2 Squirrels AI
2 Squirrels AI
Ship FDA-compliant clinical AI in 90 days — without 12-month regulatory timelines. Compliance is built in from day one, not bolted on at the end.
Most AI projects fail in healthcare — not because of technology, but because of compliance, patient safety, and data privacy requirements that generic AI teams don't understand.
A proven 12-week process that bakes regulatory readiness into every phase — so you ship compliant AI on the first try.
Map HIPAA/FDA requirements to your specific use case. Identify compliance gaps early.
Design data flows with PHI protection, encryption at rest and in transit, audit logging.
Build and validate AI models against clinical protocols. Evidence-based accuracy testing.
Generate BAA documentation, security controls, risk assessments, and audit trails.
Launch on BAA-compliant infrastructure with monitoring, alerting, and incident response.
Specialized solutions built for the unique demands of digital health.
Evidence-based AI that assists clinicians with diagnosis, treatment recommendations, and care pathway optimization.
Intelligent symptom assessment and urgency classification to prioritize patient care and reduce wait times.
NLP and OCR systems that extract, structure, and analyze clinical data from unstructured medical records.
Virtual health assistants that handle intake, follow-up, medication reminders, and patient engagement.
AI-powered medication safety checks using comprehensive pharmacological databases and patient history.
Predictive models for disease surveillance, risk stratification, and community health trend analysis.
How we built HIPAA-compliant clinical decision support for underserved communities.
AI-powered clinical decision support for underserved communities where specialists are unavailable — bringing evidence-based care guidance to frontline healthcare workers.
Deep expertise in the standards and systems that matter for healthcare AI.
End-to-end HIPAA-aware architecture, BAA documentation, and security controls.
Experience with Microsoft's healthcare-specific cloud infrastructure and FHIR APIs.
Interoperability expertise for seamless healthcare data exchange across systems.
Experience integrating with Epic, Cerner, and other major electronic health record systems.
40+ checkpoint guide to ensure your healthcare AI system passes compliance audits.
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HIPAA compliance is built into our architecture from day one — not added as an afterthought. We implement encryption at rest and in transit for all PHI, role-based access controls, comprehensive audit logging, BAA-compliant cloud infrastructure (Azure/AWS), and automated compliance monitoring. Every healthcare project includes a full security assessment and compliance documentation package.
We build systems with FDA regulatory pathways in mind. For clinical decision support that falls under FDA's SaMD (Software as a Medical Device) guidance, we implement the documentation, validation testing, and quality management processes needed for 510(k) or De Novo submissions. We also design systems to qualify for FDA's clinical decision support exemption where applicable.
Yes. We have experience integrating with major EHR platforms including Epic and Cerner using HL7 FHIR APIs and SMART on FHIR frameworks. We can pull patient data, push clinical decision support alerts, and embed AI tools directly into existing clinical workflows — minimizing disruption to your care teams.
PHI is treated with the highest level of protection throughout our systems. We implement data minimization (only collect what's needed), de-identification where possible, AES-256 encryption at rest, TLS 1.3 in transit, and strict access controls with audit trails. All PHI storage uses BAA-covered infrastructure, and we never use real patient data in development or testing environments.
Let's discuss your clinical use case and map a 90-day path to production — with compliance built in from day one.