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FDA Guidance Offers Foundation for IRB, Researcher Flexibility
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
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What Happens to Human Research in the New Pandemic Era?
The big question in the clinical research world is how things will look when the COVID-19 pandemic has ended. Will everything go back to the way it was? If not, what changes will remain?
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The Role of Surgeons in the COVID-19 Era
Accrediting body helps surgery leaders find the right path forward during unusual times.
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Hypertensive Pregnancy Disorders May Negatively Affect Children’s Psychological Development
A recently published paper revealed certain health problems during pregnancy can lead to emotional and behavioral disorders in children.
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State Supreme Court Orders New Trial in Childbirth Death Suit
This case reveals the indisputable importance of experts. Important lessons from this case relate to challenging the sufficiency of such experts and whether the experts have offered opinions relevant to the proceedings. Who qualifies as an “expert” may be the proper subject of debate.
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Appellate Court Affirms $5.1 Million Award for Patient’s Death After Hernia Repair Surgery
This case raises important considerations about making appropriate choices in the selection of equipment and methods for treatment, as well as the importance of retaining a qualified and persuasive expert witness in the event of litigation.
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Think About Record Retention Now, Not at End
Physician practices and even hospitals sometimes make the mistake of putting off decisions on record retention until they think it is time to clear out a storage facility or reduce their data storage expenses. A better approach is to determine how long certain records should be kept and then establish a destruction date.
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More Attention Now to Workplace Violence; Employers More Receptive
Workplace violence is receiving more attention from hospital and health system leaders. Now may be the time to push for worker safety initiatives that previously could not gain traction.
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Do Not Forgo HIPAA Requirements in Pandemic Response
The Department of Health and Human Services Office for Civil Rights will disregard some HIPAA violations during the pandemic response. Risk managers should understand which parts of the privacy rule are affected.
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EMTALA 1135 Waivers Allow Flexibility
The Centers for Medicare & Medicaid Services issued waivers for some Emergency Medical Treatment & Labor Act (EMTALA) requirements, acknowledging certain expectations are not reasonable to achieve during a pandemic. However, EMTALA still applies.