Original Research
mHealth App for Risk Assessment of Pigmented and Nonpigmented
Skin Lesions—A Study on Sensitivity and Specificity in Detecting Malignancy
Monique Thissen, MD, PhD,1–4,* Andreea Udrea, Eng PhD,5,*
Michelle Hacking, MD,1 Tanja von Braunmuehl, MD, PhD,6
and Thomas Ruzicka, MD, PhD6
1
Department of Dermatology, Catharina Hospital, Eindhoven,
The Netherlands.
2 who are less familiar with differentiating between benign and
Department of Dermatology, Maastricht University Medical
Centre+, Maastricht University, Maastricht, The Netherlands.
3
GROW Oncology, Maastricht University, Maastricht,
The Netherlands.
4
School for Oncology and Developmental Biology, Maastricht
University, Maastricht, The Netherlands.
5
Department of Automatic Control and Systems Engineering,
University Politehnica of Bucharest, Bucharest, Romania.
6
Department of Dermatology and Allergology, Ludwig-Maximilian
University, Munich, Germany.
*These authors are the main contributors to this work.
Abstract
Background: With the advent of smartphone devices, an in-
creasing number of mHealth applications that target mela-
noma identification have been developed, but none addresses
the general context of melanoma and nonmelanoma skin
cancer identification.
Introduction: In this study a smartphone application using
fractal and classical image analysis for the risk assessment
of skin lesions is systematically evaluated to determine its
sensitivity and specificity in the diagnosis of melanoma and
nonmelanoma skin cancer along with actinic keratosis and
Bowen’s disease.
Materials and Methods: In the Department of Dermatology,
Catharina Hospital Eindhoven, The Netherlands, 341 mela-
nocytic and nonmelanocytic lesions were imaged using
SkinVision app; 239 underwent histopathological examina-
tion, while the rest of 102 lesions were clinically diagnosed as
clearly benign and not removed. The algorithm has been ca-
librated using the images of the first 233 lesions. The cali-
brated version of the algorithm was used in a subset of 108
lesions, and the obtained results were compared with the
medical findings.
DOI: 10.1089/tmj.2016.0259 ª M A R Y A N N L I E B E R T , I N C.  VOL. 23
Results: On the 108 cases used for evaluation the algorithm
scored 80% sensitivity and 78% specificity in detecting
(pre)malignant conditions.
Discussion: Although less accurate than the dermatologist’s
clinical eye, the app may offer support to other professionals
malignant lesions.
Conclusion: An mHealth application for the risk assessment
of skin lesions was evaluated. It adds value to diagnosis tools
of its type by taking into consideration pigmented and non-
pigmented lesions all together and detecting signs of malig-
nancy with high sensitivity.
Keywords: automatic skin lesion risk assessment, mHealth
app, skin cancer, fractal analysis
Introduction
W
ith the advances of mobile technology, an in-
creasing number of mHealth applications re-
lated to dermatology emerged. A particular
segment aims for melanoma detection, but
there are few clinical studies discussing their accuracy and
this leads to criticism.1,2–5
In this context, this article presents a risk assessment
algorithm for (pre)malignant lesion detection which is inte-
grated in SkinVision mHealth application (developed by
Skin Vision B.V., The Netherlands). The app primary targets
laypersons, but can be also used by nondermatologists.
The app should be certified by appropriated regulatory
bodies and has been already certified in Europe, New Zeal-
and, and Australia.
The algorithm was initially dedicated for the analysis of
melanocytic lesions and melanoma detection. It underwent a
clinical study and scored a sensitivity of 73% in detecting
melanoma, while the specificity was 83%.6
Now, the algorithm has been adapted and recalibrated for a
much broader segment of (pre)malignant skin lesion diagno-
sis. With this study, we assess the sensitivity and specificity
of the recalibrated algorithm in the diagnosis of melanoma
and nonmelanoma skin cancer along with in situ melanoma
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THISSEN ET AL.

