The Office of the National Coordinator for Health Information Technology’s (ONC) rule on algorithm transparency and information blocking may not directly affect medtech companies, but they may be subject to third-party liability consequences.
Don’t Worry, You (Probably) Won’t Have To Deal With ONC: Algorithm Transparency Rule May Have Surprise Effects On Medtech Firms
Epstein Becker Green attorney Alaap Shah breaks down the HHS ONC’s 800-page rule on algorithm transparency and information blocking.
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Beyond the US market, Monogram is actively pursuing regulatory approvals abroad, with India as a key target. The company has partnered with Shalby Hospitals, one of India’s largest orthopedic hospital networks, to conduct clinical trials and accelerate regulatory clearance in the region.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
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About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.