Harvard T.H. Chan · MIT collaboration

AI in Healthcare Needs Trust, Safety, and Compliance

AI holds enormous potential for diagnostics, decision support, and patient care — but risks such as bias, lack of transparency, and regulatory challenges can compromise patient safety and stall adoption. SafeAI is the lifecycle platform that closes the gap.

The Problem

Clinical AI is already at scale — and the failure modes that show up in the literature are not hypothetical. They map directly onto the tools being deployed today.

1,000
primary care clinics in Rwanda receiving OpenAI-based clinical tools by 2028
138
low- and middle-income countries now deploying AI-powered TB chest X-ray devices
721K+
patients screened by AI-CAD in India in 2024 alone — a number growing every month
Risk 01

Automation bias

Clinicians over-trust algorithmic outputs even when they conflict with clinical judgment. Authority gradients make it worse.

Goddard et al., JAMIA 2012 →
Risk 02

Hallucination & sycophancy

LLMs fabricate plausible-sounding dosages, contraindications, and citations — and agree with users' mistaken beliefs.

Ji 2022 · Sharma 2023 →
Risk 03

Proxy & measurement bias

Risk scores built on proxies that track access rather than need systematically under-treat the patients in greatest clinical need.

Obermeyer et al., Science 2019 →
Risk 04

Sampling & representation

Training data under-represents demographic groups, so models fail to generalize to the patients they'll actually encounter.

Daneshjou et al., JAMA Derm 2022 →
Risk 05

Overfitting to site artifacts

Models learn hospital- or scanner-specific artifacts rather than pathology. Internal performance looks strong; external collapses.

Zech et al., PLOS Medicine 2018 →
Risk 06

Deployment drift

New protocols, devices, and populations shift the relationships the model was trained on. Performance decays silently.

Gama et al., ACM Surveys 2014
Risk 07

Aggregation bias

A single pooled model papers over real heterogeneity. Overall accuracy looks strong; specific subgroups are under-served.

Suresh & Guttag, ACM 2021 →
Risk 08

Black-box decisions

Opaque models cannot be contested by clinicians or patients, and adverse events cannot be properly investigated.

Rudin, Nature MI 2019 →

What We Do

A lifecycle response to clinical AI risk — validation, monitoring, and integration support. Built on a working prototype.

1Pre-Deployment Validation

A standard audit package for every AI solution before it goes live.

Before a single patient is touched by the model, we benchmark it against local populations and workflows — so surprises surface in evaluation, not in the clinic.

  • Local subgroup testing — benchmark on a local validation set stratified by HIV status, age, sex, BMI, with CIs that account for subgroup numerosity.
  • Site-artifact stress test — Zech-style external-hospital testing to surface spurious features before patient exposure.
  • Proxy & label audit — inspect what the model actually predicts on; flag proxies that track access rather than clinical need.
  • Clinical workflow simulation — run the tool through nurse- or CHW-led consultation simulations; measure bias and override patterns.
Pre-deployment audit · Report
4 / 4 complete
Subgroup AUC gap measured · 4 strata
Site artifacts: 2 scanner signatures flagged
Proxy audit: no cost-proxies detected
Workflow sim: 87% override accuracy
2Post-Deployment Monitoring

A pharmacovigilance layer for clinical AI, running continuously.

A dashboard per clinic and per model — visible to clinical leadership, not buried in vendor logs. Incidents get routed, not hidden. Built on our working prototype.

  • Real-time bias & drift detection — PSI and KS tests on covariate drift, calibration tracking, clinician-override rates — no waiting for lagging confirmation.
  • Hallucination & sycophancy checks — sampled expert review of live LLM outputs, rubric-scored for fabricated citations and dangerous agreement.
  • Incident reporting & investigation — pharmacovigilance-style adverse-event logs with a clinical governance dashboard.
  • Re-validation on model updates — when the underlying model changes, trigger a gated re-validation before continued use.
See the live prototype
Monitoring dashboard · Horizon pilot
Live
Subgroup parity
92%+3%
Drift (PSI)
0.18
Models monitored14
Active drift alerts2 this week
Hallucination flags (7d)0
3Integration & Live Support

Safety work only lands if it's embedded in clinical and regulatory reality.

