News & Analysis as of

Department of Health and Human Services (HHS) Final Guidance

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

Foley & Lardner LLP

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

Knobbe Martens on

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 10. In This Month’s E-News: October 2022

Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

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On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Cooley LLP

Blog: FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

Cooley LLP on

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities —...more

Morgan Lewis

Final Guidance on IRB Written Procedures Issued

Morgan Lewis on

The guidance is intended to assist institutional review boards and institutions in developing written procedures. Whether an IRB has written procedures on the topics identified in the guidance may also be a useful benchmark...more

Blank Rome LLP

Health Care Providers Responding to Ebola: HHS Issues Guidance Reminding Covered Entities that HIPAA Allows the Sharing of PHI in...

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The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance to remind HIPAA-covered entities of the ways in which they are permitted under HIPAA to share protected health information...more

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