Healthcare is one of the industries where artificial intelligence (AI) is used and applied most frequently. The US Food and Drug Administration (FDA) has recently taken a bigger step towards medical device regulation improvement, creating a new advisory committee to better understand the advantages and disadvantages of adopting technologies like AI and ML in healthcare as the wave of digitalization sweeping the industry gains momentum. The regulatory framework, thus, comes into being at a crucial time for medical innovation in this field of technologies, says GlobalData, a leading data and analytics company.

In recent years, the FDA has received a lot of requests for product approvals based on AI and machine learning (ML), and they anticipate that tendency to increase. In order to develop solutions that address people’s health, AI enables the monitoring of huge volumes of data, the search for patterns and trends, and the improvement of precision and speed in applications like medical diagnosis, assisting patient therapies, or even increasing telemedicine capabilities.

Elia Garcia, Medical Analyst at GlobalData, comments: “In 2020, the FDA advancements in digital health saw a growth in both their adoption as well as their development. The FDA announced its intention to relax some regulatory criteria for select devices in an effort to increase access to low-risk, clinically appropriate digital health solutions during the COVID-19 pandemic.”

FDA’s action plan further reinforces its dedication to digital health by connecting it directly to the Digital Health Center of Excellence, which was established in September 2020. The Center’s mission is to enable partners to improve healthcare through the responsible and superior advancement of digital health innovation.

Garcia concludes: “AI is being applied to a wide range of problems in the healthcare industry, from image interpretation to medical diagnosis. These applications would speed up processes and greatly reduce the probability of error. The rapid application of artificial intelligence has advantages, but it also comes with a number of risks that need to be carefully considered because of the highly sensitive areas they can affect. In other words, the ethical component must play a crucial role not only in its introduction but also in its development and ongoing oversight.”