Modernizing Privacy, Security & Governance for a Digital Health Provider

A HealthSec Alliance™ Case Study

Client: Global digital health and personalized wellness company

Challenge

The client developed a connected care platform integrating patient-reported data, cloud analytics, and precision health insights. As international partnerships grew, they needed to strengthen privacy, cybersecurity, and regulatory controls across healthcare and consumer systems.

Vendors processed sensitive health data inconsistently, creating compliance gaps. Evolving U.S. privacy laws introduced new risks for handling protected health information (PHI). The organization required a unified HIPAA and data-governance framework that could scale with clinical partnerships and product growth.

Key objectives:

• Validate HIPAA Security, Privacy, and Breach Notification compliance.

• Identify vendor-management and data-handling risks in cloud environments.

• Align governance with FDA, HITECH, and emerging state privacy laws.

• Build a roadmap for continuous compliance and breach-readiness.

Solution

The HealthSec Alliance™ led a privacy and cybersecurity modernization initiative to align healthcare operations with HIPAA and future regulations.

Core activities:

• Conducted a HIPAA risk assessment across infrastructure, APIs, and data flows.

• Evaluated vendor contracts and business-associate agreements (BAAs).

• Mapped data responsibilities across IT, development, and clinical teams.

• Reviewed encryption, access control, and breach-response procedures.

• Delivered updated policies, training, and a compliance maintenance plan.

Technical & Regulatory Framework

• Privacy & Security: HIPAA, HITECH Act

• State Laws: WA MHMD, TX HB 300, CA CPRA

• Health Tech: FDA 21 CFR Part 820 (QSR) for connected products

• Cyber Standards: NIST 800-66, NIST 800-53 (Moderate), ISO 27001

Outcomes & Impact

• Audit-Ready Compliance: Closed major HIPAA gaps with evidence documentation.

• Risk Reduction: Improved PHI integrity and vendor accountability.

• Operational Confidence: Strengthened trust with hospitals and digital health partners.

• Continuous Assurance: Implemented metrics for annual review and training.