Abstract Globally, governments and public health authorities are integrating Artificial Intelligence (AI) techniques in mobile apps to improve public health. For example, during the COVID-19 outbreak, AI-driven chatbots were deployed to provide immediate health information and advice. AI-based mobile apps are also used to support mental health or for preventive healthcare, such as personalized dietary recommendations. Moreover, the use of generative AI for public health purposes is rapidly increasing. In 2024, the WHO launched S.A.R.A.H - a generative AI chatbot designed to provide information on major health topics such as healthy lifestyles and mental health. By integrating AI, public institutions could potentially achieve better health outcomes, improve efficiency, and enhance access to healthcare. However, the rapid adoption of AI public health apps also raises significant ethical, legal, and regulatory challenges. The large amounts of sensitive personal data collected and processed by such apps may create issues for privacy, data protection, and cybersecurity. At the same time, the tendency of AI to exhibit biases may deepen existing health inequities. The new EU ‘digital’ legal framework does not directly address these challenges. This workshop aims to convene leading experts working on AI in health to address these issues. We bring together scholars from different disciplines (health law, health policy, bioethics, biosciences). The workshop objectives are twofold: (1) to critically assess the current landscape of AI in public health apps from a legal, ethical, and regulatory point of view, and (2) to lay the groundwork for policy recommendations on how to ensure the deployment of AI apps for public health in compliance with ethical principles and fundamental rights. First, the panel explores the differences in the data protection regulation of AI public health apps in the EU and the US (speaker: James Hazel). Second, it discusses how these apps are regulated under the new EU Artificial Intelligence Act (speaker: Hannah van Kolfschooten). Third, it investigates the consequences of the European Health Data Space regulation on how health data can be processed through public health apps (speaker: Mahsa Shabani). Finally, as the cross-border use of apps complicates regulatory efforts, it discusses the need for international cooperation in establishing and enforcing guidelines (speaker: Vasiliki Rahimzadeh). The workshop will be conducted as a round table discussion with 4 short presentations of 5 minutes each. Speakers first present a key challenge posed by AI in mobile health apps, and then suggest a potential regulatory solution. This will be followed by a dialogue between panelists and the audience to share best practices on how to regulate AI in mobile public health apps from a legal, ethical, and regulatory perspective. The input will be used to develop a submission for the Call for papers of BMC Bioinformatics. Key messages • As public institutions are increasingly integrating AI technologies into their mobile public health solutions, it is crucial to evaluate the ethical, legal, and regulatory implications. • In light of current gaps in the EU legal framework, we convene scholars from different disciplines and legal systems to design guidelines on the ethical use of AI mobile apps for public health. Speakers/Panelists James Hazel University of Amsterdam, Amsterdam, Netherlands Mahsa Shabani University of Amsterdam, Ghent University, Amsterdam, Netherlands Hannah van Kolfschooten University of Amsterdam, Amsterdam, Netherlands Vasiliki Rahimzadeh Baylor College of Medicine, Houston, USA Pramiti Parwani University of Amsterdam, Amsterdam, Netherlands