New legislation includes a broad regulatory exemption for medical software.

On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new legislation includes provisions that will affect how and whether certain health-related software products are regulated by the US Food and Drug Administration (FDA). The law codifies many current FDA policies that exempt certain low-risk software from active regulation (e.g., administrative support software, software intended to promote a healthy lifestyle, and medical device data systems). The new law also would exempt certain clinical decision support software, unless FDA finds that such software would be “reasonably likely to have serious adverse health consequences.” In addition, the law includes a new standard for classifying device accessories.

These new provisions will affect not only newly developed technologies but also many currently existing digital health products and device accessories. For example, it is unclear how FDA will handle any software products that were previously cleared or approved by FDA and may now be subject to an exemption. It is also unclear how the new device accessory standard will affect currently marketed accessories that FDA has historically regulated based on the classification of the parent device.

Broad Exemption for Clinical Decision Support and Other Software

The new legislation exempts from FDA regulation certain medical-related software, including software used for administrative support functions at a healthcare facility, software intended for maintaining or encouraging a healthy lifestyle, and electronic health record (EHR) software. The exemption also includes software for transferring, storing, converting formats, or displaying clinical lab test data and results (currently regulated as Class I laboratory information systems or LIS) or other medical device data (often referred to as medical device data systems or MDDS^[1]).

In addition, the exemption covers clinical decision support (CDS) software with the following functions:

• Displaying, analyzing, or printing medical information;
• Supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition; and
• Enabling the healthcare professional to independently review the basis for such recommendations.

Although current FDA policies already exempt many of the above software categories from active FDA regulation,^[2] the new law would codify these enforcement discretion policies, providing additional certainty for industry. We note, however, that the scope of the exemption in the 21st Century Cures Act is not co-extensive with FDA’s various enforcement discretion policies; thus, these enforcement discretion policies will continue to be relevant for digital health developers.

In addition, guidance from FDA will be needed to clarify the scope of the CDS exemption (e.g., what level of software functionality or transparency is sufficient to qualify as enabling a healthcare professional to review the basis of the CDS recommendations?). FDA guidance also will be needed to address CDS software outside the scope of this legislation, such as software intended for direct-to-consumer use and software that analyzes medical images or signals from in vitro diagnostic (IVD) devices.

Exemption Limitations

There are some limitations on the above exemptions. Specifically, the new law provides that software with EHR, LIS, MDDS, and CDS functions will be subject to FDA’s medical device oversight if FDA finds that such software would be “reasonably likely to have serious adverse health consequences” and FDA issues a final order to that effect in the Federal Register. In evaluating whether these software functions may have serious adverse health consequences, the law provides the following factors for FDA to consider:

More at: http://www.natlawreview.com/article/21st-century-cures-act-and-its-effect-digital-health