Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained. Artificial Intelligence has been broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). Artificial intelligence can use different techniques, including models based on statistical analysis of data, expert systems that primarily rely on if-then statements, and machine learning.
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device," announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically ML, are "techniques used to design and train software algorithms to learn from and act on data." FDA's proposed approach would allow modifications to algorithms to be made from real-world learning and adaptation that accommodates the iterative nature of AI products while ensuring FDA's standards for safety and effectiveness are maintained. Under the existing framework, a premarket submission (i.e., a 510(k)) would be required if the AI/ML software modification significantly affects device performance or the device's safety and effectiveness; the modification is to the device's intended use; or the modification introduces a major change to the software as a medical device (SaMD) algorithm. In the case of a PMA-approved SaMD, a PMA supplement would be required for changes that affect safety or effectiveness.
The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms. The FDA sees tremendous potential in healthcare for AI algorithms that continually evolve--called "adaptive" or "continuously learning" algorithms--that don't need manual modification to incorporate learning or updates. While AMIA supports an FDA discussion paper on the topic released in early April, the group is calling on the agency to make further refinements to the Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). "Properly regulating AI and machine learning-based SaMD will require ongoing dialogue between FDA and stakeholders," said AMIA President and CEO Douglas Fridsma, MD, in a written statement. "This draft framework is only the beginning of a vital conversation to improve both patient safety and innovation. We certainly look forward to continuing it."
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.
The use of artificial intelligence (AI) in life sciences, or "Life Tech", has increased at a rapid pace. According to World Intellectual Property Organization (WIPO), there has been "a shift from theoretical research to the use of AI technologies in commercial products and services," as reflected in the change in ratio of scientific papers to patent applications over the past decade.1 Indeed, while research into AI began in earnest in the 1950s, more than 1.6 million scientific papers have been published on AI, with more than half of identified AI inventions in the last six years alone.2,3 A review article in Nature Medicine reported last year that despite few peer-reviewed publications on use of machine learning technologies in medical devices, FDA approvals of AI as medical devices have been accelerating.4 Many of these FDA approvals relate to image analysis for diagnostic purposes, such as QuantX, the first AI platform to evaluate breast abnormalities; Aidoc, which detects acute intracranial hemorrhages in head CT scans, assisting radiologists to prioritize patient injuries; and IDx-DR, which analyzes retinal images to detect diabetic retinopathy.