patients with epilepsy.
83 Ideally, Embrace will be able to alert epilepsy
patients and caregivers of seizures.
84 Rather than just coming up with an app
that tracks sleep and activity or using existing technologies with capabilities
in this area (such as fitness trackers like Fitbit or Jawbone), Empatica has
invested in its own complex technology.
85 Most importantly, Empatica plans
on gaining FDA approval for its products, particularly those which it hopes
will be useful in clinical trials.
86 Other companies developing epilepsy
sensors, like Smart Monitor, are also conducting studies in preparation for
In explaining two of the key ways in which companies have chosen to
respond to the landscape of innovation incentives facing mobile health
companies, the above stories tell only one side of the innovation puzzle.
Equally as important are the decisions being made by agencies about when,
why, and how to regulate these technologies. Most interestingly, in the
mobile health space there have been several examples of interagency
collaboration on innovation and regulation.
III. INTERAGENCY COLLABORATION TO SHAPE MOBILE HEALTH
It is not enough to consider the choices made by any individual
administrative agency in the service of innovation and regulation. Their
coordinated actions must be considered. Several agencies, which nonetheless
lack formally shared regulatory authority over the innovation space, have
begun to collaborate in the mobile health space to promote incentives for
innovation and regulation. Much of the leading administrative law
scholarship on interagency relationships speaks in terms of coordination,
where the primary goal in situations involving agencies with interacting
jurisdictional assignments is to minimize inconsistency.
89 But it is worth
distinguishing mere coordination from a relationship that rises further to the
level of collaboration, in which agencies actively work together, exchanging
83. Advanced Research on Human Behavior, EMPATICA (2017),
https://www.empatica.com/science (last visited Apr. 7, 2017).
86. Steenhuysen, supra note 70.
88. See generally, e.g., Freeman & Rossi, supra note 54; see generally Jennifer Nou,
Intra-Agency Coordination, 129 HARV. L. REV. 421 (2015); Stuart Minor Benjamin & Arti K.
Rai, Fixing Innovation Policy: A Structural Perspective, 77 G. W. L. REV. 1, 21 (2008) (noting
that “government agencies often fail to coordinate innovation policy, resulting in incoherence
and perhaps bald inconsistency.”).