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FDA regulations
Group warns against using consumer devices to diagnose, treat sleep disorders
American Academy of Sleep Medicine cites lack of validation and clearance by FDA for apps and wearables.
FDA unveils working model for software precertification program
Agency takes pragmatic approach that trusts vendors but also verifies safety, effectiveness and performance.
FDA requests $100M to tap EHRs for evaluating medical products
The agency’s current post-market monitoring systems depend largely on the secondary use of claims data, which is not enough, says Scott Gottlieb, MD.
FDA clears AI-based system to detect diabetic retinopathy
Device uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera.
FDA approves Canon high-resolution scanner for use
CT system can resolve anatomical features as small as 150 microns at twice the resolution of current devices.
Groups say FDA draft guidance on decision support software needs work
Agency proposals would hurt patients by significantly expanding the scope of regulation, says CDS Coalition’s Bradley Merrill Thompson.
FDA calls for lowest dose in child X-rays
In ordering image studies, physicians must be sensitive to appropriate radiation dosage for pediatric patients.
FDA clears telehealth option to remotely program cochlear implants
Audiologists can make programming adjustments to the electronic hearing devices via telemedicine.
Seven key practices for ensuring medical device and IoT security
Medical device manufacturers and providers must improve practices to protect patients.
FDA approves digital pill that tracks patient compliance
Use of enhanced medication can help docs check adherence to regimens, but privacy concerns arise.
See more FDA regulations
