Regulatory Landscape for Clinical Decision Support Technology

The Journal of the American Society of Anesthesiologists, Inc. February 2018

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, authored an article in The Journal of the American Society of Anesthesiologists, Inc., titled “Regulatory Landscape for Clinical Decision Support Technology.”

Following is an excerpt:

The articles by Kheterpal et al. and Liu et al. in this month’s issue of Anesthesiology highlight the challenges and opportunities in harnessing patient data to aid clinicians in patient management through the use of clinical decision support technologies. Although their articles focus on the use of clinical decision support in the intraoperative context, these technologies encompass a wide range of clinical settings and in the foreseeable future may extend to virtually every facet of clinical care. Indeed, by 2021, the U.S. clinical decision support market is projected to reach almost $5 billion.

In addition, editorials by Sessler and by Glance et al. rightly call for rigorous validation and transparency of clinical decision support to ensure accuracy and reliability. The current U.S. Food and Drug Administration (FDA) regulatory requirements for clinical decision support systems are still under development. The regulatory framework that will achieve the right balance between promoting innovation and protecting patients is not obvious, particularly given that clinical decision support will comprise products across of a broad spectrum of complexity and indications.

This commentary therefore seeks to provide an overview of the regulatory landscape for clinical decision support, with particular focus on the current and potential future role of the FDA, to foster discussion and encourage stakeholder input into the development of a rational and beneficial regulatory framework for clinical decision support.