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AI Regulation Misunderstood by 35% Professionals Survey Reveals

Last Updated February 21, 2024 1:44 PM
Giuseppe Ciccomascolo
Last Updated February 21, 2024 1:44 PM

Key Takeaways

  • A survey shows only 9% of life science professionals fully understand artificial intelligence (AI) regulations, hindering research and innovation.
  • Complexity, regional disparity, and lack of collaboration are the top hurdles in navigating AI regulations.
  • What can help professionals working in the space to better understand these regulations?

Life sciences professionals lack a crucial understanding of evolving artificial intelligence (AI) regulations, with only 9% grasping both EU and U.S. rules, according to a survey  by the Pistoia Alliance. This knowledge gap poses a significant barrier to AI adoption in pharmaceutical R&D, potentially hindering vital medical advancements.

However, along with challenges, the survey also reveals opportunities for collaboration.

Only 9% Understand AI Regulation Well

The Pistoia Alliance, a global non-profit dedicated to innovation in life sciences and healthcare R&D, released findings from a global survey  on the impact of emerging AI regulations on pharmaceutical R&D. Alarmingly, only 9% of respondents understood AI regulations in both the EU and the US. 35% of them have no understanding at all.

Furthermore, the survey highlights the top three challenges hindering life science organizations from effectively navigating these regulations. Topping the list is the perceived complexity and ambiguity of the regulations, cited by 37% of respondents. Following closely behind are concerns about the plethora of disparate regulations across different regions (23%), and the perceived lack of collaboration between industry stakeholders and regulatory bodies (20%).

Results of The Pistoia Alliance survey
Results of The Pistoia Alliance survey I Credit: The Pistoia Alliance

The survey emphasizes the urgent need for enhanced collaboration and clarity in navigating evolving AI regulations in the pharmaceutical sector. It reaffirms the Pistoia Alliance’s dedication to tackling these challenges and promoting AI adoption through collaborative efforts outlined in its 2024 strategic priorities.

“From our Lab of the Future Report , we know AI is top of our members’ investment agendas but our new research highlights legislation is a major barrier to adopting AI successfully. We must bridge the gap between life sciences, technology companies, vendors, and legislators to harness AI in a secure and compliant way to accelerate vital health research,” commented Christian Baber, Chief Portfolio Officer of the Pistoia Alliance.

Regulations Impede Research But Collaborative Efforts Offer Hope

A notable 21% of survey respondents expressed concerns that existing regulations impede their research efforts. Additionally, respondents emphasized key areas they believe should have priority when governments are formulating new AI regulations. Topping the list of considerations are patient data privacy and security, as well as ethical guidelines and bias, listed by an overwhelming 57% of respondents.

The AI regulatory landscape is rapidly changing, with 31 countries having enacted legislation and 13 more considering AI laws. Recently, the EU introduced the ambitious AI Act, and the US issued an executive order, highlighting significant developments in AI regulation.

The EU AI Act will be among the strictest global regulatory frameworks, particularly impactful for the pharmaceutical sector. Given the EU’s significant market size and its tendency to set standards influencing other regions, these regulations will hold substantial weight.

They consider the potential risks of AI applications on consumers, with high-risk areas like medical devices and drug manufacturing requiring conformity assessments. Lower-risk applications such as chatbots must clearly label their AI nature.

What Is The Current Status Of AI Regulations Worldwide?

AI regulation has been met with varied approaches across the globe.

China has tightened control by cracking down on foreign platforms like ChatGPT while promoting domestic alternatives. Conversely, the UK and the US have taken a more hands-off approach. This allows courts and regulators to interpret existing rules within the AI context without extensive industry-wide restrictions.

The EU AI Act strikes a balance by targeting high-risk applications to establish safeguards against potential misuse. Especially in technologies like facial recognition.

Initially, Japanese officials leaned towards a regulatory approach akin to the U.S.. But a closer comparison aligns with the UK’s approach to AI regulation.

“AI is new territory for both legislators  and pharma companies that we must navigate together. Our members have raised a number of concerns regarding emerging legislation. From ambiguities surrounding risk categories, to challenges around data and AI governance, and the use of synthetic data to train future algorithms,” commented Vladimir Makarov, Project Manager of the Pistoia Alliance AI and ML Community of Experts.

” The Pistoia Alliance panel of experts will discuss how legal changes may affect research and allow pharma companies to get involved at the regulatory level. This research gives us a strong baseline to understand members’ current concerns, share back to the regulators, and shape our future discussions and projects,” he added.

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