way in which health care is delivered, analyzed, and evaluated, the legal
landscape surrounding mobile health technologies differs significantly from
that surrounding other, more typical health care technologies.
10 This Part
considers the ways in which areas of law that traditionally operate to regulate
innovation in the medical technology space—patent law, FDA regulation,
and insurance coverage—fail to read on mobile health technologies.
For most health care technologies, innovation is channeled through a series
of different legal structures. Some of these legal structures are designed
explicitly to promote innovation, like intellectual property law,
11 while others
are designed primarily to ensure the quality and accuracy of marketed
technologies, like FDA regulation and insurance coverage.
12 Companies
producing drugs and traditional medical devices must contemplate each of
these legal regimes during the innovation process.
13 However, for many
mobile health technologies, the situation has been reversed.
14 These three
areas of law are largely inapplicable to mobile health in ways that affect the
pattern of innovation we see.
Patent Law. — Current case law significantly limits the kinds of protection
that mobile apps could enjoy, particularly in contrast to those granted to
pharmaceuticals. Patent law is typically thought to play a key role in the
development of new pharmaceutical technologies.
15 Due to the high costs of
discovering new drugs and lengthy period required to bring them through the
FDA approval process,
16 pharmaceutical companies cite patent law as an
10. Khan, supra note 9, at 141–43.
11. See Heidi Williams, Intellectual Property Rights and Innovation: Evidence from
Health Care Markets, 16 INNOVATION POL’Y AND THE ECON. 53, 53–54 (2016) (“Intellectual
property rights aim to increase private research investments in new technologies by allowing
inventors to capture a higher share of the social returns to their inventions.”).
12. Cortez, Cohen & Kesselheim, supra note 9, at 5; Melanie Cozad & Bruno Wichmann,
Efficiency of Health Care Delivery Systems: Effects of Health Insurance Coverage, 45
APPLIED ECON. 4082, 4082–83 (2013), http://www.tandfonline.com/doi/abs/
10.1080/00036846.2012.750420.
13. Khan, supra note 9, at 142–43.
14. Id. at 143.
15. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575,
1617 (2003); Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87
TEX. L. REV. 503, 508 (2009); Benjamin N. Roin, The Case for Tailoring Patent Awards Based
on Time-to-Market, 61 UCLA L. REV. 672, 751 (2014).
16. Compare Joseph A. DiMasi et al., Innovation in the Pharmaceutical Industry: New
Estimates of R& D Costs, 47 J. HEALTH ECON. 20, 20 (2016) (placing the cost of developing a
new drug at $2.6 billion), with Jorge Mestre-Ferrandiz, Jon Sussex and Adrian Towse, The
R& D Cost of a New Medicine, OFFICE OF HEALTH ECONOMICS
1,
13,
16,
30 (estimating the
cost at $1.5 billion), https://www.ncbi.nlm.ni
h.gov/pubmed/26928437. For my purposes,
there is sufficient agreement that drugs are among the most costly technological goods to
develop. See Cynthia M. Ho, Drugged Out: How Cognitive Bias Hurts Drug Innovation, 51
SAN DIEGO L. REV. 419, 426, 448–57 (2014).
