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

Sound Physicians

Between 15 percent and 20 percent of our clinician compensation is tied to care quality and patient outcome metrics that are designed in partnership with your hospital or health system’s key performance indicators and goals. Terms of Use | Privacy Policy | Patient Privacy | Compliance Search Submit percent and 5.7 percent annually.

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

FDA Law Blog

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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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 final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

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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.