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In the draft guidance, the agency described a risk-based enforcement strategy to oversight software targeted at critical or severe medical conditions and also machine learning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
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
Abernethy believed the proposed approach for regulating CDS will not only endorsed previous regulation
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