In a new post on the Inside Privacy blog, our colleagues discuss the potential risk for Congressional Review Act (CRA) cancellation of Biden Administration rulemakings under the newly assembled 119th Congress.
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HHS Issues Notice of Proposed Rulemaking to Update the HIPAA Security Rule
On January 6, 2025, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking (the “proposed rule”), which proposes a number of significant updates to the HIPAA Security Rule. According to OCR’s announcement, the proposed rule seeks to “improve cybersecurity and better protect the U.S.…
FDA Announces Workshop on AI Used In Drug & Biological Product Development
FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a panel discussion around guiding principles…
FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule
On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates. We previously covered the proposed…
EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines
In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted. This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS…
EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS…
FDA Medical Product Centers Continue Focus on AI
On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle. The paper, entitled “Artificial Intelligence & Medical Products:…
Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA
Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February…
Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 1: Updates to the HIPAA Framework
On February 21, 2024, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, issued a white paper, “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era,” which proposes several updates to the privacy protections for health data. This follows Senator Cassidy’s…
HHS Publishes Final Rule to Align Part 2 and HIPAA
On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”)…