# Generative AI in Medicine and Healthcare: Moving Beyond the Peak of Inflated Expectations'
## 3 Applications and Implications of Generative AI and LLMs in Medicine
### Can We Trust Generative AI? Is It Clinically Safe and Reliable?
#### 3.1.1 Regulation, Regulatory Frameworks, and Ethics
Reform is inevitable and more agile regulatory changes are coming [37] that can better address the complexities of generative AI and the fast pace of developments in this field, protect patients, and encourage responsible innovation. [PERSON] and [PERSON] [40] are joined by [PERSON] et al., who similarly argue that current regulatory frameworks are a \"de facto blocker to AI-based personalized medicine\" and that new regulatory thinking and approaches are necessary to overcome this situation [44]. In the same vein, [PERSON] et al. call for a new regulatory framework that recognizes the capabilities and limitations of generative AI applications, but stress that this should be done while also enforcing existing regulations [45]. In August 2024, the UNESCO published its \"_Consultation Paper on AI Regulation--Emerging Approaches Across the World\"_ in which it described nine non-mutually-exclusive regulatory approaches [46]. Medical AI regulatory frameworks (current and future) in different countries will often combine two or more of these approaches:  
1. Principles-based approach: Offers core principles guiding the ethical and responsible creation and use of AI systems, emphasizing human-centered processes and respect for human rights. 2. Standards-based approach: Transfers state regulatory authority to organizations that develop technical standards to interpret and enforce mandatory rules. 3. Agile and experimentalist approach: Creates adaptable regulatory frameworks, like sandboxes, that allow businesses to test new AI models and tools under flexible regulations with government oversight. 4. Facilitating and enabling approach: Fosters an environment that promotes the development and use of ethical and human rights-compliant AI by all stakeholders. 5. Adapting existing laws approach: Updates sector-specific and general laws to improve the current regulatory system for AI. 6. Access to information and transparency mandates approach: Mandates transparency measures to ensure public access to basic information about AI systems. 7. Risk-based approach: Implements requirements based on the risk levels associated with using AI in various contexts. 8. Rights-based approach: Sets obligations to protect individuals' rights and freedoms when using AI. 9. Liability approach: Establishes accountability and penalties for the misuse of AI systems. [PERSON] et al. compiled a collection of 141 binding policies applicable to AI in healthcare and population health in the EU and ten European countries. They concluded that specific AI regulation is still nascent, and that the combination in place today of existing data, technology, innovation, and health and human rights policies is already providing a baseline regulatory framework for AI in health, but needs additional work to address specific regulatory challenges [47]. The European Union's AI Act, which came into force on 1 August 2024 [48], introduces an additional regulatory layer requiring manufacturers to address AI-specific risks and ethical considerations in any medical application or device incorporating AI or machine learning functionalities. This act underscores the importance of aligning with both standard medical device regulations (MDR) and the new AI Act-specific requirements to ensure the safe and effective deployment of AI technologies in healthcare [49; 50]. It is worth noting that the EU AI Act was the subject of strong lobbying efforts by big tech companies and EU member states to weaken much of its power through an overreliance on self-regulation and self-certification among other things [51]. The evaluation of AI-based clinical interventions is closely related to their regulation. Evaluation provides much of the evidence required by the governing regulatory frame works to secure regulatory body approval for the mainstream use of these interventions.