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Vaccine Uptake Strategies & Ethical Considerations- Part II

Integrated Care News by CFHA

Availability and Requirements Vaccination programs in communities, including schools, childcare centers, community gathering places, and homes, also successfully improve vaccine uptake, especially for children less likely to access healthcare. I discussed this debate in my previous blog post.

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4 Ways Temporary Medical Staff Maintain Patient Care

Barton Associates

Many healthcare facilities in the U.S. are already struggling with staffing shortages , but others have turned to healthcare staffing agencies like Barton Associates to fill in the gaps. These professionals play a vital role in maintaining essential services and ensuring continuity of patient care.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background. Pfizer’s Petition to SCOTUS.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” The DHT steering committee includes senior staff from CDER, CBER, CDRH, including the Digital Health Center of Excellence (DHCoE), the Oncology Center of Excellence, and the Office of Clinical Policy and Programs.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. These clearances are based on short-term (30 day) patient follow up. By Jeffrey K. Shapiro & Allyson B. 21 U.S.C. §

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Physician's Practice

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