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Compliance Map

Our compliance map outlines how PharmaFAST ensures full regulatory, data protection, and operational compliance across all platform workflows and entities.

 

PharmaFAST’s platform is built from the ground up to meet Irish pharmacy, GDPR, and HSE PCS standards, providing pharmacies with:

🔒 Data security with no compromise

🧾 Audit logs and evidence trails

📊 PCS service and reimbursement alignment

🧑‍⚕️ Role-based clinical and administrative controls

🤝 Controller-processor contracts and opt-in user experience

Legal & Regulatory

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Data Protection & GDPR Compliance

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Clinical Safety & Audit Compliance

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Technical Infrastructure & Security

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User Compliance & Training

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Consent, Opt-In & Communications

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Legal & Regulatory Compliance

🧾 Use Case: Data Protection Law

Standard / Requirement: GDPR (EU 2016/679); Data Protection Act 2018 (Ireland)
How PharmaFAST Complies: A Data Processing Agreement (DPA) is issued to all partners. Our role-based architecture ensures the pharmacy is the Data Controller and PharmaFAST acts as a compliant Data Processor.

💊 Use Case: Prescription Handling

Standard / Requirement: Medicinal Products (Prescription & Control of Supply) Regulations
How PharmaFAST Complies: We never alter prescriptions. The platform securely routes scanned or uploaded prescriptions to verified Healthmail addresses.

💼 Use Case: PCS Compliance

Standard / Requirement: HSE Primary Care Services Guidelines
How PharmaFAST Complies: Our PCS module is built using official HSE templates. The full service flow is aligned with reimbursement structures and audit expectations.

📡 Use Case: Electronic Communications

Standard / Requirement: ePrivacy Regulations; Healthmail Compliance
How PharmaFAST Complies: All clinical communication is routed via encrypted Healthmail. No prescription data is stored in the platform post-transmission.

👩‍⚕️ Use Case: Clinical Governance

Standard / Requirement: HSE & PSI Clinical Governance Protocols
How PharmaFAST Complies: Our platform includes vaccine administration logs, digital patient consent, adverse event tagging, and auditable service trails to support pharmacy compliance.

Data Protection & GDPR Compliance

🔄 Use Case: Data Roles

Control: Controller / Processor Split
Description: Pharmacies act as the Data Controller; PharmaFAST operates as the Data Processor under a signed DPA.

⚖️ Use Case: Lawful Basis

Control: Legitimate Interest / Consent
Description: Explicit consent is gathered before any data processing, ensuring legal basis for all core functions.

🛂 Use Case: Access Control

Control: RBAC + 2FA
Description: All staff access is permission-based, and sensitive functions require two-factor authentication.

📉 Use Case: Data Minimization

Control: Field Restrictions
Description: Only essential personal data is collected — such as name, date of birth, and Eircode.

🗄️ Use Case: Data Storage

Control: Encrypted + EU-Only Servers
Description: All data is securely hosted in ISO 27001-certified data centers within the EU (AWS Dublin / Azure Ireland).

🔁 Use Case: Data Sharing

Control: Secure Healthmail API Routing
Description: Patient data is only shared with verified recipients (GPs, pharmacies, HSE) through Healthmail — never stored or reused.

📋 Use Case: DPIA

Control: Available
Description: A full Data Protection Impact Assessment (DPIA) has been conducted on each platform module and is available upon request.

📜 Use Case: Audit Logs

Control: Full Tracking
Description: All interactions — from logins to patient record access — are fully logged and auditable.

🧾 Use Case: Retention Policy

Control: 7-Year Clinical Record
Description: Records are stored in line with HSE guidance unless a shorter retention period is requested

by the pharmacy.

Clinical Safety & Audit Compliance

💉 Use Case: Vaccination & Service Logs

Compliance Element: Digital Record
Details: Each log includes vaccine name, batch, expiry, injection site, and administrator signature — supporting PSI inspections.

🖊️ Use Case: Consent

Compliance Element: Digital Signature
Details: Captured electronically before each service and timestamped for audit records.

💶 Use Case: PCS Claim Trail

Compliance Element: Claim ID, Fee Code, Status
Details: Automatically generated and exportable via CSV — filterable by service, period, or pharmacist.

🚨 Use Case: Adverse Events

Compliance Element: Reporting Tag
Details: Staff can flag and document any adverse reactions, meeting PSI and HSE obligations.

📤 Use Case: Audit Readiness

Compliance Element: Real-Time Export
Details: One-click export of all activity logs and claims in an HSE-friendly format.

🧾 Use Case: Walk-In Logbooks

Compliance Element: Paperless Module
Details: A digital log of all walk-in patients, including those without prior booking, complete with timestamp.

✅ Use Case: Service Eligibility Checks

Compliance Element: Age, Gender, GP Verification
Details: Built-in logic checks patient eligibility for PCS services before submission.

Technical Infrastructure & Security

🏢 Use Case: Hosting

Feature: Secure EU Data Centers
Details: All data is hosted within GDPR-aligned, ISO-certified data environments.

🔐 Use Case: Encryption

Feature: TLS 1.3 + AES-256
Details: All data is encrypted in transit and at rest using the latest standards.

🗃️ Use Case: Backups

Feature: Redundant Daily Backups
Details: Daily secure backups are retained for 30 days to ensure disaster recovery capability.

🔍 Use Case: Pen Testing

Feature: Quarterly Penetration Testing
Details: Regular independent security assessments are conducted to identify vulnerabilities.

🛡️ Use Case: Vulnerability Management

Feature: CVE Patch Policy
Details: Zero-day vulnerabilities are patched within 24 hours of discovery.

🔐 Use Case: API Security

Feature: OAuth 2.0 + Scope Limiting
Details: All APIs are protected by industry-standard authorization protocols with role-based access tokens.

🔁 Use Case: Disaster Recovery

Feature: <1h RTO, <24h RPO
Details: Platform recovery time objective (RTO) is less than 1 hour, and data recovery point objective (RPO) is less than 24 hours.

📱 Use Case: Device Access

Feature: No Local Storage
Details: The app is fully web-based. No patient data is downloaded or stored on user devices.

User Compliance & Training

🎓 Use Case: Staff Training

Description: All users complete onboarding and receive periodic training on PCS procedures, Healthmail usage, and GDPR responsibilities.

📝 Use Case: Usage Agreements

Description: Each staff member must sign a T&Cs agreement, Acceptable Use Policy, and platform code of conduct.

🛠️ Use Case: Change Logs

Description: Platform updates are tracked with a public changelog so pharmacies can review what’s changed at any time.

📞 Use Case: Support Logging

Description: All pharmacy support queries are logged with full traceability for regulatory or follow-up use.

Consent, Opt-In & Communications

🧾 Use Case: Patient Prescription Consent

Method: SMS + Digital Consent Form
Compliance: Patients must actively consent before uploading or routing prescriptions via PharmaFAST. This ensures full GDPR and HSE alignment with informed patient participation.

📧 Use Case: Marketing Emails

Method: Double Opt-In
Compliance: Both patients and pharmacies must explicitly opt in to receive marketing or platform update emails. All communications include an easy unsubscribe option, as required under GDPR and ePrivacy laws.

💬 Use Case: GP & Pharmacy Messaging

Method: Healthmail Routing Only
Compliance: All sensitive or clinical data is transmitted only via Healthmail — a secure, encrypted channel approved by the HSE. No sensitive data is ever stored in the app or sent through unencrypted systems.

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