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The Blueprint for an AI Bill of Rights the White House recently published didn’t come a moment too soon for the health care industry.

The number of health care-related artificial intelligence models on the market has increased steadily over the past decade, with the health care AI market expected to grow from $7 billion today to $67 billion in 2027. AI is being used to detect atrial fibrillation, measure breast density via mammography, predict sepsis, diagnose liver and lung cancers via MRI and CT scans, and more. The rapid growth and changes in health care AI means both industry and regulators must evolve their oversight of its safety and effectiveness.


Most of the AI-driven applications in health care are known as software as a medical device (SaMD), which refers to software intended to be used for medical purposes without being part of a hardware device. SaMD has the potential to be transformative for patient care and includes clinical decision support software (CDSS) that helps guide decisions about patient care, typically at the point of care via a patient’s electronic medical record. One example of clinical decision support software is a model that stratifies an individual’s risk for atherosclerotic events such as ischemic stroke, coronary artery disease, or heart attack, and informs care management and treatment decisions, notably the use of statins. Another example includes predictive models of cancer and grade, which informs the timing, modality (such as mammogram or MRI), and frequency of cancer screening.

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