- Email: [email protected]
Skin scan: A demonstration of the need for FDA regulation of medical apps on iPhone
J AM ACAD DERMATOL VOLUME 68, NUMBER 3
clinically relevant, and evidence based, the relative infrequency of the podcasts made them an unreliable mode of education. This is further confirmed in our results by the infrequent and sporadic production of the 27 podcasts released by Dermatologic Clinics associated with only 2 of 12 issues over a 3-year span. In contrast, various medical journals, such as The Lancet and the New England Journal of Medicine, provide regular audio podcasts to their subscribers and demonstrate that podcasting can be a highly utilized educational resource. We conclude that it is important that dermatologic journals capitalize on this resource to provide consistent and up-to-date information to their readers and become a reliable source of information. In addition, with more reliable production of podcasts, dermatology podcasts may appeal to a greater number of listeners. Jill Henley, BA,a Mahsa Amir, BS,b Blake Sampson, BS,c Jennifer M. Tamai, MS,d and Robert P. Dellavalle, MD, PhD, MSPHb,e,f Midwestern University, Glendale, Arizonaa; University of Colorado School of Medicine, Aurorab; University of Washington, Seattlec; University of Hawaii, Honolulud; Colorado School of Public Health, Aurorae; and Department of Veterans Affairs Eastern Colorado Healthcare System, Denver f Funding sources: The U.S. Department of Veterans Affairs provided financial support for the study (to Dr Dellavalle). The sponsors had no role in the design or conduct of the study; in the collection, analysis, or interpretation of data; nor in the preparation, review, or approval of the manuscript. Disclosure: Dr Dellavalle is the social media editor for JAAD. The opinions expressed in this article represent the views of the authors and not of the U.S. government. Correspondence to: Robert P. Dellavalle, MD, PhD, MSPH, Chief, Dermatology Service, Department of Veteran Affairs Medical Center, 1055 Clermont St, Box 165, Denver, CO 80220 E-mail: [email protected] REFERENCES 1. Arican O. E-dermatology: emails about dermatological diseases on the Internet. J Dermatol 2007;34:375-80. 2. Hanson AH, Krause LK, Simmons RN, Ellis JI, Gamble RG, Jensen JD, et al. Dermatology education and the Internet: traditional and cutting-edge resources. J Am Acad Dermatol 2011;65:836-42. Epub 2011 Aug 4. 3. Thielst CB. Using social media to engage patients: many tools exist to connect, communicate and build loyalty. Healthc Exec 2011 May-Jun;26(66):68-70.
Letters 515
4. Alikhan A, Kaur RR, Feldman SR. Podcasting in dermatology education. J Dermatolog Treat 2010;21:73-9. http://dx.doi.org/10.1016/j.jaad.2012.10.032
Skin scan: A demonstration of the need for FDA regulation of medical apps on iPhone To the Editor: With the widespread use of electronic devices, it has become increasingly common for patients to seek medical advice through applications available in the App Store. Spot Check claims it will send images of your moles to a dermatologist for evaluation, WebLantis offers to teach you how to remove unsightly moles, and numerous apps claim to be able to analyze moles for their risk of evolving into or being a melanoma (Skin of Mine, Skin Prevention, Mole Detective 2, and Skin Scan). To investigate the potential danger of such apps, we searched the app store for ‘‘skin cancer’’ and the first app listed, Skin Scan, offered personal assistance with management and diagnosis of skin cancer.1 With fractal analysis, Skin Scan claims to ‘‘help regular people survive their pigmentary lesions, help in diagnosis.and can monitor moles over time to prevent skin cancer.’’ When Skin Scan detects a ‘‘high risk’’ nevus, it advises patients to see a doctor soon; patients are advised to simply keep track of nevi analyzed as ‘‘medium’’ and ‘‘low’’ risk. Skin Scan even claims that two Romanian dermatologists use this app on their patients in clinic. However, Skin Scan exonerates itself from legal wrongdoing by denying liability for any information obtained through this app. As this app is not validated, we investigated the ability of the app to detect melanoma as a highrisk lesion by having Skin Scan analyze 93 photos of biopsy-proven melanoma from Visual Dx, UpToDate, the National Cancer Institute, and Fitzpatrick’s Dermatology in General Medicine.2-5 Although Skin Scan claims it may only accurately analyze pictures taken by the iPhone or iPod, we believe the quality of the photos analyzed from the previously mentioned sources did not differ from those taken by the iPhone as the initial photo source. In our investigation, the sensitivity of Skin Scan to report a melanoma as high risk was 10.8% (10/93). The app classified 88.2% (82/93) of the melanomas as medium-risk lesions and 1.2% (1/93) of the melanomas were reported to be low-risk lesions. The app was frequently ‘‘unable to analyze’’ lesions despite repeated attempts (11% of lesions in Visual Dx, 8/71 images). As Skin Scan reports over 35,000 app downloads, the potential for harm from delays in medical treatment is substantial. Although the Federal Trade Commission has taken action against the marketers of a few apps
J AM ACAD DERMATOL
516 Letters
MARCH 2013
claiming to cure acne via light emitted from the iPhone (AcneApp and Acne PWNR), these proceedings were founded on the premise of false advertising instead of public safety.6 The Food and Drug Administration recognizes that apps which intend to analyze or interpret medical data have a strong potential for harming patients; thus, new requirements and guidelines are currently being drafted for mobile medical applications.7 Dermatologists should be familiar with the emerging technology of medical apps, its potential applications, risks, and regulation. Natalie Anne Ferrero, BS,a Dean S. Morrell, MD,a,b and Craig Nathaniel Burkhart, MDa,b Department of Dermatology, University of North Carolina School of Medicine,a and the University of North Carolina at Chapel Hillb Funding sources: None. Conflicts of interest: None declared. Correspondence to: Craig Nathaniel Burkhart, MD, Department of Dermatology, University of North Carolina School of Medicine, 410 Market St, #400, Chapel Hill, NC 27516 E-mail: [email protected] REFERENCES 1. Popoiu D. Skin Scan- Your Pocket Scan Technology for Skin Cancer Prevention. Available at: www.skinscanapp.com/ about_3. Accessed March 27, 2012. 2. Craft N, Fox L, Goldsmith L, Tharp M. Melanoma. Visual Dx. Available at: http://www.visualdx.com.libproxy.lib.unc. edu/visualdx/visualdx6/getDiagnosisText.do?moduleId¼11& diagnosisId¼51936. Accessed March 27, 2012. 3. Sweller S, Geller A. Skin Examination and Clinical Features of Melanoma. UpToDate. Available at: http://www.uptodate. com.libproxy.lib.unc.edu/contents/skin-examination-and-clinicalfeatures-of-melanoma?source¼search_result&search¼melanoma &selectedTitle¼4;150. Accessed March 27, 2012. 4. What Does Melanoma Look Like? National Cancer Institute at the National Institutes of Health. Available at: http:// www.cancer.gov/cancertopics/prevention/skin/melanomaphotos. Accessed March 27, 2012. 5. Paek S, Sober A, Tsao H, Mihm M, Johnson T. Cutaneous melanoma. In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Wolff K, Leffell DJ, et al, editors. Fitzpatrick’s Dermatology in general medicine. 7th ed. McGraw-Hill Companies, Inc; 2008. pp. 1134-57. 6. Hamilton AD, Brady RR. Medical professional involvement in smartphone ‘apps’ in dermatology. Br J Dermatol 2012;167:220-1. Epub 2012 Apr 4. 7. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiologic Health, Center for Biologics Evaluation and Research. Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications. Document Number: 1741. Document Issued: July 21, 2011. Available by e-mail request to: [email protected]. http://dx.doi.org/10.1016/j.jaad.2012.10.045
Topical antibiotic use following dermatologic procedures To the Editor: Although studies have shown that topical antibiotic prophylaxis following clean dermatologic procedures does not prevent infection and can result in complications such as allergic contact dermatitis (ACD),1,2 some dermatologists continue to use topical antibiotics after procedures.3 In 2004, the JAAD published a survey in which 81% of 64 Miami dermatologists reported such use of topical antibiotics.4 In this study, we describe current dermatologists’ practices regarding use of topical antibiotics following procedures. We conducted a cross-sectional, Institutional Review Boardeapproved study, from September to November 2011, of members