or prevention of disease.”
98 If so, they may be a medical device subject to
99 These laws—including the Food, Drug and Cosmetic Act,
HIPAA, the FTC Act, and others—are the very same ones agencies have
made choices to avoid or embrace.100 The new information from the FTC,
HHS, and FDA puts these companies on notice and provides certainty as they
This questionnaire is the first example of explicit, public collaboration
between agencies in the mobile health space. However, I do not believe it is
the first example of collaboration. Collaboration between agencies may take
place publicly, as with this questionnaire or as with initiatives like the
FDA/CMS parallel review program for medical devices.102 Alternatively,
collaboration may take place behind the scenes. While the fact of the
collaboration itself may not be public, the existence of collaboration may be
the best explanation for a given action taken by an agency—it may be acting
to implement another agency’s priorities.
In the mobile health space, behind-the-scenes collaboration may be taking
place in the context of FTC enforcement actions. To date, the FTC has taken
action against a number of mobile health apps it argues are engaging in
deceptive advertising practices.103 The FTC’s August 2015 actions against a
set of mobile apps that claimed to be able to detect melanoma once users took
pictures of their moles104 is one such example here. Like many federal
agencies, the FTC is under-resourced and must set priorities for enforcement.
The FDA and FTC have a long-standing relationship of coordination on
enforcement actions,105 and the mobile health space may be the latest
example of their work in this area. Since the FDA has opted to exercise their
enforcement discretion regarding many of these technologies, FDA officials
noticing egregious examples of health-related advertising may request FTC
involvement.106 Of note is the FDA’s similar relationship with the SEC, in
98. Mobile Health Apps Interactive Tool, supra note 95.
102. Program for Parallel Review of Medical Devices, 81 Fed. Reg. 73113, 73114 (Oct.
103. Fed. Trade Comm’n., “Melanoma Detection” App Sellers Barred from Making
Deceptive Health Claims (Aug. 13, 2015), https://www.ftc.gov/news-events/press-
105. Freeman & Rossi, supra note 54, at 1162; see also Anne V. Maher & Lesley Fair,
The FTC’s Regulation of Advertising, 65 FOOD & DRUG L.J. 589, 602 (2010).
106. Cf. DAVID
C. VLADECK, DIRECTOR, FTC BUREAU OF CONSUMER PROTECTION,
COUNCIL FOR RESPONSIBLE NUTRITION ANNUAL SYMPOSIUM FOR THE DIETARY SUPPLEMENT
INDUSTRY: PRIORITIES FOR DIETARY SUPPLEMENT ADVERTISING ENFORCEMENT (Oct. 22,