The US Food and Drug Administration (FDA) released a new set of guidance documents last Thursday (26 September) to clarify its stand on regulating clinical decision support (CDS) tools including artificial intelligence (AI) driven and mobile health software that assist medical professionals in diagnosing and treating patients. 

The new guidelines also beef up four previous final guidance revolving around medical/ healthcare mobile applications, off the shelf software packages in commercial medical devices, general wellbeing and low risk devices, as well as data systems, image storage, and communication tools, so that they are in par with the definitions underlined by the Cures Act passed in December 2016. 

A risk-based strategy 

In the draft guidance, the agency described a risk-based enforcement strategy to oversight software targeted at critical or severe medical conditions and also machine learning algorithms that do not transparently detail the process of deriving at a conclusion. That means an AI which predicts the likelihood of a patient suffering from a particular medical episode or a learning algorithm that sift through individuals at the population level to identify who is more at risk of seasonal influenza or diabetes, may be affected. 

On the other hand, FDA may not regulate low-risk software; those that were designed to assist caregivers and patients to manage non-life-threatening conditions independently. Individuals could use these programs in the absence of medical professionals, to check and follow up on their respective needs based on the software’s recommendations. 

Encourage innovations and modern regulations 

FDA’s Principal Deputy Commissioner, Amy Abernethy said in a press statement that, “patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation… We believe that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies”. 

Abernethy believed the proposed approach for regulating CDS will not only endorsed previous regulations, but also “strikes the right balance between ensuring patient safety and promoting innovation by clarifying which products would be the focus of FDA’s oversight and which would not… These documents are critical elements of FDA’s comprehensive approach to digital health. We are committed to promoting beneficial innovation in this space while providing appropriate oversight where it’s merited”. 

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Hazel Tang

A science writer with data background and an interest in the current affair, culture, and arts; a no-med from an (almost) all-med family. Follow on Twitter.