The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, the FDA recently released a publication outlining how four key agencies intend to work and collaborate in the brave new world of AI.

The latest publication, Artificial Intelligence & Medical Products: How CBER, CDER, CDHR, and OCP are Working Together, outlines four areas of focus that the stated agencies will focus on to deliver the mission of “protecting, promoting, and advancing public health…” For the pharma industry, it cannot and must not be understated that the FDA views AI as a technology to fundamentally improve healthcare. This can be a bit of a paradigm shift if not understood. History has taught us that many initiatives set forth by regulatory agencies are in response to known issues, problems, and risks. However, this is a chance to move in lock step with the Agency’s thinking and strategic deployment.

The transparency of the FDA’s execution of its strategy should help companies learn and collaborate as part of the journey, rather than wait for regulation. This will reduce performance of expensive retrospective exercises that might take away valuable resources from continuous improvement initiatives. A lesson in this scenario was the issuance of “Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application” in 2003. This guidance gave a narrowing of the Agency’s thinking regarding the scope and enforcement of 21 CFR Part 11. In this guidance, the FDA states, “We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health.” By industry alignment as these frameworks are developed, compliance will not only be better understood, but more efficient for delivering the right products at the right time.

Companies are well advised to actively align their strategies with consideration to the four main points outlined in this latest paper, especially if the company interacts with multiple agencies. These main points are:

  • Fostering collaboration to safeguard public health
  • Advancing the development of regulatory approaches that support innovation
  • Promoting the development of standards, guidelines, best practices, and tools for the medical product lifecycle
  • Supporting research related to the evaluation and monitoring of AI performance

These points, if carefully integrated into a company’s strategic plan, can not only lessen compliance burden in the future but also seamlessly create a framework for efficiently delivering quality products to patients who need them.