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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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype

Bill of Health

Previously, its authors had contributed to a related piece in this Bill of Health blog, which argued for a precautionary approach to touch in psychedelic-assisted therapy.) As each contribution emphasizes, these oversights have ethical implications for research design, informed consent processes, and public communication.

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Ivermectin controversy continues

Natalia Mazina

In my blog post “ Risk of dispensing ivermectin ,” I stressed the importance of obtaining informed consent prior to dispensing ivermectin. On the same note, a legal action was filed in Arkansas against a prescriber (among others) for treating patients (inmates) with ivermectin without prior informed consent.

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Judging in the Pandemic – A Malawian Perspective

Bill of Health

In Nyirenda v Ministry of Health , the applicants sought to review the of the imposition of mandatory vaccination, arguing that it amounted to a violation of human rights including the right of bodily integrity, as part of the right to private life and the right to free and informed consent.

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What is Healthcare Compliance Ethics?

MedTrainer

In this blog, we’ll discuss how compliance came into being and why ethics are closely monitored by federal, state, and local governments. They should not disclose patient information without proper consent or legal justification. Informed Consent: Patients have the right to make informed decisions about their healthcare.

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What is Non-Compliance in Healthcare?

MedTrainer

In this blog, we will outline what is non-compliance in healthcare, highlight various non-compliance activities, and explore how healthcare compliance software plays a crucial role in combating non-compliance. Non-compliance includes improper hand hygiene, inadequate sterilization of medical equipment, and poor sanitation practices.