Today, the U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.

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 smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.

We believe that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies. We’ve maintained, since we issued our Digital Health Innovation Action Plan in 2017, that our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation.
Our plan outlined our efforts to reimagine the FDA’s approach to ensure all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we’ve accomplished several key initiatives, including launching and testing the digital health software precertification pilot program (“Pre-Cert”) and taking steps to modernize our policies.

The guidances issued today continue those efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies. We’ve taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the intent to provide a practical oversight framework that is risk based.

The first guidance we’re announcing, Clinical Decision Support Software, is a revised draft guidance based on careful review of public comments received on the previous draft published in 2017.
We recognize that software that provides clinical decision support (CDS) has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition. An example of CDS could be software that analyzes family history, electronic health record data, prescription patterns and geographical data in order to help health care professionals identify patients who may be at risk for opioid addiction. These types of software programs are intended to inform the physician’s clinical management of their patient. This technology has enormous potential to improve clinical decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to support providers in diagnosing and treating diseases, while also ensuring the software doesn’t introduce unacceptable risk to the patient.

U.S. Healthcare Homepage