Our approach

Clinical approach Home monitoring of congenital heart disease

The clinical need, our care pathway between consultations, and our security and regulatory framework. A tool that supports care teams, never a substitute for medical judgment.

The essentials

PépiteCare at a glance

PépiteCare monitors congenital heart disease between appointments: we bring the medical record together in one place, connect caregivers and families, and flag risk signs early, from the diagnosed newborn through to adulthood.

Identified Need

People with congenital heart diseases face fragmented and complex care pathways. An enormous mental burden weighs on families without digital solutions adapted to long-term monitoring.

Our Solution

Platform designed for GDPR (HDS hosting targeted)

Digital record
Synchronized Calendar
Dedicated Messaging
Educational Content

Our roadmap

  1. 1Clinical pilot in hospitals
  2. 2Medical validation
  3. 3Progressive rollout

Security & Compliance

PépiteCare aims for the highest level of security and regulatory compliance for the protection of sensitive health data.

GDPR

General Data Protection Regulation

Compliance with European data protection standards

  • Explicit user consent
  • Right to be forgotten and portability
  • Data anonymization
  • Processing transparency

HDS

Health Data Host

French certification for health data hosting (HDS hosting targeted)

  • HDS-compliant infrastructure (targeted)
  • End-to-end encryption
  • Restricted and tracked access
  • Secure backup

MDR

Regulation (EU) 2017/745 on medical devices

CE marking pathway targeted: Class IIa medical device software

  • Medical device software (SaMD)
  • Decision support, non-diagnostic
  • Risk management (ISO 14971)
  • ISO 13485 quality system (targeted)

Data encryption

Maximum protection of sensitive information

  • AES-256 encryption in transit and at rest
  • HSM-managed encryption keys
  • TLS 1.3 protocols
  • Multi-factor authentication

Secure architecture

Robust and resilient infrastructure

  • Silo architecture for critical data
  • Environment separation
  • Real-time monitoring
  • Business continuity plan

Access control

Granular permission management

  • Strong authentication
  • Custom roles and permissions
  • Access logging
  • Automatic session timeout

🎯 Key Advantages

Simplicity and user-friendliness

Intuitive interface for patients and professionals

Social Security alignment

Possible integration with mutual insurance reimbursement

Interoperability

Compatible with Doctolib, Implicity, New Card

Workload reduction

Automation of administrative tasks

Facilitated adoption

Integration with health networks (CPTS)

Standard technology

Compatible with common medical equipment