contact Informed Consent Related Topics 
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”).
Health Law Advisor
SEPTEMBER 5, 2023
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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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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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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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.
Natalia Mazina
AUGUST 16, 2022
Due to potential side effects and investigational nature of Paxlovid, pharmacists initiating and furnishing Paxlovid should require an informed consent and release signed by their patients taking Paxlovid. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.
Medisys Compliance
FEBRUARY 29, 2024
Engage with Payer Representatives: Don’t hesitate to contact your payer representatives directly for clarification and assistance regarding complex scenarios. Capture Patient Consent: Document the patient’s informed consent for receiving care via telehealth services.
HIT Consultant
JANUARY 6, 2023
Crescendo partners with research sponsors like pharma/biopharma, medical device makers and contract research orgs to get informed consent from study participants, then collects all of their longitudinal data from their providers, payers, EHRs, pharmacy claims, and even previous clinical trials.
Medisys Compliance
APRIL 30, 2024
Patient Consent: Obtain informed consent from patients before conducting a telehealth consultation. Contact Medisys today at 888-720-8884 / info@medisysdata.com to learn more about our solutions for seamless telehealth anesthesia billing.
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