American Medical Compliance
MARCH 11, 2024
In a survey , dental providers agree that careful and precise recordkeeping is indispensable, emphasizing the importance of documenting elements such as patient histories, examination results, diagnoses, radiographs, treatment plans, consent forms, and clinic notes. This does not only facilitate comprehensive patient care.
Hall Render
OCTOBER 5, 2023
Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.
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MedTrainer
OCTOBER 4, 2023
Corporate compliance training helps healthcare organizations balance the need to provide top-notch care with adhering to a plethora of regulations. What Is Corporate Compliance Training? What Is the Difference Between Corporate Compliance Training and Regulatory Compliance Training?
HealthIT Answers
SEPTEMBER 21, 2022
The concerns raised go to privacy and informed consent as the primary issues. By Matt Fisher - In healthcare, many layers always exist around seemingly each and every issue. The ongoing utilization of extra blood from newborn heel stick samples provides the latest example.
Matt Kinley
JANUARY 22, 2017
Healthcare Compliance. Healthcare firms face a wide range of regulatory compliance matters impacting the healthcare industry. Kinley Law Practice works with businesses to create and implement safeguards to ensure that clients are in compliance with all applicable federal and state regulations. . Informed Consent matters.
Healthcare Law Today
DECEMBER 12, 2022
They want companies to disclose the relevant information. They want to make sure that the consumer has given their express and informed consent, and then, of course, making cancellations easy. They were very clear, they want upfront, non-deceptive practices. Nate Lacktman. Let’s talk about that a little bit further.
Drug & Device Law
DECEMBER 29, 2023
Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. The device labeling specifically mentioned it. And lost again on appeal in Cates.
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