Compliance Perspectives

Post by Adam Turteltaub

The European General Data Protection Regulation (GDPR) already provides considerable requirements for compliance programs. With Brexit comes a new GDPR for the United Kingdom. Adding to the complexity, the UK GDPR also contains a Children’s Code, explains Jeff Kluge (LinkedIn), Founder & CEO of Holistic Ethics. The UK has long led in protecting the data of children, and the new code follows the UN Convention on the Rights of the Child.

For companies doing business solely within the United States it is not likely to be an issue but for those operating globally he advises being aware of and in compliance with the Children’s Code’s requirements. There are standards and rules in place for connected games and toys, for using artificial intelligence (AI) and processing children's data.

So, what should compliance teams do? First, they need to understand the algorithm used in the AI their organization employs, ideally while it is still being developed. Second there should be a children's data oversight committee in place. Third the company should be asking whether they should have an ethics committee overseeing their AI-based systems.

Also, the compliance team needs to recognize that AI initiatives are often created without their knowledge. It's important to get a handle on what's going on help people understand the importance of closely monitoring artificial intelligence, particularly those systems that are autonomous.

He reports that the compliance team can be particularly helpful in identifying what data is being collected and what is the right data to be using. The team particularly needs to be monitoring what decisions are being made based by the AI.

Listen in to learn more about the UK GDPR Children’s Code and what compliance teams need to do to protect both children and their own organizations.

Post by Adam Turteltaub

San Diego-based Qualcomm was having a tough 2018. The company was going through a whole host of highly destabilizing activity including an attempted hostile takeover. Needless to say, it was a challenging time for the company and the corporate culture.

The compliance team very much wanted to be a part of the solution, Krista Wolff, Senior Manager, Corporate Compliance Communications tells us.  Their goal was to amplify the positive and strengthen the organization's culture, despite all the challenges it faced.

To help, in the Spring of that year they launched the Lead the Way employee ethics recognition program. In the Fall they launched the newly revised code of conduct and their first Compliance and Ethics Awareness Week.

Through the years since they have rolled out a number of activities to involve employees and communicate important messages. One of their more fun ideas was a “spot the issues” exercise. They staged desks, photographed them, and asked employees to spot items on the desk that could be indicative of something problematic. When the pandemic struck and people began working from home, they continued this program although now featuring desks in a home setting.

One of the more interesting efforts they did was focused on protecting confidential corporate information. As a technology company IP is very important to Qualcomm and the compliance team wanted to stress to people the importance of protecting data.

They worked with the IT department to identify printers around the globe at Qualcomm offices. They then sent to the printers in these in these offices a document marked confidential company information with a message about the importance of protecting IP and asking the employee who found it to email compliance letting them know where they found that document and when. It was a great way to demonstrate that people sometimes send things to printers that they shouldn't and leave them there far too long.

This activity had an interesting response rate that illuminated cultural differences. They found that people in Asia rarely emailed in. From Europe, by contrast, the response rates were very high, and in the US employees tended to leave the document on the printer for others to find as well.

To make other parts of the program relevant globally they worked with their ethics liaisons and in-country compliance teams around the world to plan local events. The response has been very positive, and the level of innovation has been equally high.

Listen in to learn more about how Qualcomm’s Compliance and Ethics Awareness Week both helped to meet their compliance goals and strengthen the overall corporate culture.

Posted by Adam Turteltaub

Compliance teams spend a great deal of time and effort encouraging employees to contact the helpline.  But, points out Jay Anstine, Compliance Program Director, Western Division, Banner Health, we tend to make less of an effort to train them in what happens after they make that call.

That’s a mistake, he argues in this podcast, since employees who see perceived wrongdoing tend to feel anxious and vulnerable.  They are stressed because they are uncertain what is going to happen, if anything.

By helping them understand the post-call process, we can eliminate this blind spot, he argues, greatly reduce the stress level, and increase the likelihood that they will come forward.  That means providing training that brings greater clarity to the process during on-boarding and annually thereafter.  It also means taking the time to understand the questions the workforce may have about what happens from start to finish.

Also, he advises, include in the training information about what to expect when reporting face to face, either to their supervisor, or somewhere else, including the compliance team.

Finally, Jay provides insight into how to make the reporter feel comfortable when bringing the information to compliance, and what you can do to protect his or her anonymity.

Listen in to learn more about how demystifying the helpline could help yours ring more often.

Posted by Adam Turteltaub

Procter & Gamble (P&G) is one of the best-known companies in the world, boasting top brands such as Tide, Crest and Charmin. The company is also well recognized for its highly strategic marketing and its integrity. In fact, its reputation for principled behavior is what attracts and helps retain top talent at the organization, reports Jay Ernst (LinkedIn), Director – Ethics & Compliance Office, P&G, in this podcast.

