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Mobile health care applications: authorship, regulatory challenges, and the role of medical writers.

Mobile medical and health applications (apps) have revolutionized health care; consumers, patients, and health care practitioners use these smartphone and mobile communication device-enabled applications to manage their health in ways that can put health care, quite literally, in their own hands. From apps that can help track weight, caloric intake, and exercise to apps that provide important information about the effects of medications on breast milk, these programs have the potential to guide people to make improved health-based decisions in their lives. Other apps are designed for health care professionals to help them with such complex issues as treating radiation injuries or diagnosing cancer or heart rhythm abnormalities. (1) These are but a few of the thousands of uses described by developers in the mobile health app market.

Because of the diversity of app types and audiences and the need for credible health care communication, the expanding app market is of potential importance to a wide range of medical writers and editors, including those who work on medical-device regulatory documents, patient education resources, or continuing education materials designed for researchers or practicing health care professionals. This article provides an overview of the mobile health market, the regulatory environment, standards of review within the industry, and opportunities to improve mobile health apps by the inclusion of medical writers and editors in app development.

MEDICAL AND HEALTH APPS: AN EXPLODING MARKET

Research2guidance, a German market research firm, estimated in 2014 that the mobile health app market, which reached $2.4 billion in revenue in 2013, would rocket forward to a whopping $26 billion by the end of 2017. (2) Over the past several years, the number of applications has more than doubled; in 2014, the number of health apps published for the iPhone iOS system and Android reached more than 100,000 available apps. The firm also estimates that nearly 250 million people downloaded a health app in 2012. This number was projected to double to 500 million users by 2015. By 2018, it is estimated that nearly 50% of the world's 3.4 billion smartphone and tablet users will download a mobile health app of some kind. Even though the public is seen as the main audience for many of these apps, a rather notable portion of the mobile health apps, at 43%, were designed primarily for health care professionals. (3) It is apparent from these numbers that health apps are popular with the public and with health care specialists alike, but who is it that is creating these apps, and what concerns should we consider with such authorship as this market continues to explode?

AUTHORSHIP OF MOBILE HEALTH APPS: FACTS AND CONCERNS

According to the research2guidance report, traditional health care information gatekeepers, such as hospitals and insurers, surprisingly author just 3.4% of total mobile health app publications. The reach of the apps provided by these entities is even smaller: in downloads, such apps are often far below the average. In a 2013 article in AAOS Now, a news magazine from the American Academy of Orthopaedic Surgeons, Orrin I. Franko, MD, expressed concerns with the authorship of apps. He noted that developers often write app software without any formal medical training and that because many apps are not required to be reviewed by physicians or medical associations "involvement of professional oversight is purely voluntary." (4) In 2012, O'Neill and Brady examined 68 apps focused on colorectal disease and found that only 32% had named medical professional involvement in their development or content. (5) Furthermore, as Franko noted, many apps include a legal statement of some sort, but "they are not required to disclose their limitations or information sources. As a result, a legitimate concern regarding the development of harmful apps exists." (3)

Concern regarding health apps written and published by nonexperts extends from concerns about where the information is coming from as well as the safety and soundness of some of the treatments some apps suggest to consumers. In a 2012 Washington Post article, Rochelle Sharpe of the New England Center for Investigative Reporting, noted: "Many of these apps do not follow established medical guidelines, and few have been tested through the sort of clinical research that is standard for less new-fangled treatments sold by other means." (6)

Sharpe led an effort to examine health apps in 2012 and found, in an examination of 1,500 paid health apps, that more than 1 out of 5 apps asserts that it can treat or even cure medical problems and offered options such as lights from one's cellphone or phone vibrations to aid in medical treatments. Deceptive practices can get app makers into trouble with the Federal Trade Commission (FTC). In 2015, as the result of FTC action, marketers of 2 apps agreed to settlements that bar them from continuing to make unsupported claims that their apps could detect early symptoms of melanoma. (7)

