Brooke Nelson on Reporting and Investigations [Podcast]

07/08/21 • 12 min

Post By: Adam Turteltaub Brooke Nelson (LinkedIn), Executive Director, Worldwide Compliance and Business Ethics at Amgen had a unique and broad perspective on managing compliance during the pandemic. In this podcast she shares what she has seen, including a drop in incidents in many areas. Part of that, she believes, is likely due to the fact that people were disconnected. With sales reps less able to make calls on medical practices there were less interactions and less opportunities for things to go awry. When it comes to investigations the adjustment to the pandemic has gone better than might be expected. As she notes, global organizations have always had to rely on some remote methods in the past when conducting investigations since you didn’t necessarily have compliance staff in every location. During this era, though effective investigation practices in distant locations have likely grown more effective. However, there remains a strong case for conducting at least some aspects of the investigation in person. An in-person meeting can give a clearer read of the individual. In addition, the presence of an investigation team may lead other individuals on site to share information that they might not have. An investigations team physically present also offers another benefit: it demonstrates the company takes investigations seriously. With the US and other regions hopefully soon reopening, she does warn that compliance teams should be prepared, if they aren’t already, for change. It is time, for example, to reiterate the need for the workforce to reach out and report their concerns through the helpline and other channels. Compliance should also look out across the organization to better understand what is happening on a country-by-country basis, both for the business units and for the compliance team, itself. There are likely significant disparities and a need to adjust efforts and expectations accordingly. And, of course, the way we all work has changed, perhaps permanently. Listen in to learn more about our recent past and what to consider moving forward.

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Suzanne Gellner on System Improvement Agreements [Podcast]

Post By: Adam Turteltaub A Systems Improvement Agreement (SIA) comes at a time of crisis for a healthcare organization, one in which it may even risk being terminated by CMS. As Suzanne Gellner (LinkedIn), Principal, The Gellner Group explains, an SIA involves a lot of work that must be done quickly, typically within just 12 months. For organizations undergoing an SIA she recommends creating an oversight committee made up of C-Suite leaders and others with oversight of the service areas under the SIA. This will help make sure that these same service areas are accountable. The committee would ideally have each group meet with them monthly and provide status updates. Leadership support is critical, but so too is the support of middle managers. They are going to be the major change against, she explains, who understand what is happening on the front lines, and what leadership wants to see happen. They are also the individuals who will be coaching the staff into how to meet the goals of the SIA. To help the managers, take the time to learn what their likely pain points are, what their day-to-day work life looks like and what challenges they perceive. With that knowledge you can better demonstrate how the SIA initiatives will help them in their work. Done right, it can turn them into ambassadors for the changes the SIA requires. Suzanne also recommends taking a unit-by-unit approach rather than a system-wide approach to the SIA. Each service area is going to be different. The challenges and people will vary. As a result, it’s essential to understand where they are and how the program will benefit them the best. In addition, once there is success in one unit, the others will likely notice, recognize the benefits and be more eager to implement the SIA. Listen in to learn more about how to successfully navigate an SIA in your organization.

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Justin Beals on HIPAA and HITRUST [Podcast]

Post By: Adam Turteltaub HIPAA? HITRUST? One you have to follow (or else), the other it may be time to pursue. In this podcast Justin Beals, CEO & Co-Founder of Strike Graph provides a primer on HITRUST and what companies thinking about pursuing certification need to consider. HIPAA, he explains, is a legal requirement providing rules for how healthcare data must be handled, and penalties for when it is mishandled. HITRUST is not a legal requirement but a standard. An organization can get assessed against it and even certified. Why should you pursue it? There are many reasons, but, likely the most compelling is that healthcare providers require HITRUST certification from their vendors. With approximately 70% of data breaches traceable to third parties, organizations are demanding that their suppliers take strong steps to ensure the security of their systems. Pursuing HITRUST certification can be a long process, Justin explains. As a result, one key to success is starting early and avoiding the temptation to go too fast. It’s not supposed to be fast and easy. Plus, it requires the collection of significant data. A second key to success: recognizing that this represents a culture change. Attitudes toward security will likely need to evolve, and data protection is now more important than ever, bringing with it a host of changes that need to be implemented. A concerted communications and education effort will be needed to achieve success. With so many breaches beginning with human errors, the workforce has to know what to watch out for, what to avoid, and why cybersecurity must be taken so much more seriously. Listen in to learn more about HITRUST and the challenges and rewards in implementing it in your organization.