blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

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Newspapers and Laptop.

AI, Copyright, and Open Science: Health Implications of the New York Times/OpenAI Lawsuit

By Adithi Iyer

The legal world is atwitter with the developing artificial intelligence (“AI”) copyright cage match between The New York Times and OpenAI. The Times filed its complaint in Manhattan Federal District Court on December 27 accusing OpenAI of unlawfully using its (copyrighted and paywalled) articles to train ChatGPT. OpenAI, in turn, published a sharply-worded response on January 8, claiming that its incorporation of the material for training purposes squarely constitutes fair use. This follows ongoing suits by authors against OpenAI on similar grounds, but the titanic scale of the Times-OpenAI dispute and its application of these issues to media in federal litigation makes it one to watch. While much of the buzz around the case has centered on its intellectual property and First Amendment implications, there may be implications for the health and biotech industries. Here’s a rundown of the major legal questions at play and the health-related stakes for a future decision.

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golden ring on a log.

President Joe Biden, the AI Wizard

By Bobby Stroup

Artificial Intelligence (AI) isn’t magic, but there is value in telling a magical story to non-technical stakeholders to describe how we’ll govern this transformative technology. In fact, President Joe Biden himself could benefit by borrowing from an existing legend.

Let’s pick a story that’s already popular and one where heroes successfully overcame a dangerous technology. That technology should be simple, but also one that embodies the idea of harms caused by design. Focusing on a simple device avoids the distraction of technological details, allowing us to more easily ponder the bigger picture.

With the above parameters in mind, I suggest we discuss the technology of an “evil ring.” No, I don’t mean that Ring. I’m saying we should analogize health care AI to Sauron’s One Ring from J.R.R. Tolkien’s The Lord of the Rings.

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President Joe Biden at desk in Oval Office.

What’s on the Horizon for Health and Biotech with the AI Executive Order

By Adithi Iyer

Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways:  Read More

Code on computer.

Defragmenting European Law on Medical AI

By Audrey Lebret

In the medical field, artificial intelligence (AI) is of great operational and clinical use. It eases the administrative burden on doctors, helps in the allocation of healthcare resources, and improves the quality of diagnosis. It also raises numerous challenges and risks. Balancing competitiveness with the need for risk prevention, Europe aims to become a major digital player through its AI framework strategy, particularly in the field of digital health. The following provides a rapid overview of the normative landscape of medical AI in Europe, beyond the borders of the EU and its 27 Member States. It also takes into account the treaties in force or emerging at the level of the Council of Europe and its 46 Member States. The purpose is to illustrate the reasons and difficulties associated with the legal fragmentation in the field, and to briefly mention a few key elements towards the necessary defragmentation.

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Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

By Matthew Chun

The U.S. Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. On May 10, FDA published a discussion paper on this topic and requested feedback “to enhance mutual learning and to establish a dialogue with FDA stakeholders” and to “help inform the regulatory landscape in this area.” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues.

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AI-generated image of robot doctor with surgical mask on.

Who’s Liable for Bad Medical Advice in the Age of ChatGPT?

By Matthew Chun

By now, everyone’s heard of ChatGPT — an artificial intelligence (AI) system by OpenAI that has captivated the world with its ability to process and generate humanlike text in various domains. In the field of medicine, ChatGPT already has been reported to ace the U.S. medical licensing exam, diagnose illnesses, and even outshine human doctors on measures of perceived empathy, raising many questions about how AI will reshape health care as we know it.

But what happens when AI gets things wrong? What are the risks of using generative AI systems like ChatGPT in medical practice, and who is ultimately held responsible for patient harm? This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications.

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Wooman doctor using tablet with creative glowing digital heart futuristic interface hologram. Medicine, cardiology and future concept.

The Council of Europe’s Artificial Intelligence Convention: Implications for Health and Patients

By Hannah van Kolfschooten

The Council of Europe, the most important international human rights organization on the European continent, currently is drafting a Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law (AI Convention). The Convention aims to protect fundamental rights against the harms of Artificial Intelligence (AI), and is expected to become a global leading convention, as non-European states such as the United States (U.S.) are considering becoming signatories.

As health care is one of the top industries for AI, the forthcoming AI Convention will have important implications for the protection of health and patients. This post gives a brief outline of the background, scope, and purpose of the AI Convention. It goes on to flag common human rights issues associated with medical AI and then touches upon the most important health rights implications of the current text of the AI Convention.

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Modern Medical Research Laboratory with Computer Showing Virus Genome Research Software. Scientific Laboratory Biotechnology Development Center Full of High-Tech Equipment.

How Artificial Intelligence is Revolutionizing Drug Discovery

By Matthew Chun

In recent months, generative artificial intelligence (AI) has taken the world by storm. AI systems like ChatGPT and Stable Diffusion have captured the imagination of the masses with their impressive and sometimes controversial ability to generate human-like text and artwork. However, it may come as a surprise to some that — in addition to writing Twitter threads and dating app messages — AI is also well underway in revolutionizing the discovery of life-saving drugs.

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