Compliance
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Broad Consent Issues raised by SACHRP and Others
With broad consent, patients would have an easy and speedy opportunity to opt out of future research uses of their biospecimens. But if they didn’t opt out — and most people probably would agree to the research use of their specimens — then scientific progress could proceed without the consent roadblock.
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FDA Lowers the Boom on Stem Cell Clinics
The FDA recently cracked down on two stem cell clinics for questionable research practices, including one clinic that was using smallpox vaccine as part of a treatment protocol.
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NIH Considers Action on Pay-to-Participate Trials
Recent action by federal authorities against stem cell clinics charged with questionable practices appear to validate concerns raised by bioethicists like Leigh Turner, PhD, who recently warned that some stem cell clinics are charging research subjects exorbitant fees for participation in experimental treatments marketed as clinical trials on ClinicalTrials.gov.
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IRBs Share Strategies to Prepare for New Common Rule
Some IRBs have been preparing for months for the Jan. 19, 2018, implementation of the new Common Rule. Others have taken a more casual, wait-and-see-if-it’s-delayed approach. IRBs that are preparing for a January rollout have found that preparation is time-consuming and resource-intensive.
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FDA’s Informed Consent Change Is Step Toward Harmonizing
The FDA’s recent move to allow a waiver of informed consent for studies involving minimal risk could be a first step toward harmonization with the existing Common Rule.
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Per-record Cost of Data Breaches Increasing
The cost of healthcare data breaches continue to remain the highest out of any industry, with an average cost of $380 per record, according to a recent report from the Ponemon Institute.
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New Breach Reporting Tool Helps With HIPAA Response
A new breach reporting tool should be useful for HIPAA compliance, partly because it can help providers stay on top of what is currently trending in cyberattacks and other types of breaches.
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Myriad State Requirements Complicate Breach Response
When you realize there has been a breach of protected health information, your first thought is of HIPAA and how to satisfy federal requirements for responding. But that is far from the end of your obligation, as state requirements can be just as onerous.
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Most Healthcare Workers Not Immunized for Pertussis
Though there are signs of gradual improvement, healthcare workers are still woefully underimmunized against pertussis, putting vulnerable patients such as infants at risk, the CDC reports.
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Create a Policy and Procedure Manual That Works and Is Survey-ready
The major problem ASCs encounter with creating policies and procedures is making these applicable to their facilities. The goal, particularly from an accreditation organization surveyor’s perspective, is for the P&Ps to be simple, direct, and thorough enough that employees could open them to the desired section and see exactly the policy they need to follow.