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Notes
UNDERSTANDING THE IMPACT OF THE FDA GUIDANCE
FOR MOBILE MEDICAL APPLICATIONS:
IS THERE AN APP FOR THAT?
Diane Cooper*
INTRODUCTION
During the fall of 2013, administrators and professors welcomed
the first class of medical students to the Frank H. Netter, MD School of
Medicine at Quinnipiac University in North Haven, Connecticut.1 When
students began their medical education at Quinnipiac, they found that the
curriculum included learning how to use medically related mobile
applications (“mobile apps”) in practice.2 Dr. Robert Bona, a Professor
in the Department of Medical Sciences, noted that the students would be
trained on how to research conditions, diagnose diseases, and treat
patients using both mobile apps and traditional sources.3
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* Juris Doctor Candidate, 2014, Quinnipiac University School of Law. First, I would
like to acknowledge and thank Caroline Oh for inspiring me to write on this topic. Second, I
am grateful to Professor Jennifer Herbst and Professor Brad Saxton, Dean Emeritus, for acting
as faculty advisors and for their insight, commentary, thoughtful edits, and patience. Third, I
would like to thank Dr. Robert Bona and Dr. Todd Cassese for their willingness to participate
in interviews and provide invaluable insight about how physicians use mobile apps. I also
would like to thank Professor Remy Zimmerman, Professor Leonard Dwarica, Elisabeth
Pimentel, Todd Saxton, Jesse Conrad, Sarah Gruber, and the entire editorial board and staff of
the Quinnipiac Law Review for their assistance with this Note. Finally, I would like to thank
Andy Cooper for his endless support and encouragement.
1
See generally QUINNIPIAC UNIVERSITY FRANK H. NETTER MD SCHOOL OF
MEDICINE,
http://www.quinnipiac.edu/academics/colleges-schools-departments/school-ofmedicine/ (last visited Nov. 7, 2013).
2
Interview with Robert Bona, Doctor, Professor, Dep’t of Med. Sciences, Frank H.
Netter MD Sch. of Med. at Quinnipiac Univ., in North Haven, Conn. (Oct. 23, 2012).
3
Id.
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On the other side of the industry, developers of mobile apps are
investing in the growing application (“app”) market.4 There are currently
about 97,000 health care apps available to be downloaded, each of them
offering varying levels of complexity and functionality to assist both
health care providers and consumers with health care related tasks.5
Mobile industry analysts predict that by 2017, the “mHealth”6 market
will be worth approximately $26 billion.7
The use of medically related mobile apps has become
commonplace in the careers of health care professionals.8 Many health
care professionals rely on the assistance of smartphones and tablet
devices to assist them in practice.9 The popularity of the mHealth market
is expected to continue to grow over the next several years.10 It is
estimated that, out of the pool of physicians who use smartphones, at
least thirty-eight percent already use apps on a daily basis.11
The federal government recognized the popularity and growth in
this area and, through a number of different agencies, plans to regulate
mHealth.12 Specifically, the Food and Drug Administration (“FDA”) is
concerned that the growing number of available mobile medical
applications could pose a risk to patient health and safety.13 Congress
authorized the FDA to regulate medically related mobile apps that fall
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4
Jenny Gold, FDA Regulators Face Daunting Task as Health Apps Multiply, USA
TODAY (June 27, 2012, 7:04 PM), http://usatoday30.usatoday.com/news/health/story/201206-22/health-apps-regulation/55766260/1.
5
Jonah Comstock, Report: 1.7B to Download Health Apps by 2017,
MOBIHEALTHNEWS (Mar. 14, 2013), http://mobihealthnews.com/20814/report-1-7b-todownload-health-apps-by-2017/.
6
mHealth is defined as “the use of mobile and wireless devices to improve health
outcomes, healthcare services[,] and health research.” mHealth, HEALTH INFO. TECH. &
QUALITY
IMPROVEMENT,
U.S.
DEP’T
OF
HEALTH
&
HUMAN
SERV.,
http://www.hrsa.gov/healthit/mhealth.html (last visited Nov. 8, 2013) (stating the definition
from a NIH consensus group).
7
Id.
8
See Chris Gullo, Half of Doctors to Use Medical Apps in 2012, MOBIHEALTHNEWS
(Nov. 16, 2011), http://mobihealthnews.com/14703/half-of-doctors-to-use-medical-apps-by2012/.
9
Id.
10
See Nicole Lewis, Mobile Health Apps Market Poised for Takeoff,
INFORMATIONWEEK (Jan. 18, 2012), http://www.informationweek.com/healthcare/mobilewireless/mobile-health-apps-market-poised-for-tak/232400467.
11
Gullo, supra note 8.
12
Sarah Baumann, Mobile Medical Apps: The Slow Road to Regulation, WOLTERS
KLUWER LAW & BUSINESS (Jan. 14, 2013), http://health.wolterskluwerlb.com/
2013/01/mobile-medical-apps-the-slow-road-to-regulation/.
13
Id.
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14
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See 21 U.S.C. § 321(h) (2006).
See FOOD & DRUG ADMIN., DEP’T OF HEALTH & HUMAN SERVS., GUIDANCE FOR
INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ON MOBILE MEDICAL
APPLICATIONS
(2013),
available
at
http://www.fda.gov/downloads/
MedicalDevices/.../UCM263366.pdf [hereinafter GUIDANCE]. The acronym MMA is used
only when discussing mobile apps that likely would meet the definition of MMA provided in
the Guidance.
16
See id.
17
Id. at 16–18 (describing MMAs over which the FDA will exercise enforcement
discretion).
18
See id.
19
See Ryan Minarovich, A Coming Storm: FDA Regulation of Mobile Medical
15
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under the definition of medical device in the Food, Drug & Cosmetic
Act.14 In response, the FDA has produced a Guidance (“the Guidance”)
that explains the FDA’s “current thinking” on how it should exercise its
regulatory authority for mobile medical apps (“MMAs”).15 The
Guidance provides insight on how the FDA defines and categorizes
MMAs.16
The FDA’s exercise of its regulatory authority over MMAs could
have a significant impact on app manufacturers and health care providers
that use apps in practice. This Note will specifically examine how the
regulatory structure described in the Guidance could impact developers
and users of MMAs over which the FDA plans to exercise only
enforcement discretion.17 It also will examine how health care providers
could be impacted by the Guidance’s regulatory framework.
Part I provides a working definition for medical devices, a
definition of MMA under the Guidance, and examples of how medically
related mobile apps are currently used in the health care industry. Part II
discusses the federal government’s overall plan to regulate mHealth,
including MMAs, and it reviews the regulatory framework described in
the FDA’s Guidance. While the FDA intends to regulate certain MMAs,
other, lower risk MMAs will only be subject to “enforcement
discretion,” and will face few, if any, legal or regulatory consequences if
they do not conform to the regulatory requirements.18 This Note explores
the potential impact of the FDA’s intention to exercise its regulatory
authority over some MMAs and to exercise “enforcement discretion”
over other MMAs that it considers less of a risk to human health.
Increased cost and decreased availability that often accompanies
regulation is a concern for manufacturers and early adopters of mobile
health technology, but the principal concern for health care providers
and the FDA remains the health and safety of the public.19 MMAs are
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growing in popularity with health care providers, but while MMAs may
increase efficiency and access to information, there is no guarantee that
the information provided by the MMAs is accurate.20 This Note suggests
that, although the FDA considers many MMAs to pose only low risks to
public health, health care providers should work together to self-regulate
and self-monitor the industry to help ensure that only the most accurate
and reliable MMAs are used in practice. Because the FDA will only
exercise “enforcement discretion” for some MMAs, health care
providers cannot be assured that the FDA has evaluated the quality or
safety of those MMAs.21
Part III explores how MMAs could be involved in common law
causes of action for products liability. In light of recent Supreme Court
cases analyzing preemption as applied to medical device regulation, it is
unclear whether manufacturers could be held liable for harm caused by a
health care provider’s use of an MMA.22 This risk should further
motivate health care providers to self-regulate the industry because, if
manufacturers are insulated from liability, patients likely will try to hold
health care providers liable for any harms caused by the use of MMAs in
practice. Additionally, the learned intermediary doctrine likely does not
insulate mobile app manufacturers when physicians recommend MMAs
to patients, or assist patients with using MMAs; however, the doctrine
may apply if the industry moves towards allowing apps to be accessed
by prescription only.23
The FDA does not intend to exercise its regulatory authority over
every medically related app that is available in app marketplaces (e.g.,
iTunes or Android Market).24 While the FDA is interested in protecting
human health and safety from potentially dangerous mobile apps, it does
01/02/2014 11:18:02
Applications,
THE
HEALTH
CARE
BLOG
(Oct.
24,
2012),
http://thehealthcareblog.com/blog/2012/10/24/a-coming-storm-fda-regulation-of-mobilemedical-applications/.
20
See Baumann, supra note 12.
21
See GUIDANCE, supra note 15, at 16–18.
22
See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008); Medtronic, Inc. v. Lohr,
518 U.S. 470, 502–03 (1996).
23
Diane Schmauder Kane, Construction and Application of Learned-Intermediary
Doctrine, 57 A.L.R.5th 1, 1 (1998).
24
See GUIDANCE, supra note 15, at 4.
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PART I: BACKGROUND INFORMATION AND DESCRIPTION OF HOW
MOBILE MEDICAL APPS ARE USED IN THE INDUSTRY
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99
not intend to regulate mobile apps that act only as medical reference
tools or apps that allow patients to access reference information specific
to their conditions.25 This section will define the scope of the mobile
apps that the FDA considers MMAs and provides examples of those
MMAs. It also will define “MMA manufacturer” and discuss the scope
of the term. Additionally, it will provide broad examples of how MMAs
are currently used in the health care field.
A. Mobile Medical Apps that Qualify as Medical Devices
The FDA defines a mobile app as “a software application that can
be executed (run) on a mobile platform, . . . or a web-based software
application that is tailored to a mobile platform but is executed on a
server.”26 In order to be considered an MMA under the FDA’s Guidance,
the app must fall under the definition of “device” in the Federal Food,
Drug, and Cosmetic Act (“FD&C Act”).27 The FD&C Act defines a
medical device as
Several medically related mobile apps squarely fall into section (2)
or section (3) of the definition.29 Additionally, the mobile app must
either be intended “to be used as an accessory to a regulated medical
device[] or to transform a mobile platform into a regulated medical
device.”30 Although mobile apps may be used for several purposes, the
25
01/02/2014 11:18:02
See id. at 20–21.
