training

Former HHS Counsel Discuss Enforcement Trends at PCC

NXLevel Compliance Team , , , , , , ,

Welcome! I’m poring through notes from last month’s Pharmaceutical Compliance Congress, and am going to share some recaps of the sessions in this blog. So make sure to follow!

I’ll start with Pharmaceutical Enforcement Trends, a panel discussion where former HHS OIG counsel Kate Matos and Meredith Williams shared their views on what they described as a proactive, data-driven enforcement climate for pharmaceutical manufacturers.

The big takeaway is pretty simple: enforcement is getting smarter, faster, and more connected. DOJ, HHS, CMS, and OIG are increasingly using data to spot patterns earlier, and they expect companies to be doing the same. That means compliance programs can’t just rely on policies sitting on a shelf—they need real monitoring, sharper analytics, and quicker escalation when something looks off.

Speaker programs remain a live issue, especially where the same physicians show up again and again or events start to look more like marketing than education. The same goes for free diagnostic testing and patient support services: the question regulators keep asking is whether the program genuinely helps get the right treatment to the right patient, or whether it’s really a disguised sales tool.

Another important theme is that federal guidance may not be enough anymore. State enforcers, especially in places like Texas, are taking more aggressive positions that don’t always line up neatly with OIG’s approach, so national companies need to think beyond federal standards.

Digital health and cybersecurity are also moving up the risk list, with recent settlements showing that regulators care not just about data privacy, but also about software integrity and algorithm oversight. On the pricing side, the Inflation Reduction Act adds another layer of pressure with complex reporting, certifications, and little room for error. And finally, self-disclosure keeps looking more attractive—both financially and strategically—than waiting for a whistleblower or government inquiry.

Bottom line: this is a more proactive enforcement environment, and the companies that do best will be the ones that treat compliance as an operational capability, not just a legal requirement.

It was a fun conference and we learned lots! I’ll share more as I continue to dig out. If you have anything to add, I’d love to hear it in the comments below or feel free to drop me an email: pnash@nxlevelsolutions.com.

Thanks for reading!

Paul Nash

Compliance Training and the Science of Learning

NXLevel Compliance Team , , , , , ,

Most compliance leaders didn’t set out to become instructional designers—but the reality is effective training is essential for reducing risk. Policies must be understood, behaviors must align, and lessons must hold up under pressure. Yet many well‑intended training efforts fail not because the content is wrong, but because they overload the learner’s brain.

This is where Mayer’s Principles of Multimedia Learning offer a practical, science‑based lens. Developed by Richard Mayer, a world-renowned educational psychologist, these principles recognize that the brain processes information through two separate channels (auditory and visual) and that each channel has limited capacity when processing new information.

You don’t need to be a learning expert to apply Mayer’s Principles. Think of them as a quality check to ensure your training is effective and actually sticks—especially when it comes to high-risk activities. The principles apply no matter how you’re delivering training, be it via eLearning, presentations, videos, workshops or any other way you might choose to get through to your learners.

While not an exhaustive listing of Mayer’s Principles, below are three key takeaways for compliance training. And if you’d like a handy checklist that you can use when designing, reviewing, or refining your training, send us an email at compliance@nxlevelsolutions.com.

1: Reduce extraneous cognitive load

If something doesn’t directly support the learning goal, it’s likely getting in the way. Decorative visuals, dense slides, duplicative narration, or information that’s “nice to know” but not essential all force the brain to work harder than necessary. Effective compliance training makes the key messages obvious, integrates words and visuals, and avoids narrating text that learners can already read. Less noise means more clarity—and fewer mistakes.

2: Manage essential processing

Even critical content can overwhelm working memory if it’s delivered too fast or all at once. Chunking material, introducing terms before expecting learners to apply them, and letting learners control the pace of their learning all help people process what truly matters. The goal isn’t to simplify the rules—it’s to make them understandable.

3: Foster generative processing

Learning sticks when people do the thinking themselves. Conversational language, realistic scenarios, and activities that ask learners to decide, explain, or apply concepts help them connect rules to real‑world judgments. When compliance training reflects how people actually work, it’s far more likely to make a difference in the field.

Bottom line: Small, intentional instructional design choices—applied consistently—can dramatically improve how compliance training translates into compliant behavior.

Happy Training!

NXLevel Compliance