About Us

What is clinical decision support software?

Clinical decision support software (CDS) is a critical and growing part of healthcare. Volumes of data are being generated from medical devices, health information systems and other sources daily. At the same time, the digital body of medical knowledge is growing exponentially and is essential to providing quality care. CDS is critical to effectively using this information to benefit the patient.

What is the mission of the Clinical Decision Support Coalition (CDS Coalition)?

Patient safety is one of the guiding principles of the Coalition. With CDS, what is required to ensure patient safety with CDS varies greatly depending on the risk of the product. The risk associated with a body mass index calculator is not the same as with computer aided diagnosis imaging software. As a result, all CDS cannot be regulated the same way, in fact, that many low risk CDS products should not be actively regulated at all.

Our mission is to ensure that clinical decision-making software does not become overregulated while still ensuring patient safety and enabling the advancement of innovative decision support tools that improve patient care.   The Coalition believes the key to achieving that balance is focusing on the user’s dependence – if the user is not substantially dependent on the software the CDS software should not be regulated. For more information on the CDS Coalition’s substantial dependence proposal see http://cdscoalition.org/wp-content/uploads/2013/07/CDS-Webinar-Slides.pdf.

Why was the CDS Coalition formed?

FDA initiated a process to develop guidance to define those types of CDS software that the Agency will regulate.  FDA kicked-off that initiative with a workshop in September 2011 and is now actively working on drafting guidance (expected to be released summer 2014).  This issue has become more critical as FDA, FCC and ONC prepare to deliver their joint recommendations for a comprehensive strategy for all health information technology, Congress is considering certain legislative proposals directly impacting clinical decision support software and other policy proposals are being discussed.   The Coalition was formed to provide feedback from industry, provider and patient organizations and other stakeholders on what CDS software should be regulated and what CDS should not be regulated.

What is the CDS Coalition’s focus?

The Coalition’s focus is to proactively develop a proposal for how to draw the line between regulated and unregulated CDS software. The Coalition will develop answers to two basic questions: What types of CDS software should be regulated? And for those types of CDS software that are regulated, to what level should they be regulated?

Who leads the CDS Coalition?

Brad Thompson serves as general counsel, and his firm, Epstein Becker Green, assists with the development of policies and government relation strategies.

Who are the CDS Coalition members?

The Coalition is composed of individuals and organizations who want to make or use software, including artificial intelligence, to improve the quality of healthcare. Current members include software developers, patient advocacy organizations, clinical societies, healthcare providers, and healthcare payers. The membership is diverse to ensure the Coalition can develop a policy position that balances the need for patient safety with the importance of preventing overregulation. We encourage all stakeholders to join our efforts.

How can my organization or I get involved?

To join the coalition, contact Jennifer Broeker at jbroeker@ebglaw.com or (202) 861-4199.