Hall Render
APRIL 16, 2024
Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum to state survey agency directors highlighting revisions and clarification to the Hospital Interpretive Guidelines for Informed Consent (the “Guidance”).
HIT Consultant
JANUARY 16, 2024
Director, Product & Strategy, Patient Consent, IQVIA Technologies The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. eConsent solutions utilize dashboards and reports to visually display progress in the consent processes.
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American Medical Compliance
SEPTEMBER 10, 2023
When a medical professional informs a patient of the advantages, disadvantages, and alternatives of a procedure or intervention, informed consent is obtained. According to the Joint Commission, all aspects of informed consent must be documented “in a form, progress notes, or elsewhere in the record.”
Healthcare IT Today
APRIL 4, 2023
Payers and Providers on the Same Page – XSOLIS Payers and provider organizations each make decisions based on the information they have – but that information is often not the same. She dropped by our booth to explain what outcomes organizations are looking for. Each has an incomplete picture.
Foster Swift
APRIL 16, 2024
In both circumstances, the former doctors carried out their sexual abuse under the guise of medical procedures and without the informed consent of their targets.
Health Law Advisor
SEPTEMBER 5, 2023
Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.
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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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