Devices

Clinical Decision Software Group Wants FDA Guidance

The CDS (Clinical Decision Support) Coalition has reiterated its request for more clarity on regulations governing the clinical decision support software industry. The request came in response to the Senate HELP Committee supporting the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) bill at a 3/9 committee hearing. The bill would strip FDA of its authority to monitor certain technologies, including CDS software and electronic health records, according to an online blog post by attorneys Justin Linder and Dennis Barrett (McCarter & English).

They write that while CDS software is considered low-risk and does not require FDA pre-approval before going to market, the agency has been promising to develop CDS software guidance since 2011. The coalition says the lack of any progress since then has led many projects to be delayed and abandoned.

CDS software is described as a classification of technologies ranging from software that communicates with implanted devices to tools that help providers with prescription decisions and automated alerts.

The post says that the majority of the CDS software affected by MEDTECH is low-risk since CDS software primarily provides doctors with tools for sorting and finding relevant information in patient records. MEDTECH would not exempt software that is capable of permitting doctors to confirm the software’s recommendation. “While the MEDTECH Act appears to ease the regulatory burden on some CDS software,” the authors say, “the CDS Coalition notes that the lack of a clear and consistent regulatory framework has generated innovation-stifling uncertainty among developers and investors.”

The post also covers the Senate HELP Committee’s approval of the Improving Health Information Technology Act and lawmaker requests for guidance from HHS on mobile health apps.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome