A recent article published in NPJ Digital Medicine found that large language models (LLM) used in healthcare propagate racist medical advice that has largely been debunked. This is not a surprise to me, but it is an alarming finding that reminds us that the data we use to train our AI-driven devices and healthcare decision programs is horribly biased. Industry and regulators must ensure that data being used to train these devices are diverse, equitable, and representative to prevent potential patient harm.
Read MoreOne of the greatest risks to patients from use of AI in medical devices, and healthcare in general, is the presence of bias in the models used to train them. Given that we use our histories and historical data to train our AI models, we must address the inequity, racism, disparities, and disenfranchisement present in these data. This urgent issue must be taken up by industry to generate agreement on the definition of bias and how to address it. Regulators must hold industry accountable for ensuring equity in the models being used to train AI. We cannot afford to create greater public health disparities as we rush toward a future of AI in healthcare.
Read MoreThe desire for RWD/RWE by global regulators to demonstrate medical device safety and efficacy is growing. We exist in an era of unprecedented technological capabilities for data linking, tokenization to protect privacy, and big data analytics. However, many challenges remain with the use of these data for medicines and device evaluation. Data quality, common data models, alignment on statistical methodologies, data linkage technology, data access and privacy, stakeholder agreements for data sharing, patient input and consent, and ethical concerns persist. Regulators must collaborate such that industry can leverage these capabilities in a least burdensome way and ensure RWE is used to effectively and efficiently get innovative medicines and technologies to patients around the world.
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Regulation of artificial intelligence/machine learning (AI/ML) medical devices is heating up worldwide. While FDA has only issued one guidance document and an action plan, the EU is preparing to enact significant legislation that will govern the regulation of AI, including AI medical devices, in the EU. The EU AI Act is scheduled to go into affect in 2024. Medical Device sponsors with AI/ML devices must be ready to meet the requirements of the AI Act along with EU MDR.
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