Compliance
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Five Years in the Making, FDA Issues Final Rule on Data and Devices
The FDA issued a final rule, effective Feb. 21, 2019, to revise regulations about accepting data from clinical studies involving medical devices.
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The Search for Justice in the Human Genome
With sequencing of the human genome completed at the turn of this century, there was the heady expectation that the summit to great cures was about to be climbed like the iconic spiral staircase of DNA.
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Preparation, Communication Key to Establishing IRB of Record
The first time the Vanderbilt University and Medical Center IRB served as an IRB of record was 15 years ago — a decade before the concept began to catch on with multisite clinical trials and large IRBs.
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Smart Checklists Keep IRB on Track With Study Reviews
As an IRB office prepared for accreditation, staff looked for methods to increase compliance. An answer quickly formed: use the IRB’s electronic system to develop smart checklists.
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Negligent Presurgery Procedure Results in Fatal Pulmonary Arrest, $5.5 Million Verdict
This case illustrates the need for communication in the healthcare industry. In this case, a breakdown in communication occurred interhospital, intrahospital, and between patient and medical professional.
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Physician on Probation Places Patient in Unnecessary Coma, Yielding $9 Million Verdict
The patient was left untreated for a month before a second opinion was obtained.
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Hospital and Cardiology Group to Pay $20.75 Million
A Pennsylvania hospital and cardiology group have agreed to pay the government $20.75 million to settle a False Claims Act lawsuit alleging that they knowingly submitted claims to the Medicare and Medicaid programs that violated the Anti-Kickback Statute and the Physician Self-Referral Law.
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$3.5 Million Settlement Highlights Risk Analysis
A health system’s recent settlement with the government shows how providers still are dropping the ball on compliance issues that everyone should understand by now.
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Tips on Career Advancement Include Finance, Enterprise Risk Management
Patient safety should be a top priority for risk managers hoping to advance their careers, and financial management may be another way to set yourself apart from the crowd.
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EHRs Can Work Against You in Court
Electronic health records can be used against you in court. The record may provide evidence contrary to what the defendant claims.