Emma Pounders

Gen AI medical devices must have comprehensive and full regulatory monitoring for the safety of patients and the general public, in addition to the HCP who will be prescribing and monitoring device effectiveness and outcomes. Gen AI devices can and will surpass knowledge of the prescribing HCPs, however, currently even in large language models, AI gets information wrong. As a registered nurse, I have seen first hand through AI generative reports in patient charts the misrepresentation that a procedure was performed or a medication was given, when it had not been; and inversely medication not given when it had been. This could result in omissions or over-medication administration, if HCPs are not vigilant at monitoring AI actionables/outputs. And this is a minor small scale, low risk example, that I have seen in practice. In addition, the FDA should not consider regulations and competencies of physicians, but the regulations and competencies of nurses should also be met. RNs will surely be responsible for interpreting and intervening on the patient’s behalf if/when misguided AI actionables/outputs occur. Patients who are given Gen AI devices must be made fully aware that these devices are in the trial phase and the risks that are associated with each type of device they use. The potential for risk at this point in time well surpasses benefit. We cannot unleash widespread GenAI devices without knowing how quickly it will evolve. Will HCPs be able to keep up with the outputs and what will happen when GenAI knowledge surpasses that of our brightest minds. How can we sustainably treat patients, what about patients who cannot afford GenAI devices, or insurance companies who deny coverage of them-who decides which patients are worthy; or worse, which patients get to test out GenAI devices before we know what their evolution will entail.