Our health care system has suffered a tremendous impact due to the enormous pressure on patient care resulting from the pandemic caused by SARS-CoV-2 and its infection. Dermatologists have had to attend patients admitted with COVID-19, with involvement of multiple organs and systems, including the skin, with the uncertainty inherent to the lack of knowledge regarding a novel disease.

COVID-19has made access to dermatologic care a real challenge. Following the guidelines of the World Health Organization (WHO) on social distancing and quarantine to prevent transmission, and Royal Decree 463/2020, which declared the state of alarm,1 face-to-face consultations have been limited almost exclusively to urgent or preferential cases that are carefully selected and cannot be delayed.

Online consultations or medical care provided by means of new technologies and communications systems is a genuine medical act, in which the health care professional must interpret the situation and decide on the appropriate response in each case. Telemedicine (TM) or e-health is a care system that has been proving its worth for years in hospital and primary-care settings. In the current exceptional circumstances, many hospitals and primary-care centers have been using teledermatology (TD) to treat their dermatologic patients. The ability to record, store, exchange and analyze data and images at a distance using different means of communication, such as audio, video, and image, has put virtual consultations at the center of dermatologic care. Virtual consultations have made it possible to maintain care of nonurgent diseases without exposing dermatologist or patient to the risk of infection.

TD, understood as the application of information and communication technology (ICT) to the care of skin diseases, has for many years enjoyed a favorable position in the Spanish Academy of Dermatology and Venereology (AEDV) in terms of its rational application, provided that certain basic criteria are met, to improve the quality of care in skin health problems.2

Several modes of TD exist, including direct consultation (patient-dermatologist), indirect consultation (patient-clinic-dermatologist at a distance) and specialist opinion (by dermatologists seeking opinions on dermatopathology, dermoscopy, etc.). TD can be performed in real time (synchronous) or by saving and re-sending the information and images (asynchronous). TD allows for personalized, accessible, convenient, and profitable patient care. Some countries have reported a 10-fold to 15-fold increase in teleconsultations during the COVID-19 pandemic.

Virtual consultations have, by their very nature, major limitations compared to face-to-face visits. Including virtual consultations in routine dermatology practice may lead ot new situations and problems inherent to a medical act “at a distance “in both space and time.3 This study aims to identify and clarify the main challenges and medicolegal aspects that dermatologists must deal with in regard to TC when they make it part of their practice: 1, the legal liability of the dermatologist; and 2, privacy and security of patient data.

TC is an emerging technology in the consolidation phase in Spain.4 For good reason, TD represents one of the most common uses of TM.2 Nevertheless, it should be remembered that, even today, the main activity carried out by dermatologists takes place mainly in a face-to-face setting in outpatient consultations (hospitals, primary-care centers and private clinics). In fact, TD is involved in 1% (0.3%-3.0%) of dermatologic diagnoses.5 It is considered to be a good solution for attending isolated communities, where factors such as geographic isolation or transport times and costs are major factors affecting acces to health care,6,7 and in certain social contexts, such as penitentiaries, care homes for the elderly, catastrophes, military conflicts,8 and health care at sea.

The use of TD had already been duly validated by the scientific community before the COVID-19 pandemic.9 However, the emergency health care scenario the world has been experiencing as a result of the pandemic has, among the many other changes undergone by health care, led to an exponential increase in the use of TD.10–13 It was already an accepted practice in medical care, but it has now become instated and generalize,14 with the intention of staying.15 It is fair to acknowledge that TM has made it possible to maintain access to and continuity of patient care and to provide support to the professionals on the front lines,16 by optimizing face-to-face services and minimizing transmission of infection by SARS-CoV-2,17 thus even contributing to reducing the risk of new outbreaks.18,19

TD has a number of requirements, advantages, and disadvantages,20–23 some of which are shown in Tables 1–3. Despite the considerable proven value of TD, its mass use has been accompanied by matters of medicolegal debate,24–25 some of which are already on the table.

