Compliance in the health and healthcare sector

A compliance risk analysis in the healthcare sector is more complex than in most other industries: It must not only identify financial and legal risks but also take into account industry-specific risk areas that vary significantly depending on the type of organization—a hospital, a pharmaceutical manufacturer, and a medical device manufacturer have fundamentally different risk profiles. The workshop dedicates a separate session to this topic and uses concrete case studies from all three areas to demonstrate how a structured risk analysis is methodically developed in a healthcare context, how risk areas are identified and assessed, and how the results are translated into effective process design. Those who master these fundamentals lay the groundwork for a CMS that not only works on paper but actually addresses the specific risks of their own organization.

Corruption in the healthcare sector is an issue with particularly explosive social implications: It affects not only economic interests but also patients’ trust and the integrity of medical decisions. The workshop covers the fundamentals of permissible collaboration and typical forms of collaboration in the healthcare sector, explains the relevant corruption offenses and current law enforcement practices, and illustrates the legal consequences—including sanctions, professional disciplinary actions, and code of conduct violations—that a suspicion of corruption can trigger. The workshop will also cover the codes of conduct of the relevant professional associations—an area that is often underestimated in practice but is of considerable importance for evaluating collaborations with physicians, hospitals, and other healthcare providers. Those who understand these interrelationships can integrate corruption prevention measures into their organizational practices in a targeted and effective manner.

Claims fraud is one of the most common and serious compliance risks in the healthcare industry—and, at the same time, one that is particularly difficult to detect and address in practice. The workshop addresses how to handle employee misconduct from a corporate perspective using the specific case study of billing fraud, and demonstrates which internal investigative measures are legally permissible, how internal reporting channels must be structured in a healthcare context, and how patient-centered complaint management is integrated into the compliance system. It also examines the intersection between patient data protection and physician-patient confidentiality—an area of tension that regularly leads to conflicts in internal investigations and can only be navigated safely with specific industry knowledge.

A search by law enforcement authorities—known as a “dawn raid”—is one of the most stressful and far-reaching situations a healthcare company can face. Anyone who is unprepared at that moment risks causing significant harm—both to the company and to individual employees—through careless statements, the improper release of documents, or a lack of coordination. The workshop includes a section on how to handle search procedures within the company and offers a practical dawn raid exercise in which you’ll simulate a real-life scenario and develop specific response protocols. Once you’ve practiced this process, you’ll be able to respond calmly, systematically, and in compliance with the law in an actual emergency—rather than making mistakes out of uncertainty that cannot be corrected afterward.

Artificial intelligence is rapidly making its way into medical facilities and the medical device industry—from AI-powered diagnostic tools and automated billing systems to AI applications in medical devices. The EU AI Regulation classifies many of these applications as high-risk AI and imposes correspondingly strict requirements on providers and operators. The workshop covers the obligations for providers and operators of high-risk AI under the EU AI Regulation, explains the penalties and implementation deadlines, and demonstrates how AI compliance can be implemented in everyday business operations. Particularly valuable in this context is the concept of “AI literacy” as the key to the trustworthy use of AI: Ensuring that employees can understand, critically evaluate, and use AI systems responsibly lays the foundation for AI deployment that is not only legally compliant but also ethically sound.