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Beware the bait-and-switch when it comes to HM program contracts

Sound Physicians

This ensures our team — from medical director to clinician — has skin in the game. Compared with industry-standard annual subsidy increases of between 4.2 percent and 5.7 percent, our average increase over five years is just 0.5 percent annually. Compared with industry-standard annual subsidy increases of between 4.2 percent and 5.7

IT 52
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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52
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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.