Id. at 7.
27
Id. at 8 n.4.
28
21 U.S.C. § 321(h) (2006).
29
See id.; infra Part I(B)(2).
30
GUIDANCE, supra note 15, at 7.
26
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an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part, or
accessory, which is—
...
(2) intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
(3) intended to affect the structure or any function of the body of man
or other animals, and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of its
primary intended purposes.28
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manufacturer’s intended use and purpose of the mobile app is a key
element in determining whether it should be considered an MMA.31
Intended uses can be discerned by examining the labeling associated
with the MMA or the advertising used to promote the MMA.32
The Guidance defines three categories of medically related mobile
apps.33 First are mobile apps that do not meet the MMA definition;
second are mobile apps that qualify as MMAs, but are considered low
risk; and third are MMAs that the FDA intends to regulate.34 Each of
these categories will be defined and discussed below.
1. Mobile Apps that Do Not Meet the MMA Definition
Mobile apps that do not meet the MMA definition are those that do
not meet the FD&C Act’s definition of medical device.35 The FDA does
not intend to regulate mobile apps that do not qualify as medical
devices.36 Examples of unregulated medically related mobile apps
include electronic copies of medical reference materials, training videos
and other training materials, electronic medical education resources for
patients, and apps that assist with billing or other office operations.37
Mobile apps that could be considered medical devices (e.g., a
magnifying glass app), but are not intended to assist with treating or
diagnosing medical conditions, do not meet the medical device
definition and will not be regulated by the FDA.38
Certain mobile apps may meet the MMA definition but are
considered low risk; the FDA intends only to exercise its enforcement
discretion over these low risk MMAs.39 Mobile apps in this category
31
01/02/2014 11:18:02
Alex Krouse, Note, Ipads, Iphones, Androids, and Smartphones: FDA Regulation of
Mobile Phone Applications as Medical Devices, 9 IND. HEALTH L. REV. 731, 746 (2012).
32
GUIDANCE, supra note 15, at 8.
33
Id. at 12, 20–28.
34
Id.
35
Id. at 20.
36
GUIDANCE, supra note 15, at 20.
37
Id. at 20–21.
38
Id. at 21–22.
39
Id. at 12. The FDA notes that “enforcement discretion” indicates that “the FDA
intends not to pursue enforcement action for violations of the FD&C Act and applicable
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2. Mobile Apps that Meet the MMA Definition But Are Considered
Low Risks to Patient Health
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101
“may be intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease.”40 Mobile
apps in this category are designed to assist patients and physicians with
tracking conditions or health information, and in some cases, they are
designed to enhance communication between patients and their health
care providers or between patients, providers, and personal health record
systems.41 These mobile apps also can be used to “perform simple
calculations routinely used in clinical practice.”42
An example of an MMA that aids in medical diagnosis or treatment
and performs calculations that physicians would learn from traditional
sources is MedCalc Pro.43 This app allows the user to input patient
information (e.g., height, weight, lab results) and performs calculations
using specific algorithms to generate drug dosage information,
information to assist in diagnosis, or other information intended to assist
with treating patients based on the patient information that was entered.44
This app is available to the general public through iTunes for $4.99.45
Another MMA that aids in medical diagnosis or treatment is the
Pedi QuikCalc app.46 Pedi QuikCalc is designed to assist pediatricians or
family practice physicians with tracking weights, calculating drug
dosages, and calculating IV fluid needs for pediatric patients.47 This app
can be purchased for $1.99 and was designed by a physician.48
Several MMAs that can be used to assist with treatment or
diagnosis can be downloaded for no charge. An example of a free MMA
is Differential Diagnosis, which is available on Google Play for Android
mobile phones.49 Differential Diagnosis allows users to select patient34375-qlr_32-1 Sheet No. 55 Side A
01/02/2014 11:18:02
regulations by a manufacturer of a mobile app . . . . This does not constitute a change in the
requirements of the FD&C Act or any applicable regulation.” GUIDANCE, supra note 15, at 12
n.18.
40
Id. at 23.
41
Id. at 16.
42
Id. at 17.
43
MEDCALC (PRO), http://medcalc.medserver.be/description.html (last visited Nov. 10,
2013).
44
Id.
45
MedCalc Pro (Medical Calculator), ITUNES, https://itunes.apple.com/us/app/
id384650532 (last visited Nov. 11, 2013).
46
Brittany Chan, Pedi QuikCalc App Is True to its Name, A Quick and Easy Medical
Calculator for Pediatricians, IMEDICALAPPS (Sept. 28, 2012), http:/www.imedicalapps.com/
2012/09/pedi-quikcalc-app-medical-calculator/#more-40116.
47
Id.
48
Id.
49
Differential
Diagnosis,
GOOGLE
PLAY,
https://play.google.com/
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specific symptoms and uses algorithms to determine which disease is the
closest match to the patient’s symptoms to assist with diagnosis.50
FIGURE 1: DIFFERENTIAL DIAGNOSIS51
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store/apps/details?id=botijo.differentialdiagnosis (last visited Nov. 10, 2013).
50
Id.
51
Id. (demonstrating use of the app to show diagnostic assistance given after selecting
“hives” as a symptom (screenshots taken by author on Feb. 24, 2013)).
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103
Differential Diagnosis displays a warning that tells a patient that a
physician should be consulted.52
3. MMAs that the FDA Intends to Regulate
The FDA is most concerned with mobile apps that meet the MMA
definition and that, in its opinion, cause risks to patient health and
welfare similar to the risks posed by medical devices that are already on
the market.53 These MMAs “transform a mobile platform into a
regulated medical device by using attachments, display screens, sensors,
or other such methods.”54 The FDA plans to regulate these MMAs in the
same way it would approach the regulation of existing medical devices.55
MMAs that fit into this category have a variety of functionalities.56
Some MMAs are designed to control or connect to an existing regulated
medical device, such as a blood pressure cuff or an insulin pump, while
others are designed to store or analyze data from regulated medical
devices.57 Other MMAs use attachments, such as a blood glucose strip
reader, to transform mobile devices into medical devices that have the
ability to function in a way regulated medical devices currently
function.58
The FDA also places MMAs that provide diagnosis or treatment
conditions based on patient information entered into the MMAs into this
category.59 There is no bright line between the diagnostic or treatment
functionality between the MMAs over which the FDA only plans to
52
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Id. (“Although considerable time has been spent to create and support the content in
this application, there is no guarantee of its accuracy for the user. Clinical decisions and
reasoning should only be made by an experienced and licensed medical professional. This
application should never be used in lieu of or as a second opinion to that clinical reasoning
and judgement [sic]. By clicking ‘Agree to Terms’ below, you are acknowledging and
agreeing to these terms of use.” (screenshots taken by author on Feb. 24, 2013)).
53
GUIDANCE, supra note 15, at 13.
54
Id. In May of 2013, the FDA sent an “It Has Come to Our Attention” letter to
Biosense Technologies Private Limited about its uChek Urine analyzer app that, according to
the FDA, met the definition of a “medical device” because it functioned as an “automated
strip reader” by automating the process of reading urinalysis dipsticks. Letter from James L.
Woods, Deputy Dir., Patient Safety & Prod. Quality, FDA Office of In Vitro Diagnostics &
Radiological Health, to Myshkin Ingawale, Biosense Tech. Private Ltd. (May 21, 2013)
available at http://www.fda.gov/medicaldevices/resourcesforyou/industry/ucm353513.htm.
55
GUIDANCE, supra note 15, at 13.
56
See id. at 14–15.
57
Id. at 14.
58
Id. at 15.
59
GUIDANCE, supra note 15, at 15.
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exercise “enforcement discretion” and those that the FDA plans to
regulate.60 The FDA notes, however, that the treatment or diagnostic
MMAs that will be regulated include those intended for use in dosage
calculation or in planning the delivery of medicine for radiation
therapy.61 MMAs that only assist with simple calculations, including
calculating Body Mass Index or mean arterial pressure, will only be
subject to enforcement discretion.62
An example of an MMA that assists with dosage calculations is IV
Infusion Calc, an MMA for Android phones that is available free of
charge.63 This app allows the user to enter information about the patient
and the IV drug; it uses algorithms to calculate the appropriate value to
convert from a dose to infusion rate (mL/hr) or to convert from the
infusion rate (mL/hr) to the dose.64
FIGURE 2: IV INFUSION CALC65
01/02/2014 11:18:02
See id. at 15, 23.
Id. at 15.
62
Id. at 18.
63
IV Infusion Calc, GOOGLE PLAY, https://play.google.com/store/apps/ (type “IV
Infusion Calc” in the search bar, press “Enter,” and click on the first option) (last visited Nov.
10, 2013).
64
Id.
65
Id. (demonstrating use of the app to show the ability to calculate infusion rate based on
entered values (screenshots taken by author on Feb. 24, 2013)).
61
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60
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The above images and examples of mobile apps are only meant to
provide an illustration of available functionality medically related
mobile apps. All of the mobile apps used in the examples are available to
be downloaded by the general public, and are not restricted to medical
professionals.
B. MMA Manufacturers
66
01/02/2014 11:18:02
GUIDANCE, supra note 15, at 9.
Id. at 13.
68
Id. at 9.
69
Id.
70
GUIDANCE, supra note 15, at 10.
71
See id. at 10–11.
72
Id. at 11.
67
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An MMA manufacturer is defined as “any person or entity that
manufactures mobile medical apps in accordance with the definitions of
manufacturer” provided in the regulations associated with the FD&C
Act.66 Manufacturers of medical devices, including MMAs, are
responsible for ensuring that their products are developed in accordance
with medical device regulations.67 Generally, any person or entity that
“[c]reates, designs, develops, labels, re-labels, remanufactures, modifies,
or creates a mobile medical app software system from multiple
components” is considered a manufacturer.68 Additionally, any person or
entity that “[i]nitiates specifications or requirements for mobile medical
apps or procures product development/manufacturing services from
other individuals or entities (second party) for subsequent commercial
distribution” is also a manufacturer.69 Finally, any person or entity that
develops combinations of MMAs and hardware to be used as medical
devices or that develops MMAs that provide access to MMAs through a
website is a manufacturer.70
The Guidance points out several persons or entities that do not
qualify as MMA manufacturers.71 Specifically, physicians or health care
professionals who develop apps only for use within their practices are
not considered manufacturers, nor are any persons or entities that
develop medically related mobile apps for teaching or research but not
for commercial sale.72 Additionally, third party MMA distributors,
including app marketplaces (e.g., iTunes App Store, BlackBerry App
World, Google Play or the Android market), and companies that produce
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mobile devices for general use are not considered manufacturers.73
C. Examples of MMA Use in Health Care Delivery
73
01/02/2014 11:18:02
Id. at 10.
