

** Server monitoring dashboard

** Automated backups

** Compliance with healthcare data standards

h2. Use Cases

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??Figure: Usecase??

h2. Activity Diagrams