Compliance
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Expedited Review Worksheet Includes 111-Criteria Checklist
The IRB at Central Michigan University revised its IRB application to make it more efficient and more closely aligned with federal regulations under 45 CFR § 46.111.
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Remember IRB Review Criteria When Updating Application Design
A revised application served as an educational tool for researchers, and it helped reviewers focus on the 111 criteria and avoid bringing extraneous questions into their review.
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$3 Million Verdict Affirmed for Negligent Delivery Claim
In this case, the obstetrician/gynecologist did not fail to diagnose or timely act but instead used a technique and excessive force that caused the child’s permanent injury.
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Failure to Diagnose and Treat Oxygen Deprivation During Birth Results in $50 Million Verdict
This case reveals the need for prompt diagnoses and treatment, particularly given emergent circumstances such as a patient’s oxygen deprivation.
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‘Credible’ Fraud Allegations in Billing, Data Privacy Challenge Compliance
Healthcare compliance challenges are constantly evolving, but two issues are always of concern: healthcare fraud and data privacy. Both need constant attention and a substantial amount of compliance resources.
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Avoid Simple Mistakes That Lead to HIPAA Violations, Data Breaches
A HIPAA compliance program must address the high-tech risks and threats that can lead to a data breach, but many violations are the result of simple, easily avoidable errors by employees.
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Run Drills to Improve Operating Room Emergency Responses
Hospitals typically run drills for a wide range of emergency scenarios, everything from shoulder dystocia in childbirth to an active shooter. But not as many run drills for an emergency response to the operating room.
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Obstetrical Claims Are Expensive, Require Focus on Unique Aspects of Care
The unique features of obstetrical care mean risk managers must guide clinicians to be highly attuned to the risks of individual patients while adhering to evidence-based practices — even when patients may have other wishes.
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Strict Rules Addressing Opioid Crisis Create Risks for Physicians
The opioid crisis has led regulators and law enforcement at both state and federal levels to implement strict limitations on prescribing that can create substantial risks for individual physicians and the organizations that employ them or credential them. Staying out of trouble requires a clear understanding of the rules.
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Call for Uniform Brain Death Standard: Opponents ‘Increasingly Vocal and Influential’
There are growing calls for a uniform brain death standard, but court cases and in-hospital conflicts continue to increase.