February 2, 2024

What is regulatory risk?

Regulatory risk is a type of threat that refers to the impact of potential changes to laws, regulations, or standards on an organization governed by them. This is a particular concern in the areas of IT and cybersecurity, because of the vast digitization of organizations’ operations. The complex web of rules around how information, particularly personal and sensitive data, should be handled, protected, and disclosed and the persistent threat of cyber attacks increases regulatory risk. 

Managing regulatory risk effectively requires a strategic approach that includes: 

  • Auditing systems and processes regularly to ensure compliance and identify areas for improving regulatory risk management. 
  • Conducting comprehensive risk assessments to identify areas where the organization might be at risk of non-compliance. 
  • Developing and implementing clear, comprehensive policies and procedures that align with regulatory requirements and risk management best practices. 
  • Incorporating regulatory risk awareness into regular employee training to ensure that all employees understand their role in maintaining compliance as well as the related policies and procedures. 
  • Staying informed about the latest developments in applicable laws, regulations, and standards. 
  • Utilizing technology solutions to automate regulatory risk compliance tasks, enhance security posture to align with compliance requirements, and provide monitoring and reporting capabilities. 

Regulatory changes that lead to regulatory risks

Any change in regulations creates risk for organizations as they must quickly identify gaps and adapt quickly to meet new requirements. Drivers of regulatory changes that lead to regulatory risk include the following. 

Cybersecurity threat landscape

The increasing frequency of cyber attacks (e.g., data breaches and ransomware) and the evolving threat landscape necessitate the development of stronger and more comprehensive cybersecurity regulatory measures. 

Data privacy

More stringent privacy legislation continues to be passed to enhance protections for personally identifiable information (PHI) and other sensitive information from unauthorized access and improper use, as well as to safeguard individual rights.

Political changes

Alterations in political dynamics can impact the evolution of regulations.

Different government administrations may focus on varying facets of cybersecurity, resulting in modifications to the regulatory landscape.

Public awareness

Growing public consciousness regarding the significance of data security and privacy often catalyzes changes in regulations. When consumers advocate for enhanced safeguarding of their personal data, this encourages legislators to revise and strengthen regulatory measures. 

Technological advancements

With the swift advancement of technology, regulations are evolving to tackle emerging vulnerabilities and threats. For example, innovations in areas such as artificial intelligence, machine learning, and blockchain technology require modernized and adapted regulatory structures. 

Examples of regulatory risk

Five examples of regulatory risk are: 

  1. California Consumer Privacy Act (CCPA)  
    The CCPA presents a significant regulatory risk for organizations, because of its implementation complexity. It grants consumers extensive rights over their personal data, including the right to know what data is collected, the right to request deletion, and the right to opt out of the sale of their personal information.

    Businesses must have mechanisms in place to respond to these consumer requests effectively and transparently. As one of the most comprehensive data privacy laws in the United States, it affects any business operating in California or handling the personal information of California residents.
  2. General Data Protection Regulation (GDPR)  
    This law tightened the rules around data protection and privacy, imposing stringent requirements on organizations that process European Union (EU) citizens’ personal data. It is a sprawling piece of legislation that represents a significant regulatory risk primarily due to its comprehensive nature, coupled with substantial penalties for non-compliance. It sets strict standards for data protection and privacy, impacting any organization worldwide that processes the personal data of EU citizens. 
  3. Health Insurance Portability and Accountability Act (HIPAA)  
    HIPAA represents a significant regulatory risk for entities in the healthcare sector, including healthcare providers, insurance companies, and their business associates. HIPAA requires entities to implement robust privacy and security measures for Protected Health Information (PHI), enforce data breach notification protocols, and ensure compliance by business associates. This necessitates significant operational changes, including staff training, risk assessments, and updating IT systems for security. 
  4. Payment Card Industry Data Security Standard (PCI DSS) 
    PCI DSS is a global standard that applies to any organization that stores, processes, or transmits cardholder data. PCI DSS compliance requires a deep understanding of the standard’s requirements, implementing comprehensive security measures, regular compliance auditing, and staying informed about updates to the standard, as changes to it can significantly impact the way these organizations secure payment systems and process cardholder data. Non-compliance with PCI DSS can result in penalties ranging from hefty fines to loss of payment processing capabilities. 
  5. Sarbanes-Oxley Act (SOX) 
    SOX presents a regulatory risk primarily for publicly traded companies to prevent corporate fraud. Non-compliance with SOX can lead to severe legal and financial consequences, including penalties, criminal charges, and reputational damage. It mandates rigorous internal controls over financial reporting, necessitating extensive documentation and frequent audits. SOX compliance requires significant resource investment in financial systems, controls, and personnel training.   

Regulatory risk vs compliance risk

Both regulatory risk and compliance risk are integral aspects of a comprehensive risk management strategy, and while they are interconnected, they possess characteristics that require separate consideration. Understanding the nuances between these two types of risks is crucial for effective regulatory risk management and mitigation strategies. 

Regulatory risk Compliance risk 
Regulatory risk pertains to the potential adverse repercussions on an organization due to alterations in a dynamic, external regulatory landscape.   

Notable characteristics of regulatory risk include: 
-Arises from uncertainty about how regulations are interpreted and applied 
-Comes from failing to anticipate and adapt to the legislative landscape governing cybersecurity and IT practices 
-Involves understanding complex legal texts, interpreting how they apply to the organization’s operations, and implementing the necessary technical and organizational measures 
-Originates externally from governmental bodies, regulatory agencies, or international regulatory frameworks 
-Requires organizations to be vigilant and proactive 
Compliance risk involves the organization’s conformity to both internal policies and external regulations, emphasizing its comprehensive compliance obligations.   

Notable characteristics of compliance risk include: 
-Pertains to the organization’s ability to meet established regulatory requirements and internal policies 
-Arises from failing to adhere to industry standards 
-Involves developing and maintaining an effective internal process 
-Requires establishing robust data governance frameworks, implementing effective cybersecurity measures, and ensuring continuous monitoring and reporting  

A holistic approach to effective regulatory risk management 

Effectively managing and mitigating regulatory risk requires a holistic approach that addresses both the external regulatory environment and internal processes for monitoring and responding to it. Continuous oversight and supporting systems and processes across all areas of operations are essential for protecting an organization against the myriad regulatory risks in the dynamic digital ecosystem.  

Understanding the scope and workings of regulatory risk and how this applies across an organization helps minimize potential negative impacts by assuring ongoing compliance with the evolving regulatory landscape. 

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