Compliance
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IRB Experts Offer Advice for Changing Research Landscape
It is clear that clinical trials now exist in a different world from what researchers, IRBs, and sponsors experienced in 2019. The key challenges are how to restart clinical trials, how to return to in-person visits, and how to manage the growing number of studies related to COVID-19.
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Tips for HIPAA Compliance During a Pandemic
Remember that 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 Department of Health and Human Services 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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Insufficient Expert Report Leads to Partial Defense Dismissal in Botched Hysterectomy Suit
A major lesson from this case is a successful avenue for physicians and care providers to challenge a patient’s inadequate claim: by undermining a patient’s expert. While the patient’s case against the physician defendant has yet to be decided, this ruling in favor of the hospital defendant provides an opportunity for defendants generally.
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Brain Damage Lawsuit Settles for $5 Million
This case exemplifies the benefits of resolving medical malpractice litigation through negotiation and prior to an adverse verdict. There are many factors that can affect a mutual agreement between the parties and a settlement, but such efforts can be extremely beneficial to physicians and care providers to better control payment amounts in the event of liability and to reduce negative exposure and publicity.
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Department of Justice Halts Enforcement and Civil Penalties
The Executive Office for United States Attorneys recently announced that because of the COVID-19 pandemic, the U.S. Department of Justice (DOJ) has temporarily halted enforcement actions and the collection of civil penalties. The original period ran through May 31, but DOJ said it may extend the period.
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Online Privacy Threats Increasing with More Internet Use
Online threats to patient privacy are increasing as healthcare organizations rely more on technology to interact with patients. Scammers are looking for new opportunities.
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Handle Whistleblower Complaints with Care
At the height of the healthcare industry’s response to COVID-19, some hospital employees gained national attention for their criticism of the lack of personal protective equipment and supposed failings by their employers. Some employers appeared to retaliate against those whistleblowers, raising questions about how such complaints should be handled.
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Review Insurance Policies for Benefits to Help with COVID-19 Costs
Insurance policies may include features that can produce unexpected costs from COVID-19. But policies may exclude communicable diseases.
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Limited Protection from COVID-19 Liability Available in Some States
Healthcare organizations facing potential liability related to COVID-19 may have some protection available on state and federal levels. State protections vary, but one example is New York, which recently passed legislation that provides healthcare providers and facilities with immunity against potential lawsuits related to COVID-19.