Regulating Digital Health Technologies: How the FDA is Keeping Pace with AI/ML Advancements in Healthcare

As digital health technologies continue to advance, the US Food and Drug Administration (FDA) is actively updating its regulatory policies to keep up with the changing landscape. Artificial intelligence (AI) and machine learning (ML) are two of the most promising technologies that have the potential to transform healthcare and speed up the development of new medical products. This includes both pharmaceuticals and medical devices.

In this webinar, we will delve into how the FDA regulates digital health technologies, particularly AI/ML, that are used for health-related purposes. We will also cover recent FDA developments related to AI/ML and discuss the FDA’s policies around the use of these technologies in pharmaceutical and medical device research and development activities.

The FDA has been working hard to adapt its regulatory frameworks to accommodate digital health technologies. One of its main challenges has been determining how to apply existing regulations to new types of products that do not fit neatly into existing categories. For example, a product that combines software with a physical device might be classified as a medical device or a software as a medical device (SaMD). The FDA has had to develop new guidelines for these types of products, which can be complex and time-consuming.

Another challenge facing the FDA is ensuring that digital health technologies are safe and effective for patients. While these technologies have great potential, they are still relatively untested and could pose risks if not developed properly. The FDA has established rigorous testing protocols for digital health products, including requiring clinical trials in some cases. It also requires manufacturers to conduct risk assessments before submitting their products for approval.

Despite these challenges, there is no doubt that digital health technologies have tremendous potential to improve healthcare outcomes and speed up drug development. As such, it is important for healthcare professionals to stay informed about the latest developments in this rapidly evolving field. By attending this webinar on the FDA’s approach to regulating digital health technologies, you can gain valuable insights into this exciting area of medicine.

CLE credit is currently pending approval for this webinar in various states including CA, IL, NY, PA, TX, VA