Healthcare & Life Sciences
Technical Due Diligence
Healthcare organizations, biotech, and life sciences companies require specialized technology due diligence that understands HIPAA, FDA regulations, clinical systems, and the unique requirements of healthcare data.
Technology Assessment for Healthcare M&A
Healthcare technology is uniquely complex. Electronic health records, clinical decision support, medical devices, and research platforms must meet stringent regulatory requirements while handling the most sensitive data imaginable. Our healthcare technology specialists understand these challenges and provide due diligence that addresses industry-specific risks.
Healthcare Technology Experience
Healthcare Sub-Sectors
We serve technology due diligence needs across healthcare and life sciences:
Health IT & EHR
Electronic health records, clinical documentation, and healthcare information systems
Digital Health
Telehealth platforms, remote patient monitoring, and digital therapeutics
Medical Devices
Connected devices, imaging systems, diagnostic equipment, and device software
Life Sciences & Pharma
Clinical trial systems, drug discovery platforms, and research technology
Healthcare Analytics
Population health, clinical analytics, and healthcare AI/ML platforms
Revenue Cycle
Billing systems, claims processing, and healthcare financial technology
Regulatory Compliance Assessment
Healthcare technology must meet strict regulatory requirements:
HIPAA & Privacy
- PHI protection and access controls
- Business associate agreements
- Breach notification readiness
- Audit trail and logging
- Data encryption standards
FDA & Quality Systems
- 21 CFR Part 11 compliance
- Software as Medical Device (SaMD)
- Quality Management Systems
- Validation documentation
- Change control processes
Clinical System Integration
Healthcare acquisitions often involve complex system integration:
- HL7/FHIR Capabilities: Interoperability standards compliance and API maturity
- EHR Integration: Existing integrations with Epic, Cerner, and other major EHRs
- Clinical Workflows: Impact on clinical operations and care delivery
- Data Migration: Patient data migration complexity and PHI handling
- Training Requirements: Clinical staff training and adoption planning
Healthcare Data Assessment
Healthcare data is both valuable and highly regulated:
Data Classification
PHI, de-identified data, and research data classification and handling
Data Quality
Clinical data quality, completeness, and reliability for analytics use
Consent Management
Patient consent tracking and data use authorization systems
De-identification
De-identification methods and re-identification risk assessment
Medical Device Software
For medical device acquisitions, we assess software-specific concerns:
- Device Classification: FDA classification and premarket submission status
- Cybersecurity: Medical device cybersecurity per FDA guidance
- Software Lifecycle: IEC 62304 compliance and development processes
- Post-Market: Surveillance, updates, and vulnerability management
Navigate Healthcare Technology Complexity
Healthcare M&A requires specialized technology expertise. Get the regulatory-aware assessment your deal needs.