See Gullo, supra note 8.
75
Id.
76
Id.
77
Id. (quoting Tim Herbert, Vice President of Research at CompTIA).
78
See Interview with Robert Bona, supra note 2.
79
Interview with Todd Cassese, Doctor, Dir., Clinical Arts and Scis. Course, Assistant
Professor, Dep’t of Med. Scis., Frank H. Netter MD Sch. of Med. at Quinnipiac Univ., in
North Haven, Conn. (Oct. 22, 2012).
80
Interview with Robert Bona, supra note 2.
81
Id.
82
Id.
83
Gold, supra note 4.
84
Katie Hafner, Redefining Medicine with Apps and iPads, N.Y. TIMES, Oct. 9, 2012, at
74
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MMAs are used regularly in practice to make the tasks of health
care professionals more efficient.74 In November of 2011, twenty-five
percent of health care professionals included in an online survey, created
and administered by the Computing Industry Technology Association,
were using tablets on a regular basis to help with treatment and diagnosis
of patients.75 The survey concluded that the percentage of clinicians
using tablets in practice would continue to increase.76
Medically related mobile apps are described as “user-friendly,
affordable, and powerful”77 and they provide physicians with nearly
real-time, updated information.78 Providing the updated information, the
apps are a helpful resource to physicians in answering patient questions
during appointments and in diagnosing patient conditions.79 They are
also used to review drug side effects and to look up drug references.80
The use of MMAs is prevalent throughout the medical field and
likely will continue gaining popularity and functionality over the next
several years.81 Health care professionals who are not physicians,
including nurses and physician assistants, likely will use MMAs on a
more regular basis in the near future.82 There is a great deal of
excitement and anticipation among health care professionals for new
advances in MMA technology that will help improve the health and care
of patients.83
Medical students are being trained on how to use MMAs in medical
school; MMAs are quickly becoming a regular part of medical school
curriculum.84 Handheld technology has been a part of medical education
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01/02/2014 11:18:02
D1, available at http://www.nytimes.com/2012/10/09/science/redefining-medicine-with-appsand-ipads-the-digital-doctor.html?pagewanted=all.
85
Interview with Todd Cassese, supra note 79.
86
Id.
87
Id.
88
Hafner, supra note 84.
89
Id.
90
Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra note
79.
91
Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra note
79.
92
Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra note
79.
93
See Gullo, supra note 8.
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at the University of Chicago for at least ten years.85 In the early 2000s,
the university provided medical students with PDAs through a grant
awarded to a physician with expertise in medical informatics.86 The first
mobile apps used included ePocrates and a document viewer that gave a
listing of pager numbers of students and clinicians.87 Now, “[a]ll
internal-medicine residents at the University of Chicago and Johns
Hopkins are given iPads; entering medical students at Stanford are given
vouchers they can use to buy one.”88 The University of Chicago recently
conducted a study that showed that residents with iPads were generally
able to complete order entries more quickly; most residents felt that
using iPads made them more efficient.89
Professors at the Quinnipiac University Frank H. Netter MD School
of Medicine plan to recommend certain MMAs for students to download
and will teach the students how to use the recommended MMAs
properly.90 The students will be trained on how to interpret the data and
assess the quality of the data provided by MMAs.91 Students will also be
extensively trained on how to research medical conditions and
treatments, diagnose patients, and treat patients using traditional
methods to ensure that they are not solely relying on data from MMAs to
make decisions.92
Now that medical students are being trained to use MMAs in
medical school, it is likely that the percentage of physicians using
MMAs will grow steadily as the new physicians enter practice.93
Because MMAs are growing in popularity and are becoming a standard
in the profession, the regulatory scheme proposed in the Guidance could
impact many health care providers’ practices by reducing the number
and variety of MMAs on the market.
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PART II: PROPOSED MMA REGULATORY FRAMEWORK AND
RECOMMENDATIONS FOR INDUSTRY SELF-REGULATION
The FDA’s goal is to promote public health by ensuring that
medical devices are safe and effective; the Guidance was written in the
spirit of that goal.94 The popularity of MMAs is growing; the President
himself has recognized that it is necessary to develop a regulatory
scheme for health technologies, but that the regulatory scheme must take
many factors into consideration in order to provide successful and
workable solutions.95
In order for an MMA regulatory scheme to be successful, the FDA
should continue striving for a balance between regulating the MMA
industry to further its mission to protect human health and safety. This
would allow new digital and mobile innovations that will help improve
efficiency in the medical profession to come to market.96 To strike this
balance, the FDA should work directly with app manufacturers to
understand and consider the burden that an extensive regulatory
framework will create, and to decide how much an extensive medical
device regulatory framework could hinder innovation.97
The FDA understood the need for balance when it made the
decision to apply only enforcement discretion for some MMAs.98 While
this decision may have been helpful to reduce the risk of overregulation,
health care providers cannot be assured that the FDA has reviewed the
MMAs in the enforcement discretion category, which means the MMAs
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94
See Overview of FDA Mission: Hearing Before the H. Comm. on Oversight & Gov’t
Reform, 110th Cong. (2007) (statement of Andrew C. von Eschenbach, M.D., Comm’r of
Food & Drugs), available at http://www.fda.gov/NewsEvents/Testimony/ucm154019.htm;
See GUIDANCE, supra note 15.
95
See Exec. Order No. 13,563, 76 Fed. Reg. 3,821 (Jan. 18, 2011). The exact text of
section 1(a) states:
Our regulatory system must protect public health, welfare, safety, and our
environment while promoting economic growth, innovation, competitiveness, and
job creation. It must be based on the best available science. It must allow for public
participation and an open exchange of ideas. It must promote predictability and
reduce uncertainty. It must identify and use the best, most innovative, and least
burdensome tools for achieving regulatory ends. It must take into account benefits
and costs, both quantitative and qualitative. It must ensure that regulations are
accessible, consistent, written in plain language, and easy to understand. It must
measure, and seek to improve, the actual results of regulatory requirements.
Id.
96
Cf. id.
97
See Minarovich, supra note 19.
98
See GUIDANCE, supra note 15, at 16–18.
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109
may not provide accurate or safe information.99 This section will discuss
the FDA’s current plans to regulate the MMA industry and some of the
requirements and challenges associated with its regulation. It will
include an overview of newly proposed legislation that would amend the
FD&C Act and notes on other areas of the law that could impact MMA
regulation. The section also will examine why industry self-regulation
may be appropriate for the low-risk apps, over which the FDA plans to
exercise enforcement discretion, to ensure that MMAs used in practice
are of high quality and are safe for patients.
A. Regulatory Authority for mHealth
The FDA is working with a number of other government agencies
to develop a regulatory scheme for the mHealth industry.100 Generally,
the Secretary of Health and Human Services (HHS), acting through the
FDA Commissioner, has the authority to promulgate regulations for
products that fall under the scope of the FD&C Act.101 In this case,
Congress attempted, through proposed legislation, to place a moratorium
on the FDA from issuing any further guidance.102 The threat of the
moratorium arose because of a disagreement about whether Congress
should be enacting legislation to control the MMA industry rather than
allowing the FDA to provide guidance, a position largely argued by the
Health IT Now Coalition.103 Instead of prohibiting the FDA from issuing
the Guidance, Congress allowed the FDA to move forward; in addition,
99
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See GUIDANCE, supra note 15, at 16.
See Phil Ross & Dan Vorhaus, mHealth on the Horizon: Federal Agencies Paint
Regulatory Landscape with Broad Brushstrokes, GENOMICS LAW REPORT (Dec. 5, 2012),
http://www.genomicslawreport.com/index.php/2012/12/05/mhealth-on-the-horizon-federalagencies-paint-regulatory-landscape-with-broad-brushstrokes/.
101
See 21 U.S.C. § 371(a) (2006).
102
Baumann, supra note 12.
103
Eric Wicklund, Path Opens Up for FDA Regulation of Mobile Medical Apps,
HEALTHCARE FINANCE NEWS (June 20, 2012), http://www.healthcarefinancenews.com/
news/path-opens-fda-regulation-mobile-medical-apps. The Health IT Now Coalition consists
of patient groups, health care providers and health care payers that are interested in advancing
health
information
technology.
About
Us,
HEALTH
IT
NOW!,
http://www.healthitnow.org/about-us/ (last visited Nov. 11, 2013). The list of members on the
website includes Aetna, the American Heart Association, The Dow Chemical Company, New
York Presbyterian Hospital, Verizon, and WebMD Health Corp., among others. Id. The
Coalition lists its priorities as sharing information to lower costs, assisting in creating a
regulatory scheme that will improve health, and encouraging innovation in the field of
mHealth. Id. The Coalition notes that one of its missions is to educate Congress through a
comprehensive education program and by holding briefings on Capitol Hill. Id.
100
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Congress charged the FDA with joining other agencies to produce a
report about the appropriate framework for regulation.104
The charge from Congress to the group of agencies is detailed in
section 618, Health Information Technology, of the Food and Drug
Administration Safety and Innovation Act of 2012 (FDASIA).105 The
provision in FDASIA states:
(a) REPORT.—Not later than 18 months after the date of enactment of this
Act, the Secretary of Health and Human Services (referred to in this section as
the “Secretary”), acting through the Commissioner of Food and Drugs, and in
consultation with the National Coordinator for Health Information Technology
and the Chairman of the Federal Communications Commission, shall post on
the Internet Web sites of the Food and Drug Administration, the Federal
Communications Commission, and the Office of the National Coordinator for
Health Information Technology, a report that contains a proposed strategy and
recommendations on an appropriate, risk-based regulatory framework
pertaining to health information technology, including mobile medical
applications, that promotes innovation, protects patient safety, and avoids
regulatory duplication.106
This charge did not delay the FDA from publishing its Guidance, which
was issued on September 25, 2013.107
The regulatory needs for the mHealth industry are diverse;
regulation will come under the purview of several different agencies.108
104
See Wicklund, supra note 103.
See Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144,
§ 618, 126 Stat. 993, 1063 (2012) (codified as amended in 21 U.S.C. § 301).
106
Id.
107
See GUIDANCE, supra note 15.
108
See id. (suggesting that the FDA, the Federal Trade Commission (FTC), the Federal
Communications Commission, the Centers for Medicare & Medicaid Services (CMS), and the
Office of the National Coordinator for Health Information (ONC), all have some jurisdiction
over regulating MMAs). For example, the FTC recently published a guide for mobile app
manufacturers. See FTC Publishes Guide to Help Mobile App Developers Observe Truth-inAdvertising, Privacy Principles, FEDERAL TRADE COMMISSION (Sept. 5, 2012),
http://www.ftc.gov/opa/2012/09/mobileapps.shtm. The guide focuses on helping app
developers understand and adhere to Truth-in-Advertising and Privacy Principles. Id.
Specifically, the guide urges app developers to be truthful about app functionality, to disclose
pertinent information, and to ensure that sensitive user information remains secure. Id. This
example is not exclusive; other agencies have also begun to regulate in this area. In addition to
the group of agencies that have been tasked with developing a framework for regulating
mobile medical technologies and the FTC guidelines discussed above, the FCC has released a
“National Broadband Plan” and the Department of Health and Human Services (HHS) has
required that any medical technology comply with the Health Insurance Portability and
Accountability Act (HIPAA). Ross & Vorhaus, supra note 100. See Marketing Your Mobile
105
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111
Due to the complexity of the regulatory scheme for the field,109 the
mHealth Regulatory Coalition suggested that the FDA create a division
within the agency itself that is staffed with specialists and dedicated to
reviewing and regulating mHealth products.110 It is not clear if the
division will be created, but it would likely be a useful answer to
keeping up with the regulation in this dynamic industry.
App manufacturers, app marketplaces, and app users should be
aware that the regulatory scheme for MMAs likely will include input
from agencies other than the FDA.111 While the framework for how the
agencies will work together to regulate the mHealth industry is still
being determined, the mHealth Regulatory Coalition is already
cautioning agencies against creating a “bureaucratic backlog” or an
unworkable and burdensome regulatory scheme.112
B. The FDA’s MMA Regulatory Framework
The Guidance discusses the approach the FDA plans to take to
regulate MMAs and discusses the regulations that MMA manufacturers
should follow.113 While the Guidance does not impose any legally
binding obligations, the FDA “strongly recommends” that MMA
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App: Get It Right from the Start, FEDERAL TRADE COMMISSION (Apr. 2013), available at
http://business.ftc.gov/documents/bus81-marketing-your-mobile-app, for further discussion
and general guidelines from the FTC on marketing mobile apps.
109
E-mail from Bradley M. Thompson, Esq., Epstein, Becker & Green, P.C., on behalf of
the mHealth Regulatory Coalition, to Bakul Patel, Policy Advisor, Ctr. for Devices &
Radiological Health, Food & Drug Admin. 3–4 (Oct. 19, 2011), available at
http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comment-Letter-onUDI-Proposal-10112012.pdf.
110
Id. at 10.
111
See Wicklund, supra note 103.
112
E-mail from Bradley M. Thompson to Bakul Patel, supra note 109, at 10. The
mHealth Regulatory Coalition was formed in July of 2010, and its membership includes many
non-profit associations, health care providers, mobile app developers, online marketplaces for
mobile apps, and IT companies, among others. Id. at 2. Organization members include:
AT&T, MedApps, Medical Graphics Corp., Nokia, Qualcomm Inc., Roche, Verizon Wireless,
and Massive Health. Id. The Coalition’s purpose is to meet with various stakeholders that will
be impacted by any regulatory scheme created by government agencies, and communicate the
information back to the regulatory agencies to ensure that stakeholders have a voice in the
regulatory process. Id. at 3. The Coalition charges a small fee for membership (and it appears
that for-profit entities pay dues), and it feels that exempting non-profit companies from paying
provides an incentive for a wide variety of groups to become involved in the group. E-mail
from Bradley M. Thompson to Bakul Patel, supra note 109, at 3. The organization claims to
have a very diverse yet unified view of how mobile medical devices should be regulated. Id.
113
GUIDANCE, supra note 15, at 13, 19, 32–36.
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manufacturers follow medical device regulations.114 The FDA also notes
that, although it does not intend to enforce the requirements of the
FD&C Act for certain MMAs, the Guidance does not change any
requirements listed in the FD&C Act or the associated regulations.115
Generally, the FDA recommends that all MMA manufacturers
should follow the Quality System regulations during the development of
MMAs.116 It also notes that MMA manufacturers must properly classify
MMAs under the FDA’s medical device classifications and adhere to the
requirements for those classes.117 Medical device classes I, II and III
represent the level of risk to public health and safety, with class I
carrying the lowest level of risk and class III carrying the highest level
of risk.118
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114
Id. at 4, 13. See id. at 4–5 (“This guidance represents the Food and Drug
Administration’s . . . current thinking on this topic. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and
regulations. . . . FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. . . . The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.” (emphasis omitted)).
115
Id. at 12 n.18. The FDA’s “Good Guidance Practices” explains that guidance
documents are not legally binding, but that individuals choosing to use an “alternative
approach” must still adhere to any statutes or regulations that apply to the action being taken.
21 C.F.R. § 10.115(d)(2) (2013). Additionally, “FDA employees may depart from guidance
documents only with appropriate justification and supervisory concurrence.” Id. §
10.115(d)(3).
116
GUIDANCE, supra note 15, at 13.
117
Id. See generally Classify Your Medical Device, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYour
Device/default.htm (last updated Dec. 3, 2012).
118
Class I devices pose the lowest level of risk to public safety and require the least
amount of oversight. 21 U.S.C. § 360c(a)(1)(A) (2006). The FDA is satisfied that the
requirement of general controls—e.g. registration, Quality System regulations, labeling, and
device reporting, 21 U.S.C. § 360i (2006)—is sufficient to protect public health and does not
require premarket approval for class I devices. 21 U.S.C. § 360c(a)(1)(A) (2006). A medical
device is normally considered to be class I if it is not critical to human life and does not cause
an unreasonable risk of harm to human health. 21 U.S.C. § 360c(a)(1)(A) (2006).
Class II devices need to adhere to special controls (e.g., postmarket surveillance);
however, similar to class I devices, premarket approval is not required for the devices. 21
U.S.C. § 360c(a)(1)(B) (2006). Many app manufacturers that create class I or class II MMAs
may be pleased up front that premarket approvals are not required, but not going through the
premarket approval process may have implications in later products liability suits that are
brought after the devices are on the market. See Demetria D. Frank-Jackson, The Medical
Device Federal Preemption Trilogy: Salvaging Due Process for Injured Patients, 35 S. ILL.
U. L.J. 453, 458 (2011) (noting that Congress would not have intended to immunize
manufacturers from any state or common law tort liability if a devices do not go through
premarket approval). See also infra Part III (discussing products liability).
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113
After the release of the FDA’s Draft Guidance on MMAs,119
members of the mHealth industry criticized the FDA for the expansive
scope of the Draft Guidance and the lack of clarity about which medical
apps would actually be subject to regulation.120 Some groups in the
industry were relieved that the FDA planned to provide a final guidance
to assist app developers with determining how to proceed with
manufacturing and marketing their medically related mobile apps.121 It is
still to be determined whether the Guidance provided a sufficient amount
of clarification.
D. Legal and Regulatory Challenges and Uncertainties
Challenges and uncertainties still exist due to the dynamic legal and
regulatory landscape.122 These challenges and uncertainties could cause
tension between MMA manufacturers and the FDA.123 This tension
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Premarket notification might be required for class I or class II devices, or the devices
may be exempt. Premarket Notification (510k), U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevic
e/PremarketSubmissions/PremarketNotification510k/default.htm (last updated Sept. 3, 2010);
Medical Device Exemptions 510(k) and GMP Requirements, U.S. FOOD & DRUG ADMIN.,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm (last updated Aug. 5, 2013).
“A 510(k) is a premarket submission made to FDA to demonstrate that the device to be
marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed
device (21 C.F.R 807.92(a)(3)) that is not subject to PMA.” Premarket Notification (510k),
supra.
Class III devices are used “in supporting or sustaining human life or for a use which is
of substantial importance in preventing impairment of human health, or . . . presents a
potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii)(I) (2006). These
devices require premarket approval. 21 U.S.C. § 360c(a)(1)(C) (2006). “[Premarket Approval]
is based on a determination by FDA that the PMA contains sufficient valid scientific evidence
to assure that the device is safe and effective for its intended use(s).” Premarket Approval
(PMA),
U.S.
FOOD
&
DRUG
ADMIN.,
http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketA
pprovalPMA/default.htm (last updated Jan. 24, 2012).
119
See Food & Drug Admin., Dep’t of Health & Human Servs., Draft Guidance for
Industry and Food and Drug Administration Staff on Mobile Medical Applications (2011),
available
at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm263280.htm [hereinafter Draft Guidance].
120
E-mail from Bradley M. Thompson to Bakul Patel, supra note 109, at 4.
121
See Ken Terry, New FDA Law Paves Way for mHealth Regulations,
INFORMATIONWEEK (July 24, 2012, 12:13 PM), http://www.informationweek.com/
mobile/new-fda-law-paves-way-for-mhealth-regulations/d/d-id/1105474?.
122
See Gold, supra note 4.
123
See id. (warning that “‘[t]he FDA’s current regulatory process was created when the
floppy disk was around’ – ancient history in the tech world”).
