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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
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
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more