Medical Xpress

APRIL 13, 2023

Although the Inflation Reduction Act of 2022 (IRA) aimed to increase patient access to prescription drugs and decrease spending, researchers warn that it may have unintended negative impacts on patients in the long run.

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Patients IT Medical 75

Sound Physicians

APRIL 28, 2025

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

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IT Hospital Telemedicine Clinic 52

FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products are sharing the digital moment with those classified solely as medical devices.

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FDA Law Blog

OCTOBER 10, 2022

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.

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FDA Law Blog

APRIL 8, 2024

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.

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Supply Chain Manufacturing Government Hospital 59