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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 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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S The World Health Organization supports this ban and in particular describes it as making informed consent impossible in the health care setting.

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Bringing eConsent to the Intensive Care Unit

Healthcare IT Today

The following is a guest article by Karen Maduschke, Sr. Director & General Manager, Patient Consent at IQVIA. The Challenge of Informed Consent in the ICU. Still, obtaining informed consent to participate in a clinical trial in these scenarios can be challenging. Enter eConsent. The Power of eConsent .

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How to Mitigate Ethical Challenges of AI-Driven Healthcare

Healthcare IT Today

The following is a guest article by Natalie C. The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Oehlers, Associate Attorney and Carly C.

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Regulating Medical Assistance in Dying: A Comparison of the U.S. and Canada

Bill of Health

Canada’s MAID law has some safeguards to prevent patients from being coerced into MAID, such as requiring cognitive capacity to consent, voluntary informed consent, assessors and witnesses who are independent of each other and who have no conflicts of interest, and waiting periods between different stages of the process.

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The Future of Telemedicine Transformed by Large Language Models

Healthcare IT Today

The following is a guest article by Deepak Singh, MBA, MS , Product Manager at Teladoc Health. This article represents Singh’s thoughts and don’t necessarily represent the views of Teladoc Health. Ensuring Informed Consent Develop clear and transparent policies regarding patient consent, data collection, and data usage.