HIPAA & GDPR Readiness Assessment

A HealthSec Alliance™ Case Study

Client: A global precision health and genomics company

Challenge

The client delivers personalized health and wellness insights built on genomics, clinical data, and advanced analytics. Operating globally with U.S. partners and customers, the organization needed to confirm its compliance posture under HIPAA, HITECH, and GDPR while expanding data-driven product offerings.

As a processor of sensitive health information for multiple covered entities, the client faced complex privacy, security, and regulatory alignment challenges. They required a unified readiness review to define regulatory roles, close compliance gaps, and establish sustainable data-protection governance.

Key objectives

• Evaluate HIPAA and GDPR readiness across cloud, data, and software operations

• Identify privacy, security, and breach-notification risks

• Define regulatory roles (controller, processor, or joint controller)

• Build a roadmap for continuous compliance and privacy program maturity

Solution

The HealthSec Alliance™ performed a comprehensive HIPAA and GDPR readiness assessment covering U.S. and EU regulatory frameworks. The review included technical controls, policy documentation, and operational governance, culminating in a set of prioritized actions for leadership and engineering teams.

Core activities:

• Conducted HIPAA Security, Privacy, and Breach Notification Rule assessment

• Reviewed administrative, technical, and physical safeguards for ePHI

• Evaluated vendor and data-processing relationships and required agreements

• Completed GDPR role determination and data-protection impact review

• Delivered readiness reports and roadmap for DPO, CISO, and compliance teams

Technical & Regulatory Framework

• U.S. Frameworks: HIPAA Security, Privacy, and Breach Notification Rules; HITECH Act

• EU Framework: General Data Protection Regulation (GDPR)

• Supporting Standards: ISO 27001, NIST Cybersecurity Framework, ISO 27701

Outcomes & Impact

• Compliance Readiness: Achieved clear HIPAA and GDPR alignment across systems

• Risk Mitigation: Closed high-impact gaps in encryption, access, and breach response

• Defined Governance: Clarified roles and responsibilities for controller/processor activities

• Continuous Improvement: Established ongoing advisory model for privacy and cybersecurity leadership