Events

April 27, 2017

CDS Coalition Calls for Comments on Draft Industry Guidelines by July 1, 2017

The CDS Coalition has developed the attached voluntary guidelines for use by clinical decision support, or CDS, software developers to guide the design of such software. The purpose of these guidelines is to ensure that software, as much as possible, leaves the user firmly in control of the clinical decision-making. As explained more in the guidelines themselves, we have been also influenced by some recent legislation that articulates the dividing line between FDA regulation and the practice of medicine.

The coalition is comprised of large and small software developers, including those traditionally from the medical space as well as those new to the area. The coalition also includes hospitals and other users of such software, as well as those who make pharmaceutical products and medical devices that are guided by the software. But we recognize that there is a vast universe of organizations out there impacted by CDS, and so we would like to solicit comments from all those affected.

Our plan is to collect comments through July 1, 2017, and then make appropriate revisions. After that, we plan to present these guidelines to FDA for their feedback.

If you have any questions or concerns, please let me know. Please direct your comments to me, Brad Thompson, at bthompson@EBGlaw.com.

We would very much appreciate hearing your thoughts.

Download the Guidelines in PDF format.

December 9, 2016

CDS Coalition Submits Comments on FDA’s “Draft Guidance for Software as a Medical Device: Clinical Evaluation”

On December 9, 2016, the Coalition submitted comments on FDA’s SaMD Clinical Evaluation Draft Guidance, which communicate concern about the proposed standards for clinical evaluation of medical software being more demanding than what FDA has historically required. The comments also voice administrative concerns about the draft guidance, including lack of clarity regarding the scope of what the Agency plans to adopt, and lack of linkage between the draft guidance and current US laws, regulations, and policy. Note that following discussion with FDA regarding the process behind the development of the draft guidance, the Coalition submitted a follow-up letter to its original comments.

Download the Clinical Eval Comments (PDF)

Download the Feb. 17 Comment from CDS Coalition (PDF)

September 1, 2016

CDS Coalition Files Citizen Petition Requesting That FDA Issue Guidance to Answer CDS Case Study Questions

The CDS Coalition filed a Citizen Petition requesting that through guidance the Agency answer 34 specific questions based on three separate case studies, all involving clinical decision support software used in conjunction with pharmaceutical therapy.  Our members and others need answers to those 34, pivotal regulatory questions to develop products similar to those outlined in the case studies.

Click here to download the petition.

April 28, 2016

CDS Coalition Recommends FDA Adoption of the IMDRF QMS Guidance

The Clinical Decision Support Coalition (“CDS Coalition”) would like to commend the Food and Drug Administration (“FDA”) for its participation in the International Medical Device Regulators Forum (“IMDRF”) generally, as well as specifically in drafting the October 2015 IMDRF guidance document entitled Software as a Medical Device (SaMD): Application of Quality Management System (“IMDRF QMS Guidance”). In addition, the CDS Coalition asks that FDA take steps to adopt the IMDRF QMS Guidance in the U.S.

Click here to download the full letter.

February 25, 2016

Weighing the Impact of FDA Regulatory Uncertainty on Clinical Decision Support Development

Clinical decision support (“CDS”) software is not getting the regulatory clarity it needs and deserves. Although the United States Food & Drug Administration (“FDA”) made CDS software guidance an “A-list” priority in its 2015 regulatory agenda, the Agency has yet to define the portion of CDS software it intends to regulate and, for that portion it does regulate, the appropriate regulatory pathway to market.

Of course, developing a regulatory framework for CDS software is no easy task, as FDA must strike a delicate balance between ensuring patient safety and promoting innovation. However, until a regulatory approach is defined, CDS innovators will be left in the dark with regard to the expected costs and timelines for CDS development. Such uncertainty has already contributed to delays in CDS products reaching the market and, worse yet, the abandonment of CDS development projects altogether.

In fact, in a recent survey of CDS developers, nearly two thirds reported encountering delays due to regulatory uncertainty, and one third reported that regulatory uncertainty caused them to abandon development of a CDS product. Without clear regulatory guidance on which CDS products will be regulated and, for those that are, how such products will be regulated, valuable CDS tools, which can improve health outcomes, enhance the quality and consistency of care, and increase efficiency, will be kept out of the hands of clinicians and patients.

Download the full white paper here.

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.

Contact

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

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.

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