Technology Regulatory Risk

For organizations under regulatory oversight, a proactive approach to compliance is no longer optional—it is a strategic necessity. In today’s evolving regulatory environment—where industries face diverse and complex requirements—EY helps identify, manage and mitigate both current and emerging challenges. Our approach combines strategic insight, leveraging regulatory frameworks for competitive advantage, and operational efficiency to reduce costs and disruptions, enabling leadership to focus on core business priorities while enhancing overall effectiveness and resilience.

Technology Regulatory Risk offerings include:

HITRUST

HITRUST (Health Information Trust Alliance) provides a comprehensive, certifiable framework designed to manage information security, privacy and risk management. We help organizations achieve trusted compliance and cyber resilience with our wide-spread HITRUST services. From readiness assessments and gap remediation to validated certifications, we guide you through every step using the HITRUST Common Security Framework (CSF). Our experts tailor scoping, leverage MyCSF tools and apply AI-driven risk models to drive success across healthcare and tech sectors.

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Pharma IT quality and GxP compliance

In the highly regulated world of Pharma IT, our AI- enabled GxP Validation Framework provides a compliant path to modernize critical applications such as clinical data platforms, LIMS and eQMS, supporting digital transformation. By integrating qualifications and validation early and often, we accelerate the delivery of robust systems, maintaining data integrity and patient safety while enabling promoting continuous improvement and business agility across application portfolio. Additionally, our sector teams help businesses automate their quality control, quality assurance and document management processes in line with regulatory expectations.

 FS regulatory compliance

Regulatory bodies such as the Reserve Bank of India (RBI), the Securities and Exchange Board of India (SEBI) and the Insurance Regulatory and Development Authority of India (IRDAI) have significantly raised compliance expectations in the financial services sector. There is an increased focus on technology and the related aspects of governance, risk and compliance. EY draws on deep sector experience to support businesses in assessing regulatory requirements and managing compliances to be aligned with evolving standards.

Our latest thinking

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GenAI Governance Framework from EY offers adaptive AI governance, transparency & risk management to build trust in next‑gen technology. Learn more.


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