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Outside the Lab Technology and innovation, Digital and computational pathology, Regulation and standards

Midas Touch or Fool’s Gold?

The world of healthcare has seen a technological explosion over the past few years – especially with respect to digital medical devices. But despite an estimated global digital health market of $223 billion by 2023 (1), digital pathology’s penetration into the space has been limited. Only a few of the artificial intelligence/machine learning (AI/ML)‐based medical devices approved by the US Food and Drug Administration (FDA) over the past several years have been in the digital pathology sphere (2). Now, the FDA has proposed new regulatory frameworks to account for the expected growth and iterative nature of AI/ML‐based medical devices (3) – and it’s vital that companies stay on top of the new regulatory paradigms so they can gain the necessary regulatory approvals to bring their products to market. After all, until a medical technology reaches the market, it cannot help real patients in real-world clinical settings.

Will digital pathology take advantage of this change and turn all that it touches into gold… or will it lose out on the quarter trillion‐dollar digital future?

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About the Authors

Richard Huang

Clinical Informatics Fellow in the Department of Pathology at Massachusetts General Hospital and at Harvard Medical School, Boston, Massachusetts, USA.


Veronica Klepeis

Assistant Professor in the Department of Pathology at Massachusetts General Hospital and an Instructor in Pathology at Harvard Medical School, Boston, Massachusetts, USA.

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