Regulatory & HIPAA Compliance Modernization

A HealthSec Alliance™ Case Study

Client: Global Medical Technology Manufacturer

Challenge

The client develops and distributes digitally customized health and performance products integrating clinical data with software-driven manufacturing. As operations expanded globally, their regulatory and privacy posture needed modernization to meet complex U.S. federal and state data protection laws while maintaining medical device compliance.

Disparate systems, vendor relationships, and evolving device classification rules created uncertainty around the organization’s status under FDA and HIPAA frameworks. The company required a unified strategy to confirm its regulatory pathway, reduce privacy risks, and align governance with global manufacturing operations.

Key objectives:

• Confirm medical device classification and FDA regulatory pathway

• Assess compliance against HIPAA Security, Privacy, and Breach Notification Rules

• Identify and mitigate security and privacy risks across systems and vendors

• Develop a sustainable roadmap for compliant operations and vendor oversight

Solution

The HealthSec Alliance™ conducted a comprehensive regulatory and privacy assessment covering medical device classification, HIPAA compliance, and U.S. state privacy laws. The engagement combined technical, legal, and operational perspectives to deliver an actionable modernization plan.

Core activities:

• Reviewed system architecture for FDA classification and 510(k) pathway alignment

• Conducted HIPAA risk analysis addressing encryption, storage, and remote access

• Evaluated vendor roles, data-handling responsibilities, and agreements

• Delivered remediation steps for policy, training, and infrastructure controls

• Outlined an implementation roadmap for continuous compliance and governance

Technical & Regulatory Framework

• Medical Device: FDA 21 CFR Parts 803, 806, 820; ISO 13485:2016; IEC 62304

• Privacy & Security: HIPAA Security, Privacy, and Breach Notification Rules; HITECH Act

• State Laws: Washington MHMD, Texas HB 300, and related breach-notification statutes

Outcomes & Impact

• Regulatory Clarity: Confirmed device classification and compliance obligations

• Risk Reduction: Closed privacy and data protection gaps across operations

• Operational Alignment: Defined vendor roles and secure data-sharing protocols

• Sustainable Compliance: Established a scalable framework for privacy, security, and regulatory adherence