Survey finds more than a third don’t understand AI regulations

The Pistoia Alliance survey on new AI regulations found that only 9% of respondents said they were familiar with the EU and US AI regulations, and more than a third (35%) had no understanding at all. did not.

The survey also found that more than a third (35%) had no understanding at all. The study also identified the top three challenges preventing life sciences organizations from complying with the law. Regulatory complexity and ambiguity (37%) was cited most frequently, followed by too many different regulations between regions (23%) and insufficient cooperation between industry and regulatory bodies (20%). The study was conducted as part of the Alliance's objective to overcome barriers to AI adoption through collaboration, based on its 2024 strategic priorities.

From Dr. Christian Barber, Chief Portfolio Officer, Pistoia Alliance From our Lab of the Future Report We know AI is at the top of our members' investment agenda, but our new research… reveals that legislation is a major barrier to successful AI implementation. We need to bridge the gap between life sciences, technology companies, vendors, and lawmakers to safely and compliantly leverage AI to accelerate critical health research. The Pistoia Alliance is best placed to create a forum to discuss the ambiguity and complexity of regulations as they arise. Our community of artificial intelligence and machine learning experts serves as an intersection between data science, pharmaceutical, regulatory, and government experts and has already made significant progress in accelerating the adoption of AI in life sciences. We are now encouraging more technology, compliance, and pharmaceutical professionals to join our community and express interest in our new AI initiatives.

21% of respondents said existing regulations hinder research. Respondents also shared the areas they believe governments should prioritize when developing new AI regulations. The top considerations are patient data privacy and security, ethical guidelines and bias, cited by 57%. Currently, 31 countries have passed AI laws and 13 more are debating AI laws. Recently, the European Union and the United States each announced new laws and executive orders. The EU's AI laws will be among the strictest in the world, particularly as they relate to pharmaceuticals. This is due to the block's large market size and its tendency to set standards for other regions to follow. EU rules are based on the potential risks of AI and the level of impact on consumers. High-risk applications such as medical devices, pharmaceutical manufacturing, and diagnostic AI require conformance assessment, while limited-risk applications such as chatbots must be clearly labeled as AI tools.

Dr. Vladimir Makarov, Project Manager of the Pistoia Alliance AI and ML Expert Community, added: AI is new territory for both lawmakers and pharmaceutical companies, and we must work together to navigate it. Our members have expressed a number of concerns regarding the new legislation. From ambiguity around risk categories, to challenges around data and AI governance, to the use of synthetic data to train future algorithms. The Pistoia Alliance expert panel will discuss how the legal changes could impact research and allow pharmaceutical companies to be involved at a regulatory level. This research provides a strong baseline to understand our members' current concerns, share them with regulators, and shape future discussions and projects.

The Pistoia Alliance will invite representatives from pharmaceutical, technology, and regulatory bodies to join the AI ​​and ML expert community to further discuss evolving regulations and their impact on drug discovery and development research. We are also seeking industry support to help fund this effort.

The survey was conducted among 125 life sciences professionals during a February 2024 webinar on EU and US AI regulations and their impact on pharmaceutical R&D, organized by the Pistoia Alliance. The survey is available here.

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