Compliance Information Informed Consent 
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. These solutions deliver a myriad of benefits for trial sponsors, sites and patients.
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.”
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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”).
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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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.
AIHC
NOVEMBER 12, 2024
Written by Gabriella Neff, RHIA, CHA, CHC, CHRC, CHPC This past year, in 2024, revisions were made to clarify hospital guidelines related to informed consent specifically addressing UIEs (unconsented intimate exams) to patients while under anesthesia. OCR recently issued an FAQ focusing on this right. [6]
American Medical Compliance
MARCH 11, 2024
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.
MedTrainer
OCTOBER 28, 2024
By understanding and implementing these key policies, you can equip your staff to effectively maintain compliance and accreditation, ultimately reducing the stress associated with the accreditation process. Even with all the policies in place, a lack of employee adherence can lead to gaps in compliance and control.
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