Table 1. The Pigmented and Nonpigmented Melanocytic and Nonmelanocytic Lesions Collected and Used During the Study
CASES USED FOR THE CASES USED FOR ALGORITHM
CALIBRATION EVALUATION IN TERMS
OF THE ALGORITHM OF SPECIFICITY AND SENSITIVITY
NO. OF NO. OF LESIONS NO. OF NO. OF LESIONS
LESIONS THAT UNDERWENT LESIONS THAT UNDERWENT
NO. LESION TYPE PER TYPE BIOPSY PER TYPE PER TYPE BIOPSY PER TYPE
1 Basal cell carcinoma 94 94 16 16

2 Actinic keratosis 10 10 8 3

3 Squamous cell carcinoma 7 7 3 3

4 Bowens disease 9 9 5 5

5 Melanoma 4 4 2 2

6 Melanoma in situ 2 2 1 1

7 Psoriasis 10 5 10 0

8 Eczema 3 1 0 0

9 Lichen planus-like keratosis 8 8 3 1

10 Histiocytoma 7 6 8 0

11 Folliculitis 10 3 8 0

12 Sebaceous hyperplasia 1 0 3 0

13 Angioma senilis 10 3 6 1

14 Clear cell acanthoma 1 1 1 1

15 Scar 7 1 4 0

16 Verruca vulgaris 1 1 1 1

17 Verruca seborrhoica 12 8 9 1

18 Nevus naevocellularis (dermal/compound) 12 10 11 5

19 Nevus naevocellularis (junctional/epidermal) 24 24 1 0

20 Dysplastic nevus 1 1 1 1

21 Lentigo solaris/senilis 0 0 7 0

Total 233 198 108 41

and actinic keratosis and Bowen’s disease, as premalignant
skin lesions, compared to clinical diagnosis and histopatho-
logical results.
Materials and Methods
MATERIALS AND DATA ACQUISITION
We included, in total, 341 lesions in 256 consecutive pa-
tients seen routinely for different skin problems, including
skin cancer follow-up at the Department of Dermatology,
Catharina Hospital Eindhoven, The Netherlands in the period
December 2014–April 2016, after obtaining the patients’
written informed consent. The study had been approved by the
local ethics committee (No. 2014-41).
Consecutive patients were seen by one dermatologist and
one resident in dermatology. The lesions were selected by the
dermatologist in case of clinical clear benign lesions or
during total body skin examination in patients with multi-
ple skin malignancies in the past and, also, in patients re-
ferred by general practitioner for skin malignancies. The
lesions underwent visual and dermatoscopic diagnosis and
in 239 cases either incisional or excisional biopsies were
performed, followed by histopathological examination of

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 MHEALTH APP FOR SKIN LESION RISK ASSESSMENT

The acquired data were used as follows: 233 pigmented

Table 2. Questionnaire Addressing Lesion’s Characteristics
and nonpigmented melanocytic and nonmelanocytic lesions
NO. QUESTION ANSWERS (Table 1) were used as training data set for the rule-based
1 How long does the lesion exist <1 week algorithm calibration, and the rest of 108 cases (Table 1) were
1–4 weeks used as test data set for the algorithm’s evaluation in terms of
specificity and sensitivity in detecting (pre)malignant lesions.
1–3 months
Programming was completed before biopsy results.
3 months–1 year

