Q. Artificial intelligence (AI) seems to be everywhere. Are there specific regulations covering AI for the pharma and medical devices industries?

A. There are indeed regulations; however, it is important to note that AI regulations in healthcare are rapidly evolving, and specific regulations can vary significantly between countries and regions. There certainly isn’t yet a unified global approach to regulating AI in the healthcare industry.

Though companies explore a multitude of opportunities to apply AI (e.g., for improving and strengthening the supply chain to prevent drug shortages), these technologies are still in their infancy. That is reflected in the discussion and policy papers published by the various regulators. AI algorithms are created by humans, and it is only logical to assume some level of bias. Addressing bias and ensuring fairness in AI algorithms is one of the common themes across these regulations. Avoiding bias is essential to ensure patient safety. A benefit of AI is that these algorithms are capable of learning and evolving. To avoid anyone blaming the algorithm for when an AI tool, such as an AI-based medical device malfunctions, the regulators are keen to establish clear liability and accountability frameworks.

The use of AI in the healthcare industry invariably impacts patients’ wellbeing. Any application of AI must therefore follow or adhere to ethical principles. Unlike a piece of traditional software that remains static in its output, AI is often intended to evolve and change. Companies may no longer be able to rely on a one-time validation effort to maintain transparency and explainability of AI decision-making processes.

Though the regulators do not wish to prevent the use of AI, considering the assumed benefits for patients, they do have to weigh the risks to protect patient safety, as well as patient data privacy and security. All these concerns are reflected in the current legislation. The following are merely a small number of regulations, guidance documents, and discussion papers from key regulatory agencies.

The World Health Organization (WHO) published Ethics and Governance of Artificial Intelligence for Health in 2021, which addresses the use of AI in healthcare globally (1). Most of the regulations and guidance documents have been issued for medical devices (2–9).

A more detailed overview of these regulations has been published by the Regulatory Affairs Professionals Society, though access is for members only (10).

For the most current and detailed information on AI regulations in specific countries or regions, it is always advisable to consult with regulatory subject matter experts in those areas, particularly as this is such a rapidly evolving regulatory field.

Ethics and Governance of Artificial Intelligence for Health

FDA. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. 

 updated Aug. 7, 2024 (accessed Dec. 5, 2024).

Discussion Paper on Proposed Regulatory Framework for Modifications to (AI/ML)-Based Software as a Medical Device (SaMD)

FDA. Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles. 

Guidelines on the Responsible Use of Generative AI in Research Developed by the European Research Area Forum

Future of Life Institute. The EU Artificial Intelligence Act. 

MHRA. Software and Artificial Intelligence (AI) as a Medical Device, 

MHRA’s AI Regulatory Strategy Ensures Patient Safety and Industry Innovation into 2030

The National Medical Products Administration (NMPA) (China). 

NMPA Announcement on Guidance for the Classification Defining of AI-Based Medical Software Products.

Kulshreshtha, A.; Bharadwaj, M.S. Global Regulatory Landscape for AI/ML-enabled Medical Devices. 

. 2024;4(3):5-20. Published online Sept. 18, 2024.

Siegfried Schmitt, PhD, vice president, Technical at Parexel.

®
Vol. 49, No. 1
January/February 2025
Page: 34

When referring to this article, please cite it as Schmitt, S. Regulations in AI and Other Digital Technologies. 

Articles

Ask the Expert

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Pharmaceutical Technology, JanuaryFebruary 2025

Regulations in AI and Other Digital Technologies