An even bigger problem with melanoma risk-assessing apps, Dr. Skelsey worries, is that even if the algorithms have high diagnostic sensitivity and specificity–which has not been shown to be the case, she is quick to note–they may still dissuade consumers from conducting periodic total skin exams.
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Frequently, Dr. Skelsey notes, patients and nonspecialist clinicians identify what they think looks like “a really scary mole” only to find it’s benign, but another, overlooked mole is potentially life threatening. Skin scan apps can delay a full body skin exam or discourage a patient from seeking an exam at all, when what they believed to be a worrisome mole is deemed to be low-risk by a consumer app.
“Apps must come with the caveat that they should only be used for self-surveillance and should never serve as a substitute for regular skin examinations by a dermatologist,” Dr. Lamel agreed.
Dr. Skelsey cautioned that potentially deadly, rare skin tumors like amelanotic melanomas are even more of a challenge to spot. They are frequently mistaken for eczema. “A picture may not warrant a biopsy,” Dr. Skelsey said. “An algorithm may have difficulty spotting it and it could become another place where it may delay or prevent somebody from coming in.”
A recent test run with a skin scan app by the Cancer Society of New Zealand’s health promotion manager, Jan Pearson, MD, found that Pearson’s iPhone 3 camera did not produce sufficiently high-quality images for reliable analysis by the app.6
Dr. Lamel commented that estimating the true diagnostic sensitivities of melanoma risk-assessment apps would be challenging. “Great variability exists between products and users,” she explained.
The US Food and Drug Administration (FDA) released an outline for regulatory oversight of mobile medical apps in July 2011, but the agency only regulates apps that interface with a medical device they already regulate, or apps that transform a mobile communications device into a regulated medical device with attachments or sensors.7
“To date, we’ve approved a handful of (medical) apps,” FDA spokeswoman Erica Jefferson told Chemotherapy Advisor. “I am not aware that we’ve approved or cleared any melanoma-detection applications for use with smart phones.”
Dr. Lamel and Dr. Skelsey both stated that government oversight of consumer cancer-screening apps may be a good idea. “Just as investigational drug therapies are subject to oversight by the FDA, preventative therapies such as skin cancer screening products should be too,” Dr. Lamel said. Dr. Lamel and Dr. Skelsey both agreed that teledermatological consults between a nonspecialist clinician and dermatologist are much safer than consumers’ use of cancer screening apps.
Dr. Skelsey stated that two-way communication about a patient’s history and symptoms can be helpful for patients in underserved areas. “But the apps are one-way communications that focus on the most difficult part of our jobs – determining whether or not something is a melanoma,” she said. “It can have life or death consequences.”
REFERENCES
1. Khazan O. Summit: medical devices going mobile. Washington Post. December 12, 2011:A31.
2. Senior K. Smart phones: new clinical tools in oncology? Lancet Oncol. 2011;12(5):429-430.
3. Daily Staff Report. HIT roundup: mobile app introduced for skin cancer exams. Med Device Daily. May 13, 2011. http://www.medicaldevisedaily.com. Accessed February 10, 2012.
4. Viola KV, Tolpinrud WL, Gross CP, et al. Outcomes of referral to dermatology for suspicious lesions: implications for teledermatology. Arch Dermatol. 2011;147(5):556-560.
5. Massone C, Brunasso AMG, Campbell TM, et al. Mobile teledermoscopy–melanoma diagnosis by one click? Semin Cutan Med Surg. 2009;28(3):203-205.
6. ‘Skin Scan’ should not be relied upon in isolation to detect cancer risk.” Asian News International. January 22, 2012. http://in.news.yahoo.com/skin-scan-not-relied-upon-isolation-detect-cancer-092608068.html. Accessed February 10, 2012.
7. U.S. Food and Drug Administration. FDA outlines oversight of mobile medical applications [news release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263340.htm. Published July 19, 2011. Updated July 21, 2011. Accessed February 11, 2012.