>1 year RISK ASSESSMENT ALGORITHM

2 Is the lesion always visible
3 Single or multiple lesion
A Single
B Multiple
4 Accompanying characteristics of the lesion(s)
A Fever
B Pain
C Itch
D Bleeding
E Development after traumatizing skin
F Scaling
5 Changes past weeks to 3 months
A Larger, thicker, and/or irregular
B Color (brighter or darker, multicolored)
the specimens. The rest of 102 lesions were clinically clearly
benign and not removed.
All the skin lesions have been imaged by the participant
MDs using an iPhone 5 smartphone (equipped with an 8
megapixel autofocus camera, 1080p, 30 frames/s in video
mode) using SkinVision imaging application.7 The image
acquisition is done in video mode such that quality checked
images of a skin condition can be easily acquired in real time
by a user. The obtained images are focused, without shadows
and completely containing the lesion of interest.
Yes/no The risk assessment algorithm is based on fractal and
classical image analysis and has been presented in detail in
Ref.6 For this study, the rule-based algorithm has been re-
Yes/no
calibrated to accommodate nonpigmented skin conditions.
Yes/no The training data have been used to add new rules and im-
prove the existing ones.
Yes/no
To increase the specificity regarding nonpigmented lesions
and the sensitivity regarding melanoma the following new
Yes/no
parameters were also taken into consideration: lesion area,
Yes/no mean gray scale value and standard deviation over the lesion,
Yes/no and circularity of the lesion extracted from the fractal map. The
Yes/no lesion detection followed the procedure described in Ref.7
Moreover, it was clear that images taken out of context
Yes/no
cannot offer enough information that is vital for an accurate
classification and so, to compensate this limitation, a ques-
Yes/no tionnaire regarding the lesion’s characteristics was developed
Yes/no (Table 2). The patients’ answers to the questions in Table 2
were used along with the texture, color, and geometric fea-
tures extracted from the skin lesions’ images to calculate the
associated risk degree.
The rule based algorithm results are presented as follows:
high risk if the algorithm identifies the lesion as malignant or
premalignant, medium or low risk otherwise.
STATISTICAL EVALUATION
The sensitivity, specificity, positive predictive value, and
negative predictive value were calculated using a 95% con-
fidence interval (CI) (95% CI) using the online statistical
software VassarStats.

Table 3. Results Obtained by The Algorithm Incorporating the Patients’ Answers to the Questionnaire Regarding
the Lesion’s Characteristics Versus Clinical Diagnosis—Eindhoven Database-Test Data Set
MALIGNANT
ALGORITHM OR PREMALIGNANT BENIGN SUM
High risk 28 16 44 Sensitivity (95% CI) 0.8 (0.62–0.90) Positive predictive value (95% CI) 0.63 (0.47–0.77)

Low/medium risk 7 57 64 Specificity (95% CI) 0.78 (0.66–0.86) Negative predictive value (95% CI) 0.89 (0.78–0.95)

Sum 35 73 108

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THISSEN ET AL.

Results 0.66–0.86). The positive and negative predictive values along

For the statistical analysis, we considered that benign
proven skin lesions should fall in the low- or medium-risk
lesion class, and melanoma and nonmelanoma skin cancer
along with in situ melanoma, actinic keratosis, and Bowen’s
disease should fall into the high-risk lesion class. No images
were excluded from the study due to low quality, because we
wanted to measure the performances of the algorithm as close
as possible to real use setup.
On the set of 108 cases used for accuracy evaluation, the
algorithm (incorporating the patients’ answers to the ques-
tionnaire regarding the lesion) obtained a sensitivity of
80% (95% CI 0.62–0.90) and a specificity of 78.08% (95% CI
with other results can be found in Table 3.
In the group of the (pre)malignant lesions from the test
data set 28/35 were rated high risk, 6/35 medium risk, and 1/35
low risk (Table 4). Out of the 35 (pre)malignant lesions only a
basal cell carcinoma (BCC) that appeared during the last 3
months to 1 year and not associated with any symptoms was
assessed as being low risk by the algorithm (Fig. 1a,b). All
melanomas were rated high risk.
In the group of the benign lesions from the test data set,
nearly all diagnoses were based on clinical and dermoscopic
examination by a dermatologist. Only in six lesions incisional/
excisional biopsies were taken because of clinical doubt

Table 4. Absolute Numbers and Percentage of the Different Subgroups with False Positive and False Negative
Ratings—Eindhoven Database-Test Data Set
ALGORITHM’S RATINGS ALGORITHM’S RATINGS WITHOUT
CONSIDERING THE ANSWERS CONSIDERING THE ANSWERS ALGORITHM’S RATINGS
TO THE QUESTIONNAIRE TO THE QUESTIONNAIRE BEFORE RECALIBRATION
NO. HIGH, MEDIUM, LOW, HIGH, MEDIUM, LOW, HIGH, MEDIUM, LOW,
DIAGNOSES INCLUDED N (%) N (%) N (%) N (%) N (%) N (%) N (%) N (%) N(%)
Basal cell carcinoma 16 11 (69) 4 (25) 1 (6) 9 (56) 6 (38) 1 (6) 3 (19) 11 (69) 2 (12)

Squamous cell carcinoma 3 2 (66) 1 (33) 0 (0) 1 (33) 2 (66) 0 (0) 1 (33) 2 (66) 0 (0)