of the Association of Professors in Dermatology, Philadelphia Dermatology Society, Washington University Division of Dermatology, and the Harvard Combined Dermatology Program. Using REDCap online survey tools, participants were provided clinical vignettes and asked about antibiotic use (topical or oral) following various procedures and special considerations including procedure site, procedure duration, and comorbidities: https:// redcap.bidmc.harvard.edu/redcap/surveys/?s¼4b5aec. Topical antibiotic use was defined as using a topical antibiotic in 2 of 4 vignettes (shave biopsy, punch biopsy, electrodessication and curettage [ED&C], or excision). We used univariate and multivariable logistic regression to investigate associations between topical antibiotic use and respondents’ characteristics. Univariate logistic regression was used to investigate associations between topical antibiotic use and respondents’ concerns for development of ACD with use of mupirocin or bacitracin-containing products. We included all participants answering at one or more survey questions. We performed all analyses with STATA 11 (Stata Corp, College Station, Tex.). Among more than 500 dermatologists surveyed, 196 responded (approximately 39%), of whom 137 (73%) practiced in academic settings, 47 (25%) in community settings, and 4 (0.2%) in multiplespecialty, Veterans Administration, or other settings. Among respondents, 130 (69%) identified as general dermatologists, 43 (23%) as procedural dermatologists, and 15 (8%) as ‘‘other.’’ Shave biopsies, punch biopsies, ED&C, and excisions were performed by 194 (99%), 193 (98%), 184 (94%), and 173 (88%) respondents, respectively. Topical antibiotics were used by 34 respondents (17%) (Table I). In univariate analyses, topical antibiotic use was significantly associated with more than 20 years of practice (P ¼ .03), ‘‘other’’ type of
clinically relevant, and evidence based, the relative infrequency of the podcasts made them an unreliable mode of education. This is further confirmed in our results by the infrequent and sporadic production of the 27 podcasts released by Dermatologic Clinics associated with only 2 of 12 issues over a 3-year span. In contrast, various medical journals, such as The Lancet and the New England Journal of Medicine, provide regular audio podcasts to their subscribers and demonstrate that podcasting can be a highly utilized educational resource. We conclude that it is important that dermatologic journals capitalize on this resource to provide consistent and up-to-date information to their readers and become a reliable source of information. In addition, with more reliable production of podcasts, dermatology podcasts may appeal to a greater number of listeners. Jill Henley, BA,a Mahsa Amir, BS,b Blake Sampson, BS,c Jennifer M. Tamai, MS,d and Robert P. Dellavalle, MD, PhD, MSPHb,e,f Midwestern University, Glendale, Arizonaa; University of Colorado School of Medicine, Aurorab; University of Washington, Seattlec; University of Hawaii, Honolulud; Colorado School of Public Health, Aurorae; and Department of Veterans Affairs Eastern Colorado Healthcare System, Denver f Funding sources: The U.S. Department of Veterans Affairs provided financial support for the study (to Dr Dellavalle). The sponsors had no role in the design or conduct of the study; in the collection, analysis, or interpretation of data; nor in the preparation, review, or approval of the manuscript. Disclosure: Dr Dellavalle is the social media editor for JAAD. The opinions expressed in this article represent the views of the authors and not of the U.S. government. Correspondence to: Robert P. Dellavalle, MD, PhD, MSPH, Chief, Dermatology Service, Department of Veteran Affairs Medical Center, 1055 Clermont St, Box 165, Denver, CO 80220 E-mail: [email protected] REFERENCES 1. Arican O. E-dermatology: emails about dermatological diseases on the Internet. J Dermatol 2007;34:375-80. 2. Hanson AH, Krause LK, Simmons RN, Ellis JI, Gamble RG, Jensen JD, et al. Dermatology education and the Internet: traditional and cutting-edge resources. J Am Acad Dermatol 2011;65:836-42. Epub 2011 Aug 4. 3. Thielst CB. Using social media to engage patients: many tools exist to connect, communicate and build loyalty. Healthc Exec 2011 May-Jun;26(66):68-70.