Training, regulatory mapping, and an ongoing bench of advisors — all owned by you. Lessons from one deployment transfer to the next through a shared case library.

  • Clinician & CHW training — automation bias, override protocols, how to recognize hallucinations, integrated into existing workflows.
  • Regulatory mapping — outputs mapped to EU AI Act high-risk, FDA SaMD, and emerging African Medicines Agency frameworks.
  • Ongoing advisory — a standing bench of AI safety advisors working with your team on the decisions that actually come up.
  • Knowledge library — case library of deployment failures and remediations, shared across your network.
Governance & regulatory coverage
EU AI Act
High-risk obligations mapped
FDA SaMD
Predetermined Change Control aligned
African Medicines Agency
Quarterly reporting cadence
Knowledge library
Case-by-case, continuously updated

Who We Are

A multidisciplinary team from Harvard and MIT, combining global-health operating experience, clinical machine-learning research, and production engineering — advised by the people setting the standards the field will operate under.

Core Team
Lara Grosso
Founder · DrPH on AI Safety

Harvard doctorate on AI safety in healthcare. Ten years in global health across the World Health Organization and the Clinton Health Access Initiative (Regional Manager, AHD Global Team). Ex-BCG.

Harvard
Marcus Scaramanga
Former Founder & CEO, Minexx

Former founder and CEO of Minexx, a fair-trade mining technology platform. Launched Health Intelligence Centres leveraging AI and real-time insights to transform care across Rwanda, Botswana, and CAR.

Operator
Filippo Bargagna
PhD · AI & Biomedical Imaging

PhD researcher at the University of Pisa and Harvard / MGH, specializing in Bayesian deep learning and uncertainty quantification for medical AI.

Harvard / MGH
Francesca Mussa
PhD · Harvard AIM Lab

PhD at Harvard's Artificial Intelligence in Medicine lab, working on deep learning for pediatric brain tumors and Diffuse Midline Glioma.

Harvard
Paul Tan
Head of Engineering

MIT-trained software engineer and data scientist. 20+ years of full-stack engineering leadership, including CTO roles in financial services and electronic medical records for US military clinicians.

MIT
Advisory Board
Dr Brian Anderson
CEO, Coalition for Health AI

Co-founder and CEO of the Coalition for Health AI, the leading US non-profit setting consensus standards for responsible AI in healthcare across nearly 3,000 member organizations.

CHAI
Prof. Tom Pollard
Harvard & MIT · ML and Healthcare

Professor of Machine Learning and Healthcare at Harvard / MIT. Technical Director of MIMIC, the openly-accessible critical care database used by 4,000+ researchers.

Harvard / MIT
Cyrous Massoumi
Founder, ZocDoc

Founder and former CEO of ZocDoc, the online appointment platform that reached 40% of the US population across 1,900 cities and was valued at $1.8B, backed by Jeff Bezos and others.

Founder

Our Partners

Our academic and innovation partners advancing clinical AI safety.

T.H. Chan School of Public Health
Massachusetts Institute of Technology

Awards & Recognition

Backed and recognized by the leading academic innovation programs at Harvard and MIT.

Winner · Harvard Innovation Fund Competition 2025
The largest equity-free startup competition at Harvard & MIT.
Winner Cohort 2025 · Harvard HealthLab Accelerators
Selected as one of the Top 10 Most Impactful Health Startups from Harvard.
2026 Semifinalists · President's Innovation Challenge
With the Martin Trust Center for MIT Entrepreneurship.

These recognitions underscore SafeAI's mission to define the gold standard for trustworthy, compliant, and equitable AI in healthcare.

Build Trust in Healthcare AI

Join hospitals, startups, and regulators adopting SafeAI to ensure clinical AI is safe, fair, and compliant — before, during, and after deployment.