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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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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. These solutions deliver a myriad of benefits for trial sponsors, sites and patients.

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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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How to Ensure Dental Regulatory Compliance 

American Medical Compliance

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.

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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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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What is Healthcare Compliance Ethics?

MedTrainer

That’s why healthcare compliance regulations exist. What is healthcare compliance ethics? In this blog, we’ll discuss how compliance came into being and why ethics are closely monitored by federal, state, and local governments. What is Healthcare Compliance Ethics? Who Enforces Healthcare Compliance Ethics?

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What is Non-Compliance in Healthcare?

MedTrainer

Non-compliance in healthcare refers to the failure of healthcare providers, institutions, or individuals to adhere to the laws, regulations, and standards established to protect patient welfare, maintain data security, and ensure the efficient and ethical delivery of healthcare services. What is Healthcare Compliance?