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The New Era of Clinical Trials: Adopting Electronic Informed Consent

HIT Consultant

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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Quality Data Leads to Better Outcomes, Alignment & Informed Consent at ViVE2023

Healthcare IT Today

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.

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Informed Consent in Healthcare Training

American Medical Compliance

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.”

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CMS Releases New Guidance Regarding Informed Consent for Sensitive Exams

Hall Render

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”).

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FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Health Law Advisor

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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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.

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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

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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DHHS Revises and Clarifies Guidelines for Patients’ Informed Consent When Providing Sensitive Medical Care

Foster Swift

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.