Get the Shot! Get a Fresh Risk Assessment to Inoculate Against Emerging Compliance Risks

When the potential breadth of the pandemic first came into focus last March, our perceived hazards of every day life instantly changed. Since then, our understanding of what is safe and healthy has been continually updated based on ever-changing information and our individual circumstances. After surviving a life-threatening bout with Covid-19 nearly a year ago myself, I was forced to reconsider my own personal risks. As a life science compliance consultant specializing in risk assessments, my definition of what's safe for a business is largely driven by data and science. But hundreds of additional questions about my own well-being surged through my mind as I laid in a hospital bed. Would I recover? (I was told for three days that I might not) How quickly? What new health threats would I face? And, most poignantly, how will these outcomes affect my young daughter as she grows up? 

Thanks to vigilant medical care, the support of family and friends, and my faith, I'm on the mend. But, along with millions of other Americans, we still face many unknowns. When will all this end; will it? What are long-term effects? Will there be a COVID 21 or 22, etc? Will life ever be back to "normal?" What is "normal" now? Months of mask-wearing, hand washing, and minimal social contact has drastically affected when we go out into the world and how we act when we do. Our risk factors, and consequent choices, vary depending on our unique mix of circumstances, such as age, pre-existing conditions, or exposure to others we care for. Likewise, if you're like most people right now, you're processing all available information about vaccinations. When can I get the shot? Where is it being administered? How do I sign up? Which version is most effective? Is it safe for me? Do I really need it? In short, we're constantly conducting risk assessments about our health and safety in an effort to inoculate ourselves from potential harm.

Life sciences companies face mounting challenges and risks 

When it comes to commercial compliance, life science companies are in a similar predicament. They must ask themselves many of the same questions about keeping safe, healthy, and effective as commercial enterprises in a landscape that has been utterly transformed. The combination of digital meeting technology, telehealth appointments, and evolving health care settings have ushered in elevated privacy and data concerns, for example. Rare disease therapies require greater, more personal patient support services, such as adequate access to electronic care and communications. How do you facilitate treatment in the interest of patient care without inadvertently crossing lines of privacy and security? And what if an overexuberant salesperson unwittingly offers something they shouldn't to get a Zoom meeting? How your company reacts to such evolving complexities is critical to your success.

Covid-19 is not the flu. And emerging compliance risks for biotech, pharma or medtech companies are not what we've seen in the past -- and there are new variants emerging for both. The potential outcome of both is very serious – and could be lethal to you or your company, with fines so high they could put you out of business or erase your reputational capital. Varying vulnerabilities require different levels of urgency. But without a specialized understanding of the specific risks for your particular company, therapeutic area, and product, chances are high that you're going to miss something. This convergence of commercial activity and data security/privacy risks means it's time to look in the mirror and be honest: Do you truly understand your mix of vulnerabilities and how to quantify and prioritize them? If the answer is no, conducting an imminent compliance risk assessment is a sensible, powerful solution.

Why you should conduct a compliance risk assessment now

Per the [Department of Justice https://corpgov.law.harvard.edu/2020/06/20/doj-updates-guidance-on-the-evaluation-of-corporate-compliance-programs/], administering a compliance risk assessment is the “starting point” – the single most important first step your company can and should take in implementing an effective compliance program. If you've never commissioned one, doing so as soon as possible should be a key part of your commercial compliance strategy. If it's been two or more years since your most recent “risk physical,” an update now is imperative. Even if you've conducted one more recently, staying current is critical. Any time circumstances for you or your business change – you've joined a new company as the new General Counsel, new Chief Operating Officer or as the new Chief Compliance Officer, new products are launched or made new acquisitions, for example, or gone through a once-in-a-century pandemic (imagine that!) – it's time for a “booster shot” to protect yourself against potential risks through a bespoke compliance risk assessment that lays the foundation for future commercial health and success.

The temptation with anything in life, however, is to avoid doing any initial screening because we might learn things that we don't like. We are tempted to say, "Let's just get on with it!" But getting a baseline report – whether it's for your physical health or the health of your business – can identify important hazards. Doing so is both wise and prudent. Like getting a CT scan, it is a rational way of identifying, targeting, quantifying, and prioritizing risks with precision, so you can successfully respond, adapt, and continue to operate effectively. Protecting yourself – whether from Covid-19 or this new emerging mix of compliance risks – makes abundant rational sense.

Compliance risk assessments deliver a competitive advantage 

People who may believe this is simply about ticking a box off the DOJ list are missing the real value of conducting a risk assessment. Done properly, a compliance risk assessment will help you gain powerful knowledge about your unique mix of business risks and circumstances – and deliver a decisive competitive advantage. How? With knowledge comes power – the power to compete and win aggressively by knowing what risks to avoid and how.

At TRESTLE Compliance, we dig deep into understanding your business first -- your therapeutic areas of focus, from patient classes to type of disease and beyond to help you uncover your greatest current strengths and uncover any perceived gaps. Companies making assumptions about any of this information are prone to bias and dangerous blindspots. These cannot only increase risk, but also obscure valuable, latent assets and advantages. By thoroughly evaluating your current state of risks with a detailed assessment using a highly qualified, experienced, and respected independent compliance expert, you gain crucial, credible and valuable insight into your operations. 

At it's core, an effective compliance risk assessment delivers the peace of mind and confidence you and your commercial team need to compete aggressively to win in the market place. 

A compliance risk assessment is less painful, faster and more affordable than you may think

Common misconceptions among life science companies include that compliance risk assessments are time consuming, expensive, and a hassle. At TRESTLE, we are unique in our speed, efficiency and savings. In fact, 60–90 days is all it should take for us to complete a comprehensive, customized evaluation and generate a detailed custom report, heat map of risks, and a detailed compliance implementation plan. Using our proprietary software, we precisely tailor our approach to fit your organization with minimal intrusion into the busy schedules of your employees, all while efficiently organized and crisply executed, building trust and confidence in the process with each interaction. As an entrepreneur myself, I built TRESTLE to be sensitive to your time and budget, with the ability to appropriately scale to your business. 

What makes TRESTLE's approach uniquely effective is our personal, partner-level attention throughout the process, providing maximum expertise and value at every stage. As seasoned independent compliance experts, we bring objective, targeted analysis that identifies any under- or over-estimation of internal compliance processes in place and external compliance enforcement risks. Juxtaposing your organization’s responses against our own expertise and cutting-edge analysis, we identify any internal perception gaps and vulnerabilities, and then map out analytics-based strategies and solutions. Above all, we help you understand what best practices and “success” look like for you. Our goal is to minimize your compliance exposure to maximize your competitive edge. 

In this era of paradoxes, the convergence of unprecedented physical isolation, matched by equally novel virtual access, makes it more important than ever to get “vaccinated” against new and emerging compliance risks. In this Covid-19, Zoom-focused world, a compliance risk assessment is the inoculation you need right now. This relatively painless, quick, and prudent step is precisely what leading experts (and the DOJ!) recommend for the ongoing compliance, health, and safety of your business. Get the “shot” to stay safe, be well, boost your confidence, and allow yourself and your business to adapt, live…and thrive! 

If you'd like to learn more about Compliance Risk Assessments and related commercial and corporate compliance support services, please feel free to contact me, Steve Vincze, President & CEO, TRESTLE Compliance, LLC, at [email protected] or at 617-800-3704. I look forward to speaking with you and helping you create a definitive compliance action plan that will lead your company to commercial success. Also, check out our website at www.trestlecompliance.com. Stay safe. Be well.

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Copyright ? 2021 Steve Vincze