FetalFirst Submits Ethics for First Cross-Border EHDS Pathfinder Pilot in Fetal Anomaly Detection
AI-Powered Prenatal Diagnostics Platform Leads Ethics-First Approach to Cross-Border Healthcare Data Sharing in Estonia and Finland
London, UK – October 21, 2025 – FetalFirst, the AI-powered prenatal diagnostics platform transforming maternal healthcare, today announces the submission of research ethics for a groundbreaking cross-border pilot under the European Health Data Space (EHDS) Pathfinder initiative. The pilot will validate AI-driven fetal anomaly detection across borders in Estonia and Finland, marking a significant milestone in ethical, privacy-preserving cross-border healthcare innovation.
This first-of-its-kind pilot begins Phase 1 at Tartu University Hospital Women's Clinic in Estonia, with plans to expand into Finland through strategic partnerships currently under development. The initiative represents a crucial validation of whether AI anomaly detection can be deployed safely, ethically, and reproducibly across European healthcare systems.
A Research-First, Ethics-Led Approach
"This has been in the works for a while," said Nina Abide, Founder and CEO of FetalFirst. "We've just submitted ethics for a first-of-its-kind cross-border EHDS pathfinder pilot in fetal anomaly detection using AI—starting in Estonia, with plans underway to expand into Finland."
Unlike traditional clinical deployment models, FetalFirst's approach prioritizes research validation and ethical oversight from day one. The pilot is designed with privacy by design principles, ensuring no patient identifiers, no cross-border data transfers, and no shortcuts.
"It's not clinical deployment yet. It's not fast," Abide emphasized. "It's research-only, ethics-led, and privacy by design—no identifiers, no data transfers, no shortcuts. The data is anonymised, processed securely inside hospital environments, and built in full alignment with EHDS principles
The Central Question: Can AI Scale Ethically Across Borders?
The pilot seeks to answer a fundamental question that could reshape prenatal care across Europe and beyond:
Can we validate anomaly detection AI across borders, safely, ethically, and reproducibly?
If successful, this model could unlock scalable AI-powered diagnostics across the European Union and internationally, demonstrating that advanced healthcare AI can respect national data sovereignty while delivering consistent clinical value.
"If yes—this becomes a model that could unlock scale across the EU and beyond," said Abide.
Phase 1: Tartu University Hospital Women's Clinic
The pilot launches at Tartu University Hospital Women's Clinic in Estonia, one of the country's leading maternal-fetal medicine centers. Phase 1 will focus on:
Validating AI anomaly detection accuracy in real-world clinical settings
Ensuring full GDPR and EHDS compliance
Demonstrating privacy-preserving data processing within hospital infrastructure
Establishing ethical frameworks for cross-border AI validation
All data will be anonymized and processed locally within hospital environments using FetalFirst's edge AI deployment architecture, ensuring that sensitive patient information never leaves secure clinical systems.
Preparing for Phase 2: Finnish Partnerships
FetalFirst is currently preparing the framework for Phase 2, which will expand the pilot into Finland through strategic healthcare partnerships.
"We're now preparing the framing for Phase 2—and beginning to explore Finnish partnerships," Abide explained.
Phase 2 will build on the learnings from Estonia, testing whether the validated AI model can deliver consistent performance across different healthcare systems, languages, and clinical workflows—a crucial step toward demonstrating true cross-border reproducibility.
Privacy by Design: EHDS Principles in Action
The FetalFirst pilot exemplifies the privacy-first, ethics-led approach mandated by the European Health Data Space framework. Key design principles include:
No Cross-Border Data Transfers: All patient data remains within national borders, processed locally at participating hospitals
Anonymisation by Default: No patient identifiers are used; data is anonymized before AI processing
Edge AI Deployment: FetalFirst's NVIDIA IGX Orin edge computing architecture enables secure, on-device inference without cloud uploads of raw clinical data
Hospital-Controlled Infrastructure: All processing occurs within hospital security perimeters, maintaining institutional data sovereignty
Ethics Committee Oversight: Independent research ethics review at each participating institution
This approach aligns with EHDS goals of enabling cross-border health data use for research and innovation while maintaining the highest standards of privacy protection and patient trust.
Strategic Partnerships Driving Innovation
The pilot has been shaped through collaboration with key partners committed to ethical healthcare AI innovation:
"Huge thanks to those who've helped shape this with care—especially Accelerate Estonia, clinical team and IT leads at Tartu," said Abide. "More to come."
Accelerate Estonia, the government-backed startup accelerator, has provided critical support in navigating Estonia's progressive digital health ecosystem. Tartu University Hospital's clinical and technical teams have contributed expertise in maternal-fetal medicine and healthcare IT infrastructure to ensure the pilot meets rigorous clinical and operational standards.
What This Means for Prenatal Care
If validated, FetalFirst's cross-border AI model could significantly improve access to specialist-level prenatal diagnostics across Europe. Currently, fetal anomaly detection expertise is concentrated in major urban centers, creating health inequalities for families in rural or underserved regions.
By demonstrating that AI can deliver consistent, accurate anomaly detection across different healthcare systems—while respecting data sovereignty and patient privacy—the pilot could pave the way for:
Equitable Access: Real-time specialist-level diagnostics available at any participating maternity clinic
Earlier Detection: Reduced delays in identifying fetal anomalies, enabling timely interventions
Clinical Decision Support: AI-powered severity grading and risk assessment to guide clinician decision-making
Research Acceleration: Anonymized, privacy-preserving data networks for continuous AI improvement
The Path Forward
FetalFirst's EHDS Pathfinder pilot represents a measured, responsible approach to healthcare AI innovation—prioritizing ethical oversight, privacy protection, and clinical validation over speed to market.
"The question we're working on is simple: Can we validate anomaly detection AI across borders, safely, ethically, and reproducibly?" said Abide.
The coming months will provide critical answers as Phase 1 progresses at Tartu University Hospital and Phase 2 partnerships take shape in Finland. Success would establish a replicable model for cross-border healthcare AI that balances innovation with patient trust, clinical rigor, and regulatory compliance.
About FetalFirst
FetalFirst is an AI-powered prenatal diagnostics platform that detects fetal anomalies from ultrasound and genomic data in real-time, enabling early intervention and better outcomes. Built on Google Cloud with edge AI deployment via NVIDIA IGX Orin, FetalFirst combines cutting-edge technology with privacy-first architecture to transform prenatal care from reactive to predictive.
The platform features dual interfaces: a clinician diagnostic tool delivering severity-graded results within seconds, and a parent companion app providing personalized care coordination, educational resources, global telehealth access, and community support.
FetalFirst has secured NHS ethics approval, NHS Data Security & Protection Toolkit certification, and is a member of the NVIDIA Inception program. The company is backed by advisors from NHS, Imperial College London, UCL, and Tartu University Hospital.
About the European Health Data Space (EHDS)
The European Health Data Space is the EU's flagship initiative to enable secure, privacy-preserving sharing of health data for healthcare delivery, research, and policy-making. EHDS aims to give citizens control over their health data while facilitating cross-border data use that respects national sovereignty and GDPR requirements.
Pathfinder projects like FetalFirst's pilot serve as real-world testbeds for EHDS principles, demonstrating how advanced health technologies can operate within the framework's ethical and technical requirements.
About Accelerate Estonia
Accelerate Estonia is a government-backed initiative supporting startups and innovation in Estonia's digital ecosystem. The program provides mentorship, resources, and connections to help companies navigate Estonia's progressive regulatory environment and scale across European markets.
