Compliance & Certifications
ProteusDx™ maintains the highest standards of regulatory compliance, data security, and quality management to ensure patient safety and data protection.
HIPAA Compliant
Full compliance with Health Insurance Portability and Accountability Act
FDA Cleared
FDA-cleared Class II medical device for diagnostic use
CLIA Certified
Clinical Laboratory Improvement Amendments certified
SOC 2 Type II
Audited security, availability, and confidentiality controls
HIPAA Compliance
ProteusDx™ is fully compliant with the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. We implement comprehensive administrative, physical, and technical safeguards to protect Protected Health Information (PHI).
Administrative Safeguards
Physical Safeguards
Technical Safeguards
FDA Clearance
Our capsule endoscopy technology has received FDA 510(k) clearance as a Class II medical device for visualization of the small bowel and colon. We maintain compliance with FDA regulations including:
21 CFR Part 820 - Quality System Regulation
Comprehensive quality management system covering design controls, manufacturing processes, corrective and preventive actions (CAPA), and post-market surveillance.
21 CFR Part 11 - Electronic Records
Electronic records and signatures meet FDA requirements for authenticity, integrity, and confidentiality with comprehensive audit trails.
Medical Device Reporting (MDR)
Established procedures for reporting adverse events and device malfunctions to the FDA in accordance with 21 CFR Part 803.
Post-Market Surveillance
Ongoing monitoring of device performance, safety, and effectiveness through systematic data collection and analysis.
CLIA Certification
Our laboratory operations are certified under the Clinical Laboratory Improvement Amendments (CLIA) for high-complexity testing. We maintain compliance with all CLIA requirements:
Personnel Qualifications
Laboratory director, technical supervisors, and testing personnel meet CLIA qualification requirements.
Quality Control
Daily quality control procedures ensure accuracy and reliability of test results.
Proficiency Testing
Participation in external proficiency testing programs to validate testing accuracy.
Quality Assurance
Comprehensive quality assurance program with regular audits and performance reviews.
Patient Test Management
Established procedures for specimen handling, result reporting, and record retention.
Inspections
Regular inspections by CMS or accrediting organizations to maintain certification.
Information Security Standards
SOC 2 Type II Compliance
We maintain SOC 2 Type II certification, demonstrating our commitment to security, availability, processing integrity, confidentiality, and privacy. Our controls are audited annually by independent third-party auditors.
ISO 27001 Alignment
Our information security management system (ISMS) is aligned with ISO 27001 international standards, covering risk assessment, security policies, asset management, access control, cryptography, and incident management.
NIST Cybersecurity Framework
We implement controls based on the NIST Cybersecurity Framework, including Identify, Protect, Detect, Respond, and Recover functions to manage cybersecurity risk.
Data Protection & Privacy
GDPR Readiness
While primarily operating in the United States, we maintain practices aligned with the European Union's General Data Protection Regulation (GDPR) for international patients:
CCPA Compliance
We comply with the California Consumer Privacy Act (CCPA), providing California residents with rights to know, delete, and opt-out of the sale of personal information (note: we do not sell personal information).
Quality Management System
Our Quality Management System (QMS) is designed to ensure consistent delivery of safe, effective diagnostic services:
ISO 13485 Alignment
Medical device quality management system aligned with ISO 13485 requirements for design, development, production, and post-market activities.
Document Control
Comprehensive document management system ensuring all procedures, work instructions, and records are controlled, reviewed, and approved.
Risk Management
Systematic risk management process following ISO 14971 to identify, evaluate, and mitigate risks throughout the product lifecycle.
Corrective and Preventive Actions (CAPA)
Formal CAPA process to investigate nonconformities, implement corrections, and prevent recurrence.
Internal Audits
Regular internal audits to assess QMS effectiveness and compliance with regulatory requirements.
Management Review
Periodic management reviews to evaluate QMS performance, customer feedback, and opportunities for improvement.
Training & Competency
All personnel receive comprehensive training to ensure competency in their roles and compliance with regulatory requirements:
HIPAA Training
Annual HIPAA privacy and security training for all workforce members with access to PHI.
Clinical Competency
Healthcare professionals maintain current licenses and complete ongoing clinical education.
Quality System Training
Training on QMS procedures, document control, and CAPA processes.
Security Awareness
Regular security awareness training covering phishing, social engineering, and data protection.
Incident Response
Training on security incident identification, reporting, and response procedures.
Competency Assessment
Regular competency assessments to verify understanding and skill proficiency.
Independent Audits & Verification
We undergo regular independent audits and assessments to verify compliance with regulatory requirements and industry standards:
Annual SOC 2 Type II Audits
Independent auditor assessment of security and privacy controls
Biennial CLIA Inspections
CMS or accrediting organization laboratory inspections
FDA Quality System Inspections
Periodic FDA inspections of manufacturing and quality systems
Penetration Testing
Annual third-party penetration testing and vulnerability assessments
Internal Quality Audits
Quarterly internal audits of quality management system effectiveness
Compliance Inquiries
For questions about our compliance programs, certification status, or to request audit reports (subject to confidentiality agreements), please contact:
Compliance Officer
FirstVitals dba ProteusDx™
2605 Camino Tassajara #2500
Danville, CA 94526
Email: [email protected]
Phone: 925-299-8000