THE PROMISE OF MOBILE HEALTH APPS FOR PRACTITIONERS

Some health apps, of course, have great promise, especially the segment of the market designed for health care professionals. "To be sure, there are many outstanding health apps, particularly those intended for doctors and hospitals, that are helping to revolutionize medical care," Sharpe noted. (6)

C. Lee Ventola wrote in the May 2014 issue of Pharmacy and Therapeutics that among medical school health care professionals (HCPs) and students, "the use of medical apps has become frequent and widespread; 70% of medical school HCPs and students reported using at least one medical app regularly, with 50% using their favorite app daily." (8) Apps assist health care practitioners with integral tasks such as reviewing and updating health records, information management, patient and internal communications, reference gathering, and research. Apps can even, according to Ventola, be helpful in clinical decision making and medical education and training--confirming the FDA's assertion that practitioners may use apps to help diagnose major diseases. Most importantly, Ventola suggested, such apps benefit health care professionals by providing "increased access to point-of-care tools, which has been shown to support better clinical decision-making and improved patient outcomes."

However, despite these benefits, many health care professionals have still shown hesitation towards the use of apps. Ventola posited this reluctance stems from a mistrust of the standards and validation practices: "Despite the benefits they offer, better standards and validation practices regarding mobile medical apps need to be established to ensure the proper use and integration of these increasingly sophisticated tools into medical practice." (7)

FDA GUIDANCE ON MOBILE HEALTH APPS

The US Food and Drug Administration has made some attempt to guide mobile health apps with its "Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff," issued first in September 2013 and updated in February 2015. (8) This document explains that the agency's oversight relates to apps that can be considered to be medical devices and that the agency focuses "only on the apps that present a greater risk to patients if they don't work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices." However, these guidelines are simply that--guidelines or recommendations--which, in most cases, are not legally binding and merely represent the FDA'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." (9)

Furthermore, it is only a select group of the thousands of existing mobile health care apps that are wholly covered by these guidelines. The FDA states that it "intends to apply its regulatory oversight only to those mobile apps that are medical devices," essentially covering apps that could be used as an accessory to a regulated medical device or that can turn a smartphone or computer into a regulated medical device. The FDA refers to these apps by the term medical app. The document also indicates that there are some apps that may meet the definition of a medical device but that will not be regulated because they are deemed to pose lower risk to the public (Box 1).

The FDA is clear in its intent to not fully regulate even these devices. Franko wrote of the FDA's stance: "It is clear from the draft guidelines that, although mobile apps have the potential to pose risks to public health, the FDA recognizes it is not properly positioned to validate the content of mobile medical applications." (3)

Thus, it is evident that while mobile health apps provide important information to consumers and health care practitioners alike, there is a potential for problems when one considers where the app's information comes from (it is often unknown or potentially not credible) and the limited oversight by the FDA and FTC. In the absence of such oversight, how can users be sure of the quality of mobile health apps entering the market?

MAKING MOBILE HEALTH APPS BETTER

Some have suggested that publication information about mobile health apps should be made full and transparent. Boulos and colleagues suggest that apps should readily:

(1) provide authorship information, including detailed information about authors' affiliations and credentials and about any medical professional involvement in content preparation; (2) list all references or sources of content (attribution); (3) fully disclose any app sponsorship or other commercial funding arrangements, and any potential conflicts of interest; and (4) ensure a balanced, non-biased coverage of facts and information currency (up-to-datedness). (10)
Box 1. Types of Apps That Do or Do Not Qualify as Regulated Medical
Apps

General Health
App (Not
Regulated)       Low-Risk Medical Apps       Regulated medical Apps

Medical          Apps that help patients     Apps that use a sensor or
dictionaries     with diagnosed              lead that is connected to
                 psychiatric conditions      a mobile platform to
                 (eg, post-traumatic         measure and display the
                 stress disorder [PTSD],     electrical signal
                 depression, anxiety,        produced by the heart
                 obsessive compulsive        (electrocardiograph or
                 disorder) maintain their    ECG)
                 behavioral coping skills
                 by providing a "Skill of
                 the Day" behavioral
                 technique or audio
                 messages that the user
                 can access when
                 experiencing increased
                 anxiety

