The impact of artificial intelligence on regulatory compliance in the pharmaceutical and medical industries

In the dynamic world of pharmaceuticals and medical technology, innovation is constant and regulations are constantly evolving. In recent years, this interplay has been turbocharged with the advent of artificial intelligence (AI)a force with the potential to streamline processes, increase productivity and improve patient outcomes.

However, the emergence of artificial intelligence is accompanied by concerns that if left unchecked it could undermine fundamental democratic values ​​such as transparency, accountability, privacy and equality. As a result, governments around the world are developing regulations to safely harness the power of artificial intelligence, which has far-reaching consequences for pharmaceutical and medical technology (medtech) companies.

In light of these changes, it is imperative that businesses can effectively track and comply with these regulations. Even with growing calls for regulatory coordination in the global arena, companies operating in multiple jurisdictions have no choice but to keep pace with multiple changing landscapes.

A delicate balance of regulation

From medical imaging and diagnosis to surgery and clinical trial design, the possibilities of artificial intelligence are enormous. For companies looking to optimize its use, it is important to understand the dual goals of regulatory bodies in democratic societies: to support innovation and improvement, while ensuring data privacy, responsibility and patient safety. As such, emerging regulations will strive to be robust, precise and clear – even as rapid advances in the use of artificial intelligence are likely to lead to frequent regulatory updates.

The guiding principles of these regulations are beginning to crystallize. Legislative initiatives governing AI prioritize interdisciplinary collaboration, protection of individuals from unintended consequences, safeguards against data misuse, transparency, non-discrimination and accountability of AI creators and implementers. Future regulations aim to align AI systems with democratic values ​​and prevent them risk that automated systems undermine civil rights.

EU regulations and their impact

The European Union is leading the way in regulating artificial intelligence, sensitive to both the risks and benefits of its widespread adoption. EU proposal Artificial Intelligence Act aims to establish a comprehensive regulatory system covering areas such as data management, algorithmic transparency and risk analysis. The Act proposes impact assessment and compliance assessment mechanisms, outlines an AI governance agenda, and suggests areas for global coordination and voluntary commitments. It also provides a framework for identifying high-risk systems and explicitly prohibits certain practices and features – such as facial recognition and so-called “social scoring”.

This framework is based on a set of democratic values ​​that will also underpin legislation in other countries, especially the United States. We see this in the Biden administration design under the Artificial Intelligence Bill of Rights and in laws passed by many US states.

State Artificial Intelligence Laws in the US

In the last five years 17 states have passed 29 laws regulating artificial intelligence. While California, Colorado and Virginia have proposed the most comprehensive guidelines to date, almost all states emphasize data privacy and liability. Other topics also reflect the principles set out above: multi-stakeholder collaboration in the development and application of artificial intelligence, safety guardrails, transparency of use and non-discrimination/equal treatment of citizens.

FDA’s strategy for artificial intelligence in medical products

They were recently published by the US Food and Drug Administration regulatory strategy for AI in medical products includes all applications of AI that support drug development and regulatory compliance: from drug development to clinical trial design to post-market surveillance. This will have particular implications for the design of medicines and the processes used to collect data post-marketing.

The FDA framework includes four priorities – broad collaboration among stakeholders; clear and predictable regulations that support and anticipate innovation; development of standards throughout the entire life cycle of a medical product; and evaluating/monitoring artificial intelligence through demonstration projects. The FDA will publish guidance on these topics on an ongoing basis, provide post-market feedback, and share best practices with manufacturers developing strategies to use AI in their products.

Implications for companies: strategies and risks

The overall implications of these changes are clear. As companies race to harness the power of AI, understanding and adapting to the regulatory environment is of paramount importance. Currently, over 60 countries are developing regulatory frameworks for artificial intelligence; furthermore, it is likely that as these regulatory systems develop, category-specific guidance will emerge, e.g devices supporting machine learningFor example. Given these dynamics, now is the time for the industry to actively engage with regulators to provide feedback and influence regulatory developments.

The risk of falling behind in these areas is significant. For example, without rigorously analyzing the impact of AI on safety and performance, a company could leave competitors free to bring more competitive and safer products to market. Once this superiority is demonstrated, competitors may push for new mandatory safety standards. Once adopted by regulatory agencies, these new rules would leave the original company scrambling to play catch-up and incur significant costs to fill performance gaps in its product.

As companies develop innovative applications of AI in pharmaceutical and medical technology and navigate the evolving regulatory landscape, proactive regulatory intelligence strategies will be essential. These strategies should include monitoring and analysis of regulations (both regional and global) and internal processes, systems and products. In implementing these strategies, companies should adopt a holistic approach that integrates human knowledge and experience ethics with artificial intelligence capabilities. This will ensure that companies are well-prepared not only to ensure regulatory compliance and mitigate risk, but also to harness the full, transformative power of AI.