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Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

Posted 16 May 2019 | By Ana Mulero 

Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials.

Among the FDA officials on its scientific leadership board are Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), CDRH’s lead of cybersecurity initiatives, Suzanne Shwartz, and FDA Oncology Center of Excellence Associate Director Sean Khozin.

DiMe kicked-off three research projects, for which it began accepting applications on launch day, related to ethical considerations in digital medicine, verification and validation of digital medicine tools and measuring adherence.

But the new society is not the only one looking to break down health-related challenges through multi-stakeholder collaboration with FDA. The FDA-industry, mutually-funded National Evaluation System for health Technology (NEST) is a similar initiative. And the Clinical Trials Transformation Initiative, a public/private partnership co-founded by Duke University and FDA, also has made progress in developing recommendations and resources to facilitate the adoption of mobile technologies in research.

In an interview with Focus, Jennifer Goldsack, DiMe interim executive director, discussed her society’s approach to research and member regulators’ role in the evolving landscape.

Q: The regulatory space in the field is evolving, with projects ranging from how CDRH’s PreCert to increased requirements under the EU’s medical device regulation (MDR). How will member regulators inform future work amid the evolving landscape?

DiMe Executive Director Jennifer Goldsack: It was not hard to get the regulators at the table. I think the timing is exactly right. We collectively see the need for a disinterested nonprofit society to bring everyone to the table and insist on an evidence base for digital medicine. That really was attractive to all the regulators we approached.

DiMe’s regulators were very enthusiastic. Our regulatory colleagues seem incredibly keen to partner, collaborate and learn with us. This is a demonstration of a fantastic culture and approach to collaboratively learn as quickly as possible about how to make the best use of digital tools in health care.

MDR is going to be implemented next summer. That is coming whether we do something about it or not and I think, frankly, how much weight we put behind supporting folks through those adjustments will be based on what our membership tells us. If folks tell us that they are worried and they need help, we will do it. Our regulators are at the table, in my opinion, because we want to build this together and advance the field together. This is their professional home where we can all collaborate to spur digital medicine.

Q: How will DiMe tackle the lack of evidence, fragmentation and isolated silos in the field?

Goldsack: Everything is multi-stakeholder, which is how we can do the most good. There are other organizations out there that address specific questions for a subset of these issues. We are uniquely positioned to focus on answering questions needing everyone to be at the table.

Distinguishing digital health, digital medicine and digital therapeutics as subsets of one another will be very useful. Thinking about these definitions as concentric circles, at the broadest level is digital health.

There are tens of thousands of digital apps that are intended for health and wellbeing. But many of them are not evidence-based. We define digital medicine as being evidence-based, which is one of our metrics. Tools must also be intended to support the practice of medicine. From digital therapeutics and diagnostics to tools for population health management, preventative care or for tracking an individual during a clinical trial or a patient after joint replacement surgery, anything that supports the practice of medicine, is evidence-based and contains high-quality software falls into our digital medicine definition.

Q: How will DiMe develop its research pipeline?

Goldsack: The initial ideas for research came through the DiMe boards. We already have a good amount of interest from a variety of experts in participating in those projects and will spinoff work groups as soon as we are able to build balanced, multi-stakeholder teams. We also already have people expressing interest in these working groups and at least one working group will be up and running by early June.

Going forward, we will take a top-down, bottom-up approach to selecting new projects. We have a research committee that will oversee new suggestions and support the development of projects. The boards will continue to have input, if recommended, and the research committee will review their input.

Should one of our regulatory colleagues come to us with a question that we can support, we would be delighted to do so. But there is an opportunity for all our members to suggest new projects and they do not have to commit to doing it. Applicants, for example, can request support for being issues like being asked by Institutional Review Boards to evaluate digital tools for use in research and all of our members get to weigh-in on suggestions. We will then spinoff projects where it is clear they will be of great value.

I think the most important thing that we need to do in considering the initiatives we take on is: If we take this on, can we truly have impact with it, are we the right group and is it a pressing challenge?

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