How strong is the organization’s commitment to ethical behavior?  In annual surveys the company's purpose, values and principles are cited most frequently by employees as something that they do not want to change.

For its annual Corporate Compliance & Ethics Week celebration, which they have dubbed the “Do The Right Thing Celebration”, the compliance team ties the program and compliance training into one of three commitments – respect, integrity and stewardship -- that are part of their refreshed code of conduct.

In 2021 the theme was “Leading with Respect”. Activities included marquee events featuring external or high-profile internal speakers. They also had videos highlighting challenges people may face, risk areas and how to deal with them.

To make the program relevant to its employees around the world, they enlisted the help of the employee relations group, which helped them identify individuals to lead the local activation of the program. The same people each year now lead the activities in their region.

While the local activation follows the common theme, there is opportunity to customize the program to increase the relevance to their communities. Each year there are even global recognition awards for activations that demonstrate creative activity and engagement.

The company also has a peer recognition program known as the Power of You, which recognizes excellence across a range of areas, including ethics. Employees can nominate their peers who have gone above and beyond in their work. It has proven to be an excellent opportunity to recognize ethical actions on a peer-to-peer basis.

Listen in to learn more about P&G’s experience and how you may be able to apply it to your own organization.

Posted by Adam Turteltaub

Getting employees to come forward and provide feedback on the corporate compliance and ethics program is often a challenge. Many are hesitant to talk to compliance at all. Still others may fear that their conversation may lead to more scrutiny by the compliance team.

Mary Shirley, Head of Culture of Integrity and Compliance Education at Fresenius Medical Care and co-host of the Great Women in Compliance podcast, found an interesting way to change the dynamic. She made feedback an integral part of the organization's annual Corporate Compliance & Ethics Week celebration.

The compliance team there recognized that during the week-long celebration people are eager to participate. That means there is a golden opportunity to collect data from them that can provide insights that might not otherwise be captured. This includes both informal conversations and using things like quizzes to determine how much information from earlier training has been retained.

Also, games can help.  In one fun exercise they had a ring toss in which to get a ring the individual had to answer correctly a question related to compliance.

The program has yielded remarkable insights. For example, one part of the compliance team was concerned that it was sending too much email. When they used this opportunity to ask employees what they felt, they were surprised to discover that it was actually a preferred means of communications.

Listening has one other benefit: it enables the compliance team to demonstrate that it is responsive to employee workplace concerns.

Listen in to learn more about how you can turn Corporate Compliance & Ethics Week into a learning experience both for employees and for the compliance team.

Post by Adam Turteltaub

While we have all grown accustomed to seeing access ramps and automated doors in the physical world, it is easy to forget that the Americans with Disabilities Act (ADA) requires digital accessibility as well. In this podcast, Michelle Landis, co-founder of Accessible360, explains that the challenges start with organizations not even realizing that the ADA sets numerous requirements that organizations must comply with.

The challenge posed by this knowledge gap has been both exposed and increased by the pandemic, which has accelerated the need for online resources that are available to all. How do you bank, order groceries, and work from home if the websites you need are not accessible to individuals with physical challenges?

For organizations looking to catch up with the digital requirements of the ADA, she recommends starting by taking an inventory of your consumer facing websites and mobile apps.  Those are the ones most likely to be subject to litigation.

Next, get a live user assessment by individuals trained in this area and from people who are living with disabilities. She advises being cautious around companies promising to provide a quick fix with a simple overlay.

Another pitfall, she warns, is underestimating the time it takes to implement suitable changes to your websites and apps that need them. When faced with a demand letter for changes within 21 days, you should engage your legal team to respond in an appropriate way.

Finally, she advises that, as with the physical world, it is better to build in accessibility from the start rather than adding it later. That means keeping it front and center when designing and evolving your organization's digital assets.

Posted by Adan Turteltaub

There are a lot of things you can do to make your organization’s celebration of Corporate Compliance & Ethics Week a success. But sometimes, less is more.  Adam Balfour, vice president and general counsel for corporate compliance and Latin America, Bridgestone America's, explains in this podcast that they realized that it would be better to evolve their celebration from a lot of different activities to just a few and to make them bigger.

So what are they doing?

For the last few years they have bestowed a series of Leading With Integrity awards. These go to managers who have been nominated by employees for their exemplary leadership when it comes to compliance and ethics issues. All 50,000 of the organization's employees can nominate any leader, manager or supervisor that they think deserves the prize.

The nominations are evaluated by a cross functional panel which is good for bringing in and engaging other leaders in the organization. Then five or six winners are selected each year, and they are announced during a leadership panel with about 1100 employees on the call.

