As the chief compliance officer of Johns Hopkins Medicine International (JHI), Renata J. Matsson is responsible for meeting an incredibly wide range of best practices, laws, and regulations. That can span from legal consideration and pre-engagement due diligence to ongoing risk assessment, data privacy, and security, as well as business continuity planning. This also extends across global services that include providing healthcare for Saudi Aramco’s roughly 350,000 employees and their families, nursing programs in Brazil, joint university-based medical research in Colombia, as well as consulting, management, training programs, and various other collaborative agreements throughout the Middle East, Asia, South America, and the Caribbean.
Additionally, Matsson manages compliance for patient services, which brings international patients to the United States for medical treatment. In order to manage a variety of different details, she relies on an extensive network of internal JHI specialists, as well as outside legal, consulting, and accounting experts. Her guiding principle to motivate and enable internal personnel and external partners to meet all necessary requirements is to engage in clear and ongoing communication.
“Compliance doesn’t come easily to anyone,” Matsson explains. “That’s why it’s so important to constantly remind everyone to build it into the workflow of every project and to be proactive when there are questions. It’s always harder to fix something after it’s broken than it is to get it right in the beginning.”
After years of experience as a compliance professional, Matsson has learned many lessons. One of the most significant goes beyond simply knowing the applicable regulations. The key is understanding the cultures where they apply. For example, procedures in the United States for obtaining various types of permits or registrations are typically clear and precise. In other regions of the world, however, authoritative sources of information can be vague and diffuse. Even government ministers may not be able to provide complete information, and unwritten rules frequently come into play.
“It’s not uncommon in a foreign jurisdiction to feel as if the application of laws and rules are constantly changing, but it’s important not to appear frustrated, act aggressively, or raise your voice,” Matsson says. “Your success has less to do with the specific law or regulation than it does with the quality of the relationship you develop with the local official.”
Another important aspect of her role is managing expectations. Because of JHI’s reputation, assumptions are often made about the level of expertise and solutions it can provide to overcome any challenges that might stand in the way of a project’s success. In one instance, an international partner expected JHI to implement a working telemedicine program. However, the local technology infrastructure and internal knowledge base were subpar to what was needed to support that goal. Extensive discussions were required to convince the partner that JHI could provide training to move them closer to their objective. But providing a full “telemedicine package” simply wasn’t possible.
Complying with the US Foreign Corrupt Practices Act (FCPA) has become another increasingly challenging task. When working with public universities and health systems, the term “foreign official” becomes more difficult to define when all of the institutions’ staff are, technically, government employees, or “foreign officials” under the law. Additionally, numerous countries have enacted their own anti-bribery legislations that are even more restrictive. For example, while the FCPA permits so-called “facilitating payments” to expedite processing visas and permits, the new laws prohibit such payments.
“We provide extensive training so that everyone knows what’s permissible under the laws,” Matsson says. “The key is to build awareness so that even if someone doesn’t know every detail, they know enough to ask questions.”
Training has also been essential in situations such as when a patient or their family offers expensive gifts as thanks for successful treatment, which staff are generally not permitted to accept. Instead, the gift can only be accepted on behalf of the organization, or in the case of cash, as a donation to Johns Hopkins.
Cultural considerations also enter into working with international patients in the United States. Their customs may prohibit being treated by a clinician of the opposite sex or prevent a woman from giving her own consent for a medical procedure (since in many countries, consent must come from a husband or other male family member). In these situations, a great deal of sensitivity is essential.
“We can explain our protocols for their care and safety, but still need to be able to adapt,” Matsson says. “That can mean getting consent from a patient and her husband.”
Adapting may also mean softening the language during an end-of-life situation in order to avoid taboos against directly mentioning death. In some cases, “‘You should be with your family as much as you can’ would be preferable to saying, ‘You have two months to live,’” Matsson explains.
The compliance and risk-management challenges Matsson has to meet are always changing. Terrorism has altered how travel risks are assessed, and growing concerns with national security threats, political changes, and regulatory pressures have also increased the importance of thorough due diligence of foreign parties, which may even include patients.
No matter how issues evolve, Matsson believes JHI will be successful in meeting all its compliance obligations.
“Compliance goes beyond legal considerations,” she says. “It’s intrinsically linked with ethics, the organizational culture, and a commitment to corporate social responsibility. By being sensitive and flexible, we can balance diverging interests and serve the best interests of our stakeholders and the foreign patients and partners we work with.”
Photo by Mike Halstad