Among the ways AI is expected to change health care in the next decade are in predictive care, improved networking between health centers and better experiences for patients and medical staff.
future of AI in healthcare look bright—yet it still has challenges. A human programmer must set up the system and ask the right questions without bias to create a well-constructed algorithm that will produce the desired results—so even highly sophisticated software has the risk of error. In addition, audio recordings need to be high-quality and clear, with a speaker who articulates well, for computer transcription to be accurate, although doctors usually have an opportunity to review reports and make corrections. And in identifying problem areas on scans, the minute detail AI analysis provides can produce more information than a physician needs. Worries about privacy and security are also an issue. MarinHealth reports that it takes a rigorous and principled approach to evaluating the security, effectiveness, ethics and potential outcomes of any new AI adoption and development. To do so, it has gathered a cross-functional team of experts to ensure that any initiative is safe and feasible within its technology framework and that the expected workflow will benefit clinicians in helping them make better decisions in caring for their patients. Oversight The FDA is responsible for the oversight of software in health care and has approved many of the AI products currently in use, although not all. The 21st Century Cares Act, which Congress enacted in 2016 to provide substantial funding for research to the NIH, exempts many AI tools from FDA regulation if health care providers don’t rely on them to make diagnoses or decisions on treatment. In 2022, however, the FDA announced
that it would categorize some types of tools—such as smartwatch software that uses data from electrocardiograms to detect arrhythmias—as medical devices, so greater scrutiny is likely as the use of AI grows. In October 2023, the FDA announced that it had reviewed and approved 171 AI and ML-enabled medical devices, including the irregular rhythm notification feature on Apple’s watch. The FDA released the list as a service to the public and reports that its review focused on the devices’ overall safety and effectiveness. “Digital health technologies are playing an increasingly significant role in many facets of our health and daily lives, and AI/ML is powering important advancements in this field. Ensuring that these innovative devices are safe and effective and that they can reach their full potential to help people is central to the FDA’s public health mission,” the announcement says. Despite the growing pains, AI has the potential to provide groundbreaking innovations that do a great deal of good and ensure better outcomes—much as X-rays, mammograms and vaccines did when they were first introduced. It holds the promise of more to come, but AI is already making a difference, and as time goes on, functions that once seemed to be in the realm of science fiction could very well become reality. J
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February 2024
NorthBaybiz 25
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