Robert Jarrin, JD, senior director of government affairs for Qualcomm Incorporated, is a speaker for the HIMSS virtual event, “The FDA’s Mobile Medical Applications Guidance: Impact and Compliance,” which will take place on Wednesday, Oct. 23. Registration for this event is free of charge.
Jarrin represents Qualcomm on U.S. domestic regulatory matters relating to wireless health and life sciences. His areas of responsibility include wireless health policy, FDA regulation of converged medical devices and CMS reimbursement of telehealth. Jarrin chairs the mHIMSS Advisory Council. Before joining Qualcomm, Jarrin worked as a manager of strategic partnerships for Ericsson Wireless Communications, served as a law clerk in the White House Office of Counsel to President Clinton, and also served as a law clerk and subsequent consultant in the U.S. Department of Justice to Attorney General Janet Reno.
Jarrin frequently speaks at public conferences, federal workshops, and hearings. He is on the faculty of the George Washington University School of Medicine and Health Sciences as an adjunct assistant professor of Emergency Medicine, and lectures on mHealth and medical device regulations for Case Western Reserve University, Case School of Engineering.
HIMSS: How did you become involved with HIMSS?
Jarrin: Qualcomm became involved with HIMSS when mHIMSS, the mobile initiative, was created. The timing coincided well as Qualcomm Life, Qualcomm’s wholly-owned medical device subsidiary, was launched around the same time. It was a natural fit for us to be a part of one the world’s leading organizations devoted to improving health through information technologies, including wireless and mobile health.
HIMSS: What has been the most rewarding aspect of your involvement with HIMSS?
Jarrin: The exposure to stakeholders from every aspect of healthcare has been quite rewarding. On any given issue, we have the ability to collaborate with those who are being impacted most directly by policy or regulatory decisions. Being able to frame issues and opportunities through the lens of various perspectives helps us be more strategic, and ultimately, more effective.
HIMSS: What are some of the greatest challenges of using mobile medical apps? What are some of the greatest benefits?
Jarrin: Access tomobile medical apps (as opposed to non-medical mobile health, wellness, fitness and educational apps) is one of the biggest challenges faced by the patient or consumer. Most mobile medical apps that are currently listed with FDA are not sold directly to consumers; instead, vendors sell them to providers and healthcare practices who either use them in their practice or make them available to patients. The greatest benefit of mobile medical apps is that we are seeing how doctors and patients are utilizing some incredibly innovative technologies, virtually anywhere and anytime. If you had asked me what the greatest challenge is of using health-related mobile apps (i.e., non-medical), I would have said “variety.” It’s both a challenge and a benefit. With over 500 new mobile health apps launched every week and more than 27,000 unique mobile health apps offered through the various app marketplaces, the unfamiliar patient or consumer faces daunting choices. This is a good challenge to face, because it also presents the greatest benefit of health-related mobile apps – the variety. Interestingly, that challenge is being met by the marketplace. I’ve seen a number of articles, websites, and even blogs, profiling what exists, where to find them, and even, how well they operate.
HIMSS: Why is guidance from the FDA needed in the use of mobile medical apps?
Jarrin: The guidance from FDA was needed because innovators lacked basic clarity on 1) what is considered a mobile medical app, 2) what is not a mobile medical app, and 3) what the FDA was willing to not enforce. The guidance had been a long time coming, and many people from various perspectives seemed to have an opinion on whether the guidance should, or should not, be released. FDA issued its final guidance on mobile medical apps on Sept. 25. The good news is the guidance aims to be deregulatory and clarifies a number of ambiguities. In some respects, it goes further than I thought it would.
HIMSS: What will be the main focus of your discussion during the Oct. 23 event?
Jarrin: I’ll be highlighting some of the more provoking aspects of the mobile medical guidance document and providing context when applicable. I think HIMSS and mHIMSS members, many who are solo innovators, garage entrepreneurs and medical professionals that are developing technologies, have many questions about what’s in the guidance and how it affects their innovations. I’m going to try to answer some of those questions.
HIMSS: What advice would you give professionals just entering the healthcare or IT field?
Jarrin: You’ve chosen an industry where innovation is moving at the speed of light. Ensuring patient safety, technology efficacy and economic success are not mutually exclusive. Know your regulatory obligations, reach out to business experts, and ask questions whenever you can. We are all learning, as this exciting area continues to evolve.