Interactive      Apps that help people       Apps that alter the
anatomy          with asthma to track        function or settings of
diagrams or      inhaler usage, asthma       an infusion pump
videos           episodes experienced,
                 location of user at the
                 time of an attack, or
                 environmental triggers of
                 asthma attacks

Medical flash    Apps that keep track of     Apps that calibrate,
cards and        medications and provide     control, or change
quizzes          user-configured reminders   settings of a cochlear
                 for improved medication     implant
                 adherence

General                                      Apps that connect to a
patient                                      nursing central station
education                                    and display medical
materials                                    device data to a
                                             physician's mobile
                                             platform for review

The text and examples here are excerpted from the US Food and Drug
Administration's Mobile Medical Applications: Guidance for Industry
and Food and Drug Administration Staff. (9)


Boulos and colleagues also discussed the Health Apps Library project of the National Health Service (NHS) in England. In the apps library, the organization recommended various apps that have been reviewed by the service itself. These authors suggested that app reviews of this kind could cover factors such as an app's purpose, effectiveness, and value. Finally, they suggested that "these factors should be routinely considered by app developers and publishers, perhaps in the form of a checklist to be added to their existing quality assurance (QA) procedures as a kind of industry self-regulation and/or voluntary certification." (9)

While this model of review was promising, the NHS's pilot program of the Health Apps Library was shut down in late 2015 after concerns that the screening process had led to the inclusion of apps with lenient security standards and questionable effectiveness. (11) In the online publication iMedicalApps, Satish Misra, MD, wrote that "a fundamental problem with ... the NHS approach ... was that they applied a one-size-fits-all solution to the problem of finding good health apps."

Misra noted that many players may join the efforts to evaluate apps, including public and private health care systems, sites such as PatientsLikeMe that could offer consumer reviews, and websites such as iMedicalApps.
   Certainly many apps will warrant a very high level of
   scrutiny through some centralized evaluation model
   administered by well-resourced organizations. But it
   would be impractical to say that all health apps will
   get that degree of scrutiny. So in many cases, it will be
   left to the end-users, patients & clinicians, to assess an
   app themselves and make an informed decision. (10)


In 2015, Stoyvanov et al. suggested a new Mobile App Rating Scale that would provide "a reliable, multidimensional measure for trialling, classifying, and rating the quality of mobile health apps." (12) Stoyvanov et al. indicated that although future research would be needed to determine the scale's long-term suitability, the methodology shows promise as a reliable measure of health app quality.

PATIENT PRIVACY

In addition to potential issues regarding the content of mobile health apps, there are also issues such as patient privacy and app compliance with the Health Insurance Portability and Accountability Act (HIPAA) to consider. Mobile health apps that share patient data with physicians, hospitals, or insurance companies should be compliant with HIPAA. In February, the Department of Health and Human Services published a document online to help app developers understand how HIPAA might apply to their industry. (13)

The document addresses 2 main questions: 1) How does HIPAA apply to health information that a patient creates, manages or organizes through the use of a health app? 2) When might an app developer need to comply with the HIPAA Rules?

The document notes that even if the developer's work is not affected by HIPAA, the privacy of consumer information is still important. The FTC has developed another aid for app developers--an online tool to help them understand what federal laws and regulations might apply to their apps. (14)

INVOLVING MEDICAL WRITERS

When we combine the various ways apps can potentially fail their users, whether from lack of oversight, ethics, compliance, transparency, or accurate and effective communication of medical information, the potential role of a qualified medical writer in the development of mobile health apps becomes apparent. While app developers often focus on technical usability, evaluating the nature of the language provided in these apps is not always made a priority. Boulos et al noted: "presenting correct, unbiased information but in a way that is hard to understand by the intended audience not only renders this information useless, but also makes misunderstanding a likely possibility, which can have serious negative health consequences." (9) As such, mobile health app developers should consider consulting with qualified medical writers to help ensure the information and language provided in their apps are understandable and useful for their intended audience. Furthermore, in consultation with medical writers with HIPAA training, apps can become compliant in this area as well. Ventola encourages collaboration and stronger authorial standards: such measures "will raise the barrier for entry into the medical app market, increasing the quality and safety of the apps currently available for use by health care practitioners." (7)

