This post was co-authored by Josh Yoo, legal intern at Robinson+Cole. Josh is not admitted to practice law.
Health care entities maintain compliance programs in order to comply with the myriad, changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial intelligence (AI) are
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.
The Communication, while directed towards the broader biotech sector, refers to the aim to
Last month, the Federal Trade Commission (“FTC”) hosted its annual PrivacyCon event, featuring an array of experts discussing the latest in privacy and data security research. This post, covering healthcare privacy issues, is the first in a two-part series on PrivacyCon’s key takeaways for healthcare organizations. The second post will cover topics on artificial intelligence
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:
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
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”).
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
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
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
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,