information and resources, to achieve shared goals.
90 My focus going
forward is on this category of true collaboration, although the personal and
institutional relationships supporting relationships of mere coordination are
often a precondition for collaboration as well.
In another work,
91 I argued that health-related agencies within the
Department of Health and Human Services (HHS), such as the FDA, Centers
for Medicare and Medicaid Services (CMS), and National Institutes of Health
(NIH) engage in collaboration to perform a number of functions.
share information among themselves that can be used to set priorities for
research and regulation, engage jointly in research that advances agency
priorities, and make decisions more efficiently about product approvals and
93 Agency collaboration is similarly present in the mobile
health context, although thus far observable collaboration has taken a
different form: collaboration between traditional health-related agencies and
traditional enforcement agencies.
In 2016, the Federal Trade Commission (FTC) worked with HHS and
FDA to create and make publicly available an online tool for developers of
mobile health apps.
95 The goal of the tool is to “help the developers
understand what federal laws and regulations might apply to their apps.”
The agencies created a clear user interface that marches developers through
a series of questions about their product, at each stage providing information
about laws that might affect the choice one way or the other.
97 As one
example, the app asks developers if their product is “intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation, treatment
90. To be sure, the literature itself—rather than just the terminology it applies—is
concerned with both. Requirements for interagency consultation frequently fall into the
coordination category, while joint rulemakings are often closer to collaboration, and there are
instances of true collaboration. Id. at 1157, 1163, 1166.
91. Rachel E. Sachs, Administering Health Innovation, 23 (unpublished manuscript)
(draft on file with author).
92. See generally Sarah Fellay, Changing the Rules of Health Care: Mobile Health and
Challenges for Regulation, AM. ENTERPRISE INST. (Aug. 4, 2014),
93. Sachs, supra note 91.
94. See generally Fellay, supra note 92.
95. Mobile Health Apps Interactive Tool, FED. TRADE COMM’N. (Apr. 2016),
96. FTC Releases New Guidance for Developers of Mobile Health Apps, FED. TRADE
COMM’N., (Apr. 5, 2016), https://www.ftc.gov/news-events/press-releases/2016/04/ftc-