2025 Guide to Regulatory Intelligence
Regulatory Intelligence and Compliance Monitoring Overview
- How do you stay abreast of changes to the vast sea of regulatory data?
- Are you losing a competitive edge with delayed regulatory insights?
- Are you able to distill trends and patterns from in-the-weeds regulatory changes?
- Can you demonstrate compliance to a regulatory authority?
- Can you audit your current regulatory processes?
With an ever-increasing regulatory landscape, automation is a must. Technical solutions allow for quicker, more accurate, and comprehensive business insights.
However, regulatory intelligence projects can be challenging. Not only must you onboard and learn sometimes complex new software, but also integrate the output of that software into your organization. This can be ambitious, particularly as the initial days of any web intelligence initiative often don't realize value.
After successfully deploying multiple enterprise-level automation initiatives around the world, we've learned some tips and tricks to help.
Let's dig in.
Key Challenges for Regulatory Teams
- Monitoring Complexity of Modern Websites
- Monitoring Process Need Updating
- Distilling the Right Regulatory Insights
Drivers for Regulatory Intelligence and Compliance Monitoring Success
- Defining your Regulatory Intelligence Goals
- Synchronizing Multiple Site Monitoring
- Optimizing Monitoring Report Data
- Best Project Practices for Monitoring Teams
- Regulatory Intelligence Audit Capabilities
- Intersection of Machine Learning and Regulatory Intelligence
- The Automation Advantage for Regulatory Teams
Key Challenges
The difficulties with regulatory automation surprise customers.
After all, it's assumed that "automating" something provides immediate benefits. Yet, while the ultimate goals are time and cost reductions of current processes, this is seldom realized at the start.
Monitoring today's web is hard.
At its core, regulatory intelligence often comes down to monitoring websites for changes.
Why?
Because these changes are the key inputs to any regulatory automation solution. Indeed:
- Business insights are distilled from changes to regulatory bodies' websites: innumerable rules, laws, and administrative actions
- Compliance risk is surfaced from assessing key changes -- such as content related to privacy, marketing, and disclosures -- to regulated industries' websites
It might be tempting to assume that monitoring website changes is straightforward. Just install a Chrome extension to monitor websites and receive alerts on your desktop, right?
This approach can work in some cases. But it is untenable for any significant monitoring effort, including the need to oversee more than a few dozen pages, or adding more colleagues.
Among other issues, the following difficulties soon reveal themselves with any significant web change monitoring effort:
- "Dynamic" websites whose core content is loaded via asynchronous JavaScript calls, requiring the use of a full desktop browser
- Orchestration requirements, such as clicking on certain buttons, logging in, or other interactive steps
- Frequent, irrelevant content changes that produce false-positives
- Anti-crawl technologies designed to thwart automated crawling
Introducing new processes is hard.
Above all, in the enterprise, even half-broken processes are sometimes favored over-optimized, "perfect" ones. This is because regulatory workflows are often complex, including:
- How to update URLs to monitor?
- How and when to alert staff to key changes?
- How to integrate web change alerts into backend systems or processes?
- How to divide work among multiple team members?
- How to coordinate workflow between analysts, reviewers, and managers?
Consider, also, an often significant "care and feeding" of any automation system.
Distilling business insights from regulatory changes is hard.
As aforementioned, most regulatory intelligence solutions rely on website change monitoring. As a result, expect to receive an often overwhelming number of alerts.
What to do with these?
Not only must you have a clear strategy for handling and reducing false-positives, but you must summarize and articulate those changes internally, too.
Automation projects often replace existing processes. As such, a lot of the value that can come from these projects is missed. Trends, patterns, and other insights are key outputs from an automation project, and they can lend themselves to remarkable grist for a machine learning engine.
Drivers for Regulatory Intelligence Success
What are your core regulatory intelligence goals?
We recommend spending some time exploring the objectives of any project like this.
Typically, goals may include:
- Cost savings: replace costly existing processes
- Scale
- Trends and pattern analysis
- Speed, accuracy, comprehensiveness: get faster and higher quality results
- Meet organizational "digital transformation" goals
- Formalize an ad hoc process: sometimes, regulatory automation is introduced to add structure to an informal process
What does success look like? After answering, take a step back, and ask yourself again: what does progression to that success look like? As we've already highlighted, true automation takes time.
What's your regulatory data "story" today?
Important learnings can come from probing how your organization detects, prioritizes, and communicates regulatory insights at present.
The "automation" part of any regulatory intelligence solution is a unique, often small facet. All of the surrounding processes are essential: they augment points of friction that must be realized and handled in any novel automation solution. As much as possible, the goal will be to reduce and automate these frictions. Yet doing so can be difficult or impossible.
A typical story may be something like:
- On the first of every month, IT Joe has a calendar alert to check the FDA for new label changes.
- Joe checks with Business Sally to ensure he has an up-to-date list of products.
- Sally updates Joe after first confirming with regional staff if they have any discontinued or new products.
- Joe then emails his team an equal number of items from a shared Excel spreadsheet to review.
