Compliance
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The Winds of Change
In the United States, the way more than 50 million surgical procedures are handled annually is bound to transform after the pandemic ends. There are bound to be sweeping changes, and the industry needs to be ready.
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Tips for HIPAA Compliance During a Pandemic
The pandemic response may create unique Health Insurance Portability and Accountability Act compliance risks. Time, staffing, and focus are at a premium, but staying cognizant of patients’ privacy remains important.
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COVID-19 Changes HIPAA Compliance, But Caution Necessary
The Office for Civil Rights has issued waivers and notices of enforcement discretion for several issues related to Health Insurance Portability and Accountability Act compliance, but healthcare organizations still must be careful to comply with the privacy law even during the pandemic.
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Shortcuts in Clinical Trials May Cause More Harm Than Good
Dozens of potential treatments for COVID-19 are under investigation: existing antiretrovirals, anti-malaria drugs, monoclonal antibodies, and Chinese traditional medicines among them. Additionally, companies are rapidly developing new drugs. But poorly designed studies subject patients to the risks of adverse events without learning if the intervention works.
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Second Phase of Pandemic Raises More Questions, Concerns for IRBs
Research organizations and IRBs continue to face challenges and make tough decisions based on the best available information about a pandemic that changes daily as it spreads across the world.
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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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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.