Committed to ethical AI in clinical care.
Advancing clinical AI carries responsibility. This page describes how PathFree Technologies approaches fairness, transparency, and regulatory rigor for AiMediQ™ and datasyteAI™ — with honest labeling of what is current, in progress, and planned.
Thinking ethics of AI.
Understanding the ethical implications of AI in healthcare is fundamental to how we build.
Video courtesy of UNESCO.
Identify, measure, and reduce bias — as a discipline, not a claim.
Fairness is treated as an engineering practice: representative data, continuous testing, tracked metrics, and alerts that route into review.
Diverse training data
Datasets are curated for representation across demographics, care settings, and geographies so model behavior is evaluated on the populations the system is meant to support.
Continuous bias testing
Statistical parity, disparate-impact, and intersectional bias checks run on every model update, with interpretability tools surfacing the features driving disparate outcomes.
Fairness metrics
Multiple fairness metrics — demographic parity, equalized odds, calibration — are tracked over time so equity is measured, not assumed.
Bias detection alerts
Threshold-based monitoring flags disparities in real time and routes them to the ethics review workflow for investigation and remediation.
Ethics of AI: challenges and governance.
Governance frameworks shaping responsible AI development worldwide.
Video courtesy of UNESCO.
Independent algorithm review with NAMSA.
We are engaging NAMSA to perform independent audits of the algorithm as part of a proactive bias and safety program.
Pre-market
Algorithm accuracy, bias assessment, and clinical validation are documented in formal reports before any deployment.
Ongoing
Post-deployment monitoring, periodic bias audits, and drift detection sustain performance across changing populations.
Transparent
Executive summaries of audit findings and remediation actions are intended for publication so partners can evaluate accountability.
Building against recognized standards.
AiMediQ™ is being developed against the standards that govern Software as a Medical Device, with quality, privacy, and international market access designed in from the start.
FDA regulatory pathway
AiMediQ™ is being developed against FDA guidance for Software as a Medical Device, with Design History File, formal V&V, and post-market surveillance planning maintained through the program.
HIPAA-aligned handling
Encryption in transit and at rest, role-based access, audit logging, and Business Associate Agreements are defined per deployment with the institution's privacy and security teams.
ISO 13485 quality system
The quality management system is designed against ISO 13485 — design controls, risk management (ISO 14971), CAPA, supplier management, and traceability — with third-party certification as a planned milestone.
EU MDR preparation
Technical Documentation is being prepared per EU MDR Annex II, including clinical evaluation, risk-benefit analysis, and post-market clinical follow-up planning.
AiMediQ™ approval timeline.
A phase-by-phase view of the regulatory path. Dates are current projections and may shift with regulatory feedback and testing outcomes.
- In ProgressPhase 1 · Q3 2026
Pre-submission preparation
Design history, risk management, and software documentation compiled to submission-ready standards.
- Complete Design History File (DHF)
- Finalize Risk Management File (ISO 14971)
- Software documentation (IEC 62304)
- Clinical Evaluation Plan
- PlannedPhase 2 · Q4 2026
FDA pre-submission meeting
Formal Q-Submission to align on regulatory pathway, testing expectations, and submission strategy.
- Submit Pre-Submission request
- Prepare meeting briefing document
- Conduct FDA pre-submission meeting
- Incorporate FDA feedback
- PlannedPhase 3 · Q1 2027
Verification & validation
Comprehensive software V&V including usability engineering and clinical validation.
- Software verification testing
- Usability studies (IEC 62366)
- Clinical validation studies
- Cybersecurity documentation
- PlannedPhase 4 · Q2 2027
FDA 510(k) submission
510(k) premarket notification demonstrating substantial equivalence to predicate devices.
- Compile submission package
- Submit to FDA eCopy portal
- Respond to FDA questions
- Target 510(k) clearance
- PlannedPhase 5 · Q2–Q3 2027
EU MDR certification
Notified Body conformity assessment and CE marking for EU market access.
- EU MDR Technical Documentation
- Engage Notified Body
- Clinical evaluation (MEDDEV 2.7/1)
- Obtain CE Mark
- TargetPhase 6 · Q4 2027
Market launch
Commercial launch in US and EU with post-market surveillance in place.
- US commercial launch
- EU commercial launch
- Post-market surveillance
- International expansion planning
De-risking a medical device clinical trial.
Video courtesy of NAMSA.
When is a Data Safety and Monitoring Board required?
Video courtesy of NAMSA.
Ethics & compliance — FAQ
Find answers to common questions about our technology and services
Explore AiMediQ™ and how it's built.
See the platform and the security posture that supports it.