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

Sound Physicians

While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. Not all contracts are created equal As CEO for Hospital Medicine , I’ve heard a version of this story time and again.

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

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

Clinic 52
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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

CDRH is building an extensive library of similar reports and white papers as it prepares its final guidance for medical device cybersecurity, scheduled to come out next Fall. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

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Does the Drug Shortage White Paper Fall Short?

FDA Law

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.