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Boston QSP June Event "Innovation in Biopharma & Digital Health": The Science Blog

Keeping up with Regulation in Digital Health

Author: Sarah Yunes

Editor: Rajiv Shretha, Caroline Pechon-Vallee

Digital health research is in its infancy and it is rapidly evolving. As a result, the regulation of digital health software and devices is of growing interest and is unclear to many. To discuss this complicated and rapidly changing topic, the Boston QSP June event titled “Evolving Regulatory Landscape in Digital Health” was held in collaboration with World Pharma Week at the Inaugural Digital Health Pharma Congress. It was part of our Innovation in Biopharma and Digital Health Series. Our panel discussion included three experts in digital health regulation, Sarah Fairfield, Matthew King, and Krystin Meidell, who fielded questions from our moderators and the audience. Sarah Fairfield is a Regulatory Affairs Advisor for Canon’s Healthcare Research Optics Laboratory. Matthew King in a Regulatory Affairs Consultant for Johnson and Johnson. Krystin Meidell is the Manager of Regulatory CMC Medical Devices and Combination Products at Biogen.

Panelists: Matthew King, Sarah Fairfield, Krystin Meidell (left to right)

One of the challenges with the regulation of digital health technology is that there are a wide variety of opinions on what is included in this definition. Part of the difficulty is that the amendment that added medical devices to the purview of the Food and Drug Administration (FDA) in 1976 did not include a framework for software. In addition, it can be challenging to regulate because software changes rapidly and sometimes needs to be updated very quickly. Our panelists concluded that digital health includes anything with software in it that is meant to work with or in place of a medical device. Krystin stated that it is anything “software based that is intended to increase the precision or the benefit derived from a medicine in a digital fashion”. Sarah and Matthew further emphasized the focus on the software, with Matthew saying that these things are “not made of titanium, steel, or plastic” and Sarah summarizing that it is “anything that you cannot destroy with a hammer”.

Due to a variety of definitions even within the FDA, it can be very difficult to determine what a digital health company needs to do from a regulatory perspective, but it depends on what the product is intended to do. The best way to find out is to talk to the FDA directly to see how they view the proposed technology, but all of this process is very new. At this time, it is unclear if the FDA even has the statutory authority to enact their proposed pre-certification process for software. This process, which is similar to one the European Union is abandoning, is trying to find a way around the lengthy times typically required for making changes to medical devices, particularly if the change is high risk. This is further complicated by a lack of experts in software development at the FDA. The FDA is actively seeking advice and guidance from various Silicon Valley giants, as the industry is most familiar with software and has access to the experts in this ever changing field.

One issue that our audience wanted to know more about is how to know when to get the FDA involved. All of our panelists agreed that the best way to know is to consult a regulatory expert and ask the FDA. Despite all the sketchy things you might see on late night television, Matthew said that “you don’t want to test the FDA’s patience on safety and efficacy”. A warning letter from the FDA can mean shutting down an entire facility or bankruptcy. It is difficult to assess the risk of something that one is personally invested in and as Matt said, “it is all about risk”. Sarah re-emphasized the value of having an experienced regulatory expert who can “tell [the developers] NO when [they] need to hear it” and focusing on what you claim the device can do, as anything that makes a medical claim will need to be regulated.

Using digital health technology to collect data in a clinical trial does not necessarily mean that the device needs to be approved along with the prospective therapeutic. The device or software generally will be considered a part of the therapeutic if the data is used prospectively or if it is needed for full efficacy. Otherwise, the data just needs to be validated as any other data would need to be for an FDA submission. The best way, our panel agreed, to find out what regulatory path your technology needs to go down is to hire an experienced regulatory expert and discuss it with a pre-submission meeting with the FDA. It requires some upfront investment, but, as Sarah stated, “the alternative is very expensive”.

The event was preceded by a 4th of July Celebration and Networking event as a part of World Pharma Week.

We would like to thank the Digital Health Pharma Congress, World Pharma Week, and the Cambridge Healthcare Institute for sponsoring the event and the venue.

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Boston QSP is a 501(c)(3) non-profit organization whose mission is to foster the sharing of QSP knowledge, challenges, solutions, and opportunities to advance the field​ as an interdisciplinary community in Boston.

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