The FDA is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the adaptive nature of these technologies. Traditionally, the FDA regulates medical devices through pathways like premarket clearance (510(k)), De Novo classification, or premarket approval, and also reviews significant modifications to existing devices. However, AI and ML-driven software changes often necessitate a premarket review due to their dynamic nature.

Tracking your health data through devices like Fitbits can be more than just a tool for personal wellness; it can also have significant financial benefits. S. Jay Olshansky, a public health professor and chief scientist at Lapetus Solutions, highlights the rise of a "health-data economy," where your daily activities, such as the number of steps you take, can be of great interest to various firms, including medical, actuarial, and retail manufacturers.

In recent years, the application of artificial intelligence (AI) in the healthcare sector has expanded significantly, with tools like OpenAI's ChatGPT offering innovative methods for data analysis and summarization. One such application is the generation of summaries for individual health data, which can then be utilized in creating comprehensive electronic health profiles. Leveraging the natural language processing (NLP) capabilities of ChatGPT, raw and complex medical data can be translated into accessible, patient-friendly language. This can help patients better understand their health status and facilitate more effective communication with healthcare providers.