- Each of Joe's staff goes to the FDA website, searches for a product, and attempts to spot any immediately obvious changes. Then, the shared spreadsheet is updated.
- Joe verifies some of the work, as it's common for updates to be overlooked.
- Joe then sends the spreadsheet to Business Ivan.
- Business Ivan reviews all of the modifications, and distills the data into a Word document.
- (And so on.)
By documenting each step, you may be surprised at the sheer number of steps and "friction points!"
Often, the biggest frustration comes from input and output integration. In other words, how do you keep an automation solution humming along with accurate and up-to-date data, such as sites to monitor for changes? And, by the same token, how do you integrate the results of that automation solution into your organization?
Input integration: how to synchronize sites to monitor?
As you reconsider a new data story for automation, examine how the sites to monitor are kept up-to-date in whatever product you employ.
This sounds simple: send a spreadsheet over!
However, this friction point can often frustrate even the best planned engagements. Generating the list itself is often an ad hoc process: but it must be formalized to ensure proper operation of a regulatory intelligence solution. After all, these sites are the true fuel for the automation engine. If they are not up-to-date, then the value of this entire operation can be questioned.
Output integration: what happens with change results?
The best regulatory intelligence solutions often fall victim to "yet another emailed report" syndrome. That is, web change intelligence systems produce reports: emailed or available via spreadsheet. Unless you have a clear process, these reports are sometimes disregarded.
We recommend building output integration from the start:
- Reduce manual processes as much as possible: if the results of an automation effort are sent to a person via email, automate that person's task. For example, you might consider automated Webhook or API integration to push results into Sharepoint.
- Divide and conquer: expect a multitude of results. More than you anticipate. Make sure to categorize all monitored sites, and divide those among your team members.
- Lower result expectations internally. At the start, the results of an automation process are almost all "junk." False-positives, failures, or configuration needs are evident. It's rare that valuable results are captured in the first few weeks of launch.
Consider a phased approach to improve project success.
Regulatory intelligence projects can be grueling. Not only is there a need to onboard a software solution, but there's significant process re-engineering that must happen. As such, projects are at risk of failure.
To better ensure success, avoid a "waterfall" process as much as possible. This may be organizationally impossible. But... try, try, try! Projects like this often gradually reveal true business, technical, and process requirements.
We recommend a cadenced approach: even in a waterfall-prone organization, this forces more frequent re-evaluations and course corrections. We've found the following key phases successful:
- Proof-of-concept (POC) or Pilot: rapidly demonstrate real value internally.
- Integration: dovetail regulatory intelligence into new or existing processes, with a focus on replacing manual processes with automation, such as
- Webhooks, API integration, and machine learning
Scale: go big! Extend the automation solution beyond a core set of materials. - Innovate: grow the project in new ways. This may require automating trend analysis to distill big picture analyses from the core monitoring solution
Build audit capabilities from the start
It's essential that any regulatory intelligence solution provides comprehensive audit logs. This traceability offers insights and provides valuable proof internally and to external regulators.
To the extent that your core solution is web change monitoring:
- Preserve complete crawl logs, including for crawls that did not themselves result in a detected change
- Understand the preservation policy for all captured versions
- Know what data is captured: do you need HTML, screenshots, extracted text, cookies, network activity, or, more likely, only a subset of this crawl data
- What special policies apply to your company or industry? For instance, many industries must use "WORM compliant," ensuring that all preserved records are "write once" but "read many times."
Is your project suitable for machine learning?
We don't like the hype that surrounds "artificial intelligence." In general, anyone who mentions this term is either misusing it or their project isn't a great candidate.
Albeit that is changing. And your regulatory intelligence project may have opportunities to explore in that regard.
How?
Regulatory intelligence can be suitable for machine learning:
- Machine learning can be "off the shelf": it's quite simple to get up-and-running and requires relatively little custom engineering.
- Regulatory data is standardized: that is to say, the content you are looking at is templatized and labeled. This standardization offers finer ways for an ML classifier to detect patterns to better surface insights.
- "False-positives" are a concern in any regulatory intelligence project. Dedicated individuals need to manually review, write rules and filters to reduce them, or develop ML categorization to better separate wheat from the chaff.
Consider, also, that the immediate goals of a machine learning approach might be just to reduce false-positives. Think beyond this!
What sort of patterns can we surface: can we move this project from providing tactical value to middle management staff, and surface real insights to the C-level? Can we offer those executives a "heartbeat chart" of the regulatory landscape that impacts your organization?
Indeed, by onboarding regulatory changes into an intelligence system, it's often possible to tune into patterns, trends, and other indicators that can be reflected in simpler, chart-worthy metrics.
Experts can build, optimize, and integrate an automation solution
As you continue your regulatory intelligence journey, it might be worthwhile to seek the assistance of outside specialists. Enlist consultants who have demonstrated success with these projects.
We welcome your exploration of our product. We welcome an introductory email, too. Software is often just one facet of a successful automation project. You need a team, and Fluxguard can become that team for you.