Compliance CentreAll Systems Compliant

Regulatory Compliance &
Certification Documentation

My Fertility Insights operates under rigorous compliance frameworks across all jurisdictions. Our HIPAA, GDPR, and MHRA documentation is independently audited and updated annually.

HIPAACompliant
GDPRCompliant
MHRARegistered
UK GDPRICO Registered
7
Compliance Frameworks
94
Security Controls
Jan 2025
Last External Audit
Jan 2026
Next Review Due

Compliance Certificates

Independently audited β€” updated annually

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HIPAA

Health Insurance Portability and Accountability Act

ActiveMFI-HIPAA-2024-0031
Issued
15 January 2024
Valid Until
14 January 2026
Audited By

CyberArk Healthcare Compliance Group

Scope

All systems processing Protected Health Information (PHI)

Key Controls
Privacy RuleSecurity RuleBreach NotificationOmnibus Rule
Documentation
  • Business Associate Agreement (BAA)
  • HIPAA Risk Assessment Summary
  • Security Incident Response Plan
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GDPR

General Data Protection Regulation (EU) 2016/679

ActiveMFI-GDPR-2024-0088
Issued
28 February 2024
Valid Until
27 February 2026
Audited By

DataGuard GmbH β€” EU Privacy Certification

Scope

All personal data processing of EU/EEA data subjects

Key Controls
Data MinimisationPurpose LimitationSCCsDPIA Procedures
Documentation
  • Data Processing Agreement (DPA)
  • Standard Contractual Clauses (SCCs)
  • Records of Processing Activities (RoPA)
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MHRA

Medicines & Healthcare Products Regulatory Agency

RegisteredMFI-MHRA-2024-0014
Issued
10 March 2024
Valid Until
Annual Review β€” March 2025 completed
Audited By

NHS Digital Clinical Safety Group

Scope

Software as a Medical Device (SaMD) Classification Review

Key Controls
DCB0129 Clinical SafetyAI/ML Software GuidanceUKCA AssessmentCyber Essentials Plus
Documentation
  • Clinical Safety Case Report (DCB0129)
  • MHRA CDS Classification Statement
  • Cyber Essentials Plus Certificate

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Clinician
Individual

Welcome to My Fertility Insights

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This platform serves both healthcare professionals and individuals. Select your role to receive the appropriate safety information and experience.

Your selection determines the safety terms and experience you receive. You may change your role at any time from Settings. Both modes operate under GDPR, UK GDPR, and HIPAA data protection standards.