CDS Coalition Files Citizens Petition at FDA Objecting to the Agency’s 2022 Final Guidance on Clinical Decision Support Software

On February 6, 2023, the CDS Coalition filed a citizens petition at the U.S. Food and Drug Administration in response to FDA’s publication of the Final Guidance on Clinical Decision Support Software on September 28, 2022. The Petition requested that the FDA Commissioner rescind the final CDS Guidance and repropose the guidance to align with the statutory language, as explained in the petition.

Download the petition in PDF format.

Startup Roadshow Encore Webinar: AI in Healthcare

See Below to Download Materials from the July 11 Encore Lecture

Much is changing with regard to how the U.S. Food and Drug Administration (FDA) approaches software generally, and artificial intelligence in particular. Some of that change is driven by the remarkable innovation going on right now at universities and in industry. But some of the change originates with the government.

For example:

In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software.
In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
Throughout 2018, FDA will be engaging in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”

Bradley Merrill Thompson (Chairman of the Board of consulting firm EBG Advisors) and Scott Thiel (Director of Navigant Consulting) will discuss FDA regulation of artificial intelligence in healthcare and methods the FDA uses to regulate devices that include artificial intelligence. This webinar highlights presentations on the same topic from the highly successful in-person roadshow held at eight major engineering schools around the country.

We understand you may have missed the opportunity to join us in-person at the roadshow. Therefore, please join us for this last lecture of the Startup Roadshow – AI in Healthcare. We look forward to you attending this encore webinar!

For more information on the agenda, click here.

Who Should Attend

The webinar is focused on entrepreneurs and experienced developers of artificial intelligence for the health care industry.

For questions about the Startup Roadshow, please contact Ohemah Addai at oaddai@ebglaw.com.

Download the Encore Lecture PDFs

Brad Thompson: What Uses of Artificial Intelligence in Healthcare Does FDA Regulate?
Scott Thiel: Background Information

Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

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Startup Roadshow: AI in Healthcare - Register Now

Register for the Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software.
In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
Throughout 2018, FDA engaged in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”

In assembling our speakers for the Startup Roadshow, we drew heavily from the medical software community already subject to FDA regulation. You will hear directly from experts as well as experienced medical software executives and Epstein Becker Green attorneys. For more information on the agenda, click here.

Dates/Locations

The Startup Roadshow will be held at the following locations:

January 24, 2019: University of Michigan

February 21, 2019: University of California, San Diego

February 28, 2019: Georgia Tech

March 26, 2019: Carnegie Mellon University

April 12, 2019: Johns Hopkins University

April 16, 2019: Rutgers University

April 25, 2019: University of California Berkeley

May 2, 2019: MATTER, in Chicago

For more information, please contact Wesley Hayden at whayden@ebglaw.com

Hosts

Hosts of the Startup Roadshow: University of Michigan, UC San Diego, Georgia Tech, Carnegie Mellon, Johns Hopkins, Rutgers, UC Berkeley, MATTER (Chicago)

Additional Sponsors

Sponsors of the Startup Roadshow: BNY Mellon Wealth Management, Fast Forward Medical Innovation, University of Michigan Tech Transfer, Pittsburgh Life Sciences Greenhouse, Innovation Works, Big Idea Center

Download the Presentation PDFs

Brad Thompson: What Uses of Artificial Intelligence in Healthcare Does FDA Regulate?

Scott Thiel: Startup Roadshow: Background Information

CDS Coalition Seeks Industry Input on the Elements of FDA’s Proposed Software Precertification Program

The CDS Coalition is distributing a survey designed to get input from the medical software industry on the FDA’s new vendor precertification program. FDA’s planned program will replace at least some product-specific premarket review for class II software medical devices, with precertification of software vendors to assess whether they meet quality guidelines the agency is still developing.

The survey assesses the extent to which software companies are willing to subject themselves to these additional quality screens, in exchange for the easier path to market. We are gathering this information to present the results at a public workshop FDA plans to hold in January 2018. We will continue to collect survey responses until January 12, 2018, giving us time then to analyze the results before the public workshop.

The survey targets vendors that develop, or plan to develop in the future, standalone software (meaning software that does not drive a hardware medical device) that FDA regulates in class II. The reason is simple: FDA’s objective is to lessen the premarket regulatory requirements for class II devices. Most class I medical devices do not undergo premarket review.

We are not asking participants to register because we want to afford them anonymity. While it’s probably impossible for survey participants to coordinate with all of their colleagues, we are interested in receiving only one response per company.

If your company is interested in participating, please click here to take the survey by January 12, 2018.

CDS Coalition publishes final industry guidelines, together with responses to public comments

In response to public comment on draft guidelines addressing the design of medium risk clinical decision support software, the CDS Coalition made significant improvements to the final guidelines. The Coalition also developed a companion memorandum to address the major comments, giving context to help interpret the guidelines. That memo accompanies the final guidelines.

