world, free from both innovation-promoting tools and regulatory
enforcement strategies used by most of the administrative agencies
traditionally operating in the healthcare space.
Many scholars have considered the regulatory landscape around mobile
health technologies and argued for a different regulatory system, or used the
landscape to analyze the safety of mobile health applications or the privacy
of the data they gather.
9 This essay expands this scholarly focus in two ways.
First, it focuses on the innovation incentives created by this legal framework,
a topic considered by few scholars. Second, and perhaps more importantly,
it focuses on the ways in which different administrative agencies with
different statutory responsibilities both do and should coordinate to promote
incentives for innovation in mobile health technologies.
Part I considers the ways in which traditional innovation incentives like
patents and FDA regulation fail to cover mobile health technologies in the
way that they cover traditional health care technologies. Part II goes on to
consider two key ways in which mobile health companies have adapted to
this novel regulatory environment—either by attempting to avoid regulation
or, alternatively, by embracing it. Part III shifts focus from the companies
responding to the innovation landscape to the administrative agencies setting
it. Specifically, Part III considers the ways in which agencies have begun to
coordinate their efforts in the mobile health space. How do—and how can—
these agencies, which lack formally shared regulatory authority over the
innovation space, nonetheless cooperate to promote incentives for
innovation? Administrative law and health innovation scholars have begun
to consider this question more generally, and this essay extends the argument
to the mobile health space.
I. THE LEGAL LANDSCAPE SURROUNDING MOBILE HEALTH
Although mobile health technologies have great potential to change the
8. Jordan Cohen & Joanne Hawana, Mobile Health Apps Continue to Make Headlines,
MINTZ LEVIN (Jan. 25, 2017, 3: 25 PM),
9. See, e.g., Nathan Cortez, The Mobile Health Revolution?, 47 U. C. DAVIS L. REV. 1173
(2014); Nathan G. Cortez, I. Glenn Cohen, & Aaron S. Kesselheim, FDA Regulation of Mobile
Health Technologies, 371 N. ENG. J. MED. 372 (2014); Fazal Khan, The “Uberization” of
Healthcare: The Forthcoming Legal Storm over Mobile Health Technology’s Impact on the
Medical Profession, 26 HEALTH MATRIX 123 (2016); Anna B. Laakmann,
A Property Theory
of Medical Innovation, 56 JURIMETRICS J. 117 (2016); Nicolas Terry & Lindsay F. Wiley,
Liability for Mobile Health and Wearable Technologies, 25 ANNALS OF HEALTH LAW 62
(2016); Nicolas Terry, Will the Internet of Things Transform Healthcare?, 19 VAND. J. ENT.
& TECH. L. 327 (2017).