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Things to Consider When Determining the Regulatory Requirements for Software (Hint: It s More Than the Device Classification) | Mintz - Health Care Viewpoints

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many.

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Things To Consider When Determining The Regulatory Requirements For Software (Hint: It s More Than The Device Classification) - Healthcare

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning.

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Regulatory Requirements for Digital Health Technology

Regulatory Requirements for Digital Health Technology
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States pharmacopeiaExamples of software functions forNational formularyDrug administrationClinical decision support softwareDevice software functionsSoftware forSoftwarea deviceSoftware function under enforcement discretionSoftware intendedSoftware for prescription or counterPre market approvalFederal foodCosmetic actUnited states pharmacopeiaAct section

FDA Oversight of Health Care Provider AI Software

FDA Oversight of Health Care Provider AI Software
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FDA Oversight of AI Software Developed by Health Care Providers | Epstein Becker & Green

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative.

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