Compliance and due diligence in healthcare: international experience and implementation challenges

Abstract

Aim: To analyse the international experience of applying compliance and due diligence procedures in healthcare and to identify the main challenges to their implementation. Materials and Methods: The study is based on the systematisation and comparative analysis of regulatory and empirical data on the implementation of compliance and due diligence procedures in healthcare. The empirical base includes data from the U.S. Sentencing Commission and the U.S. Department of Justice Fraud Section (2019–2025), illustrating the influence of compliance and ethics programmes on organisational accountability, supplemented by legislative frameworks and case law from the United States, the European Union, and Ukraine. The assessment covered eight indicators. Dialectical, hermeneutic, comparative, analytical, synthetic, and systems analysis methods were used. Conclusions: The main challenges to implementing compliance and due diligence procedures include the absence of a legislative mandate for healthcare institutions and a low level of corporate culture and ethical awareness.