Hospital
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IRBs Can Work on Ground Floor With Start-Up Technology Firms
New companies using cutting-edge technology can enter the research arena, but they might lack resources and a knowledge base that academic research organizations take for granted. IRBs can help companies fill some of those knowledge and experience gaps by forming a collaborative relationship and working with them from the beginning of the study design process.
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New Tech Research Raises Ethical Challenges for IRBs and Investigators
Some new technology companies that are developing novel human subjects research face challenges and design issues that have never been explored. Companies engaging in cutting-edge technological services and solutions can raise public concerns for what they do on the business side, but there is less public awareness of privately funded research.
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Wrong Person Receives Bill, OCR Secures $2.175 Million Fine
Sentara Hospitals in Virginia and North Carolina agreed to take corrective actions and pay $2.175 million to settle potential HIPAA violations stemming from a complaint alleging the organization sent a bill to an individual containing another patient’s PHI. OCR determined Sentara mailed 577 patients’ PHI to wrong addresses.
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HIPAA Settlements Hold Lessons on Right of Access, Breach Reporting
The Office for Civil Rights (OCR) recently announced two HIPAA settlements that offer lessons for covered entities regarding right of access and failure to notify after a breach. In early 2019, OCR announced it would take steps to enforce the rights of patients to receive copies of their medical records timely and at a reasonable cost. This led to the introduction of the HIPAA Right of Access Initiative.
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Expect More High-Tech Breaches, Attorney General Audits This Year
The trend for HIPAA compliance is toward more breaches and complex breaches than seen in earlier years of efforts to follow the privacy rule, say some experts. A sharp increase in cyberattacks also may be coming this year.
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Appellate Court Reverses Summary Judgment Based on Expert’s Disqualification
This case demonstrates the importance of expert witnesses, which not only can determine a case at trial, but even potentially before trial. Although the outcome of this case remains uncertain, and the patient has not been awarded any monetary damages, the appellate court ruling certainly is a setback for the defendant care provider, and reopens a window of opportunity for the patient to continue the allegations of malpractice.
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Failure to Remove Sponge Results in $10.5 Million Verdict
The facts of the case left little doubt as to whether hospital staff had violated their duty of care. In addition to the ethical requirement to tell the patient about the retained sponge, there is a licensing and regulatory requirement as well.
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Top Factors to Consider in Choosing Outside Counsel
Risk managers may be involved in helping choose outside counsel for the hospital or health system. There are many factors to consider before making the right choice.
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Choose Outside Counsel Carefully; Avoid Common Mistakes
When risk managers are involved in selecting outside counsel for the hospital or health system, the task can seem daunting. Choosing the right counsel involves considering a multitude of factors, including fees, availability, experience, size of the firm, and even whether it seems like a good fit culturally.
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Include Communications in Adverse Event Plans
When planning to respond effectively to adverse events, it is important to include a crisis communication plan. A key part of the plan is a designated crisis team including members for each defined functional area of the organization.