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Authored By: Tasha Mohseni
Welcome to This Week Inside HHS, FDA, and the NIH!
Updates from the prior week from agencies that impact research and public health.
As a general reminder, any questions you may have about legal information within this article should be discussed with your attorney or legal counsel at your institution.
Table of Contents:
Inside HHS
HHS will conduct a virtual Tribal consultation on the proposed rule โModifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement“. This consultation will address proposals in the Notice of Proposed Rulemaking (NPRM) to:
- Strengthen individualsโ rights to access their own protected health information, including electronic information
- Improve information sharing for care coordination and case management for individuals
- Facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises.
- Enhance flexibilities for disclosures in emergency or threatening circumstances
- Support the use of telecommunications relay services by individuals and workforce members of HIPAA covered entities and business associates who are deaf, hard of hearing, deaf-blind, or who have a speech disability
- Expand the Privacy Rule permission to use and disclose protected health information of Armed Forces personnel for national readiness purposes so that it applies to all uniformed services personnel
HHS Secretary Kennedy appoints two OB-GYNs to CDCโs Advisory Committee on Immunization Practices (ACIP). These new members include:
- Adam Urato, M.D., Obstetrician and Gynecologist specializing in Maternal-Fetal Medicine. Dr. Urato has held academic appointments at Harvard Medical School, the University of South Florida, and Tufts University School of Medicine. His clinical roles have included Maternal-Fetal Medicine attending positions at MetroWest Medical Center, Beth Israel Deaconess Medical Center, Boston Medical Center/St. Elizabethโs, and Tufts Medical Center. Dr. Urato received his B.A. from Harvard College and his M.D. from Harvard Medical School. He has also published extensively in peer-reviewed journals and participated in FDA advisory panels.
- Kimberly Biss, M.D., Obstetrician and Gynecologist in St. Petersburg, Florida. Dr. Biss has held multiple hospital leadership positions at Bayfront Health/Orlando Health Bayfront Hospital, including Chief of Staff, Chairman of Obstetrics and Gynecology, and Medical Executive Board Officer. She is board-certified in Obstetrics and Gynecology and maintains membership in several professional medical associations. Dr. Biss received her M.D. from Tufts University School of Medicine. Her experience includes clinical education roles and publication on COVID-19 vaccine safety for pregnant women.
SAMHSA announced $231M funding opportunity to administer 988 Lifeline. The 988 Lifeline is comprised of a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded 988 network administrator.
Inside FDA
The FDA announced the availability of a draft guidance for industry entitled โUse of Bayesian Methodology in Clinical Trials of Drug and Biological Products.โ This guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of Bayesian methods in clinical trials. According to this press release, this guidance is intended to satisfy the FDAโs commitment in the Prescription Drug User Fee Act (PDUFA) VII.
Inside NIH
Nicole C. Kleinstreuer, Ph.D., has been named NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. Prior to her current position, Dr. Kleinstreuer served as director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), within the National Institute of Environmental Health Sciences (NIEHS). She is deeply committed to mentorship, public health protection, and scientific innovation.
NIH shared a video update on what reviewers are saying about the Simplified Review Framework (SRF). SRF has been used for peer review on the majority of competing research project grant (RPG) applications in summer 2025.
I hope you found this bite-size weekly update helpful!
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