Compliance in the health and healthcare sector

 Introduction: Integrity, ethics, and compliance culture in healthcare

 Special features of compliance risk analysis in the healthcare sector

• Recap: Fundamentals of CRA.
• Process design.
• Identification and assessment of risk areas based on case studies (hospitals, pharmaceutical manufacturers, medical device manufacturers).

 Preventing corruption in healthcare

• Fundamentals of permissible cooperation and typical forms of cooperation.
• Corruption offenses in the healthcare sector and criminal prosecution practices.
• Sanctions, professional, and code implications of a suspected case.
• Corruption prevention measures in business practice.
• Codes of conduct of the associations.

Misconduct, internal investigations, and whistleblowing in the healthcare sector

• Special features and challenges from the perspective of companies in the healthcare industry.
• Dealing with employee misconduct from a company perspective using the example of accounting fraud.
• Internal reporting offices and patient-oriented complaint management.
• Patient data protection and medical confidentiality.
• Digression: Dealing with search measures in the company (guidelines/dawn raid exercise).

AI applications in medical devices

• Use of artificial intelligence (AI) in medical facilities.
• Obligations for providers and operators of high-risk AI under the new EU AI Regulation.
• Implementation of AI compliance in operational practice.
• AI literacy as the key to the trustworthy use of AI.
• Sanctions and implementation deadlines under the EU AI Regulation.

NIS2 implementation in the healthcare sector

• Those affected in the healthcare sector.
• Risk management and obligations to maintain a minimum level of IT security.
• Specific duties for managers.
• Procedure for security incidents: Reporting, notification, and information obligations.