AI/ML-Enabled Medical Devices â 4 Keys To Obtain Global Regulatory Approval Artificial intelligence (AI) and machine learning (ML) are disrupting and improving our world. With intelligent machines capable of high-level cognitive processes like thinking, perceiving, learning, problem-solving, and decision-making, coupled with advances in data collection and aggregation, analytics, and computer processing power, AI and ML present opportunities to complement and supplement human intelligence. Application of AI and ML in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. Artificial intelligence has the potential to provide incremental value to medical device designers and manufacturers and is expected to be the key source of competitive advantage for firms that adopt it. Global regulators have understood that AI and ML models do not fit well within the current medical device regulatory framework and are feverishly working to achieve a harmonized approach to the management of AI medical devices. The International Medical Device Regulators Forum is attempting to standardize oversight of AI- and ML-based medical devices, and the terminology associated with those devices, among its members. Nonetheless, aside from the regulatory submission and review process, which as of right now is very different from jurisdiction to jurisdiction, medical device companies must realize that data is one of the primary drivers of AI/ML solutions and, thus, appropriate handling of data to ensure privacy and security is of prime importance. Challenges include data usage without consent, risk of identification of individuals through data, data selection bias and the resulting discriminatory nature of AI/ML models, and asymmetry in data aggregation.