Gynecology and Obstetrics 2022

Nadia Schwirtzek

Berlin, Germany

Title: Avoidance of harm to patients and physicians = avoidance of litigation and protection against liability and loss of assets in healthcare through compliance management systems (CMS)


Sustainable CMS can prevent/minimize harm to women and children during pregnancy and childbirth. Study results in recent years have shown that white-collar crime is an ongoing issue for management, the board of directors, and the administrative or supervisory boards, and is taken correspondingly seriously. There is also the potential personal liability, not only of executives but also of a company's employees. This is an international problem with large-scale damage, loss of reputation and value for companies as a result of crimes committed in companies, to companies and by companies. In this context, all employees, managers and bodies of a company can damage it through criminal acts, also in cooperation with external third parties, e.g. in order to gain unfair competitive advantages. CMS can minimize the risks of criminal or anti-competitive behavior. Compliance refers to the totality of measures introduced by a company to ensure that externally specified rules are adhered to. In addition, the derivation of internal rules and their observance is the task of the CMS. The compliance requirements arise individually for each company. The sustainable design and review of compliance in the company have moved significantly into the focus of legal advice for the benefit of companies and their employees, since due to incomplete systems for the prevention of criminal behavior, there is a high risk of litigation, which is associated with uncertainty regarding the duration of the investigation, the restrictions due to the investigation, as well as the outcome and the amount of the penalty or asset forfeiture. Through CMS, CEOs, board members, medical directors/leaders, physicians/employees/auxiliary staff can be exonerated from potential charges for which they could be personally liable. CMS is certifiable. Certification adds value and improves the reputation of the organization. It plays a major role with overwhelming practical importance based on cost-benefit alone.


Nadia Schwirtzek studied law and forensic medicine and graduated with the qualification to become a judge. Since 2005, she has been working as a specialist in medical law in her own law firm and advises, among others, hospital operators, physicians, researchers and developers as well as service providers in the healthcare sector and medical technology - also in terms of corporate, commercial and employment law. In 2017, she achieved certification from Steinbeis University Berlin as a Compliance Officer. She is currently working on her doctoral thesis with Prof. Dr. Martin Heger at the Law Faculty of the Humboldt University of Berlin in the field of Medical Industry Criminal Law on the topic: "Relevance of compliance management systems regarding the criminal liability, also in the broader sense, of members of corporate bodies of legal entities, shareholders, executives and employees of companies in the healthcare sector".