Actinic keratosis 8 7 (88) 1 (12) 0 (0) 7 (88) 1 (12) 0 (0) 3 (43) 3 (43) 1 (14)

Bowens’ disease 5 5 (100) 0 (0) 0 (0) 5 (100) 0 (0) 0 (0) 1 (20) 3 (60) 1 (20)

Melanoma 2 2 (100) 0 (0) 0 (0) 2 (100) 0 (0) 0 (0) 1 (50) 1 (50) 0 (0)

Melanoma in situ 1 1 (100) 0 (0) 0 (0) 1 (100) 0 (0) 0 (0 0 (0) 0 (0) 1 (100)

Psoriasis 10 0 (0) 0 (0) 10 (100 7 (70) 2 (20) 1 (10) 5 (50) 4 (40) 1 (10)

Eczema 0 — — — — — — — — —

Lichen planus-like keratosis 3 2 (66) 0 (0) 1 (33) 2 (66) 0 (0) 1 (33) 1 (33) 1 (33) 1 (33)

Histiocytoma 8 2 (25) 1 (13) 5 (63) 3 (38) 2 (25) 3 (37) 2 (25) 3 (38) 3 (37)

Folliculitis 8 0 (0) 0 (0) 8 (100) 5 (62) 1 (13) 2 (25) 2 (25) 5 (62) 1 (13)

Sebaceous hyperplasia 3 2 (66) 1 (33) 0 (0) 2 (66) 1 (33) 0 (0) 2 (66) 1 (33) 0 (0)
a
Nevus naevo-cellularis 13 2 (15) 2 (15) 9 (70) 3 (23) 2 (15) 8 (62) 2 (15) 5 (38) 6 (47)

Verruca vulgaris 1 1 (100) 0 (0) 0 (0) 1 (100) 0 (0) 0 (0) 1 (100) 0 (0) 0 (0)

Verruca seborrhoica 9 2 (23) 3 (33) 4 (44) 2 (23) 3 (33) 4 (44) 2 (23) 4 (44) 3 (33)

Senile angioma 6 0 (0) 2 (33) 4 (66) 0 (0) 1 (17) 5 (83) 0 (0) 1 (17) 5 (83)

Clear cell acanthoma 1 0 (0) 0 (0) 1 (100) 0 (0) 0 (0) 1 (100) 0 (0) 0 (0) 1 (100)

Scar 4 0 (0) 0 (0) 4 (100) 4 (100) 0 (0) 0 (0) 1 (25) 3 (75) 0 (0)

Lentigo solaris/senilis 7 3 (42 2 (29) 2 (29) 3 (42) 3 (43) 1 (15) 0 (0) 6 (85) 1 (15)

Total 108
Values shown in bold represent false positive and negative results.
a
All nevi (junctional, dermal, and dysplastic) have been merged in one subgroup.

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 MHEALTH APP FOR SKIN LESION RISK ASSESSMENT

Ludwig Maximilian University,

Munich (LMU study).6 The
database contained 144 melano-
cytic lesions: 118 benign nevi and
26 melanomas (without the an-
swers to the questions as input).
Comparing the algorithm result to
the histopathological results, one
can observe a significant increase
in sensitivity: 88% (initially, the
sensitivity in detecting melanoma
was 73%), while the specificity
dropped to *79% (initially 83%).
The results can be found in Table 7.

