Identifying and overcoming challenges in the EMA's qualification of novel methodologies: a two-year review.

The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and submitted data. This policy brief analyses QoNM submissions providing policy messages and recommendations to stakeholders on how to better prepare qualification applications in this regard. The recommendations include: 1.

The ménage à trois of healthcare: the actors in after-AI era under patient consent.

Introduction: Artificial intelligence has become an increasingly powerful technological instrument in recent years, revolutionizing many sectors, including public health. Its use in this field will inevitably change clinical practice, the patient-caregiver relationship and the concept of the diagnosis and treatment pathway, affecting the balance between the patient's right to self-determination and health, and thus leading to an evolution of the concept of informed consent. The aim was to characterize the guidelines for the use of artificial intelligence, its areas of application and the relevant legislation, to propose guiding principles for the design of optimal informed consent for its use.

Smoking-related cue reactivity in a virtual reality setting: association between craving and EEG measures.

Background: Cue-reactivity is the array of responses that smokers exhibit when exposed to conditioned and contextual stimuli previously associated to substance use. The difficulty to experimentally recreate the complexity of smokers' spatial experience and context requires more ecological models. Virtual reality (VR) creates a state of immersion close to reality allowing controlled assessments of behavioral responses.