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Regulation

By Jessica Hagen | 02:19 pm | March 19, 2025
The company has secured 510(k) clearance for its Apple Watch-powered seizure monitoring platform, expanding the role of wearables in epilepsy care.
By Jessica Hagen | 04:29 pm | March 07, 2025
Leaders of government public policy at HIMSS are prioritizing health equity, AI regulation, cybersecurity and workforce development while urging unified policies that support healthcare innovation.
By Jessica Hagen | 03:36 pm | March 06, 2025
The Global Digital Health Partnership works to foster international collaboration to strengthen digital health infrastructure, interoperability and system resilience globally.
By Jessica Hagen | 03:21 pm | February 26, 2025
The AI-enabled technology detects a lack of pulse, confirms the condition using motion sensors and infrared signals, and automatically alerts emergency services if needed.
By Jessica Hagen | 12:22 pm | February 19, 2025
The firings included 20 individuals in the FDA's Office of Neurological and Physical Medicine Devices.
By HIMSS TV | 11:49 am | February 10, 2025
If finalized, the rule aims to improve the safety of patient data at healthcare institutions and addresses a national security topic by protecting data from bad actors who want to disrupt services, says Eric Avigdor, chief product officer of Votiro.
By Jessica Hagen | 06:48 pm | February 06, 2025
The EU guidelines highlight prohibitions on harmful manipulation, real-time biometric identification and social scoring.
HIMSS25
By HIMSS TV | 11:08 am | February 05, 2025
Gunnar Trommer of BCG X and Erik Adams of BCG give highlights of their upcoming HIMSS25 panel on the capital needed to develop and commercialize AI-powered medical devices and on completing regulatory milestones like 510(k) clearance.
By Anthony Vecchione | 04:05 pm | January 31, 2025
The Sentinel Camera allows point-of-care retinal imaging and eliminates the need for a visit to an eye specialist's office. 
By Jessica Hagen | 01:35 pm | January 24, 2025
Ashkan Afkhami of BCG X sat down with MobiHealthNews during JPM to discuss the U.S. health system's strengths, challenges in cost control and the transformative potential of AI.