Regulation
LifeSemantics plans to commercialise its mobile app-based AI screening solution by yearend.
The ONC's new rules could include advancements around public health IT certification requirements, electronic prior authorization, patient engagement tools and refinement to info blocking rules, says Sean Sullivan, a partner at Alston & Bird.
Carolyn Metnick, partner and Healthcare and Privacy & Cybersecurity team member at Sheppard Mullin, recommends that healthcare organizations follow basics such as following HIPAA security rule compliance and doing a security risk analysis.
The company's Dream Sock, which received FDA 510(k) clearance in November, gathers real-time health readings, including a baby's sleep trends and pulse rate.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.
They had been designated as innovative medical devices.
Epitel received 510(k) clearance for two remote monitoring offerings and Curio Digital Therapeutics received clearance for its postpartum prescription digital therapeutic.
HIMSS24
Patricia MacTaggart, program director and teaching instructor at George Washington University and 2024 Changemaker Award winner, discusses how Medicaid’s innovative use of telehealth as a care modality influenced Medicare and other payers.
Ernie Crawford, CEO at Crawford Technologies, discusses how the 2024 CMS Final Rule pertaining to materials and content is bringing health equity to payer market communications.