Fig. 1. (a) BCC rated low risk by the algorithm (b) associated fractal map. Color images
available online at www.liebertpub.com/tmj
about (pre)malignancy or the lesion was excised because of
complaints. Out of 73 benign lesions, however, 14 were rated as
high risk by the application and 11 as medium risk (Table 4).
Four of these lesions were examined histopathologically (re-
sults: one lichen planus-like keratosis, one dysplastic nevus,
one verruca vulgaris, and one verruca seborrhoica).
The algorithm has also been evaluated on the same test set
without patient’s answers to the questionnaire (details per
class in Table 4); in this setup, the sensitivity was 71%, and the
specificity was 56% (Table 5).
The original algorithm, the one dedicated to melanocytic
lesion analysis and to melanoma detection, obtained, on the
same set (details per class in Table 4), a sensitivity of 25% and
a specificity of 75% (Table 6). The poor results in this case were
inherent due to the fact that the algorithm contained no
specifications on how to treat nonpigmented lesions.
To identify the recalibrated algorithm’s performance on
melanocytic lesions, for melanoma identification only, we rerun
the tests on the database of images with histopathology that was
used during the algorithm’s first investigation performed at
Discussion
This prospective study targeted
melanocytic and nonmelanocytic
skin lesions to test the ability of an mHealth app in detecting
melanoma and nonmelanoma skin cancers, specifically BCC
and squamous cell carcinoma (SCC), and their precursors. We
have considered that actinic keratosis and Bowen’s disease
should be included in the high risk class, too, to urge the users
to visit the doctor because these lesions may progress to in-
vasive skin cancer in the future.
Although no images were excluded from the study due
to low quality, the image acquisition step revealed to
be problematic for those skin lesions with ulcerations or
bleeding on top, surrounded by mottled or extremely tan-
ned skin, localized in skin folds and hairy areas and finally
those with other skin lesions in close proximity. Focusing
on and capturing them proved difficult and the image
quality was quite low. This was also the case in four out of
six malignant skin tumors (three BCC and one SCC) re-
ceiving the medium or low risk ratings. The above listed
situations are defined to be exclusion criteria for partici-
pation in future studies. In addition, in the app itself, these
criteria are clearly mentioned as factors that might alter the

Table 5. Results Obtained by the Algorithm Without Incorporating the Patients’ Answers to the Questionnaire
Regarding the Lesion’s Characteristics Versus Clinical Diagnosis—Eindhoven Database-Test Data Set
MALIGNANT
ALGORITHM OR PREMALIGNANT BENIGN SUM
High risk 25 32 57 Sensitivity (95% CI) 0.71 (0.53–0.84) Positive predictive value (95% CI) 0.43 (0.30–0.57)

Low/medium risk 10 41 51 Specificity (95% CI) 0.56 (0.44–0.67) Negative predictive value (95% CI) 0.80 (0.66–0.89)

Sum 35 73 108
CI, confidence interval.

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THISSEN ET AL.

Table 6. Results Obtained by the Algorithm for Melanoma Detection and Melanocytic Lesions (the Algorithm
Before Recalibration) Versus Clinical Diagnosis—Eindhoven Database-Test Data Set
MALIGNANT
ALGORITHM OR PREMALIGNANT BENIGN SUM
High risk 9 18 27 Sensitivity (95% CI) 0.25 (0.13–0.43) Positive predictive value (95% CI) 0.33 (0.17–0.53)

Low/medium risk 26 55 81 Specificity (95% CI) 0.75 (0.63–0.84) Negative predictive value (95% CI) 0.67 (0.56–0.77)

Sum 35 73 108
CI, confidence interval.

Table 7. Results Obtained by the Recalibrated Algorithm Versus Histopathological Results on the Ludwig Maximilian
University Database
ALGORITHM MELANOMA BENIGN LESIONS SUM
High risk 23 25 48 Sensitivity (95% CI) 0.884 (0.68–0.96) Positive predictive value (95% CI) 0.47 (0.33–0.62)

Low/medium risk 3 93 96 Specificity (95% CI) 0.788 (0.70–0.85) Negative predictive value (95% CI) 0.96 (0.90–0.99)

Sum 26 118 144

CI, confidence interval.

