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In the 21st Century Cures Act, Congress excluded from FDA regulation certain clinical decision support, or CDS, software.
Let’s say your company has developed a drug for adults with ADHD. However, fewer than 20% of adults with ADHD are currently diagnosed by psychiatrists, in part because ADHD presents differently in adults than it does in children (1). Your company wants to change that through a digital strategy that both helps raise awareness of adult ADHD, and also provides psychiatrists with better medical information to aid them in making the proper diagnosis. In light of some changes in the FDA regulatory environment, now may be a good time to pursue those strategies.
In December 2016, in the 21st Century Cures Act, Congress excluded from FDA regulation certain clinical decision support, or CDS, software. Let’s assume that your company wants to distribute to psychiatrists a mobile app that embodies the Brown Attention-Deficit Disorder Scale diagnostic form. Through a structured questionnaire, the app applies that scale to patient specific information entered by the psychiatrist during a patient interview. At the end of the interview, the app provides the results to the psychiatrist.
Right now that can be done on paper with only modest calculations. But the app makes it convenient, and reduces the risk of mathematical errors or other mistakes. In a nutshell, the app brings greater discipline to the process. To encourage the use of these sorts of software programs, Congress removed them from FDA oversight so long as they are designed to enable the professional user to review the basis for the recommendation.
Beyond that congressional action, to further improve the regulatory environment, an industry group called the CDS Coalition last year filed a petition with FDA asking the agency to clarify exactly what software used in connection with pharmaceutical products is regulated as a medical device. The coalition submitted to FDA three different typical scenarios, and requested that FDA issue guidance that explains how the agency determines in those cases whether the software constitutes a regulated medical device. The agency says it is working on response to the petition.
For software that is FDA regulated, the agency is developing an approach that lessens the regulatory burdens. FDA is considering : what if premarket clearance could be done through a process akin to TSA pre-check? The innovation behind pre-check was the realization that for frequent travelers, TSA could require less intrusive security measures on the day of travel if the travelers underwent prescreening. It is a simple trade-off: in-depth security checks using fingerprints, interviews and other information upfront in exchange for no longer requiring the removal of shoes and computers from bags on the day of travel.
The software industry and FDA are now discussing whether a similar innovation could be used to prequalify software vendors so that FDA’s product-specific premarket reviews could be lessened. Those discussions are at an early phase, but there is a lot of creative thinking going on.
As companies map out their digital health strategies, it is important that they not inadvertently fall into medical device regulation by, for example, making their software an accessory to an existing medical device, such as a blood glucose meter. Software that, for example, provides analysis of blood glucose data coming from the meter may be regulated as an extension of the meter.
Another line pharmaceutical software developers may not want to cross is using software to measure a patient attribute. Software that, for example, presents a patient with puzzles on a computer screen and then assesses whether the patient gets the right answer and records how long it takes is not serving as clinical decision support. Such software is measuring patient functions for the purpose of assessing such areas as memory, attention, executive function, and information processing. That’s a measurement tool, not CDS.
While it is possible to avoid medical device regulation, much of the software distributed by pharmaceutical companies will end up being FDA-regulated as drug labeling. But at least drug labeling regulation is a familiar beast with more modest requirements, and does not require adapting to unfamiliar medical device regulations. Consequently, if pharmaceutical companies decide that a digital health strategy will create value by, for example, improving clinical outcomes or reducing the total cost of care, now may be a good time to pursue it. For the present and near future, the regulatory environment will support quicker execution of these digital health strategies, at a lower cost.
(1) Ylva Ginsberg, MD, PhD, et al., Underdiagnosis of Attention-Deficit/Hyperactivity Disorder in Adult Patients: A Review of the Literature, Prim Care Companion CNS Disord. 2014; 16(3):
Bradley Merrill Thompson is a shareholder in the law firm of Epstein Becker & Green, P.C. There he counsels software, medical device, and drug companies on a wide range of FDA regulatory issues. Mr. Thompson also serves as General Counsel to the CDS Coalition.