Regulatory Compliance Requirements: What You Need to Know (2024)

Regulatory compliance is essential for any business and can actually be financially rewarding by avoiding fines and finding vulnerable areas in your company.

What Is Regulatory Compliance?

Regulatory compliance is the process of adhering to laws, regulations, standards, and other rules set forth by governments and other regulatory bodies. It is an important aspect of doing business, as companies are required to follow certain laws and regulations to maintain their operations.

Regulatory compliance helps ensure that companies do not engage in unethical or illegal practices, and can be used to protect both their employees and customers, often by protecting their data, namely personally identifiable information and protected health information (PII/PHI). These compliance standards are specific to industries and locations and can result in large penalties if not followed correctly.

Regulatory Compliance Requirements: What You Need to Know (1)

What Benefits Can Organizations Gain by Ensuring Regulatory Compliance?

There are many benefits to an organization for achieving or demonstrating regulatory compliance. A major benefit is business continuity and improved trust in the industry and among customers. Some other benefits include:

  1. Improved Operational Efficiency: Adhering to regulatory compliance can help organizations ensure all operations are conducted efficiently and in accordance with the set regulations. This, in turn, helps organizations streamline procedures and processes, leading to improved operational efficiency and reduced costs.
  2. Reduced Risk and Liability: Regulatory compliance helps organizations stay up to date with the changing laws and regulations and abide by them, thus reducing the risk of penalties, fines, and other forms of liabilities.
  3. Improved Public Image: Organizations that comply with regulations gain a positive public image, as they demonstrate a commitment to safe and ethical operations. This can lead to improved public trust and increased confidence, which can lead to increased brand value.
  4. Greater Resilience: Organizations that are compliant are more resilient to changing regulations, as they already have systems in place to meet regulatory demands. This helps organizations plan better for future change, promoting greater business continuity.
  5. Increased Efficiency: By establishing clear procedures, processes, and systems to ensure regulatory compliance, organizations can become more efficient in the way they operate, which leads to improved productivity and cost savings.

How Does Regulatory Compliance Work?

In any industry, there are regulations, and organizations operating in those industries must comply with these regulations. Compliance can cover a variety of different practices, processes, and operations within an organization. An organization will likely have more than one area of compliance.

Some of the different kinds of compliance include the following:

  • Financial Compliance: Organizations must maintain fair, transparent financial records and refrain from unethical or illegal financial practices that harm stakeholders or consumers.

    Examples of such regulations are the Federal Deposit Insurance Corporation (FDIC) rules for consumer protection and the Sarbanes-Oxley Act (SOX) that requires financial reporting and transparency for corporations to mitigate fraud.

    Additionally, Service Organization Control 2 (SOC 2) compliance is an attestation to investors and insurers regarding the security of systems holding customer data. It is administered by the American Institute of Certified Public Accountants.

  • Regulatory Compliance: This unique form of compliance emphasizes the legal obligations an organization faces as part of its operation. Regulations are a legal form of governance that is predicated on legislation and oversight, typically from a governmental or adjacent regulatory body.

    This form of regulation can often overlap with the others. Compliance usually includes financial, IT, reporting, and audit logging requirements in many cases.

Because there are significant overlaps between different types of regulations, it is essential to understand where such laws come from. For example, HIPAA is a regulatory requirement for all healthcare providers, insurance companies, and associated vendors instituted and administered by federal and local governments. HIPAA, however, contains several provisions for cybersecurity and financial protection.

Conversely, SOC 2, while containing several provisions governing data management, security, and privacy, is not a regulatory requirement. It is not governed by law and is not required as part of any industry standards.

What Are Some Regulatory Compliance Regulations?

Different industries will typically include unique regulations. Some regulations will transcend industry and apply to a wide swath of common organizational types.

Some of the common regulations include:

Organizations Applies To

Organization Governed By

Areas of Coverage

Requirements

Health Insurance Portability and Accountability Act (HIPAA)

Covered entities (hospitals, doctors, insurance companies) and their business associates

Department of Health and Human Services (HHS)

Protecting Private Health Information (PHI) from unauthorized disclosure

Cybersecurity controls; physical and administrative privacy controls

Sarbanes-Oxley Act (SOX)

Publicly traded corporations

U.S. Securities and Exchange Commission (SEC)

Requiring transparency in corporate financial reporting

Corporations must implement security, transparency, and accountability into financial reporting to stakeholders and the government

General Data Protection Regulation (GDPR)

All businesses collecting consumer data in the European Union

The EU Information Commissioner’s Office (ICO)

Protecting consumer information in EU jurisdictions

Businesses must implement privacy, security, and consent controls to protect consumer data from disclosure or abuse

California Consumer Privacy Act (CCPA)*

Midsize and large businesses in California

California Privacy Protection Agency (CPPA)

Protecting consumer information in California jurisdictions

Businesses must implement privacy, security, and consent controls to protect consumer data from disclosure or abuse

Federal Risk and Authorization Management Program (FedRAMP)

Cloud service providers working with federal agencies

The Joint Authorization Board (JAB) and Program Management Office (PMO)

Securing cloud systems used by federal agencies through third-party vendors

CSPs must implement NIST 800-53 and other controls to meet minimum standards

Cybersecurity Maturity Model Certification (CMMC)

Digital contractors working with Department of Defense agencies

The Department of Defense

Securing defense-related IT systems in the DoD supply chain

Contractors must implement NIST 900-171 and NIST 800-172 controls to work in the supply chain

* As of January 1, 2023, the CCPA was amended into the California Privacy Rights Act (CPRA) with expanded regulations and controls.