Click here to download both the final guidelines and the explanatory memorandum.

Survey Shows That the Development of Clinical Decision Support Software Is Being Significantly Impeded by FDA Regulatory Uncertainty

In a survey of clinical decision support (or CDS) developers, one third reported having to abandon CDS product development efforts because of FDA regulatory uncertainty. Of those who pressed ahead despite the uncertainty, almost two thirds encountered significant delays. Those delays were greater than one year in 20% of those cases.

The CDS Coalition conducted the online survey to better understand the impact of FDA policy, or more specifically the lack of FDA policy, on CDS. Forty-eight companies participated, providing a range of information intended to better understand the nature of the industry, including the sophistication and size of companies developing this software. The survey results indicate that the industry is comprised of both venture backed startups as well as large, healthcare oriented companies such as pharmaceutical companies. The software these companies are developing is aimed at improving patient outcomes, increasing adherence to treatment and reducing errors and adverse events, among other things.

The survey’s objective was to evaluate the impact on CDS development of the lack of any clear FDA guidelines addressing when such software is regulated. FDA has been publicly promising to develop that guidance since 2011, but has yet to do so. The development of this FDA guidance document was one of the agency’s highest priorities in 2015, the agency’s so-called A list, according to the agency’s website. But so far, FDA has not issued even a draft for public input.

Dr. Michael Robinson, a practicing endocrinologist in Marina del Rey, California who uses various clinical calculators when treating patients with diabetes, explains “With the enormous explosion in clinical information, and with the digitalization of patient health records, CDS can help doctors dramatically improve the quality of care. I am anxiously awaiting mobile apps that will allow me to better guide my patients in such areas as the titration of the new long-acting long-acting basal and pre-meal insulins. There also are several areas of my practice where I would welcome new clinical decision support software to help me sort through the many options.”

According to Manan Trivedi, MD, MPP, a practicing hospitalist and Chief Medical Officer of Clinovations Government + Health, “CDS offers doctors important insights into the best care for a particular patient, and challenges doctors to think more deeply about possible alternatives.” Based in Washington, D.C., Clinovations Government + Health works to support and educate clients in understanding the implications of health IT policy and regulations. Trivedi observes, “Unfortunately, many potentially important CDS products are stuck in the pipeline because developers lack clear guidance from FDA.”

Congress is considering legislation to bring some clarity to the scope of FDA regulation, including the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act (S. 1101), sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.). The purpose of the legislation is to resolve the ambiguity so that developers know the rules of the road. The legislation is slated to be discussed as a part of a March 9, 2016 executive session of the Senate Health committee in regard to the committee’s biomedical innovation bills.

For more information concerning the survey, please read the white paper found here.

About the CDS Coalition

The CDS Coalition is a diverse group of stakeholders consisting of software providers, IT infrastructure manufacturers, healthcare providers, medical device and pharmaceutical manufacturers, trade groups, and members of the clinical community. Focused clinical decision support software (CDS), the coalition’s goal is to ensure a risk-based and clearly defined regulatory system for such software that appropriately balances the need for regulatory oversight with the need for innovation and access to new technology.

Contact

Bradley Merrill Thompson
bthompson@ebglaw.com
202-861-1817

Download this press release in PDF format.

CDS Coalition Pharmaceutical Use Cases

There are several types of decisions in relation to the proper use of pharmaceuticals that standalone software can support:

Is the patient a candidate for the drug, and will the patient likely respond to the drug?
How can I select a particular drug from an approved class of drugs with the same mechanism of action?
What is the evolving post-marketing safety profile of the drug and how can I select/change therapy based on this information?
How should the drug be administered, including dosage calculations?

The CDS Coalition is dedicated to clarifying the FDA oversight of all clinical decision support software, including that which is used to support decision-making around the use of pharmaceuticals. As a result, the coalition is vitally interested in how FDA regulates, if at all, CDS used for those purposes.

For the list of case studies, CDS Coalition Pharmaceutical Use Cases.

CDS Use Cases

July 15, 2015

The goal of this document is to put together a list of example CDS use cases, together with the appropriate regulatory status for each, to evaluate FDA and congressional proposals to determine if they achieve appropriate results. Of course, any policy proposal from FDA or Congress needs to be written broadly enough to anticipate future new use cases, but this document can be a starting point to evaluate federal policy initiatives.

For the list of examples, CDS Use Cases.

CDS Coalition Proposal for an HIT-Type Medical Devices Master Classification Plan

July 8, 2015

Classification is the language of medical device regulation. For software that meets the statutory definition of a medical device and therefore is subject to FDA regulation, the starting point for any regulatory analysis is the determination of the classification in which the software fits.

For the full proposal, CDS Classification Proposal Final.

How the FDA can improve regulation of mobile health, according to FDASIA workgroup

http://mobihealthnews.com/30501/how-the-fda-can-improve-regulation-of-mobile-health-according-to-fdasia-workgroup/#more-30501

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