If this were not enough, an exponential increase in the use of ICT is expected in the future in the field of dermatology, not just TD. In fact, today, where the mass use of instant messaging platforms on smartphones is ubiquitous, a recent study found that the preferred tool of dermatology patients for teleconsultations is the WhatsApp® application. In this regard, the lack of a clear legal framework or improper use of images may have negative repercussions for the dermatologist, which will make it necessary to regulate this type of consultation.26

TD is a useful educational tool for trainee specialists. It can contribute to improving the dermatology training of primary-care physicians and trainee specialists in both family medicine and dermatology.27 However, training in e-dermatology should not be seen as a substitute for in-person training of dermatologists. Both forms of training can coexist naturally, as a true reflection of current dermatologic practice, where in-person visits and TD visits will probably end up coexisting.

The spectacular technological progress, especially in ICT, and the social normalization of it uses and applications make it necessary to define and, if applicable, update the legal and ethical guidelines that affect them. We therefore have an historic opportunity to consolidate the rational use of TD, which must be seized to try, at the same time, to resolve the medicolegal questions it raises.

Patients must receive specialist guidance prior to the virtual visit. The option of receiving distance care must be accepted and agreed with the patient, and the decisions that derive from it must also be agreed and not imposed by any of the parties involved.

It is absolutely essential to establish a policy that ensures data protection, not only by the different authorities but also by all the health care professionals involved, both in the transfer of data and images and in their receipt and storage.28

Different EU directives exist that can help to develop the activities of TM, but no specific legislation exists that regulates this practice and ensures respect for privacy and data protection without violating the standards of good clinical practice. According to EU legislation, TM is considered to be a health and information service. It is therefore subject to regulations relating to medical care and those relating to the information society. Thus, with regard to TD at present, the following documents must be taken into consideration: Directive 95/46/EC (General Data Protection Regulation [GDPR]), Directive 98/34/EC (Directive on Services of the Information Society), Directive 2000/31/EC (Directive on Electronic Commerce), Directive 2002/58/EC (Directive on Privacy and Electronic Communication), and Directive 2011/24/EC, relating to the application of patients’ 4 rights in cross-border health care. Nevertheless, several authors have highlighted and insisted on the need for a unified legislation for TD. Many point out the need for uniform guidelines to ensure the maximum security of data, similar to the General Data Protection Regulations in force in the European Union.

On the face of it, it seems evident that TD will lead to less diagnostic security and a greater number of erroneous diagnoses in specialist medical care. As an emerging technology, it therefore requires extreme caution in its use in diseases in which less diagnostic accuracy has been suggested,31 including inflammatory skin diseases and skin tumors.

The promotion of evidence-based medicine, the use of checklists and clear and visual standardized tools to facilitate medical activity and prevent errors, and the use of protocols and clinical-practice guidelines have proven to be effective tools for improving clinical security and for ensuring the quality of the medical act32 and, as a result, avoiding potential suits relating to medical professional liability Although dermatology is a specialty with a low risk of suits, both worldwide and in Spain,31 it would be advisable for AEDV to draft a proposal for clinical practice guidelines specific to TD, with the aim of regulating the process and providing dermatologists with clinical security.

The vast majority of medical professional liability (MPL) insurance policies do make specific mention of TM, although because it is a medical act, it is unequivocally covered by these policies. Malpractice in TM represents a new form of negligence but, for practical purposes, is not significantly different from malpractice in visits in which the patient is physically present. Some authors suggest expanding or implementing specific civil liability insurance policies for the practice of TM.3 Appropriate training of dermatologists is recommended in order to avoid and prevent these situations of “telemalpractice”.

The use of TD must ensure the right to the autonomy of the patient, doctor-patient confidentiality and data protection, and privacy. This requires an implicit will and consent, at least verbally, by the patient, responsible family member, or legal guardian, as applicable, which must be recorded in the patient’s medical records. The physician must have direct knowledge of the patient’s medical history or access to it at the time medical care is provided, and confidentiality and the patient’s privacy must be preserved, and doctor-patient confidentiality must be protected. The virtual medium used to perform the consultation and the recommendations and medical treatment prescribed must be indicated in writing in the patient’s medical records.

The practice of TD requires a procedure for informing on the purposes and uses of the images taken and transmitted. Any TD application must meet the confidentiality and privacy requirements set out in the law on the protection of personal data.2 Furthermore, and specifically in TD, special attention must be paid to the encryption of photographs when they are included in the clinical records or when they are updated, to make access by unauthorized users impossible.33 The necessary computer processing that makes such encryption possible is usually the responsibility of the care centers, whether private or public. Moreover, it must be remembered that in the case of private consultation, it is the physician who shall ensure the appropriate encryption of these data. The information must be stored in servers protected by computer firewalls.34 Whenever possible, the consultation should be recorded and stored in the clinical records as a clinical security measure for the patient and a legal security measure for the professional.

