The number of medical smartphone applications (apps) is increasing rapidly, providing patients and clinicians with new organizational and informational resources. However, the majority of these products have not been clinically tested or regulated for use in medical practice.

In September 2013, the Food and Drug Administration (FDA) announced that it will regulate some smartphone and tablet apps, with a strong focus on those that are used as diagnostic devices, such as the controversial melanoma detection apps.

Putting Power in the Physicians’ and Patients’ Hands

Smart phones and tablets are revolutionizing diagnostic medicine and clinical care, providing portable access worldwide to such tools as prescription dosing calculators and diagnostic, prognostic, and treatment guidelines, to medical imaging tools, and real-time electrocardiogram, blood pressure, and glucose monitoring.1-4

Surveys suggest that as many as half of clinicians use medical apps to help with clinical assessments or decision-making.5 There is some preliminary evidence that apps might help shorten the length of hospital stays and even reduce hospital mortality risks.6,7

Oncology has seen a growing variety of new mobile phone apps as well, most of which are informational (like ChemotherapyAdvisor.com’s app). Others seek these apps to replace paper files or help patients navigate and manage the cancer care process.2  For example, ASCO’s patient information site, Cancer.net, includes an iPhone and iPad app (Cancer.net Mobile), available in English and Spanish, that can help patients identify and organize questions for their clinicians, as well as record answers.8 The app has received awards from the Web Marketing Association and Health Information Resource Center, among others.8

Other apps, like iChemoDiary and iHealthLog, also allow patients to better keep track their appointments, treatments, and symptoms.2 My Net Manager, specifically designed for patients diagnosed with neuroendocrine tumors, helps them to schedule appointments, keep track of medications, and document any side effects.2

As children and adolescents increasingly carry smartphones, apps specific to their needs are emerging as well. For example, the Pain Squad app for children diagnosed with cancer helps them to document the duration, severity, and location of pain—potentially valuable information for their oncology team.2

Apps like these are seen by many as welcome developments that can empower patients, improve medication adherence, better manage symptoms, and subsequently, clinical outcomes.

With Great Power Comes Great Responsibility

In sharp contrast to the generally positive reception received by these promising tools, controversial and potentially error-prone apps also abound, including those marketed as at-home melanoma detection tools; these apps in particular have recently raised serious concerns about their lack of accuracy and potential for misdiagnosis.1,2,9,10

Related: Smartphone Melanoma Screening Apps

Medical apps are frequently marketed alongside lifestyle games and fad diet apps at the iTunes App Store. This kind of crossover in a consumer-focused arena often results in medical apps being inappropriately labeled with parental warnings over references to alcohol, tobacco or drug use references, for example (see below for a warning on a dermatology app).

While many of these medical apps are free, systematic comparisons of different apps are few and far between; this may leave consumers unsure of which apps are appropriate and safe to use.6

Although estimates vary, between 12,000 and 100,000 medical apps are currently available overall. Just how many medical apps are out there depends on how one defines a medical app, as opposed, say, to health promotion, diet, or lifestyle apps.2,6

Indeed, that question—what exactly qualifies an app as “medical”—has been at the center of the FDA’s efforts to catch up with the field and regulate some of these tools as medical devices.2 However, developers are concerned that too much regulation could stymie the field.2  One example is the FDA’s July 2013 draft regulatory framework, which listed prescription drug dosage calculators as apps that might be regulated as medical devices.

Ultimately, the agency announced in September 2013 that it would observe “enforcement discretion” and would not regulate informational apps that pose a low risk to the public’s health, including patients’ disease and symptom-tracking apps. Instead, the FDA plans to focus its regulatory efforts on “a subset of mobile medical apps that present a greater risk to patients if they do not work as intended,” including those marketed for melanoma detection.11,12

“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” noted Jeffrey Shuren, MD, JD, of the FDA Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation.”

The FDA regulations will emphasize oversight of apps that serve as an “accessory to” regulated medical devices—particularly diagnostic tests—and apps that effectively transform a mobile device into a regulated medical device; these include such as apps that have attachments that turn smart phones into stethoscopes, ultrasound devices, or glucose monitors.13,14


References

1. Furlow B. Smartphone apps screen for melanoma. Clinical Advisor. 2012. www.clinicaladvisor.com/smartphone-apps-screen-for-melanoma/printarticle/240206/.

2. Burki TK. Technology: Cancer apps. Lancet Oncol. 2013;14:580-581.

3. Godwin ZR, Bockhold JC, Webster L, et al. Development of novel smart device based application for serial wound imaging and management. Burns. 2013;39:1395-1402.

4. Renard E, Cobelli C, Kovatchev BP. Closed loop developments to improve glucose control at home. Diabetes Res Clin Pract. (In press.) http://dx.doi.org/10.1016/j.diabres.2013.09.009.

5. Hogan NM, Kerin MJ. Smart phone apps: smart patients, steer clear. Patient Educ Counsel. 2012;89:360-361.

6. Sondhi CV, Devgan A. Translating technology into patient care: smartphone applications in pediatric health care. MJAFI. 2013; 156-161.

7. Issac T, Zheng J, Jha A. Use of UpToDate and outcomes in US hospital. J Hosp Med. 2012;7:85-90.

8. American Society of Clinical Oncology. Mobile applications. http://www.cancer.net/multimedia/mobile-applications.

9. Chang-Brewer A, Endly DC, Henley J, et al. Mobile applications in dermatology. JAMA Dermatology. Online ahead of print: September 25, 2013. doi:10.1001/jamadermatol.2013.5517.

10. Ferrero NA, Morrell DS, Burkhart CN. Skin scan: a demonstration of the need for FDA regulation of medical apps on iPhone. J Am Acad Dermatol. 2013;68(3):515-516.

11. US Food and Drug Administration (FDA). FDA releases final guidance on mobile medical apps: Tailored approach supports innovation while protecting consumer safety. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm.

12. Shuren J. FDA releases final rules on mobile apps. Healthcare IT News. http://www.healthcareitnews.com/news/fda-releases-final-rules-mobile-apps.

13. Tavernise S. FDA to regulate some health apps. New York Times. Sept. 23, 2013. http://www.nytimes.com/2013/09/24/health/fda-to-regulate-only-some-health-apps.html?_r=0.

14. Kamerow D. Regulating medical apps: which ones and how much? BMJ. 2013;347:f6009.