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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. We take on significant financial risk across temp labor, clinical performance, clinician quality, payer collection, and fluctuation in volume.

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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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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

FDA Law

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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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.

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FDA’s Summer Plans May Include LDT Rulemaking

FDA Law

See , e.g. , ACLA White Paper on LDTs here. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The Notice of Proposed Rulemaking (NPRM) for LDTs is scheduled to be published in the Federal Register in August. Of course, the rulemaking process has its own uncertainties.

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