Additionally, several standards are not required or governed by law but apply specifically to either industry practices or optional adoption by a company:

Organizations Applies To

Organization Governed By

Areas of Coverage

Requirements

Service Organization Control (SOC) 2

Any who adopt the standard

American Institute of Certified Public Accountants (AICPA)

Data security, privacy, confidentiality, and integrity

Organizations must meet minimum security and privacy standards and undergo regular audits

International Organization for Standardization (ISO) 27000 Series

Any who adopt the standard

International Organization for Standardization (ISO)

Data and IT infrastructure security

Organizations design, develop, implement, and maintain Information Security Management Systems (ISMS)

Payment Card Industry Data Security Standard (PCI DSS)

Retailers and merchants accepting credit card payments

Payment Card Industry (including credit card companies like Visa, Mastercard, American Express, etc.)

Credit card and payment information

Payment processors and merchants must implement security practices to secure payment information from theft

Regulatory Compliance Requirements: What You Need to Know (4)

Kiteworks touts a long list of compliance and certification achievements.

Regulations and Regulatory Compliance Outside the U.S.

Regulations and regulatory compliance vary significantly from nation to nation. Most nations outside the U.S. have established laws, regulations, and guidelines for business activities, including environmental, health, and safety laws and regulations. Nations may also have laws and regulations that impact the labor and employment practices of businesses. This includes data privacy laws such as the European Union’s General Data Protection Regulation (GDPR), Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA), the United Kingdom’s Data Protection Act of 2018, Australia’s Information Security Registered Assessors Program (IRAP), and many more. Companies doing business in different countries may have to comply with other regulations, such as anti-bribery laws, export control laws, and restrictions on foreign investment.

The laws and regulations of a particular country will depend on its own laws and the global treaties and conventions that it has signed. It is important for businesses to understand the laws, regulations, and standards of a country in which they are operating or that they are exporting to. Companies should also understand their obligations when it comes to regulatory compliance and how these obligations may differ in different countries.

In addition to understanding the laws and regulations of a particular nation, companies should also be aware of the enforcement capabilities of the nation’s regulatory authorities. Companies must comply with the laws and regulations of the nation and may face inspections, fines, and other penalties if they do not. It is also important for companies to understand how a nation’s laws and regulations may change over time and the implications of those changes on their operations.

Companies should also be aware of how the laws of a particular nation may interact with laws and regulations of other nations. For example, a company operating in multiple countries may be subject to both the regulations of their home country and those of the countries in which they are operating. It is important to understand the implications of any conflicts between these regulations and how to comply with all applicable regulations.

What Is Governance, Risk, and Compliance?

Regulations often fall under a larger umbrella of strategies and practices that businesses follow, generally known as governance, risk, and compliance.

GRC includes the following practices:

  • Governance: Integrated strategies and capabilities around governing business practices, data management, and security. Governance includes high-level planning and execution of business processes and objectives.
  • Risk: Risk assessment and management are the practice of measuring financial risks, security vulnerabilities, or other potential hazards and using that information to make decisions around cybersecurity, IT infrastructure, administration, and other business decisions.
  • Compliance: Governance and risk practices must be used to fuel compliance now and into the future.

Why Is It Important to Have a Regulatory Compliance Policy in Place?

Having a regulatory compliance policy in place is important to ensure that a business is operating in accordance with all applicable laws and regulations. A regulatory compliance policy outlines what specific regulations the business must comply with, as well as the steps it needs to take to remain compliant. Having a regulatory compliance policy in place also helps to protect the business from liability and provides assurance to customers and stakeholders that the business is operating within the law.

What Are Some of the Penalties for Noncompliance?

Compliance, often governed by law, can carry significant penalties. Even frameworks governed in the private sector can affect how a company does business.

Some potential penalties include the following:

  • Financial Penalties: Financial penalties range from smaller fees to crippling fines. HIPAA compliance requirements, for example, scale financial penalties based on the severity of the breach. GDPR, on the other hand, only allows for two different tiers of penalties, each containing significant financial obligations on the part of the noncompliant organization.
  • Loss of Licensing or Authorization: Some frameworks, like FedRAMP or CMMC, come with a baseline loss of certification for severe noncompliance. Here, organizations can no longer only operate in their industry.
  • Legal Liability: If noncompliance leads to severe harm to an organization or individuals, organizations may find themselves legally liable. HIPAA contains several tiers of legal penalties, including jail time, for severe breaches or in cases of fraud.
  • Impact on Business Operations: Some non-government regulations, like PCI DSS, work because the governing body can control how companies function in a business market.

