Today's changing business landscape brings with it a myriad of regulatory challenges, including large volume and pace of changes to laws and regulations across jurisdictions, states, and countries. The regulatory landscape is constantly evolving, and understanding it demands a deep knowledge of the organization's operations, past, present, and future.
In fact, a recent KPMG study[1][2] found that 43% of chief ethics and compliance officers (CCOs) believe that new regulatory requirements pose the greatest challenge to their compliance efforts. To manage this challenge, 45% of CCOs say they are targeting compliance around industry-specific regulations as the most critical area to improve, where regulatory mapping and change management are prioritized for automation over the next two years. 73% of the participants predict that the level of focus on compliance, particularly in relation to regulatory expectations and scrutiny, will rise.
Moreover, the Public Company Accounting Oversight Board (PCAOB) has proposed substantive changes to auditing responsibilities regarding a company’s noncompliance with laws and regulations (NOCLAR). These changes if finalized would have significant impacts on companies, including an uptick in the cost of audits due to the increased amount of laws and regulations the auditor will need to consider. Further, company management would need to dedicate an increased number of resources toward identifying relevant laws and regulations and the identification and investigation of NOCLAR. For more information read the “PCAOB proposal would expand auditors' responsibilities”[3] analysis of the potential impacts of the PCAOB proposal. This is just one example of the increasing focus on regulatory compliance.
Additionally, highly regulated industries such as the healthcare industry is experiencing an influx of new players, including technology companies, private equity companies, and other non-traditional service providers. Many of these new players lack familiarity with the unique regulations in the healthcare sector, as well as the various Federal and State government agencies (e.g., Department of Justice, Department of Health and Human Services Office of Inspector General (OIG)) that oversee the industry and enforce fraud and abuse laws. Recently, the OIG published the “General Compliance Program Guidance[4],” which emphasizes the need for existing players and new entrants to develop a solid understanding of applicable rules, laws, and regulations.
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Given the aforementioned factors, it is important for companies to have effective methods to monitor and evaluate regulatory changes in real time.
The following are some of the methods our clients use to of mitigate the risk associated with regulatory changes:
These tools help companies to stay up to date, prepare for changes, and ensure compliance with ever-changing regulatory requirements. As presented above, each method has its strengths and weaknesses.
Historically, CCOs were estimated to spend approximately one third of their time tracking legislative changes.[1] However, due to a lack of sufficient qualified in-house compliance professionals, many companies have chosen to outsource their compliance function and regulatory tracking, which is typically a short-term solution due to cost pressures. Consequently, companies are seeking cost-effective, long-term solutions to assist with regulatory compliance.
With the increased need for fast, reliable monitoring of regulatory changes, automation tools have emerged to address this challenge. Companies now widely use automated tools to identify, analyze, monitor, mitigate, and report external noncompliance risks. By automating their monitoring of external data sources, companies can comply with regulatory requirements, monitor wrongdoing, develop a more comprehensive approach to data management, and improve overall efficiency.
Moreover, companies can now access the relevant data related to their industry quickly and without adding hours of manual effort to their staff workload. The most effective software solution can crawl the web, collect appropriate data, structure it into a unified data feed, and enable filtering and searching by specific attributes for more granular data analysis.
The advantages of using automated tools for regulatory monitoring and tracking are manifold. First, automating the monitoring process saves time, boosting overall efficiency and productivity. Second, automated tools enable companies to identify and mitigate potential risks quickly, reducing the likelihood of noncompliance violations.
Automation can accelerate the inventorying of regulations, laws, and obligations from global regulatory sources; provide real-time notification of new rules, proposed rule changes, and guidance; track regulation lifecycles; and enable a quicker impact analysis when such obligations change (through a mapping of the regulations to applicable controls).
KPMG has developed a proprietary regulatory tracking tool that streamlines the regulatory tracking process and addresses the underlying challenges. This tool allows regulatory changes to flow from the initial tracking in the inventory of obligations, through mapping, and to compliance testing and reporting. Like other regulatory tracking software, the KPMG regulatory tracking tool collects regulatory data in real-time and parses the relevant information. However, the KPMG tool provides an end-to-end solution with several additional potential benefits, including:
Each of these features facilitates prompt identification and comprehension of new or changed legislation and establishes actionable steps towards complying with regulatory requirements. In addition, within the customizable workflow technology embedded in the tool, KPMG uses AI and Gen AI to tag laws and rules to topic categories, extract regulatory obligations, provide legislative summaries, as well as map laws and rules to compliance documents.
In conclusion, the use of automated tools for regulatory monitoring and tracking is a necessity, not a luxury for businesses operating in a constantly evolving business environment. Companies considering adopting technology to stay ahead on compliance requirements can gain competitive advantages in their respective industries.
Determining appropriate follow-up actions and having a documented procedure in place is as important as promptly identifying legislative changes. To ensure effective compliance and management, companies can establish a policy governance procedure that outlines clear and actionable steps for updating current policies and procedures in line with the applicable regulatory changes. The typical policy governance procedures include the following:
Companies with effective compliance programs can demonstrate to regulators, auditors, and internal stakeholders their ability to regularly amend policies and procedures to align with regulatory changes. Having clear processes in place that can manage any applicable and relevant regulatory change, gives companies confidence that their key risks are mitigated.
This, in turn, allows senior leadership time to focus on developing business across the world. With proper policies and procedures in place to address new and changing legislation, companies can safely do business in any market in the world.
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