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Written by: Jerry Temko, Managing Director, In-House Counsel Group, Major, Lindsey & Africa.
The huge potential of AI technology is no longer a topic confined to Silicon Valley startups or boardrooms at major tech companies keenly trying to position themselves as leading innovators in this space. With the advent of high-profile and highly versatile AI tools, such as ChatGPT, AI is now permeating into boardrooms across all industries.
The life sciences sector was arguably one of the early adopters, as the applications of AI in drug development or R&D for new medical devices were apparent even when the technology was in its infancy.
However, beyond boardrooms, AI is also being discussed by lawmakers and regulators – and now conversations are beginning to make their way into the written rules. In the EU, new rules for AI development and adoption have recently been approved in Brussels. The UK is similarly calling on regulators to submit their initial proposals for AI rules by the end of April. But with policymakers looking to strike a balance between ensuring safety and encouraging innovation, the regulatory and legal landscape is still a work in progress. For life sciences businesses keen to leverage the technology now, whilst not risking being in breach of the evolving legislation, this poses a unique challenge.
Striking a balance between opportunity and risk is causing many businesses in the life sciences sector to consider what guardrails they will need to establish as they integrate AI, and what internal legal counsel they will need to put in place to monitor such guardrails. All roads lead to finding an in-house AI legal expert.
Given that the technology itself, as well as the surrounding regulatory framework, is so new and still evolving, it cannot be definitively said that this type of legal mind truly exists yet. So, what can life sciences businesses do now?
Avoiding Past Mistakes
The situation with AI in many ways reflects the advent of GDPR and other privacy laws. When GDPR was first introduced, it affected every business, including life sciences companies who were suddenly being held accountable for safeguarding highly sensitive medical and personal information of patients or clinical trial participants.
Many businesses failed to put a suitable custodian in place when GDPR came into effect. In large part this was because privacy experts did not truly exist, much like the current absence of AI experts. As a result, some businesses ended up with this new and highly important compliance function being headed up by a relatively junior in-house lawyer, simply because they were willing to take on the role and were perceived to be tech-savvy. This quickly proved to be an untenable solution, and these businesses were left with an even greater headache than already caused by GDPR.
The same mistakes cannot be made once AI regulation begins to take effect, or businesses run the risk that their investments into AI technology may fail altogether.
The Profile
So, whilst a fully-fledged and clearly defined AI legal expert may not yet exist, there are certain backgrounds, professional profiles, and skills that may represent a solid basis for an in-house counsel to become an AI legal expert.
Another fallacy that businesses must avoid is assuming that merely poaching a tech lawyer will be the solution. Of course, AI regulation will likely be strongly tied to tech knowledge, so there is value in an in-house counsel having this background. But given the vast scope of AI’s potential, a transactional tech law or even broader computer science background will by no means exhaustively encompass the legal knowledge that an AI lawyer will require to be effective. Moreover, there are only so many tech lawyers to go around.
Based only on the initial conversations we have had with life sciences businesses seeking to invest in AI, as well as some of the initial cases that have come to court (for example, the New York Times lawsuit against OpenAI for training its chatbot on copyrighted material), we can safely assume that an AI legal expert will need some experience or knowledge of intellectual property law, privacy, and litigation.
For the life sciences industry, there are areas of the law that will require even more specific knowledge. For example, for drug development to be compliant with current regulations, tests must be provable as being controlled, measured, and repeatable. If an AI tool is carrying out the process, lawyers must ensure that the requisite level of quality control over AI exists to support robust results.
Benefits Beyond the Law
Clearly, there is a need for life sciences businesses to be more strategic than simply hiring a tech lawyer to be responsible for the legal safeguards that need to be put up around AI. Those that consider early how they will look to integrate AI, and then seek a legal expert with the relevant skills and background, will be best positioned to absorb any impact of incoming regulation and seamlessly pivot their operations in line with the new legal regime.
But the benefits of placing the right legal expertise within the business go beyond compliance. As AI legal experts begin to refine and hone their specialism, they will naturally get a feel for where the best opportunities of AI lie. Businesses are currently in the learning stages of how AI can deliver the best return on investment, what AI tools are best for their sector and their business specifically, and how the technology can be smoothly and safely integrated into operations.
These considerations will only benefit from a sharp legal mind that is focusing efforts on better understanding the AI landscape from both a regulatory and commercial perspective. Investing the time and resources to securing the best potential candidate for an in-house AI lawyer should also include finding people with good commercial acumen and strong communication skills, so that their legal and operational expertise with regards to AI can be directly fed into wider C-suite strategising.
Overall, CTOs, CFOs, and CEOs would be wise not to overlook the positive influence that an AI-savvy general counsel could have on AI transformation strategy, including beyond the compliance aspect. To reach this end goal, it begins with searching in the right places, for the right people.