News & Analysis as of

Institutional Review Board (IRB) Health Insurance Portability and Accountability Act (HIPAA)

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

King & Spalding

FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations

King & Spalding on

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

King & Spalding

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

King & Spalding on

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Burns & Levinson LLP

Healthcare and Innovators, Take Note: The HIPAA Privacy RFI Can Benefit You

Burns & Levinson LLP on

This past Friday, the Office of Civil Rights within the U.S. Department of Health and Human Services published a formal Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. The RFI’s publication...more

6 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide