President Biden's Executive Order (EO) on AI highlights the role the biopharmaceutical industry has in deploying AI to advance medicine while protecting the interests of patients. In an earlier post, I felt that this period of rapid regulatory advancement coupled with significant regulatory unknowns was very similar to the late 1990s when the industry was besieged with an unprecedented number of Consent Decrees authored by the Office of Inspector General.
Let’s look at the most relevant components of this EO for our industry.
Patient Safety and Privacy:
The industry clearly knows the importance of patient safety and privacy, but this EO adds a layer of uncertainty as AI is deployed to broader and more complex data sources. New federal standards to mitigate risks and protect patient data in drug discovery and patient data analysis will be required. This should not slow down the implementation of AI but should cause the industry to reassess on the safety and privacy systems that are likely already in place.
Mandatory Reporting on Training of AI Tools:
The EO demands transparency with assurances that the methods used to train AI tools are designed to prevent bias and help ensure accuracy in patient-directed applications. This process of reporting on AI training is somewhat new for the industry and will be area for initial investment in order to gain the promised returns from AI supported patient monitoring systems.
Funding and Federal Reporting:
In what seems like an effort to expand government oversight of the pharma industry, the EO links federal funding with biosynthesis (a big word for creating complex molecules from living cells) screening requirements for AI projects. This requirement seeks to reinforce the importance of protections over patient-related data and scientific research.
In the biopharmaceutical industry, our experience with regulatory uncertainty equips us to navigate the new terrain of AI regulation. These initial government directives will require refinement. We have proven that our industry's adaptability is one of our greatest strengths. And our shared commitment to advancing medical science and protecting patient interests will help to guide us.