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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. Conventional, paper-based methods can overwhelm patients with lengthy, complex documents to read.

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How to Ensure Dental Regulatory Compliance 

American Medical Compliance

These are recordkeeping and documentation. 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.

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Comply with Privacy Rights to Avoid Unconsented Intimate Exams

AIHC

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]

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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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Safeguarding Patient Privacy Through EMR Compliance

Compliancy Group

Understanding the HIPAA rules and the security steps to take can help protect patient information and maintain EMR compliance. The HIPAA Security Rule requires healthcare organizations to protect EMRs through measures like encrypting stored information, access control, and keeping information trails for procedures like audits.

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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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Is Verbal Consent Permitted for HIPAA?

Compliancy Group

We review the fundamentals of HIPAA informed consent and discuss situations allowing HIPAA verbal consent to release information. The Law Behind HIPAA Informed Consent As the HIPAA Privacy Rule outlines, informed consent helps prevent the unauthorized use and disclosure of PHI.

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