Healthcare Analytics, Population Health Management, Healthcare Big Data

mHealth and the FDA

FDA Tackles Artificial Intelligence with New Software Review Plan

January 8, 2019 - The FDA is moving quickly to ensure the development of a safe and effective artificial intelligence ecosystem in healthcare by releasing new documents intended to offer guidance to the health IT community. The agency has published a new Software Precertification (Pre-Cert) Pilot Program working model test plan and a regulatory framework explaining how it plans to regulate the next...

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FDA: Medical Device Innovation Can Combat the Opioid Crisis

by Jessica Kent

Combating the opioid epidemic will require advanced medical devices and sophisticated data analytics that can help detect and treat abuse, FDA officials wrote in a recent blog post. Opioid abuse is one of the most significant health...

FDA Foresees Few Patient Safety Issues with Data from Rx Apps

by Jennifer Bresnick

The FDA is suggesting a hands-off approach to reviewing prescription drug applications that present data with low risks to patient safety, the agency said in a request for comments published in the Federal Register. The solicitation...

FDA Launches App to Support Clinical Trials, Real-World Evidence Collection

by Jessica Kent

The FDA has introduced the new MyStudies app, which will collect real-world evidence through mobile devices and increase the diversity of information available for clinical trials and other healthcare research. After conducting a...

FDA App Challenge Honors Opioid Abuse, Overdose Tool

by Sara Heath

A California-based startup has won an FDA app challenge aimed at fighting opioid abuse and preventing deadly overdoses. OD Help, created by PwrdBy, connects potential opioid overdose victims with naloxone carriers, said the FDA in a blog...

FHIR, Big Data to Support FDA Medical Device Development Network

by Jennifer Bresnick

Emerging standards that support the seamless flow of big data across multiple entities, such as FHIR, will form the foundation of the FDA’s planned National Evaluation System for health Technology (NEST), states a new report from the...


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