Tag Archives: wearables

Data, Cybersecurity, healthcare

Critical Issues in Remote Monitoring: Data Capture and Quality

By Jennifer Kent, Ph.D.
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Data, Cybersecurity, healthcare

As more healthcare activities take place from home, passive continuous monitoring solutions and new technology such as artificial intelligence will be critical to communications between providers and patients. In addition, new solutions that offer overnight monitoring will play a crucial role in helping to fill the gaps, particularly in assessing patient deterioration or changes in health conditions. The pandemic has forever changed the trajectory of healthcare and specifically virtual care.

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Artificial intelligence, medical devices

The Regulatory Aspects of AI/ML-based SaMD

By Zuhal Reed
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Artificial intelligence, medical devices

Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.

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