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grows from pressure on IT companies to innovate rapidly and pressure
on the federal government to carefully review and evaluate devices that
affect human health.124 Examples of the challenges and uncertainties
include the increased cost and time associated with getting regulated
MMAs to market and the existence of proposed legislation to amend the
FD&C Act.125 Beyond the scope of this paper, other uncertainties exist
that also could impact the MMA industry, including questions over
patient privacy and the implementation of the new medical device tax,
which would apply to regulated MMAs.126
Regulation likely will increase the cost and time associated with
getting the MMAs to market.127 Mobile MIM, a radiology app, was the
first medically related mobile app to receive approval from the FDA
after the FDA required Apple to remove it from its app store because it
met the definition of a medical device.128 It took two and a half years for
Mobile MIM to obtain FDA approval.129 Another app manufacturer
estimated that obtaining FDA approval could cost hundreds of thousands
of dollars.130 It is very likely that, because of the increase in the time and
cost for the apps to meet regulatory requirements, physicians and health
care providers may see price increases on MMAs in order for app
manufacturers to bring apps into compliance with FDA regulations.131
In October of 2013, House Representatives Blackburn, Green,
124
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See Felasfa Wodajo & Rene Quashie, FDA Regulation of mHealth, Part 2: FDA Scope
& Culture, IMEDICALAPPS (July 27, 2011), http://www.imedicalapps.com/2011/07/fdaregulation-mhealth-part-2-fda-future/.
125
See Minarovich, supra note 19; Press Release, Marsha Blackburn, Representatives
Blackburn, Green, Gingrey, DeGette, Walden and Butterfield Introduce SOFTWARE Act
(Oct.
22,
2013),
available
at
http://blackburn.house.gov/news/
documentsingle.aspx?DocumentID=356090.
126
See Peter McLaughlin & Melissa Crespo, The Proliferation of Mobile Devices and
Apps for Health Care: Promises and Risks, BLOOMBERG LAW (2013),
http://about.bloomberglaw.com/practitioner-contributions/the-proliferation-of-mobile-devicesand-apps-for-health-care-promises-and-risks/; Peter Overby, Why a Medical Device Tax
Became Part of the Fiscal Fight, NPR (Oct. 15, 2013, 5:56 PM),
http://www.npr.org/2013/10/15/234864058/why-a-medical-device-tax-became-part-of-thefiscal-fight; 26 U.S.C. § 4191 (2006) (imposing excise taxes on taxable medical devices).
127
See Minarovich, supra note 19.
128
Felasfa Wodajo, How the iPad Radiology App MobileMIM Became the First to Get
FDA Approval: Interview with CTO Mark Cain, IMEDICALAPPS (Apr. 14, 2011),
http://www.imedicalapps.com/2011/04/how-the-ipad-radiology-app-mobilemim-became-thefirst-to-get-fda-approval-interview-with-cto-mark-cain/.
129
Id.
130
Dan Gorenstein, Medical Apps Get the Once Over from the FDA, MARKETPLACE
(Mar. 29, 2013), http://www.marketplace.org/topics/tech/medical-apps-get-once-over-fda.
131
See Minarovich, supra note 19.
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9-/<3);165: .964 ;0- *-/15515/ 6. ;0- ,-=-3674-5; 796+-:: ;6 -5:<9-
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)5, ;0); ;0-@ ,6 56; 76:- <59-):65)*3- 91:2: ;6 7);1-5;:
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14769;)5; 06>-=-9 ;0); )5 <59-):65)*3- 3-=-3 6. 9-/<3);165 ,6-: 56;
015,-91556=);165>0-9-1;4)@56;*-5-+-::)9@
.;0-)5,;0-
6;0-9-5;1;1-:),,;664)5@),,1;165)33)>:699-/<3);165:;0-.-)96.)
“bureaucratic backlog” or “overburdensome regulation” could become
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a reality, and it could chill innovation and reduce the number of apps
that are developed and brought to market.138
E. Health Care Provider and App Marketplace Contributions to SelfRegulation of the MMA Industry
Although there are still uncertainties about the legal and regulatory
landscapes for MMAs, members of the MMA industry and health care
providers can contribute to industry self-regulation and self-monitoring
in order to ensure that only the highest quality MMAs are used in
practice and that MMAs are used to promote improved patient care.
1. Health Care Providers’ Role in MMA Industry Self-Regulation
138
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Id. at 10.
See Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra
note 79.
140
Krouse, supra note 31, at 745.
141
See generally WEBMD, http://www.webmd.com/ (last visited Nov. 14, 2013).
142
Interview with Todd Cassese, supra note 79.
143
Id.
144
Interview with Robert Bona, supra note 2.
139
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Health care providers are conscious of potential risks associated
with the use of MMAs in practice.139 This section will address three
broad concerns: the use of MMAs by the general public, MMAs
providing incorrect or incomplete information, and physicians failing to
pay close attention to patients during face-to-face appointments. Health
care professionals could address all of these concerns with selfmonitoring.
One concern is that the general public will download and utilize
dosing or diagnostic apps to diagnose and treat conditions without the
advice of a trained health care professional.140 Although this is a
concern, in general, any information that the general public can obtain
through an MMA is also available from other Internet sources (e.g.,
WebMD.com141) or hard copy sources.142
Health care professionals can involve themselves in their patients’
use of MMAs by asking patients if they have consulted MMAs, or if
they are currently using MMAs to obtain health related information.143
Patients, rather than relying solely information from the MMA, should
discuss the information with their health care providers.144 Even if
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145
01/02/2014 11:18:02
Interview with Todd Cassese, supra note 79.
See Interview with Robert Bona, supra note 2.
147
Krouse, supra note 31, at 745.
148
See Interview with Robert Bona, supra note 2. See, e.g., supra note 52 and
accompanying text.
149
See Interview with Todd Cassese, supra note 79.
150
Eric Wicklund, FDA Sets Its Sights on Mobile App Regulations, MHEALTHNEWS (July
19, 2011), http://m.mhealthnews.com/blog/fda-sets-its-sights-mobile-app-regulations.
151
Interview with Robert Bona, supra note 2. See also Interview with Todd Cassese,
supra note 79.
152
Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra note
79.
146
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physicians have never recommended the use of an MMA for patients or
caregivers, physicians likely would be willing to work together with
patients or caregivers to help them understand an MMA and to help
them learn how to use the MMA properly.145 In general, it seems that
MMAs could be a valuable source of information for patients, and could
be used as part of a patient care plan with the advice and input of a
health care provider.146
It was argued that the FDA should create strict regulations of
diagnostic apps because they could be downloaded and used by a
consumer without supervision.147 Since the information obtained from
the MMAs is readily available from other sources, the general public
should not be restricted from downloading the apps, but manufacturers
should include warnings or otherwise communicate to users that it is
advisable to speak to health care providers about the information
obtained from the MMA.148 It is unlikely that patients having access to
medical information would be harmful; health care professionals
approve of patients being able to do research on their own to learn about
medical information so long as the MMA is not being used as a
substitute or replacement for advice from a physician or other health
care provider.149
A second concern is that MMAs could provide physicians with
incorrect or incomplete information that, if used, could harm patients.150
While MMAs that provide assistance with treatment or diagnosis are
regularly used in practice, they are still considered only to be tools.151
Physicians presumably would not make snap decisions simply because
an app is giving them information, and physicians have stated that there
have been times when they have used professional judgment to
“overrule” an app.152
A third concern is that physicians could spend too much time
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153
01/02/2014 11:18:02
Interview with Robert Bona, supra note 2.
Id.
155
Iltifat Husain, Getting in Trouble for Mobile Medical Learning, IMEDICALAPPS (Jan.
20, 2013), http://www.imedicalapps.com/2013/01/trouble-mobile-medical-learning/.
156
Id.
157
Id.
158
Id.
159
See Husain, supra note 155 (“I think the onus is on the medical school for instilling a
culture of mobility . . . .”); Interview with Robert Bona, supra note 2; Interview with Todd
Cassese, supra note 79.
160
See Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra
note 79.
161
See Interview with Todd Cassese, supra note 79.
154
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looking at an iPhone or iPad during a patient appointment instead of
focusing on the patient.153 Because of this concern, it is becoming more
important to teach new physicians to be present with the patient during
appointments, even if they briefly need to consult a mobile tool for
information.154
Other health care professionals share this concern.155 One physician
noted that he presented his brother with an iPad to use for his clerkship
rotation during his third year of medical school.156 In a conversation that
he had with his brother later, he discovered that his brother had been
reprimanded for using the iPad during his rotations.157 The negative
evaluation stated that he was relying too much on digital information,
but the managing physician suggested that the instructors felt that his
brother was using the iPad for “non-medical purposes” during the
rotation.158 Although medical school professors may be concerned with
students who are relying too heavily on digital resources, or with
students who use their mobile devices for purposes that are not related to
the practice of medicine, the new technology likely improves efficiency
overall, and with additional monitoring and training, MMAs can
probably be valuable learning tools for medical students.159
Physicians recognize and appreciate the concerns caused by the use
of MMAs for treating patients; in the absence of clear and binding
government regulation, they can use self-regulation to reduce these
concerns.160 Physicians or health care providers are in a position that
allows them to initiate conversations to inquire whether patients are
using MMAs for treatment or diagnosis advice.161 If patients were using
MMAs, the physicians could work with the patients to answer any
questions they might have or the physicians could assist the patients with
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using the MMAs.162 Additionally, physicians could review MMAs and
recommend trusted MMAs to other practicing health care
professionals.163 Further, medical school professors could recommend
trusted MMAs to students and teach students how to balance the use of
apps and traditional sources.164 Finally, while teaching students how to
properly use MMAs, medical school professors could take the
opportunity to teach students to balance the use of mobile devices with
the importance of being attentive to patients while meeting with patients
in person.165
2. App Marketplaces’ Role in MMA Industry Self-Regulation
App marketplaces may be able to contribute to the self-regulation
of the MMA industry. At least one website that reviews MMAs
voluntarily makes an effort to ensure that physicians have access to apps
that are reviewed and certified by the medical community.166
Happtique.com, a mobile medical app review website, has developed its
own standards guide that it uses to certify medical apps sold through
online app marketplaces.167 In contrast, iMedicalApps.com, a similar
website, has included a comprehensive disclaimer on the bottom of the
front page of its website:
162
01/02/2014 11:18:02
See Interview with Todd Cassese, supra note 79 (being mindful that there may be
liability implications attached to giving a patient advice or “prescribing” an MMA to a
patient). See also Interview with Robert Bona, supra note 2. For more information on
products liability, see infra Part III.
163
Interview with Robert Bona, supra note 2.
164
See Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra
note 79.
165
See Husain, supra note 155; Interview with Robert Bona, supra note 2.
166
See generally HAPPTIQUE, http://www.happtique.com/ (last visited Nov. 14, 2013).