Letters 515
4. Alikhan A, Kaur RR, Feldman SR. Podcasting in dermatology education. J Dermatolog Treat 2010;21:73-9. http://dx.doi.org/10.1016/j.jaad.2012.10.032
Skin scan: A demonstration of the need for FDA regulation of medical apps on iPhone To the Editor: With the widespread use of electronic devices, it has become increasingly common for patients to seek medical advice through applications available in the App Store. Spot Check claims it will send images of your moles to a dermatologist for evaluation, WebLantis offers to teach you how to remove unsightly moles, and numerous apps claim to be able to analyze moles for their risk of evolving into or being a melanoma (Skin of Mine, Skin Prevention, Mole Detective 2, and Skin Scan). To investigate the potential danger of such apps, we searched the app store for ‘‘skin cancer’’ and the first app listed, Skin Scan, offered personal assistance with management and diagnosis of skin cancer.1 With fractal analysis, Skin Scan claims to ‘‘help regular people survive their pigmentary lesions, help in diagnosis.and can monitor moles over time to prevent skin cancer.’’ When Skin Scan detects a ‘‘high risk’’ nevus, it advises patients to see a doctor soon; patients are advised to simply keep track of nevi analyzed as ‘‘medium’’ and ‘‘low’’ risk. Skin Scan even claims that two Romanian dermatologists use this app on their patients in clinic. However, Skin Scan exonerates itself from legal wrongdoing by denying liability for any information obtained through this app. As this app is not validated, we investigated the ability of the app to detect melanoma as a highrisk lesion by having Skin Scan analyze 93 photos of biopsy-proven melanoma from Visual Dx, UpToDate, the National Cancer Institute, and Fitzpatrick’s Dermatology in General Medicine.2-5 Although Skin Scan claims it may only accurately analyze pictures taken by the iPhone or iPod, we believe the quality of the photos analyzed from the previously mentioned sources did not differ from those taken by the iPhone as the initial photo source. In our investigation, the sensitivity of Skin Scan to report a melanoma as high risk was 10.8% (10/93). The app classified 88.2% (82/93) of the melanomas as medium-risk lesions and 1.2% (1/93) of the melanomas were reported to be low-risk lesions. The app was frequently ‘‘unable to analyze’’ lesions despite repeated attempts (11% of lesions in Visual Dx, 8/71 images). As Skin Scan reports over 35,000 app downloads, the potential for harm from delays in medical treatment is substantial. Although the Federal Trade Commission has taken action against the marketers of a few apps
J AM ACAD DERMATOL
516 Letters
MARCH 2013
claiming to cure acne via light emitted from the iPhone (AcneApp and Acne PWNR), these proceedings were founded on the premise of false advertising instead of public safety.6 The Food and Drug Administration recognizes that apps which intend to analyze or interpret medical data have a strong potential for harming patients; thus, new requirements and guidelines are currently being drafted for mobile medical applications.7 Dermatologists should be familiar with the emerging technology of medical apps, its potential applications, risks, and regulation. Natalie Anne Ferrero, BS,a Dean S. Morrell, MD,a,b and Craig Nathaniel Burkhart, MDa,b Department of Dermatology, University of North Carolina School of Medicine,a and the University of North Carolina at Chapel Hillb Funding sources: None. Conflicts of interest: None declared. Correspondence to: Craig Nathaniel Burkhart, MD, Department of Dermatology, University of North Carolina School of Medicine, 410 Market St, #400, Chapel Hill, NC 27516 E-mail: [email protected] REFERENCES 1. Popoiu D. Skin Scan- Your Pocket Scan Technology for Skin Cancer Prevention. Available at: www.skinscanapp.com/ about_3. Accessed March 27, 2012. 