Digital Health

Artificial Intelligence Digital Health Medical Devices RegulationOctober 31, 2024

FDA Drives ‘Stake In Ground’ With Glossary For AI, Digital Health Terms

By Shawn M. Schmitt Communications Specialist, Enzyme The US Food and Drug Administration (FDA) has taken a critical step toward ensuring that makers of medical devices are all on the same page when it comes to defining terms related to artificial intelligence (AI) and digital health, says an ex-agency official. Posted online in late September,...

Artificial Intelligence Digital Health PharmaJune 6, 2023

FDA Releases Discussion Paper for AI in Drug Development

This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.

Digital Health Medical Devices SaMDApril 27, 2023

Digital Tools Ease the Burden of Clinical Trial Monitoring

Clinical trial monitoring for FDA-regulated products can be expensive and troublesome, but digital health technologies (DHTs) can make the process less painful and more cost-efficient. However, in order for clinical trial sponsors to enjoy these benefits, proper planning and execution will be necessary, according to a new FDA guidance for clinical trial monitoring.

Artificial Intelligence Digital Health PharmaApril 5, 2023

FDA Takes Next Step Toward Digital Health in Drug Development

The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.

Digital HealthJanuary 1, 2022

Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements

The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.

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