“development of credible information about the effects of drugs.”
insight extends to the device context as well.
44 Although the lack of FDA
oversight in the mobile app context means that many companies will be able
to come to market more quickly and cheaply, it also means that information
about the quality and accuracy of their products will be comparatively
Insurance Coverage. — Most traditional health care technologies are not
marketed or sold directly to patients, but are instead prescribed or
administered by a health care professional and purchased with the aid of
45 Insurers can therefore serve as intermediaries: by refusing to
cover technologies until more information about their efficacy has been
developed, they can force companies to produce information about their
quality, even beyond that required by the FDA.
46 This can serve a valuable
role in many cases, such as when medical devices are studied in ideal
populations rather than populations which are representative of a disease’s
47 Therefore, insurance coverage is, in some ways, both innovation-enhancing and access-enhancing. It enhances innovation just as FDA
regulation does, by requiring companies to study their products extensively
before selling them to consumers. And it enhances access by enabling
patients to afford expensive health technologies.
But most patient-facing mobile health technologies are marketed and sold
directly to patients, outside of the doctor-patient relationship and without the
insurer as intermediary.
48 Helpfully, this does mean that many mobile health
apps will be priced affordably and will be accessible without the aid of
49 More problematically, it also means that the quality control
function of insurance coverage is not available for most mobile health
50 Patients purchasing such apps cannot be sure that trusted
45. Jessica Smith & Carla Medalia, U.S. DEP’T. OF COMMERCE: ECON AND STATISTICS
ADMIN., HEALTH INSURANCE IN THE UNITED STATES: 2013, at 3 (2014).
46. See, e.g., Liz Richardson, HEALTH AFFAIRS POLICY BRIEF: ALIGNING FDA AND CMS
REVIEW 2–3 (Aug. 27, 2015).
47. Id. at 3.
48. Derek Newell,
5 Ways Mobile Apps Will Transform Healthcare, FORBES, (Jan. 26,
2017 12: 21 PM), http://www.forbes.com/sites/ciocentral/2012/06/04/5-ways-mobile-apps-
49. Isabel de la Torre-Diez et al., Cost-Utility and Cost-Effectiveness Studies of
Telemedicine, Electronic, and Mobile Health Systems in the Literature: A Systematic Review
21 TELEMEDICINE AND E-HEALTH 81, 82 (2015) (Most research studies in the literature have
concluded that telemedicine systems are cost-effective; however, in this article, two studies
have been found in which the cost-effectiveness of telemedicine is not an explicit conclusion).
50. See generally NAT’L ASS’N OF INS. COMM’RS, EXCHANGES PLAN MANAGEMENT
FUNCTION: ACCREDITATION AND QUALITY WHITE PAPER (2012),