In the ever-evolving world of Medicare audits, 2025 is shaping up to be a year of Alice’s wonderland. Enter stage right: Artificial Intelligence (AI), a sleek, analytical wonderland where data reigns supreme and human error is no longer allowed to slip through the cracks. If you’ve ever found yourself lost in the tangled forest of
Procedure: Gen AI practice note adjustments (NSW).
Practice note SC GEN 23 (Link to Supreme Court).
As foreshadowed in its initial publication, the Generative AI practice note may require periodic updates. That has already occurred (before the starting date on 3 February 2025), with the issue of a new version on 28 January 2025.
The principal amendment is to the former
House Task Force on AI Issues Report and Proposes Healthcare Recommendations
On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in artificial intelligence (AI), including in the healthcare sector. The Report is intended to serve as
Virtual and Digital Health Digest – January 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2024 and early January 2025 from the United Kingdom, and European Union.
In this issue, we feature the emerging trends in digital health in 2024 that
HHS Recent Guidance on AI Use in Health Care
The U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights (“OCR”), recently issued a “Dear Colleague” letter, Ensuring Nondiscrimination Through the Use of Artificial Intelligence (“AI”) and Other Emerging Technologies, which emphasizes the importance of fairness and equity in AI use in patient care decision support tools (e.g., clinical
FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making
On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based tools.
The guidance
Healthcare & Life Sciences Private Equity Deal Tracker: WindRose Invests in CIVIE
WindRose Health Investors has announced a strategic investment in CIVIE.
CIVIE, founded in 2018 and based in Plano, Texas, is an artificial intelligence-powered ecosystem of radiology solutions.
WindRose, founded in 2000 and based in New York, pursues equity investments in healthcare companies. The firm invests in a broad range of industry segments, including
OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity
On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (the Proposed Rule) to strengthen the cybersecurity protections that HIPAA-regulated entities are required to maintain for electronic protected health
Healthcare & Life Sciences Private Equity Deal Tracker: New Mountain to Acquire Machinify
New Mountain Capital has announced it will acquire Machinify.
Machinify, founded in 2016 and based in Palo Alto, California, is a provider of artificial intelligence (AI)-powered software focused on healthcare claims and payments.
New Mountain, based in New York, is a growth-oriented investment firm. Founded in 1999, the firm manages private equity, credit and