New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
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Expanded Information Block Rules Go into Effect
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Exploring Digitization of Health and Medical Data and Records Part One
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more