In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency…
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The U.S. Department of Veterans Affairs announced a proposal to eliminate telehealth copayments for veterans and establish a grant program to fund designated VA telehealth access points in non-VA facilities.WHY IT MATTERS
This week the…
Background: Effective management of non-communicable diseases requires ongoing coordination and monitoring, often facilitated by e-health technologies such as mobile health (mHealth) applications. The end-user Mobile Application Rating Scale (uMARS) is a valuable tool for…
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This week at the HLTH conference in Las Vegas, FDA Commissioner Robert Califf sat down with John Brownstein, chief innovation officer at Boston Children’s Hospital, to discuss the current state of healthcare AI, as…
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Introduction
Artificial Intelligence (AI) is rapidly transforming healthcare, offering revolutionary tools for diagnosis, treatment, and patient care. However, the complexity and potential risks associated with AI necessitate robust regulation to ensure its safe and effective…
The following is a guest article by Nick Barger, PharmD, Vice President, Product at DrFirst. This article is the fifth in the Healthcare Regulatory Talk series.
With the public comment period now closed, the newly…
What You Should Know:
– miRoncol, a medtech startup, has announced the completion of proof-of-concept studies for a groundbreaking multi-cancer early detection blood test.
– The test utilizes microRNA analysis and machine learning, two technologies recognized…
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In multicentric studies, data sharing between institutions might negatively impact patient privacy or data security. An alternative is federated analysis by secure multiparty computation. This pilot study demonstrates an architecture and implementation addressing both…
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Science and technology secretary Peter Kyle has announced the launch of a regulatory office, which will support the healthcare sector to deploy AI innovations safely.
The Regulatory Innovation Office (RIO) aims to reduce the burden…
As the public comment period for the Assistant Secretary for Technology Policy’s HTI-2 proposed rule ends, the EHR Association has published a letter raising concerns about the potential impact on IT developers, providers, and…
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