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FDA Publishes Action Plan for Oversight of Artificial Intelligence/Machine Learning-Based Medical Software

On January 12, 2021, the U.S. Food and Drug Administration (“FDA”) released its Artificial Intelligence/Machine Learning (“AI/ML”)-Based Software as a Medical Device (“SaMD”) Action Plan (“Action Plan”).

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Ropes & Gray Digital Health Download – Spring 2021 Issue


Time to Read: 1 minutes Practices: Digital Health

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Over three months into 2021 and the pace of digital health innovation shows no signs of abating. Investments in big data platforms, such as Clayton, Dubilier & Rice’s investment in M2GEN, an oncology-focused health informatics solutions company, are on the rise. Digital health SPAC deals also continue, as demonstrated by SPAC SC Health Corp’s merger with Rockley Photonics and Owlet Baby Care’s merger with SPAC Sandbridge Acquisition Corporation.

This quarter, Ropes & Gray attorneys continued to offer their perspectives on emerging trends, including the unique legal considerations in data-centric life science collaborations, as well as FDA regulatory developments in the area of AI and machine learning. We also discussed in Bloomberg Law anticipated digital health trends for 2021, including the continued expansion of big data, AI, and telehealth.

We’ve summarized the recent digital health updates that have captured our interest. If you have questions about digital health, please contact us or your usual Ropes & Gray advisor.

Click here to read the full Digital Health Download.

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