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Editor's E-Note
Data is the fuel that health care runs on, and ensuring that it’s as accurate as possible is a top priority. In the case of medical devices, accurate data is essential for safety and efficacy. Recently, the FDA discovered that data from two third-party testing companies raised questions about reliability and validity. To find out more, read this month’s exclusive.
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— Dave Yeager, editor |
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FDA Addresses Data Integrity Concerns With Chinese Firms
The FDA’s Center for Devices and Radiological Health (CDRH) issued general correspondence letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.
“Let me be clear. The FDA has no room for bad actors. Once we discover data integrity issues, we will respond accordingly,” says FDA Commissioner Marty Makary, MD, MPH. “Such false and shoddy activity jeopardizes access to new devices for patients and health care providers, negatively impacts product sponsors, and potentially disrupts the medical device supply chain.”
The general correspondence letters were sent to Mid-Link Technology Testing Co, Ltd (Mid-Link) in Tianjin, China, and Sanitation & Environment Technology Institute of Soochow University Ltd (doing business as SDWH) in Suzhou, China. The letters state in part, that because the FDA could not ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities, the agency will reject those testing facilities’ data generated for use in premarket device submissions.
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The UK Trains Health AI to Predict Disease
The National Health Service has trained a new AI model with anonymous health records from 57 million people. It plans to forecast future illness, anticipate hospitalizations, and guide a shift from reactive to preventative health care, reports ZME Science.
AMA Statement on House Passing Reconciliation Bill
The American Medical Association is concerned that recent legislation will have a significant impact on the eligibility of people to access and maintain coverage under Medicaid, as well as access to medical school and student loans.
HIMSS Urges Congress to Reauthorize Cybersecurity Law
HIMSS is urging congress to reauthorize the Cybersecurity Information Sharing Act of 2015 before its sunset date of September 30, 2025. The law allows real-time sharing of cyber threat indicators and strengthens responses to emerging threats through collaboration between health care organizations and federal entities. |
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COVER STORY
A HIPAA Security Overhaul
Proposed security rule changes for HIPAA are intended to bring guidelines up to current standards.
FEATURE
Guiding CDI
Experts share best practices for improving CDI.
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