HIMSS and PCHAlliance Comment on FDA CDS Software Draft Guidance

HIMSS and the Personal Connected Health Alliance (PCHAlliance) provided written comments to the Food and Drug Administration’s (FDA’s) Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff (Docket Number: FDA-2017-D-6569), focused on developing a clinical decision support (CDS) software regulatory framework that sustains rather than stifles innovation in order to drive healthcare transformation. In addition, we asked FDA to ensure that there is an acceptable level of clarity and predictability in terms of regulation and/or oversight while continuing to support reasonably safe and effective medical devices. The nature of health IT and its role in healthcare delivery decisions continues to evolve, and we recommended that any new policy offers predictable processes for health IT products.

As this Draft Guidance is FDA’s second iteration on this topic, our comments build on HIMSS’s previous letter from February 6, 2018.

We also encouraged FDA to include additional examples in the Draft Guidance to ensure that the entire community is clear on expectations. One approach for FDA to consider is for the agency to create a CDS software section within the FDA.gov website, thus allowing the agency to periodically add new de-identified examples of both Device and Non-Device CDS software.

Overall, our comments provided the following thoughts on the information included in the Draft Guidance:

Support for FDA’s Efforts to Develop a Risk-Based Oversight Framework for CDS Software Functions

Based on the provisions of the 21st Century Cures Act, HIMSS and PCHAlliance supported FDA’s move toward implementing risk-based regulatory policies for CDS software functionality. HIMSS and PCHAlliance offered several ideas on how to strengthen and streamline the broad framework to provide greater clarity to the community around FDA CDS software oversight.

Streamline and Simplify the Concepts Underlying the International Medical Device Regulators Forum (IMDRF) Framework in Guidance Document

HIMSS and PCHAlliance questioned the direct inclusion of the IMDRF risk framework in the Draft Guidance as it leads to complexities around what is included under FDA regulation, as either an oversight focus or part of enforcement discretion.

More Definitional Clarity is Needed around Several Terms in the Draft Guidance

HIMSS and PCHAlliance asked FDA for more precision around several definitions to reduce ambiguity and appropriately advise the community on implementation questions, with a particular focus was on definitions around “Independently Review” and “Rely Primarily.”

Ensure that the CDS Guidance Empowers Patients and Caregivers

HIMSS and PCHAlliance emphasized that patients are often very experienced in treating their own conditions and diseases, and therefore should have a role in any care processes that directly impacts them.

The Interface of Artificial Intelligence / Machine Learning (AI/ML) and CDS software

HIMSS and PCHAlliance asked the Draft Guidance to strike a balance and ensure that our regulatory infrastructure is appropriately supportive of more development and innovation in the AI/ML space, leading to even better and faster processes that help practitioners analyze more data while also delivering better outcomes for their patients.

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