Coalition Finalizes Guidelines for the Design of Medium Risk Clinical Decision Support Software


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article on LinkedIn, titled “Coalition Finalizes Guidelines for the Design of Medium Risk Clinical Decision Support Software.”

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Following is an excerpt:

Under the 21st Century Cures Act, certain CDS software is now outside the scope of FDA regulation. While FDA will need to interpret the exact line drawn by the statute, the CDS Coalition wants to give FDA confidence that for that software the Agency does not regulate, industry will do an adequate job of self-regulation. In addition to the task of interpreting the statutory language, the legislation provides an avenue for FDA to clawback into regulated territory any software the Agency finds may lead to serious injury or death in patients. If industry does an adequate job of self-regulating and therefore avoiding patient injury, we can reduce the likelihood that FDA will need to expand the scope of its regulation.

To that end, today the CDS Coalition is releasing final guidelines for the design of medium risk CDS software, or MR-CDS. At a high level, the goal of the guidelines is to identify when additional software validation is required, beyond the normal baseline, because the software will be taking over certain clinical decision-making from the healthcare professional. In other words, the guidelines are intended to make sure that companies are very deliberate and thoughtful about when they cross the line to take over decision-making from the healthcare professional. Such a line should not be crossed casually, nor should it be crossed without giving thought to the additional validation such a step may require.