167
Happtique Releases Draft App Certification Program Standards for Public Comment,
HAPPTIQUE (July 11, 2012), http://www.happtique.com/2012/07/11/happtique-releases-draftapp-certification-program-standards-for-public-comment/.
168
IMEDICALAPPS, http://www.iMedicalApps.com (last visited Nov. 14, 2013).
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The iMedicalApps team does not endorse or affirm the validity of the medical
content contained in the medical or healthcare technology we review or
mention. Almost all mobile healthcare or medical applications are not
regulated or reviewed by medical bodies, and as such the validity of their
content should be determined by the end user[;] the iMedicalApps team does
not take this responsibility. When making medical decisions use your own
clinical judgment.168
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169
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See GUIDANCE, supra note 15, at 10–11.
DRAFT GUIDANCE, supra note 119, at 16–17 (calling app marketplaces distributors
and requiring them to ensure that necessary actions like removal of an app from distribution is
done quickly).
171
E-mail from Bradley M. Thompson to Bakul Patel, supra note 109, at 3.
172
Id. at 7.
173
Id.
174
See, e.g., Krouse, supra note 31, at 752–53 (noting that Apple requires developers to
follow laws and regulations for MMAs).
175
In December of 2013, Happtique posted updated standards for its certification
program. Health App Certification Program, Certification Standards, HAPPTIQUE (Dec. 9,
2013), http://www.happtique.com/docs/HACP_Certification_Standards.pdf. The standards
170
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According to the Guidance, there is no plan to hold companies or
websites responsible as manufacturers if they solely act as
marketplaces.169 It is not clear whether providing app certifications, app
reviews, or app demonstrations could cause a website that is actively
certifying and putting stamps of approval on certain MMAs available in
app marketplaces, like Happtique, to fall within the purview of the
Guidance.
In the Draft Guidance, app marketplaces were considered
distributors and were expected to work with manufacturers to ensure that
any required actions for apps were done in a timely manner.170 The
mHealth Regulatory Coalition disagreed with the view that mobile
medical app marketplaces should have any accountability under FDA
regulations, and instead argued that app marketplaces should not be
treated as distributors, or be regulated at all.171 The Coalition disagreed
with app marketplace regulation because of the belief that a marketplace
is comparable to a “shopping mall” where the mall itself is only a venue,
and nothing more; it also noted that treating app marketplaces as
distributors would place too significant a burden on app marketplaces.172
The Coalition communicated a fear that placing too significant a burden
on app marketplaces would discourage the marketplaces from carrying
mobile medical apps altogether.173 The Guidance reduced accountability
for online marketplaces seemingly based on the Coalition’s feedback.
While it might not be necessary to name online marketplaces as
regulated entities, the marketplaces could be an integral and useful
resource for an industry effort to self-regulate mobile medical apps.174
Online marketplaces could contribute to self-regulation by working with
websites like Happtique, and perhaps putting Happtique certified apps in
a special category to draw attention to any particular apps have been
reviewed and certified.175 Additionally, app marketplaces could require
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app developers to sign agreements that ensure any mobile medical apps
that are sold through the marketplace comply with all laws and
regulations, including all FDA regulatory requirements.176 Apple
currently requires this from any mobile medical app developers that it
works with.177 Admittedly, marketplaces may not be amenable to
singling out certain apps with seals of approval because marketplaces are
trying to sell all medical apps, whether they are approved or not; the self
regulation efforts should not, however, be too burdensome for app
marketplaces to take part in the industry’s self-regulation efforts, and the
marketplaces may act as valuable assets since they offer a place where a
person can go and find a large group of apps to purchase at one time.178
PART III: THE EFFECT OF PROPOSED FDA REGULATION ON THE
PRODUCTS LIABILITY CAUSE OF ACTION FOR HARM CAUSED BY AN APP
THAT ASSISTS IN DIAGNOSIS OR TREATMENT OF DISEASE
One of the major areas of law that could be affected by the FDA’s
intention to regulate MMAs is the area of products liability.179 With the
intended regulation described in the Guidance,180 plaintiffs and app
manufacturers might question whether state or common law products
liability causes of action would be preempted. Recent Supreme Court
decisions show that, although an express preemption clause exists in the
Medical Device Amendments of the FD&C Act, there is no guarantee
that federal law would preempt state or common law products liability
claims for MMAs.181
This section will review the current common law framework for
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cover operability, privacy, security, and content of the mobile apps it certifies. Id. at 2.
Standard OP9 specifically deals with whether the app complies with the FDA’s medical
device regulations. Id. at 6.
176
See Krouse, supra note 31, at 752–53.
177
Id.
178
E-mail from Bradley M. Thompson to Bakul Patel, supra note 109, at 7.
179
MMAs should be considered products based on the standard definition of the word.
Black’s Law Dictionary defines “product” as “[s]omething that is distributed commercially
for use or consumption and that is usually (1) tangible personal property, (2) the result of
fabrication or processing, and (3) an item that has passed through a chain of commercial
distribution for ultimate use or consumption.” BLACK’S LAW DICTIONARY 601 (4th Pocket
ed. 2011). While the MMA on its face does not seem to be a tangible product, the MMA
transforms the mobile device into a tangible medical device based on its functionality.
180
See generally GUIDANCE, supra note 15.
181
See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22 (2008); Medtronic, Inc. v.
Lohr, 518 U.S. 470, 495 (1996).
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products liability causes of action. It will also discuss whether federal
law would preempt common law or state law products liability causes of
action for harm resulting from the use of MMAs. Finally, it will discuss
whether the learned intermediary doctrine would shield MMA
manufacturers from products liability causes of action.
A. Products Liability Framework
In the absence of federal preemption due to regulation under federal
law, products liability for medical devices is either addressed by state
law,182 or by the Restatement under a common law torts theory in states
that have chosen to adopt the provisions of the Restatement.183 Levels of
liability can vary significantly based on the products liability regime that
a particular court chooses to follow.184 MMA manufacturers should be
mindful of the common law liability framework, because there is no
guarantee that federal preemption will always apply.185
Several states follow the framework set out in the Restatement
(Second) of Torts to determine the level of liability for manufacturers of
products that cause harm to users.186 In section 402A, the Restatement
(Second) explains that a manufacturer of a product is strictly liable for
harm that comes to a consumer or user if the product was unreasonably
dangerous due to a defect, where the product’s condition was
substantially the same as when the manufacturer sold it.187 Because this
is a strict liability theory, the manufacturer is still liable even if “all
possible care” was used when the product was manufactured, and even if
the consumer did not purchase the product directly from the
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Individual state laws will not be discussed in detail here as states differ on how
products liability cases are decided. Jim Beck, What’s up with the Third Restatement?, DRUG
& DEVICE LAW BLOG (Sept. 10, 2010), http://druganddevicelaw.blogspot.com/
2010/09/whats-up-with-third-restatement.html. Many state courts follow either the
Restatement (Second) or Restatement (Third) paradigm when deciding products liability
cases. Id. Other states (e.g., Arkansas, Indiana, and Ohio) have specific products liability
statutes that courts follow. Id. Still other states (e.g., Delaware, Michigan, and North Carolina)
do not adopt strict liability theories. Id. Delaware actually declared strict liability
“impermissible judicial legislation.” Beck, supra.
183
DAVID G. OWEN ET AL., MADDEN & OWEN ON PRODUCTS LIABILITY § 23:4, at 607
(3d ed. 2012).
184
Beck, supra note 182.
185
See Lohr, 518 U.S. at 495.
186
See OWEN ET AL., supra note 183, § 23:4, at 607.
187
RESTATEMENT (SECOND) OF TORTS § 402A (1965).
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182
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188
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Id.
Johannsen v. Zimmer, Inc., No. 3:00CV2270, 2005 WL 756509, at *7 (D. Conn. Mar.
31, 2005) (noting that Connecticut uses a “modified consumer expectation” test which
contemplates that a consumer may not be able to “‘form expectations of safety’” for products
that are complex).
190
RESTATEMENT (SECOND) OF TORTS § 402A cmt. g (1965).
191
Id. § 402A cmt. j.
192
Id.
193
Id.
194
See RESTATEMENT (SECOND) OF TORTS § 402A cmt. k (1965).
195
Id.
196
Id.
197
See, e.g., IV Infusion Calc, supra note 63.
189
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manufacturer.188 The approach set out in the Restatement (Second) of
Torts is sometimes called the “consumer expectation test” in which strict
liability is applied when the product is unreasonably dangerous due to
flaws in the manufacturing process and flaws in the design that are not
generally known (or contemplated) by the consumer.189
The manufacturer or seller of the product is not liable for harm
suffered by a consumer or user due to the consumer or user mishandling
or using the product in an unreasonable manner unless the misuse is
foreseeable or if a design innovation could have protected against the
misuse.190 To ensure that a product is not used in an unreasonable way,
the manufacturer may need to provide a warning to consumers.191 A
warning is required if the danger related to the product would not be
generally known to or discernible by a consumer.192 Manufacturers can
assume that consumers or users will read and abide by warnings that are
given, so long as they are clear; they can also assume that the warning
will preclude the finding that the product was “defective” or
“unreasonably dangerous” to consumers unless the manufacturer has
failed to address a readily foreseeable danger.193
Some products, including pharmaceutical products and medical
devices, could be considered “unavoidably unsafe products.”194 In the
case of an unavoidably unsafe product, the benefits that the product
brings to society are balanced against the danger or risk that is inherent
in the product.195 If the societal benefit outweighs the danger, if the
product is “properly prepared and marketed, and if proper warning is
given,” the manufacturer of the product will not be subject to strict
liability should a consumer suffer harm while using the product.196
Currently, MMAs do not always warn users of improper use.197 The
Differential Diagnosis app is one that currently provides a warning to
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198
01/02/2014 11:18:02
Differential Diagnosis, supra note 49.
Id.
200
See RESTATEMENT (SECOND) OF TORTS § 402A (1965).
201
See id.
202
See RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. § 2 cmt. a (1998). The
Restatement (Third) of Torts: Products Liability includes a special section for prescription
drugs and medical devices. Id. § 6. Because MMAs that aid in diagnostic and treatment are not
solely being offered by prescription only, but instead, are offered to the general public or
health care providers, this section does not apply broadly to this discussion. See id.
203
Id. § 2 cmt. a.
204
RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. § 2 cmt. a (1998).