The limitations of the use of TD should be specified in a safeguard clause included in the reports issued,2 especially in relation to asynchronous TD, where there is greater exposure of the dermatology specialist deriving from the accuracy of the information sent by the family physician from the patient history taken, and from the characteristics and greater or lesser quality of the means used and, therefore the audiovisual material sent.

If dermatologists simply accept these circumstances, provided the requisites of professional liability are met, the obligation of the physician to compensate (from their compulsory civil liability insurance policy) will arise. Dermatology specialists must, therefore, adapt the clinical documentation to this situation and these patient-care limitations. The fundamental measure in this regard would be to inform the patient in writing, by means of an informed consent document or an information leaflet signed by the patient, explaining these limitations and circumstances, while including a safeguard clause in the medical report issued describing the limitations and fallibility of the system used. An approximate formula is that used by ultrasound specialists in the reports issued during pregnancy controls. An example of a safeguard clause might be the following: “Telemedicine is a procedure for performing medicine that has the advantage of preventing the patient from having to travel in person but that obliges the physician to base his or her clinical judgement on image-capturing methods that, while efficacious and advanced, have limitations that may affect the diagnosis.”

Thus, as well as strictly complying with the protocol of the Organic Law on protection of personal data,35 we propose further specifying, in the general advice on compliance with the law on patient autonomy,36 the specific need to include on the information sheet the potential limitations and vicissitudes of the system, signed and accepted by the patient, and the safeguard clause in the medical report issued by the dermatologist, indicating the fallibility of the procedure. We would thus achieve, as described, good legal protection for the dermatologist against a potential liability suit.

Consent by the patient requires a thorough explanation of the unique characteristics of TM: it should include a clear and understandable demonstration of how it works, the advantages and disadvantages, and an explanation of potential privacy problems.

In conclusion, the practice of TD during the COVID-19 pandemic has facilitated access to specialist care and has made it possible to minimize unnecessary travel by patients, increase availability of services, and ensure the safety of patients and health care personnel. However, in order to protect both patients and professionals performing TD, the ethical and legal connotations that may arise from a virtual visit must be considered.

Prior to using TD, dermatologists require training that allows for the normal performance of these visits.

Before any visit by means of TD, technical image quality and appropriate information must be ensured that facilitate the correct technical performance of the visit, together with the computer security measures that ensure the confidentiality of the data transferred.

The use of TD is only justified by the best interests of the patient. As a result, the patient, in application of the principle of autonomy, must accept, by means of informed consent, this type of care act and the utility of establishing a safeguard clause must be considered.

A telemedicine (TM) consultation is a medical act. As a result, it is governed by all the ethical and medicolegal considerations and consequences that apply to any doctor-patient relationship.

TD requires appropriate planning and standardized and protocolized visit methods are therefore recommended, including checklists to facilitate basic aspects of clinical security such as patient identification and date and time of consultation.

The use of TD must meet the criteria of the normal practice of patient care (quality care, i.e., care administered with competence, due diligence and skill, efficacy, and efficiency).

The use of TD must ensure the right to autonomy of the patient, doctor-patient confidentiality and data protection, and privacy.

The use of TD requires that any circumstances relating to the medical act must be indicated in the clinical records (circumstances of the medical act, indicating whether it is a follow-up visit or an initial visit, or whether TD is synchronous or asynchronous, the problem in question, any missing data, indication of the intervention of other physicians, etc.).

If, after a visit, doubt remains regarding the diagnosis, or if the dermatologist deems it necessary for any other reason, the patient must be referred, in accordance with clinical-security criteria, by recommending a face-to-face medical visit.

Dermatologists must be completely independent and free to choose or reject a visit by means of TD. When its use is accepted, the dermatologist assumes the professional responsibility of that medical act and everything that it involved, especially in terms of diagnosis, advice, therapeutic opinions and direct medical interventions, as well as the need for referral to a face-to-face consultation.

The authors declare that they have no conflicts of interest.