2. Craft N, Fox L, Goldsmith L, Tharp M. Melanoma. Visual Dx. Available at: http://www.visualdx.com.libproxy.lib.unc. edu/visualdx/visualdx6/getDiagnosisText.do?moduleId¼11& diagnosisId¼51936. Accessed March 27, 2012. 3. Sweller S, Geller A. Skin Examination and Clinical Features of Melanoma. UpToDate. Available at: http://www.uptodate. com.libproxy.lib.unc.edu/contents/skin-examination-and-clinicalfeatures-of-melanoma?source¼search_result&search¼melanoma &selectedTitle¼4;150. Accessed March 27, 2012. 4. What Does Melanoma Look Like? National Cancer Institute at the National Institutes of Health. Available at: http:// www.cancer.gov/cancertopics/prevention/skin/melanomaphotos. Accessed March 27, 2012. 5. Paek S, Sober A, Tsao H, Mihm M, Johnson T. Cutaneous melanoma. In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Wolff K, Leffell DJ, et al, editors. Fitzpatrick’s Dermatology in general medicine. 7th ed. McGraw-Hill Companies, Inc; 2008. pp. 1134-57. 6. Hamilton AD, Brady RR. Medical professional involvement in smartphone ‘apps’ in dermatology. Br J Dermatol 2012;167:220-1. Epub 2012 Apr 4. 7. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiologic Health, Center for Biologics Evaluation and Research. Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications. Document Number: 1741. Document Issued: July 21, 2011. Available by e-mail request to: [email protected]. http://dx.doi.org/10.1016/j.jaad.2012.10.045
Topical antibiotic use following dermatologic procedures To the Editor: Although studies have shown that topical antibiotic prophylaxis following clean dermatologic procedures does not prevent infection and can result in complications such as allergic contact dermatitis (ACD),1,2 some dermatologists continue to use topical antibiotics after procedures.3 In 2004, the JAAD published a survey in which 81% of 64 Miami dermatologists reported such use of topical antibiotics.4 In this study, we describe current dermatologists’ practices regarding use of topical antibiotics following procedures. We conducted a cross-sectional, Institutional Review Boardeapproved study, from September to November 2011, of members of the Association of Professors in Dermatology, Philadelphia Dermatology Society, Washington University Division of Dermatology, and the Harvard Combined Dermatology Program. Using REDCap online survey tools, participants were provided clinical vignettes and asked about antibiotic use (topical or oral) following various procedures and special considerations including procedure site, procedure duration, and comorbidities: https:// redcap.bidmc.harvard.edu/redcap/surveys/?s¼4b5aec. Topical antibiotic use was defined as using a topical antibiotic in 2 of 4 vignettes (shave biopsy, punch biopsy, electrodessication and curettage [ED&C], or excision). We used univariate and multivariable logistic regression to investigate associations between topical antibiotic use and respondents’ characteristics. Univariate logistic regression was used to investigate associations between topical antibiotic use and respondents’ concerns for development of ACD with use of mupirocin or bacitracin-containing products. We included all participants answering at one or more survey questions. We performed all analyses with STATA 11 (Stata Corp, College Station, Tex.). Among more than 500 dermatologists surveyed, 196 responded (approximately 39%), of whom 137 (73%) practiced in academic settings, 47 (25%) in community settings, and 4 (0.2%) in multiplespecialty, Veterans Administration, or other settings. Among respondents, 130 (69%) identified as general dermatologists, 43 (23%) as procedural dermatologists, and 15 (8%) as ‘‘other.’’ Shave biopsies, punch biopsies, ED&C, and excisions were performed by 194 (99%), 193 (98%), 184 (94%), and 173 (88%) respondents, respectively. Topical antibiotics were used by 34 respondents (17%) (Table I). In univariate analyses, topical antibiotic use was significantly associated with more than 20 years of practice (P ¼ .03), ‘‘other’’ type of