HIPAA and FDA GxP (21 CFR Parts 11 and 820)

As a medical solution vendor serving the U.S. market, you must ensure that your subcontractors comply with HIPAA and GxP guidelines.

At BioT, our software development practices incorporate an internal HIPAA Checklist, ensuring that every new feature meets HIPAA compliance requirements.

Internally, BioT adheres to the following HIPAA policies:

Data Security Policy
Global Information Technology Policy
Disaster Recovery Policy
Business Continuity Plan
Use and Disclosure of PHI
Privacy Training
Sanctions for Privacy and Security Violations
Safeguarding/Retrieval of Service Record
Security of PHI
Breach Analysis
Security Management Process
Workforce Security
Information Access Management
Security and Awareness Training
Security Incident Reporting
Contingency Plan
Evaluation
Quality Access Controls
Workstation Use and Security
Device and Media Controls
Controls: Technical Safeguards
Integrity Controls
Person or Entity Authentication
Transmission Security
Risk Assessment & Risk Management
Facility Access Controls

BioT clients benefit from Business Associate Agreements (BAAs)** that shift cybersecurity and privacy liability to BioT, ensuring regulatory compliance and reducing risk exposure.

As part of 21 CFR Part 11 compliance, customers must establish and enforce written policies that hold individuals accountable for actions taken under their electronic signatures. These policies help deter record and signature falsification, ensuring data integrity and regulatory adherence.