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...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more
Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more