Healthcare & Medical Devices
Healthcare organizations face converging regulatory pressures: HIPAA, FDA AI guidance, EU MDR, and emerging AI governance requirements. We bring one team that covers AI governance, privacy compliance, security, and technology assessment — without the handoffs between siloed practices that slow down Big 4 engagements.
What we deliver
- - AI governance for clinical and operational AI systems
- - HIPAA security and privacy compliance assessments
- - Medical device software (SaMD) technology assessment
- - Technology due diligence for healthcare M&A
- - Data governance and de-identification strategy
- - SOC 2 readiness for health tech companies
Frequently asked questions
Do you handle HIPAA compliance assessments?
Yes. Our compliance team includes CPA and dual-CIPP credentials. We assess HIPAA administrative, physical, and technical safeguards and help health systems and medtech companies implement compliant AI systems.
Can you audit AI used in clinical decision support?
Yes. Our Certified AI Auditor credentials and experience building LLMs give us the technical depth to evaluate clinical AI systems for bias, safety, and regulatory compliance under FDA guidance.
Do you work with medical device software companies?
We assess SaMD (Software as a Medical Device) and SiMD for technology due diligence, security, IP compliance, and AI governance — particularly relevant for FDA and EU MDR requirements.