    For example, if a merchant fails to comply with PCI DSS, there is not a default legal repercussion. Instead, the PCI (made up of all the major credit card providers like Visa, Discover, American Express, Mastercard, etc.) can levy fines for continued use of the credit card payment networks.

    Continuing noncompliance can force the PCI to label merchants with a negative rating, including higher fees and limited payment processing capabilities.

    Finally, the PCI can simply close a merchant’s account and make processing payments impossible.

Operationalize Regulatory Compliance

Regulatory compliance is a significant part of any business and must play a role in business strategy and IT infrastructure. Any company operating in regulated industries with standards must use technology to support regulations.

Sensitive content communications is involved in virtually every compliance regulation, and organizations must ensure they have the right policy controls and security processes in place. Learn how Kiteworks unifies, tracks, controls, and secures critical data as it moves into, within, and out of an organization for compliance across myriad regulations, such as HIPAA, PCI DSS, FedRAMP, and others, by scheduling a custom demo.

Additional Resources

Blog Post:

What Are HIPAA Compliance Requirements? [Complete Checklist]

White Paper:

What You Need to Know About NIST 800-171 and Sensitive Content

Blog Post:

How MFT Can Become CMMC Compliant

Blog Post:

Understanding SOC 2 Reporting When It Comes to Sensitive Content Communications

Glossary:

PCI Compliance Overview

Glossary:

How to Manage Third-party Risk

Blog Post:

Blog Post:

What Is Data Compliance?

Regulatory Compliance Requirements: What You Need to Know (5)

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Regulatory Compliance Requirements: What You Need to Know (2024)

FAQs

Regulatory Compliance Requirements: What You Need to Know? ›

Regulatory compliance is the process of adhering to laws, regulations, standards, and other rules set forth by governments and other regulatory bodies. It is an important aspect of doing business, as companies are required to follow certain laws and regulations to maintain their operations.

What are the regulatory compliance requirements? ›

Regulatory compliance requires companies to analyze their unique requirements and any mandates specific to their industry and then develop processes to meet these requirements. Typical steps to achieve regulatory compliance include the following: Identify applicable regulations.

What is a regulatory compliance checklist? ›

It is a tool that helps businesses to ensure that they are meeting all the necessary legal requirements and avoiding potential legal and financial penalties. This checklist covers a wide range of areas, including data privacy, security, accounting and financial reporting, employment laws, and environmental regulations.

How to ensure compliance with regulatory requirements? ›

7 Ways to Meet Regulatory Compliance and Standards
  1. Implement a robust quality management system: ...
  2. Document control: ...
  3. Utilize a comprehensive training software system: ...
  4. Prepare for regulatory audits: ...
  5. Operate in a validated environment: ...
  6. Appoint a compliance officer: ...
  7. Establish and maintain policies and procedures:

What type of requirements are regulatory requirements? ›

Regulatory requirements are rules that businesses must follow. They are invoked by designated regulators and compliance officers – those who make and enforce the rules. Also known simply as regulations, these obligations can specify different things.

What are the 5 key areas of compliance? ›

This global template organizes key enforcement and regulatory issues into five essential compliance program elements: leadership, risk assessment, standards and controls, training and communication, and oversight.

What are the 7 core requirements of a compliance program? ›

Seven Elements of an Effective Compliance Program
  • Implementing written policies and procedures. ...
  • Designating a compliance officer and compliance committee. ...
  • Conducting effective training and education. ...
  • Developing effective lines of communication. ...
  • Conducting internal monitoring and auditing.

What is the regulatory compliance rule? ›

Regulatory compliance is the process of adhering to laws, regulations, standards, and other rules set forth by governments and other regulatory bodies. It is an important aspect of doing business, as companies are required to follow certain laws and regulations to maintain their operations.

What are the common compliance regulations? ›

Some of the major regulatory compliance examples related to financial and non-financial sectors include the Sarbanes-Oxley Act, Health Insurance Portability and Accountability Act (HIPAA), Payment Card Industry Data Security Standard (PCI DSS), Federal Information Security Management Act (FISMA), and the European ...

How do you assess regulatory compliance? ›

Here's how to identify compliance risks:
  1. Research regulations. Understand the laws and standards applicable to your industry.
  2. Internal audits. ...
  3. Employee input. ...
  4. Third-party evaluation. ...
  5. Analyze history. ...
  6. Tech and data check. ...
  7. Training review. ...
  8. Stay updated.
Sep 15, 2023

What are examples of regulatory requirements and why are they important? ›

For example, security regulations exist to help protect against data breach, financial regulations are there to protect against fraud, and safety regulations are designed to keep workers safe.

What is included in regulatory requirement? ›

Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements, guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.

What are the 3 types of regulation? ›

Three main approaches to regulation are “command and control,” performance-based, and management-based. Each approach has strengths and weaknesses.

What are examples of compliance requirements? ›

Examples of regulatory compliance
  • GDPR, the General Data Protection Regulation that covers any organization processing data on EU citizens.
  • Requirements to file annual financial reporting.
  • The requirement for in-scope U.S. organizations to file an EEO-1 Report.
  • The need for compliance with the Sarbanes-Oxley Act.
Dec 20, 2023

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