205
Id. § 2 cmt. d.
199
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consumers.198 The warning states that accuracy is not guaranteed for any
of the information contained in the MMA, and it notes that the app
should not be used in place of seeking an opinion from a licensed
medical professional.199 Without a warning to consumers, it is possible
that a consumer could trust the MMA to provide an accurate diagnosis or
calculation for dosing a drug, and the consumer may not be able to
discern whether the product is giving accurate information.200 Without
an adequate warning, liability may be imposed on the app
manufacturer.201
The Restatement (Third) of Torts created categories of defects,
refining the analysis for products liability actions where a person was
harmed by a defective product.202 The Restatement (Third) retains the
strict liability theory for manufacturing defects based on the rationale
that holding manufacturers to a strict liability standard would create
incentives for manufacturers to focus on safety during the manufacturing
process.203 It also retains strict liability for manufacturing defects on
fairness grounds, because many manufacturing defects are caused by
failures in the manufacturers’ quality control programs, and
manufacturers, in the absence of strict liability, would likely be able to
avoid liability because it is very difficult for plaintiffs to prove that those
failures actually occurred.204
Additionally, in products liability actions based on product design
defects or inadequate warnings, the Restatement (Third) moves away
from strict liability and, instead, advances a “risk-utility balancing”
analysis theory.205 This theory allows courts to complete an independent
evaluation of the sacrifices to product usefulness and efficiency that
were made in order to make the product safer, and of the sacrifices to
safety that were made in order to make the product more efficient or
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206
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Id. § 2 cmt. a.
Id.
208
RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. § 2 cmt. a (1998).
209
Id.
210
Id. § 2 cmt. b.
211
GUIDANCE, supra note 15, at 26–28.
212
Id. at 5. See also Benjamin Jelle Visser & Jonathan Bouman, There’s a Medical App
for That: Students Should Be Wary when Using Medical Apps, But a Few Questions Can Help
Sift
the
Good
from
the
Bad,
MEDSCAPE
TODAY
NEWS
(2012),
http://www.medscape.com/viewarticle/763009_3 (recognizing that “the advent and rapid
growth of the medical app market has increased the risk of using an app that is unreliable”).
213
See Visser & Bouman, supra note 212.
214
Id.
207
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useful.206 The Restatement (Third) moved to this model because it is
difficult to determine what consumers expected from product designs or
warnings.207
The Restatement (Third) also notes that liability for product design
and product warnings should only be based on risks that were
foreseeable at the time that the product was marketed because, if a strict
liability theory applied, it would encourage the manufacturer to increase
safety precautions that would cause an unreasonable decline in
efficiency in the product.208 To clarify this point, the Restatement
(Third) notes: “Society does not benefit from products that are
excessively safe—for example, automobiles designed with maximum
speeds of 20 miles per hour—any more than it benefits from products
that are too risky.”209 In the alternative, section 2(b) states that a product
could be considered defective in design where foreseeable risks could
have been avoided by using an alternative design for the product.210
While MMAs improve efficiency in medical practice, many unique
safety and risk issues are associated with this technology that may not be
present in more traditional medical devices (e.g., x-ray machines).211 It is
both difficult and important to recognize and define the risks associated
with MMAs because technology and design of apps is changing at a
rapid pace.212
One unique concern about MMAs is that they offer sophisticated
functionality and are widely available to large groups of people through
app marketplaces, but once most apps are downloaded, the actual apps
are predominately used offline and may not be able to be recalled from
the market.213 Dangerous MMAs could be removed from online
marketplaces in order to stop consumers from downloading them, but
this would not effectively recall the apps from all current users.214 Some
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mobile apps include the functionality that allows app developers to track
information from people who download the apps, and this may offer a
way for developers to recall devices.215 The FTC, however, has asked
that a do-not-track feature be added to mobile apps in order to protect
consumers’ privacy.216 It is unclear whether this would hinder app
developers’ abilities to track and recall MMAs that pose dangers to
consumers.
Another concern is the chance that bugs217 could be present in
MMAs, which could make the MMAs function improperly.218 Bugs in
apps are common, and it is very difficult for all of the bugs to be worked
out of an app before its release.219 There are some tools available for app
manufacturers that allow them to look for bugs in a program, but the use
of those tools do not guarantee that an app will be bug-free.220
MMAs are unique products and different concerns are associated
with MMAs than those from traditional medical devices.221 MMA
manufacturers should closely monitor changes in how common law or
state law products liability actions are handled by courts across the
country to ensure that the risks are addressed with potential liability in
mind.222
B. Federal Preemption of State and Common Law where a Person Has
Been Harmed by an MMA
FDA regulation of MMAs, in certain circumstances, could lead to
215
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Understanding
Mobile
Apps,
ONGUARDONLINE
(Sept.
2011),
http://www.onguardonline.gov/articles/0018-understanding-mobile-apps.
216
Edward Wyatt, F.T.C. Suggests Privacy Guidelines for Mobile Apps, N.Y. TIMES
(Feb. 2, 2013), at B1, available at http://www.nytimes.com/2013/02/02/technology/ftcsuggests-do-not-track-feature-for-mobile-software-and-apps.html?_r=0.
217
A software bug is defined as a problem with the logic in a software program (e.g., an
app) that causes the software to crash. Definition of: Software Bug, PC MAG,
http://www.pcmag.com/encyclopedia/term/51664/software-bug (last visited Nov. 23, 2013). A
software bug can also cause an app to give incorrect information without crashing, which is
why testing is needed to try to find bugs before an app is put on the market. See id.
218
See Seth Porges, 5 Things that Keep App Developers up at Night, FAST COMPANY
(July 25, 2012, 1:55 AM), http://www.fastcompany.com/1843635/5-things-keep-appdevelopers-night.
219
See id.
220
Id.
221
See GUIDANCE, supra note 15, at 6.
222
See Nicholas Weiss, An App a Day Will NOT Keep the FDA Away: The Rise of Mobile
Medical
Applications,
JD
SUPRA
LAW
NEWS
(Apr.
26,
2013),
http://www.jdsupra.com/legalnews/an-app-a-day-will-not-keep-the-fda-awa-87306/.
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preemption of state or common law causes of action if an individual is
harmed by an MMA.223 Health of citizens is traditionally a concern of
the state, but courts have ruled that federal laws that regulate medical
devices can preempt state strict liability and state tort law.224 Conflicts
could arise between federal administrative law and state tort law because
the laws are thought to serve separate purposes.225 State tort law has
been recognized as having the purpose of deterring bad behavior and
making the victim of a tortfeasor whole.226 Federal administrative
regulation has been recognized as being a tool used to define guidelines
and achieve societal benefits through regulation of specific industries or
fields.227 Preemption occurs when a federal statute expresses that it will
preempt state law, or when a federal statute implies that it will preempt
state law.228 Implied preemption is usually recognized in two different
cases: conflict preemption or field preemption.229
In the case of medical devices, there is an express preemption
clause in the 1976 Medical Device Amendments of the Food, Drug, and
Cosmetic Act.230 The text of section 360k(a) states:
(a) General rule
Except as provided in subsection (b) of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a
device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under this
chapter.231
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See Riegel v. Medtronic, Inc., 552 U.S 312, 321–22 (2008).
See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 493–94 (1996).
225
Peter H. Schuck, FDA Preemption of State Tort Law in Drug Regulation: Finding the
Sweet Spot, 13 ROGER WILLIAMS U. L. REV. 73, 75 (2008).
226
Id. at 75–76.
227
Id. at 76.
228
Id. at 79.
229
Schuck, supra note 225, at 80 (stating conflict preemption happens when there is
inconsistency between federal statute and state law, and stating field preemption happens
when the federal regulatory scheme is meant to regulate the entire field in question).
230
21 U.S.C. § 360k(a) (2006).
231
Id. Subsection (b) notes that the Secretary may grant exemptions for a state that
applies for an exemption if there is compelling reason to do so, the requirement is more
stringent than required by federal law, and the requirement does not make the device violate
any of the provisions under the chapter. Id. § 360k(b).
224
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232
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See Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22 (2008).
See, e.g., id. at 330; Medtronic, Inc. v. Lohr, 518 U.S. 470, 502–03 (1996).
234
Lohr, 518 U.S. at 493–94 (holding that there was no preemption where a pacemaker
did not undergo a full premarket approval but was approved under a substantial equivalency
theory).
235
See Matthew Coleman, FDA to Regulate Mobile Medical Apps, EMERGENCY
MEDICINE
NEWS
(Nov.
17,
2011),
http://journals.lww.com/emnews/Fulltext/2011/11171/FDA_to_Regulate_Mobile_Medical_Apps.3.aspx; Medical Device
Exemptions 510(k) and GMP Requirements, supra note 118; Lohr, 518 U.S. at 493–94.
236
518 U.S. at 493–94.
237
Id. at 494 (noting that the 510(k) exemption was only meant to maintain the “status
quo” and that status quo included medical device manufacturers having to defend their
products against products liability claims).
238
Gregory J. Wartman, Life After Riegel: A Fresh Look at Medical Device Preemption
One Year After Riegel v. Medtronic, Inc., 64 FOOD & DRUG L.J. 291, 297 (2009).
233
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While this express preemption seems to preclude the use of common law
claims in all medical device cases, courts must make additional inquiries
about whether state law or common law claims are “different from” or
“in addition to” any requirements established by the FDA.232 According
to recent case law, MMA manufacturers cannot assume that all common
law claims will be preempted by federal regulations.233
The Supreme Court has held that claims involving medical devices
that have not gone through the premarket approval process may not be
subject to federal preemption.234 It is important for MMA manufacturers
to understand that they might still be liable under some state or common
law claims, because many MMAs intended to aid in diagnosis or
treatment likely would be classified as class I or class II devices and may
qualify for exemption from the premarket approval process.235 In
Medtronic Inc. v. Lohr, the Supreme Court explained that the FDA did
not impose any specific requirements on the manufacturer of a
pacemaker because the pacemaker was exempted from the premarket
approval process.236 The Court also noted that there was no evidence that
Congress intended the 510(k) exemption process to allow a medical
device manufacturer to avoid having to defend against common law
negligent design claims.237 It has been suggested, and some courts have
held, that manufacturers of medical devices that do not undergo
premarket approval may still be able to assert a preemption defense if
the FDA evaluated the specific device and imposed additional safety
requirements on the manufacturer.238
In addition, MMA manufacturers cannot assume that a state would
not be able to award damages to a plaintiff where the plaintiff’s claims
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239
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Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008).
