For immediate assistance with a network intrusion, ransomware
attack, or BEC, please contact: IrongateResponse@irongatesecurity.com  

The Health Insurance Portability and Accountability Act (HIPAA) establishes security requirements to protect electronic Protected Health Information (ePHI) from unauthorized access, breaches, and misuse. Compliance is mandated for covered entities (e.g., healthcare providers, insurers) and business associates handling ePHI. 

Key Security Control Requirements: 

The current HIPAA requirements establish specific guidance for security controls. Notable controls below. 

• Risk Management & Assessment – Regularly identify and mitigate security risks
  (45 CFR § 164.308(a)(1)(ii)(A)). 
• Access Controls – Implement user authentication, least privilege, and audit controls to restrict ePHI access
  (45 CFR § 164.312(a)(1)). 
• Data Encryption & Integrity – Protect ePHI in transit and at rest using encryption and secure transmission protocols
  (45 CFR § 164.312(e)(2)(ii)). 
• Incident Response & Breach Notification – Detect, contain, and report security incidents, notifying affected parties within 60 days as per the HIPAA Breach Notification Rule (45 CFR §§ 164.400-414). 
• Audit Logging & Monitoring – Track access and activity related to ePHI to detect unauthorized use
  (45 CFR § 164.312(b)). 

Failure to implement these security controls can result in Office for Civil Rights (OCR) enforcement actions, including fines per violation and mandatory corrective action plans. Compliance with HIPAA’s Security Rule helps organizations safeguard sensitive health data, reduce risk exposure, and maintain regulatory integrity. 

Post Data Breach Investigation Expectations 

Following an investigation into unauthorized access to ePHI, businesses must determine the scope, impact, and root cause of the incident. Depending on the amount of affected records, the organization may be required to not only notify OCR, but also the affected individuals as well as media outlets. Organizations are expected to conduct a risk assessment, implement corrective actions, and enhance security controls to prevent future incidents. Non-compliance may result in OCR investigations, fines, and corrective action plans. Be sure to consult with a data privacy attorney to understand all the legal requirements for each situation.

IronGate Experience 

IronGate has assisted healthcare clients with performing a HIPAA Risk Assessment and Security Rule Risk Analysis.  

HIPAA Risk Assessment: IronGate assisted a healthcare client following unauthorized access to their ePHI during a ransomware attack. After the investigation, the client proactively notified OCR and engaged IronGate to conduct a HIPAA Risk Assessment in anticipation of regulatory requirements. The assessment involved interviewing key personnel, reviewing HIPAA and cybersecurity procedures, and collecting evidence of implemented security controls. Findings were analyzed and presented in a formal report, providing the client with actionable remediation guidance and corrective measures to strengthen their security posture. 

Security Rule Risk Analysis: Following correspondence with OCR regarding unfavorable findings from a ransomware attack, OCR directed the client to conduct a Security Rule Risk Analysis per 45 C.F.R. §164.308(a)(1)(ii)(A). This analysis is a comprehensive assessment of risks and vulnerabilities affecting the confidentiality, integrity, and availability of ePHI. IronGate assisted the client by evaluating cybersecurity practices, assessing HIPAA compliance, and identifying threats to ePHI stemming from security gaps or compliance deficiencies. Upon completion, IronGate delivered a detailed report of findings along with targeted recommendations to strengthen cybersecurity controls and align with HIPAA requirements. 

Contact us today to learn more about our Digital Forensics and Incident Response (DFIR) services.

Steve Ramey has spent the past two decades helping clients protect, investigate, and respond to events involving their digital interests. He has led hundreds of data breach investigations, assessed incident response and security programs, and successfully advised organizations through extortion negotiations.