By Sergiy Troitskyi in Solutions —

Undergoing certifications

To develop a HIPAA-compliant, ICD-10-certified, and ISO 9001-certified software portal for dental practices, I followed these steps.

1. ICD-10 Compliance

Objective: Ensure software supports accurate medical coding and documentation.
Steps:

  • Integrate latest ICD-10-CM/PCS codes:
    • Use CMS’s April 2025 ICD-10-PCS code update files for procedures.
    • Implement CDC’s diagnosis code revisions.
  • Add dental-specific coding support:
    • Map common dental conditions to ICD-10 codes (e.g., K00-K14 for oral diseases).
    • Included auto-suggest features for code selection based on clinical documentation.
  • Enable detailed clinical documentation:
    • Design EHR templates to capture granular data (e.g., tooth location, severity) required for ICD-10 coding.
  • Validate with stakeholders:
    • Partnered with dental practices to test coding accuracy and CMS billing compatibility.

2. HIPAA Certification

Objective: Protect electronic protected health information (ePHI).
Steps:

  • Conduct a risk analysis:
    • Map ePHI flow through the software using network diagrams.
    • Identify vulnerabilities in data storage/transmission.
  • Implement technical safeguards:
    • Encrypt ePHI at rest (AES-256) and in transit (TLS 1.3).
    • Add role-based access controls with automatic logoff.
    • Enable multi-factor authentication for all user accounts.
  • Develop audit controls:
    • Track access to patient records with timestamped logs.
    • Conduct bi-annual vulnerability scans and annual penetration tests.
  • Establish BAAs:
    • Sign Business Associate Agreements with cloud hosts, billing services, and third-party vendors.
  • Prepare breach response:
    • Create a 72-hour system restoration plan per 2025 HIPAA updates.

3. ISO 9001:2025 Certification

Objective: Build a robust quality management system (QMS).
Steps:

  • Develop a QMS framework:
    • Align with ISO 9001:2025’s focus on digital transformation and sustainability.
    • Create a quality manual with dental-specific processes (e.g., appointment management, claims submission).
  • Conduct gap analysis:
    • Compare current SDLC practices against ISO 90003 guidelines for software.
    • Prioritize updates like automated testing and version control.
  • Train development team:
    • Host workshops on ISO 9001:2025’s risk-based thinking and documentation requirements.
  • Implement digital tools:
    • Integrate AI-driven code review systems to reduce errors.
    • Use configuration management tools (e.g., Git) for traceability.
  • Schedule audits:
    • Perform internal audits every 6 months using ISO 9001 checklists.
    • Partner with certification bodies like WCA Global™ for external audits.