Hospital Management
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LabCorp and Quest Breaches Show Vulnerability of Data
All sectors are seeing an increase in breaches due to third-party service providers, business associates/partners, and even commercial off-the-shelf products compromised during manufacture.
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Supreme Court Extends False Claims Act Limit to 10 Years for Most Cases
The decision involving Cochise Consultancy addressed which of two statutes of limitation in the False Claims Act applies in the event a relator brings an action but the government has not intervened.
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Healthcare Risk Management Wants to Hear From You
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Time Component Is One of Major Takeaways in Guidance
The U.S. Department of Justice guidance on corporate compliance includes an important time component instructing prosecutors to consider the effectiveness of a compliance program not only when misconduct occurred, but when making charging decisions and upon resolving a case.
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DOJ’s New Guidance on Corporate Compliance Provides Valuable Tool for Risk Managers
The Department of Justice issued new guidance on corporate compliance programs that risk managers should use to tailor and optimize their compliance programs.
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FDA Streamlines Expanded Access to Oncology Drugs
Project Facilitate calls for a new call center, which will be a single point of contact for physicians seeking expanded access to investigational oncology drugs. FDA oncology staff will help physicians through the process of submitting the request for expanded access and follow-up as needed.
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Unique Informed Consent Challenges of Sequentially Randomized Trials
Some people initially appear to be good candidates for transplant. But complications of treatment may develop — changing the risk-benefit analysis. A repeat consent conference is necessary before each sequential randomization.
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Study Finds That All Financial Conflicts of Interest Influence Findings
All financial conflicts of interest influence whether study authors report findings favorable to industry sponsors, according to a recent investigation.
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IRBs and Institutions Could Improve Monitoring Sites for Protocol Fidelity
When IRBs review multisite studies, particularly when the sites are at different research institutions, there is a question about how faithfully each site sticks to the protocol and avoids deviations. With large, multisite, non-biomedical studies, fidelity — or maintaining protocol compliance — requires considerable resources.
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NIH Urges Vigilance to Protect Research
The FBI is continuing an investigation into “utterly unacceptable” foreign theft of and influence on research by the National Institutes of Health.