Id. The plaintiffs in Riegel sued after Charles Riegel was harmed during an
angioplasty where an FDA-approved Evergreen Balloon Catheter was overinflated, even
though the warning accompanying the device indicated that the device should not be inflated
beyond a certain pressure. Id. at 320.
241
Id. at 330.
242
Wartman, supra note 238, at 299–300.
243
Id. at 300.
244
Frank-Jackson, supra note 118, at 485.
245
See Riegel, 552 U.S. at 330; Medtronic, Inc. v. Lohr, 518 U.S. 470, 493–94, 502–03
(1996) (holding that none of the Lohrs’ claims were preempted).
246
See GUIDANCE, supra note 15, at 12, 12 n.18 (noting that, although those mobile apps
meet the MMA definition, the FDA does not intend to enforce the FD&C Act requirements
240
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are “parallel” to federal requirements.239 The plaintiffs in Riegel v.
Medtronic, Inc. did not prevail on a “parallel” claim theory because they
failed to argue that their claims were parallel under state law either to
any courts below or in their brief to the Supreme Court.240 A “parallel”
state law claim would be under a state law that had the purpose of giving
a damages remedy to plaintiffs in the event that the offending medical
device was manufactured in a way that violated FDA regulations.241
In the years following Riegel, plaintiffs have changed the way that
they plead medical device cases in attempts to show that their state law
claims impose liability parallel to federal law, but not different from or
in addition to federal law.242 Parallel claims have included “failing to
comply with FDA requirements—i.e., the medical device was not
manufactured, labeled, packaged or marketed in accordance with its
PMA approval.”243 It has been argued that courts should not
automatically rule that common law causes of action are preempted
under the Medical Device Amendments because Congress intended for
the Medical Device Amendments to offer protection to consumers, and
because granting preemption would effectively exempt device
manufacturers from accountability under traditional state police
powers.244 Given the decision in Lohr, and the potential avenues around
federal preemption discussed in Riegel, MMA manufacturers should not
assume that causes of action brought against them under common law
theories will enjoy a federal preemption defense.245
For cases where state and common law products liability regimes
are preempted by FDA regulation, the Guidance may have created a
category of manufacturers of MMAs that could effectively be insulated
from liability in a products liability causes of action without their MMAs
ever having been evaluated by the FDA.246 MMA manufacturers are still
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required to follow the FD&C Act and the applicable regulations for all
MMAs, but the FDA has defined several MMAs as being low risk to
human health and has made clear that it only intends to use enforcement
discretion for those MMAs.247 If state and common products liability
laws were preempted, plaintiffs likely would have no recourse against
the MMA manufacturers because the Supreme Court held that “an
agency’s decision not to take enforcement action should be presumed
immune from judicial review,” and that the choice of an agency not to
pursue an enforcement action is generally left to the absolute discretion
of that agency.248 If an MMA manufacturer is immune from products
liability causes of actions, plaintiffs likely will try to hold health care
providers liable for any harm caused by MMAs. This risk may provide
additional incentive for health care professionals to self-regulate the
MMA industry.
C. Manufacturer Duty to Warn and the Learned Intermediary Doctrine
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even though the requirements still exist for those MMAs).
247
Id.
248
Heckler v. Cheney, 470 U.S. 821, 831–32 (1985).
249
See Kane, supra note 23, at 1.
250
See Gold, supra note 4.
251
See, e.g., mRx Prescribing Tool, HAPPTIQUE, http://www.happtique.com/mrx-mobileplatform/ (last visited Aug. 28, 2013).
252
Kane, supra note 23, at 1.
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The learned intermediary doctrine may apply in the context of an
MMA products liability failure-to-warn action.249 Currently, many
MMAs that aid in diagnosis and treatment are available to the general
public through app marketplace websites rather than by prescription.250
Because of the fast developing MMA industry, however, the time is
coming in which physicians could regularly prescribe apps that aid
patients in diagnosis and treatment.251
The learned intermediary doctrine is traditionally applied in
products liability failure-to-warn cases where a physician or other
learned intermediary prescribes a drug or a medical device to a
patient.252 The doctrine is premised on the idea that manufacturers of
medical devices that are only available with a prescription do not have a
duty to warn consumers or recipients of the potential adverse effects or
risks associated with the medical device directly, but rather that the
manufacturers only have to warn a prescribing “learned intermediary” of
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those potential issues.253 At least one jurisdiction has applied the learned
intermediary doctrine to medical devices and drugs.254
In contrast, manufacturers of over-the-counter products are required
to warn consumers or users directly.255 Because manufacturers have a
duty to warn consumers directly about potential adverse effects or risks
that could be caused by a product available over-the-counter, the learned
intermediary doctrine has not applied in cases in which a medical device
was available over-the-counter.256 In Mitchell v. VLI Corp., the court
pointed out that the learned intermediary doctrine did not apply where a
physician recommended the use of an over-the-counter contraceptive
sponge to a patient and provided the patient with a sponge during an
office visit, because the product was available to be purchased over-thecounter, without a prescription.257 Similarly, the MMA manufacturer
likely could not use the learned intermediary defense where a physician
recommended an over-the-counter, or non-prescription, MMA to a
patient, or worked with a patient to teach him or her how to use or
interpret data that was provided by an MMA.258
If MMAs are available only by prescription in the future, app
manufacturers could use the learned intermediary doctrine as a defense,
or plaintiffs could bring medical malpractice claims against physicians
where federal law has preempted causes of action against the app
manufacturers.259 Happtique recently introduced a program called the
mRx Mobile Platform that allows physicians to prescribe certain MMAs
to patients based on the patients’ needs.260 This program allows
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253
Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1366–67 (S.D. Fla. 2007). See id. at 1368
(“The rationale behind the doctrine is that patients do not have access to prescription
medicines without the intervention of the learned intermediary . . . . Given that rationale, it
makes even more sense to apply the doctrine in the context of medical devices. While some
individuals could conceivably gain access to prescription drugs without their doctor’s
assistance, it is not reasonably conceivable that an individual could obtain and implant a
device that requires a trained surgeon without the intervention of a physician. Moreover, it is
highly likely [that] a patient and doctor spend considerably more time discussing the risks and
benefits of a surgically implanted device than they would discussing the risks and benefits of
routinely prescribed prescription drugs.”).
254
Id. at 1367 (discussing applicability of the learned intermediary doctrine for a
prescription prosthetic knee medical device).
255
Mitchell v. VLI Corp., 786 F. Supp. 966, 970 (M.D. Fla. 1992).
256
Id.
257
Id.
258
See id.
259
See Kane, supra note 23, at 1.
260
mRx Mobile Prescribing Tool, supra note 251.
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physicians to prescribe MMAs by sending an e-mail with a secure link to
the app.261 It would seem to follow that if the app that the physician
prescribed met the definition of a medical device, and if the app also
were only available to the patient through the secure link, and not
through a general app marketplace, the patient or the app manufacturer
could argue that the app was a prescription medical device, and that the
learned intermediary doctrine should apply.262 Although this program is
new to the market, a physician’s involvement with prescribing MMAs
could insulate the MMA manufacturer from a lawsuit.263
CONCLUSION
261
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Id. (noting that videos and material other than apps can also be sent to patients under
this program).
262
See Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1367 (S.D. Fla. 2007) (discussing
applicability of the learned-intermediary doctrine for a prescription prosthetic knee medical
device).
263
See id.
264
Gullo, supra note 8.
265
Hafner, supra note 84.
266
GUIDANCE, supra note 15, at 4.
267
Interview with Robert Bona, supra note 2; Interview with Todd Cassese, supra note
79.
268
See Minarovich, supra note 19.
269
See E-mail from Bradley M. Thompson to Bakul Patel, supra note 109, at 5.
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MMAs are being used with increasing frequency in medical
practice; regulation of the MMA industry will impact both app
manufacturers and health care professionals.264 MMAs have become
common tools to use in the medical industry and medical schools are
training physicians to use apps and interpret the quality of app data.265
The FDA issued its Guidance to address concerns about the risk of
mobile medical app use to patient health and safety.266 While some
physicians agree that the FDA should regulate certain types of mobile
medical apps, they are concerned that over-regulation could cause delays
in the release of technology that can help them be more efficient and
effective in practice.267
App manufacturers must prepare for and be conscious of the
increased levels of responsibility associated with the proposed regulatory
paradigm.268 Health care providers must be conscious that proposed
regulations could potentially chill innovation and cause a decrease in the
availability of MMAs.269 Additionally, because the FDA will only
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270
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See GUIDANCE, supra note 15, at 16–18.
See Nicholas Weiss, supra note 222; Interview with Robert Bona, supra note 2;
Interview with Todd Cassese, supra note 79.
272
See Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008); Medtronic, Inc. v. Lohr, 518
U.S. 470, 502–03 (1996).
273
See Kane, supra note 23, at 1.
271
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exercise “enforcement discretion” over some MMAs, health care
providers will not have assurance that the FDA evaluated the quality or
safety of those MMAs.270 Members of the health care community,
including health care providers and app marketplaces may be able to
work together to provide some self-regulation of the industry to help
ensure safety and quality care for patients.271
The proposed regulations could also change the landscape of
products liability for MMAs. Although app manufacturers may assume
that FDA regulation of MMAs will guarantee that they are insulated
from common law products liability actions, in light of recent Supreme
Court cases analyzing preemption as applied to medical device
regulation, it is unclear whether manufacturers could be held liable for
harm caused by a health care provider’s recommendation of an MMA.272
This risk should further motivate health care providers to self-regulate
the industry because, if manufacturers are insulated from liability,
patients likely will try to hold health care providers liable for any harms
caused by the use of MMAs in practice. Additionally, while the learned
intermediary doctrine would likely not apply when physicians
recommend “over-the-counter” MMAs that aid in diagnosis or treatment
to patients or assist patients with using those apps, the doctrine may
apply if the industry moves towards allowing apps to be accessed by
prescription only.273
Ultimately, the FDA should work closely with the health care
community to ensure balance between allowing important innovation
that will ultimately benefit the practice of medicine to move forward and
advancing an extensive regulatory paradigm that is meant to advance
patient health and safety.