Abstract & Overview
Artificial intelligence (AI) has become an integral part of modern healthcare, with its algorithms and other AI-enabled applications supporting medical professionals in clinical and research settings. The digital revolution is transforming the way we approach medical care. Currently, numerous AI products have been developed to cover various aspects of healthcare, such as predicting the risk of acute and chronic diseases (e.g., cardiovascular risk, gastrointestinal bleeding, and eye conditions) and forecasting cancer risk, among other cases. Artificial intelligence has the capacity to revolutionize the utilization of health information collected in datasets. However, the specific characteristics of AI, including vagueness, complexity, data dependency, and automated behavior, can pose potential risks to users’ fundamental rights and safety. Therefore, it is crucial to recognize and mitigate these risks and provide legal solutions for any harm resulting from these risks. In the realm of healthcare, AI plays a pivotal role in advancing reliable prediction capabilities. Consequently, the storage and processing of data are imperative for emerging diagnostic and decision-making technologies. Nevertheless, these advances also introduce privacy risks, raising significant legal challenges for medical institutions. Understanding the various levels of these risks assists healthcare professionals and institutions in managing these challenges and complying with regulations. This descriptive research article comprehensively examines and implements the regulatory frameworks governing the United States and the European Union. Additionally, it draws upon documented research in this field to discuss the utilization of AI in healthcare, along with the associated legal issues, including informed consent and malpractice.