UMD-FDA Workshop on Mobile Health and Social Media Analytics for Product Safety

UMD Smith Researchers to Join Experts to Address Harnessing mHealth, Social Media Data for Medical-Product Safety

The Food and Drug Administration is looking to get, and stay, on the same page with producers and users of medical wearables. The FDA mission to regulate medical devices to protect consumers is challenged by the mobile health field continuously innovating new products.  

Harnessing user data from mobile devices and social media is one way to keep pace. Thus, regulators and experts from industry and academia will gather on Friday, Sept. 11, 2015 in the Colony Ballroom of the University of Maryland’s Adele H. Stamp Student Union to discuss the opportunities and challenges these data sources create.

The 12:30-5 p.m. workshop is open to the public and billed as “It's big, but is it useful? A scientific inquiry into how mobile health and social media data may inform medical product safety.” The event is organized by UMD’s FDA-funded Center of Excellence in Regulatory Science and Innovation (CERSI) and the Center for Health Information and Decision Systems (CHIDS) at UMD’s Robert H. Smith School of Business.

CHIDS Co-Director and Associate Professor Gordon Gao and Smith marketing professor William Rand will participate on separate panels to address:

• The current landscape and future of mobile health and social media data
• New technologies and tools needed to support useful, nearer real-time analysis
• Methodological opportunities and challenges in making sense of the data
• The role of standards and interoperability in mobile health
• Understanding, trusting and influencing within social media data

Regarding the latter, Rand, who directs Smith’s Center for Complexity in Business, will demonstrate social media as a means to support public health surveillance. He’ll join a related 3-3:45 p.m. panel with Epidemico Chief Data Scientist Nabarun Dasgupta and Stony Brook University professor Andrew Schwartz.

In a preceding [1:45-2 p.m.] “Envisioning the Future of Mobile Informatics” panel, Gao will join FDA Associate Director of Digital Health Bakul Patel and Isaac Chang of the FDA Office of Surveillance and Biometrics, Center for Devices and Radiological Health.

Part of the current landscape, the FDA recently released guidelines identifying devices like Apple Watch, the Misfit Shine and FitBit as “general wellness” products not needed to be regulated for safety. Conversely, “low risk” devices that imply a claim to impacting chronic diseases and conditions should be regulated to protect patients, the FDA recommends. Such products include Embrace [monitors epileptic seizures], the Neumitra biowatch [measures and manages brain health] and Imec’s smart ECG necklace [detects heart arrhythmias].

The workshop will open with remarks from Skip Francis, director of Data Mining for the FDA’s Center for Drug Evaluation and Research in the Office of Translational Sciences. Ritu Agarwal, Smith’s senior associate dean of faculty and research and founding co-director of CHIDS, will speak to close the event.

Those planning to attend should register in advance here. For more information, contact Ann Anonsen at 301-405-0285 or aanonsen@umd.edu.