October 3, 2018

Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

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  • In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not.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.”

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.

Share the Roadshow:


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
  • April 12, 2019: Johns Hopkins University
  • April 16, 2019: Rutgers University
  • April 25, 2019: University of California Berkeley
  • May 2, 2019: MATTER, in Chicago


Who Should Attend: The Startup Roadshow is focused on entrepreneurs and experienced developers of artificial intelligence for the health care industry.

Cost: Admission is $100.

To register for the Startup Roadshow, click here now.

For more information, please contact Lisa Blackburn at



Epstein Becker Green is pleased to sponsor the Startup Roadshow.

October 31, 2017

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.

August 30, 2017

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.

February 25, 2016

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.


Bradley Merrill Thompson

Download this press release in PDF format.

December 3, 2015

CDS Coalition Pharmaceutical Use Cases

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

  1. Is the patient a candidate for the drug, and will the patient likely respond to the drug?
  2. How can I select a particular drug from an approved class of drugs with the same mechanism of action?
  3. What is the evolving post-marketing safety profile of the drug and how can I select/change therapy based on this information?
  4. 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.

August 7, 2015

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.

August 7, 2015

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.

February 18, 2014

8 types of medical apps a Senate bill asks FDA to stop regulating

Bradley Merrill Thompson’s, one of the general counsels for the CDS Regulatory Coalition, examples of the types of apps that the PROTECT Act would instruct the FDA to stop regulating were featured in a mobihealthnews article here: The examples were also featured in a Fierce Mobile Healthcare article available here:

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