For the winners the greatest impact comes from the recognition and knowing that the CEO knows your name and for a very positive reason.

This program has also helped the compliance team gain exposure to people they didn't realize were embodying the organization's commitment to compliance.

Another event that they do, or more accurately two events, are leadership panels wherein employees are invited to join in and listen as leaders discuss compliance and ethics issues. It sets a clear tone at the top for the organization and illustrates ethical decision making.

Each year, for a little bit of fun, the compliance team puts together an event using ethics issues found in popular TV shows and movies. This helps teach compliance in a more relatable way and leverages good adult learning theory.

Finally, the compliance organization offers a Compliance Battle Royale every year.  It's a big production with a bracket of 16 teams competing against each other over a period of four days.  There is daily elimination, and it gets very competitive.

Got any good ideas of your own to share? If so add them to the comments below. And be sure to listen to this podcast.

Posted by Adam Turteltaub

If you have ever considered joining the Health Care Compliance Association (HCCA) but haven’t, this podcast will give you cause to reconsider.

Julie Sheppard, Founder and President of First Healthcare Compliance joined the association a decade ago when she was looking for a reliable source of information on healthcare compliance issues.  She wanted an unbiased, trusted source of information that would keep her updated on the challenges of managing compliance.

Through the years she has taken advantage of a wide range of HCCA programs, from an Academy to web conferences to reading the magazine Compliance Today.

She also obtained her Certified in Healthcare Compliance (CHC) designation, which she sees as a means to differentiate herself and demonstrate her expertise.

Listen in to learn more about her journey with HCCA and how she sees healthcare compliance evolving over the next few years.

Posted by Adam Turteltaub

Conflicts of interest are a particularly challenging issue in healthcare.  Medical professionals may moonlight at a rival hospital, have an interest in a medical device or real estate a hospital is thinking of acquiring, and, of course, family members who might work at a key vendor.

Steven Melinosky, Regional Director Compliance/Investigations and Policy at Trinity Health of New England, explains in this podcast that managing conflicts of interest is possible, with the right policies and procedures in place.

That begins with recognizing that one policy is likely not enough.  The conflicts faced by leadership and the board are likely quite different than those faced by rank-and-file employees.  Conflicts for senior leaders and board members likely should be reviewed by the board chair.  Those for employees can typically be handled by the compliance team working with frontline managers.

Underlying  these efforts must be a culture of compliance from the top down and bottom up.  The danger of conflicts of interest must be taught from day one, along with encouragement to report and a clear explanation of the disclosure process.  Supervisors need to be trained to identify conflicts, and periodic reminders need to be scheduled.

One tool that can help make conflict of interest management simpler is something he created and calls a “Conflict of Interest Dictionary.”  It is a spreadsheet designed to help respond to common conflicts.  It contains several columns:

* What the conflict is

* What else needs to be known about it, such as if the individual affected has purchasing authority, is in management and at what level

* Why this issue poses a conflict

* Standardized action plans that lay out expectations for behavior

Having this dictionary helps to ensure consistency in the process and greatly expedites actions since a starting point (and potentially an ending post) is already in place.

Along with this dictionary it’s important to take the time to assess the risk – both likelihood and potential impact – of a conflict and to ensure that the plans put in place are sufficient to mitigate the risk.

He also recommends providing both the affected employee and his or her manager with a written plan which includes the background, the risks and expectations.

Listen in to learn more about how to better manage conflicts of interest and whether a Conflict of Interest Dictionary is right for your program.

Posted by Adam Turteltaub

The 340B program was set up to providers of care to Medicaid patients to stretch federal dollars.  Hospitals and clinics are able to buy covered, outpatient drugs at a discounted price from manufacturers.

As usual, though, what sounds like a simple program poses compliance risks for manufacturers and front-line providers, explains Peggy Tighe (LinkedIn) and Mark Ogunsusi (LinkedIn) of the law firm Powers Pyles Sutter & Verville PC.

Providers can either pass the discounted price along to patients or dispense the drugs and get reimbursement from a private or federal payer at regular rates, using the difference to support their services.

While the 340B program is designed to be flexible, there are several strings attached.  Providers need to ensure that the drugs prescribed go to the patient.  In addition, the individual has to meet specific guidance as to what constitutes a patient.  Simply writing a prescription is not enough.  A set of criteria must be met, and those rules are strict enough that an entire category of software providers has emerged to manage this issue.

Other risks for providers to consider include virtual inventories and over purchasing 340B drugs

For drug manufacturers, it’s essential to ensure that price data is accurate, and that prices do not exceed the ceiling price.  A mistake could lead to civil monetary penalties and even termination from the program.  Duplicate discounts are also prohibited and pose another risk.

Listen in to learn more about how to avoid the many compliance challenges of 340B drug pricing programs.