assessment quality in the Contraindication section (Terms application might be useful for early detection of the most
and Conditions). common types of skin cancer and their precursors (Fig. 2a, b).
Most of the verruca seborrhoica and lentigo solaris, two The recalibrated algorithm (with or without the patients
harmless but frequently appearing skin lesions, were not answers to the questions regarding the lesion) has a higher
classified as low risk (55% and 71%, respectively). In practice sensitivity than the original algorithm both on the Eindhoven
this means that patients could panic unnecessarily. Because in and LMU data sets. The specificity is low for the Eindhoven
many patients these lesions are multiple, in future studies data set when disregarding the patients input on the lesion.
adjustment of the questionnaire might be helpful for better (The low specificity is due to the fact that in the test set there
differentiation by the application. have been included mainly skin lesions belonging to non-
A limitation of the study is the low number of SCCs. Only melanoma skin cancer differential diagnosis.) Considering the
three tumors were included, one
of them being localized in an area
with extreme skin folds which
may be the reason for receiving a
medium rating. In three sub-
groups of benign lesions the
number of included lesions was
also limited to three for each di-
agnosis (lichen planus-like kera-
tosis, sebaceous hyperplasia, and
verruca vulgaris), which may in-
terfere with the results of the
analysis, too.
According to the answers given
in the questionnaire, 25 out of 35
(pre)malignant lesions appeared
during the last 1 month to 1 year. Fig. 2. (a) BCC rated high risk by the algorithm (appeared in the last 1 to 3 months, no changes, no other
In this context, it is clear that the symptoms) (b) associated fractal map. Color images available online at www.liebertpub.com/tmj

6 TELEMEDICINE and e-HEALTH D E C E M B E R 2 0 1 7 ª MARY ANN LIEBERT, INC.

 MHEALTH
lesion characterization provided by the patients, the speci-
ficity increases with 22% (mainly due to correct identification
of folliculitis, scars, and psoriasis), while the sensitivity in-
creased with 9% (by correctly identifying as dangerous a se-
ries of the bleeding BCCs). Providing context to an image
increases the accuracy of the diagnosis. The specificity ob-
tained on the LMU data set was not substantially decreased
(4%) by adapting the algorithm to also analyze non-
melanocytic lesions, but the sensitivity increased with *15%.
Although not evaluated in this study, from previous liter-
ature it is obvious that the app is not as sensitive and specific
as the dermatologist’s clinical eye.6 In contrast, skin lesions
are also treated by professionals who are less familiar with
differentiating between benign and malignant, like general
practitioners and (plastic) surgeons, scoring much lower8–10
which may result in overtreatment (unnecessary excisions in
case of benign lesions) or incorrect referral to secondary care.
In case they are willing to improve their diagnostic skills,11 the
app might support them in accurately recognizing benign
lesions and differentiating them from skin malignancies or
might offer them the opportunity to communicate with der-
matologists in case of doubt; however, this should be further
investigated in the future.
Conclusions
At this point, the mHealth application for skin lesion risk
assessment cannot serve as a diagnostic tool, but it is useful in
raising awareness for both melanoma and nonmelanoma skin
cancer among users without creating panic or a false sense of
security.
The presentation of the algorithm’s results intends to offer an
assessment and information on the analyzed lesion. For ex-
ample, if a lesion receives a ‘‘high risk’’ rating, the user is in-
formed that the lesion strongly resembles a skin cancer, but
there is the possibility that the lesion is benign; if a lesion re-
ceives a ‘‘low risk’’ rating the user is informed that the lesion
seems healthy, but there is a small probability that the lesion is
malignant. For all ratings, the user is informed that the ‘‘as-
sessment does not intend to provide an official medical diag-
nosis, nor replace visits to a doctor.’’ The user is encouraged to
periodically test his/her lesions and archive both the images and
the results to compare the lesion’s evolution in time. Moreover,
the user can share the archive with his/her doctor.
The app might also be helpful for some practitioners in de-
ciding whether or not in treating a lesion or referring a patient.
Further and larger multicenter studies are already taken
into consideration to gather more data to improve the overall
accuracy of the algorithm and to investigate the impact of the
app on the supply of healthcare by different professionals.
ª M A R Y A N N L I E B E R T , I N C .  VOL. 23
APP FOR SKIN LESION RISK ASSESSMENT
Acknowledgment
The design and oversight of this study was supported, in
part, by SkinVision B.V.
Disclosure Statement
M.T., M.H., and T.B. have nothing to disclose. A.U. and T.R.
report receiving fees from SkinVision B.V., during this study.
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Address correspondence to:
Andreea Udrea, PhD
Department of Automatic Control and Systems Engineering
University Politehnica of Bucharest
313 Spl. Independentei
060042 Bucharest
Romania
E-mail: andreea.udrea@acse.pub.ro
Received: December 9, 2016
Revised: March 22, 2017
Accepted: March 25, 2017
NO. 12  DECEMBER 2017 TELEMEDICINE and e-HEALTH 7