Employee Management
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Is It Standard of Care, Research, or Something Else?
Researchers and IRBs sometimes have questions about studies and treatment that fall in the gray area between research and personalized medical care. Is it innovative care that is intended to benefit a specific patient — or an innovation that has the potential of being generalizable?
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Researchers' Advertising Can Fall Into Noncompliance
Investigators might begin to market their study to potential participants even before they have received IRB approval, or make changes to their advertising and recruitment materials after an original version and format were approved.
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Preventing Rogue Researchers Should Be on IRBs’ Priority List
Bioethicists and the human research protections industry have been shocked in recent years by reports of rogue researchers carrying out investigations that raise huge red flags and, in some instances, could be regulatory breaches.
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WHO Calls for International Registry, Oversight of Gene Editing Research
Plans call for the committee to gather information from a wide range of sources with the goal of developing recommendations for “a comprehensive governance framework that is scalable, sustainable, and appropriate for use at the international, regional, national, and local levels."
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Appellate Court Confirms Surgeon Not Negligent in Performing Laparoscopic Cholecystectomy
An important lesson from this case is that although a patient may have suffered an unexpected injury, it does not necessarily mean that a physician or care provider was negligent.
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Patient Settles With Hospital and Physicians for Alleged Malpractice Leading to Paralysis
This case serves as an example of both the importance of ensuring that information on a patient is clearly communicated among physicians and staff when multiple physicians are involved in the care of the patient, as well as the importance of timely diagnosis and prompt treatment.
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800 Hospitals Dinged by Medicare for Hospital-Acquired Conditions; Payments Held
Since the program began, Medicare has penalized 1,756 hospitals at least once. In 2019, 110 hospitals are being denied payments for the fifth straight year.
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HHS Warns of Advanced Persistent Threats, Zero-Day Exploits
The Department of Health and Human Services Office for Civil Rights is warning about the threat to healthcare organizations from advanced persistent threats and zero-day exploits.
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Hospital Apologizes to Patients Videotaped in Gynecological Procedures
The hospital had been trying to catch someone who was stealing drugs from anesthesia carts on the surgical unit, and the motion-activated cameras inadvertently recorded women during clinical care in three operating rooms.
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Cryptojacking Among Latest Cyberthreats for Healthcare
New threats are emerging in cybersecurity. One risk for healthcare organizations involves using the victim’s computing power.