For quite a while, artificial intelligence and machine learning models are leveraged in the healthcare industry to improve patient outcomes. They have been utilized in various scans, for diagnosing various diseases, for the drug manufacturing and planning the treatment for various diseases. The involvement of these AI/ML models is observed in the surgical process as well. With the amount of data being generated nowadays, the traditional AI/M- based software models are often scrutinized under the lens of performance and accuracy. As new advances are shaping the future of healthcare, the modification of the existing software models has been recognized by healthcare professionals.

For quite a while, artificial intelligence and machine learning models are leveraged in the healthcare industry to improve patient outcomes.

The findings come from a cross-sectional study, published in BMJ Open, of the comments submitted to the US Food and Drug Administration (FDA) 'Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)--Discussion Paper and Request for Feedback'. Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care, continually incorporating insights from the vast amount of data generated every day during the delivery of health care. Many such devices must have regulatory approval or clearance before being available for clinical practice, and in the US that regulation falls to the FDA. The suitability of traditional medical device regulatory pathways for AI/ML have been called into question because the nature of the technology means it is continually evolving and adapting to improve performance. Under the current framework it would mean that as devices evolved they would require further review and approval, which could be time consuming and may affect patient safety and interests.

The EU could temporarily ban the use of facial recognition technology in public places such as train stations, sport stadiums and shopping centres over fears about creeping surveillance of European citizens. A prohibition lasting between three and five years is seen as a way for Brussels to manage the risks said to be posed by the breakneck speed at which the software is being adopted. The option is contained in an early draft of a European commission white paper obtained by the news website Euractiv. The final version is due to be published in February as part of a wider overhaul of the regulation of artificial intelligence. The draft document points to the right under the General Data Protection Regulation for EU citizens "not to be subject of a decision based solely on automated processing, including profiling."