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As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more
Ellipsis Health, a digital health startup based in San Francisco, recently announced that it raised $45 million in a Series A-1 funding round led by Salesforce Ventures, CVS Health Ventures, and Khosla Ventures. The funding...more
As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more
The Evolution of Health Care AI Benchmarking - Artificial Intelligence (AI) foundation models have demonstrated impressive performance on medical knowledge tests in recent years, with developers proudly announcing their...more
As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more
In attempt to deliver more effective and affordable care, Oracle, Cleveland Clinic, and G42 have announced a strategic partnership that will build a global AI-powered healthcare platform....more
WHAT WE'RE SEEING - In this Life Sciences & Healthtech edition of The Download, we take on key trends at the intersection of tech and healthcare, continuing the energizing conversation from JPM Healthcare last week. 01 A...more
As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
Expansion of AI in Healthcare - At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more
Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently,...more
The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more
Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more