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:
Virtual and Digital Health Digest, March 2024
This digest covers key virtual and digital health regulatory and public policy developments during February 2024.
Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating
Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision
In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).
UK Government Outlines New Action to Tackle Biases in Medical Devices
On March 11, 2024, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”). The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the
DOJ Announces New Whistleblower Compensation Pilot Program, Ratcheting Up Pressure on Corporate Voluntary Self-Disclosures
Below is an excerpt of a Robinson+Cole legal update co-authored by Government Enforcement and White-Collar Defense Team co-chair Seth Orkand and member David Carney.
On March 7, 2024, Deputy Attorney General (DAG) Lisa Monaco announced the contours of a new Department of Justice (DOJ) pilot program (Pilot) offering financial incentives to individual whistleblowers who
USPTO’s New Guidance on AI-Assisted Inventions: The Impact on the Use of AI in the Life Sciences
On February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). We previously discussed the Guidance here.
Following up on the Guidance, the USPTO released two examples illustrating what the USPTO considers proper inventorship analyses for AI-assisted inventions. Each example sets forth
Healthcare Policy Developments to Watch in 2024
The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers,
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
Virtual and Digital Health Digest, February 2024
This digest covers key virtual and digital health regulatory and public policy developments during January 2024.
The UK’s pro-innovation approach to AI: What does this mean for life science companies?
A version of this article was first published in Life Sciences IP Review
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government