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.
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.
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.
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.
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.
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.
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.
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: http://mobihealthnews.com/29895/8-types-of-medical-apps-a-senate-bill-asks-fda-to-stop-regulating/. The examples were also featured in a Fierce Mobile Healthcare article available here: http://www.fiercemobilehealthcare.com/story/protect-act-would-deregulate-high-risk-cds-mobile-medical-apps/2014-02-13.
Read the Clinical Decision Support Software Coalition’s thoughts on CDS software regulation here: http://mobihealthnews.com/29524/ohio-passes-medicaid-reimbursement-for-telehealth-cds-regulation/