A.I. In Medicine
WORCESTER MEDICINE
AI in Healthcare: Balancing Innovation with Regulation Continued serve as guidance documents and do not establish legally enforceable responsibilities on AI companies. On the other hand, the European Union (EU) has enacted actionable regulations through the European Medical Device Regulation (EU-MDR), which aim to enhance the scrutiny of AI tools in healthcare [5]. They include measures such as categorizing AI tools by risk levels, enforcing stricter clinical evaluation standards, and post-marketing surveillance. Compliance with these rules results in a ‘certificate of conformity’ that is required to place medical devices on the market anywhere in the EU. Similar regulatory advancements are necessary in the US to enhance the safety and performance of medical AI devices. Once regulations are updated, there will be a need for more prospective trials involving AI tools. As of now, the majority of studies that apply AI in healthcare use retrospective data for both training and testing models. In conclusion, just like any other facet of healthcare, patient safety is of utmost importance. For over a century, strong regulatory oversight in the United States has ensured the safe introduction of medical products and services. It is thus crucial that we maintain this rigorous tradition and ensure that our regulatory framework keeps up with the fast-paced world of AI. + Vinit Gilvaz, MD, Rheumatologist at Lifespan Rheumatology, Providence, RI Zeba Hashmath, MD, Chief Cardiology Fellow at East Carolina University, Greenville, NC References: 1. Topol, E. J. (2019). High-performance medicine: the convergence of human and artificial intelligence. Nature medicine, 25(1), 44-56. 2. Henry, K. E., Adams, R., Parent, C., Soleimani, H., Sridharan, A., Johnson, L., ... & Saria, S. (2022). Factors driving provider adoption of the TREWS machine learningbased early warning system and its effects on sepsis treatment timing. Nature medicine, 28(7), 1447-1454. 3. Johnson, A. E., Brewer, L. C., Echols, M. R., Mazimba, S., Shah, R. U., & Breathett, K. (2022). Utilizing artificial intelligence to enhance health equity among patients with heart failure. Heart Failure Clinics, 18(2), 259-273. 4. Singhal, K., Azizi, S., Tu, T., Mahdavi, S. S., Wei, J., Chung, H. W., ... & Natarajan, V. (2023). Large language models encode clinical knowledge. Nature, 620(7972), 172-180. 5. Niemiec, E. (2022). Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?. Digital Health, 8, 20552076221089079.
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Winter 2023
