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White paper recommends expanding endoscopic classification of esophagogastric junction integrity beyond hill grade

Medical Xpress

A new white paper by the American Foregut Society recommends expanding the classification of the esophagogastric junction (EGJ) to increase an assessment of the axial hiatal hernia length, hiatal hernia aperture diameter, and presence or absence of the flap value, making it more comprehensive.

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New white paper finds Medicare coverage for weight loss therapies could generate significant cost-offsets

Medical Xpress

A new USC Schaeffer Center white paper finds the value to society of Medicare coverage for new classes of weight loss drugs would equal nearly $1 trillion over ten years.

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New white paper offers solutions to ensure greater patient access to prescription drugs

Medical Xpress

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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Increasing cyber and ethical risks to safety means care homes' need for insurance protection is greater than ever

Medical Xpress

The cyber and ethical risks posed by telemedicine to care homes could outweigh its value unless safeguarding steps are taken, says a new white paper.

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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

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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices.

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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.

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