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2 months ago | 
jdsupra.com | Melissa Bianchi |Mark Brennan |Katy Milner
On February 6, 2025, the Trump Administration released published a Request for Information (RFI) on behalf of the White House Office of Science and Technology Policy (OSTP) concerning the development of an Artificial Intelligence (AI) Action Plan. This initiative follows Executive Order 14179, titled "Removing Barriers to American Leadership in Artificial Intelligence," signed by President Trump on January 23, 2025.
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Jan 22, 2025 | 
jdsupra.com | Melissa Bianchi |Ashley Grey |Bert Lao
The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which provides a comprehensive, risk-based framework to help sponsors evaluate and manage AI models.
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Jan 15, 2025 | 
jdsupra.com | Melissa Bianchi |Michael Druckman |Melissa Levitt
The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage transactions involving access to bulk U.S. sensitive personal data and transactions involving access to bulk human genomic data (now expanded to certain ‘omic data) or biospecimens from which such data can be derived.
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Oct 29, 2024 | 
jdsupra.com | Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
AB 3030 requires health facilities, clinics, physician’s offices, or offices of a group practice to present prominent disclosures about their use of generative AI to generate written or verbal patient communications pertaining to patient clinical information, effective January 1, 2025. Depending on the specific form of the communication, the “use of generative AI” disclaimer must be provided either at the beginning of the communication or throughout the communication.
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Oct 28, 2024 | 
hoganlovells.com | Marcy Wilder |Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
News
Recent actions by state and federal lawmakers are trending toward increased regulation and oversight of uses of AI in health care. From patient communications to medical necessity determinations and more, legislators and regulators are focused and willing to act on the use of AI in the health care industry. Several of the flurry of AI-related laws signed by California Governor Newsom on September 28, 2024, will impact health care companies.
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Oct 28, 2024 | 
lexology.com | Marcy Wilder |Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
Recent actions by state and federal lawmakers are trending toward increased regulation and oversight of uses of AI in health care. From patient communications to medical necessity determinations and more, legislators and regulators are focused and willing to act on the use of AI in the health care industry. Several of the flurry of AI-related laws signed by California Governor Newsom on September 28, 2024, will impact health care companies.
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Oct 22, 2024 | 
jdsupra.com | Melissa Bianchi |Robert Church |Ashley Grey
October 22, 2024 Melissa Bianchi, Robert Church, Ashley Grey, Wil Henderson, Bert Lao, Melissa Levine, Jodi Scott, Blake Wilson Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: [co-author: Lauren Massie] Last week, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials published a “Special Communication” in JAMA titled, “FDA Perspective on the Regulation of...
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Oct 8, 2024 | 
jdsupra.com | Melissa Bianchi |Mahmud Brifkani |Ken Choe
CMS used the publication of the Final Guidance to also issue a number of related issuances: a revised template MFP file, a definitions document, and updated Information Collection Request (ICR) forms for data submission for small biotech exception and biosimilar delay requests. CMS is soliciting comment on the updated ICR forms, with comments due on November 1, 2024.
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Oct 8, 2024 | jdsupra.com | Melissa Bianchi |Mahmud Brifkani |Ken Choe
CMS used the publication of the Final Guidance to also issue a number of related issuances: a revised template MFP file, a definitions document, and updated Information Collection Request (ICR) forms for data submission for small biotech exception and biosimilar delay requests. CMS is soliciting comment on the updated ICR forms, with comments due on November 1, 2024.
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Oct 8, 2024 | 
lexology.com | Alice Valder Curran |Ken Choe |Melissa Bianchi |Joy Sturm |Allison Pugsley |Kathleen Peterson | +6 more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA) (“Final Guidance”). The Final Guidance largely represents a continuation of CMS’s IPAY 2026 approach.