In building any strong mobile health app, developers should work in consultation with a qualified medical professional and a medical writer. Then, app publishers can exert a stronger ethos by publishing authorship information and perhaps be subject to vetting through models such as the Mobile App Rating Scale. Until regulators exert stronger guidance in the area of mobile health apps, it is industry self-regulation and collaboration with qualified health professionals and medical writers that will enable the creation of apps that truly help people and practitioners manage health care for the better.

Author disclosure: The author has no affiliation or financial interests in the subject matter or materials discussed in this manuscript.

Author contact: erin.trauth@gmail.com

References

(1.) US Food and Drug Administration. What are mobile medical apps? Mobile Medical Applications. 2015. www.fda.gov/MedicalDevices/ DigitalHealth/MobileMedicalApplications/default.htm. Accessed May 2, 2016.

(2.) Research2guidance. mHealth App Developer Economics 2014. May 6, 2014. http://research2guidance.com/r2g/research2guidance-mHealthApp-Developer-Economics-2014.pdf. Accessed May 2, 2016.

(3.) Research2guidance. 500m people will be using healthcare mobile applications in 2015. 2010. http://research2guidance. com/2010/11/10/500m-people-will-be-using-healthcare-mobileapplications-in-2015-2/. Accessed May 5, 2016.

(4.) Franko OI. How helpful are mobile healthcare apps? American Academy of Orthopaedic Surgeons. AAOS Now. 2013;7(3).

(5.) O'Neill S, Brady RR. Colorectal smartphone apps: opportunities and risks. ColorectalDis. 2012;14(9).

(6.) Sharpe R. Many health apps are based on flimsy science at best, and they often do not work. The Washington Post. 2012.

(7.) FTC Cracks Down on Marketers of "Melanoma Detection" Apps [press release]. www.ftc.gov/news-events/press-releases/2015/02/ftc-cracksdown-marketers-melanoma-detection-apps

(8.) Ventola CL. Mobile devices and apps for health care professionals: uses and benefits. HT. 2014;39(5):356-364.

(9.) US Food and Drug Administration. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. 2015. www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf

(10.) Boulos MNK, Brewer AC, Karimkhani C, Buller DB, Dellavalle RP. Mobile medical and health apps: state of the art, concerns, regulatory control and certification. Online JPublic Health Inform. 2014;5(3):229. doi:10.5210/ojphi.v5i3.4814.

(11.) Misra S. NHS Health Apps Library closing amid questions about app security & quality: what can we learn? iMedicalApps and Medpage Today. October 16, 2015. www.imedicalapps.com/2015/10/nhs-healthapps-library-closing-commentary. Accessed May 1, 2016.

(12.) Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile App Rating Scale: A New Tool for Assessing the Quality of Health Mobile Apps. J Med Internet Research. doi:10.2196/mhealth.3422

(13.) Health App Use Scenarios & HIPAA. http://hipaaqsportal.hhs.gov/ community-library/accounts/92/925889/OCR-health-app-developerscenarios-2-2016.pdf. Accessed May 1, 2016.

(14.) FTC Releases New Guidance For Developers of Mobile Health Apps [press release]. www.ftc.gov/news-events/press-releases/2016/04/ftcreleases-new-guidance-developers-mobile-health-apps. Accessed May 1, 2016.

By Erin Trauth, PhD/Associate Director of Composition, University of South Florida, Tampa, FL
COPYRIGHT 2016 American Medical Writers Association
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Author:Trauth, Erin
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Date:Jun 22, 2016
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