As the wave of digitalisation sweeping across healthcare becomes more prevalent, the US Food and Drug Administration (FDA) has established a new advisory committee to understand the benefits and risks of using technologies such as artificial intelligence (AI) and machine learning (ML).

The committee, which the FDA says should be operational by 2024, will help the agency tackle issues not just around AI and ML, but also applications of technologies such as virtual and augmented reality, wearable tech, remote patient monitoring and digital therapeutics.

The committee is equally not solely device-focused, with its role in discussing decentralised trials, healthcare cybersecurity and patient-generated health data also highlighted by the agency.

The FDA stated it will ask the committee – which will be made up of a core of nine voting scientific and technical members – to support the development of safe and effective digital health technologies. The committee will also have additional temporary members selected for the particular topic under discussion.

The FDA has a range of committees that meet regularly to discuss topics such as gene therapies, vaccines and oncology drugs.

Director of the FDA Digital Health Centre, Troy Tazbaz, said: “Technology moves at an incredible pace, and we are excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards.

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“Many of these technologies are novel and tend to rapidly change; it is our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”

In April 2023, the FDA published draft guidance that outlines its support for sponsors developing iterative improvements to ML-enabled software.