Many doubts and questions still arise concerning the legal, ethical, and regulatory aspects of the practice of teledermatology. Moreover, many of them are still not addressed or regulated by the existing legal framework, where only very brief generic references are made to this practice. Key issues, including professional responsibility, data protection, and the ethics of care, need to be properly analyzed and formulated to ensure the safe practice of teledermatology with maximum guarantees for both patients and medical professionals. In this article, we offer a general overview of the medical and legal aspects of the practice of teledermatology.

A review of European legislation and the current national and regional framework in Spain revealed no specific references to the practice of teledermatology. However, legislation relating to the practice of telemedicine in general applies, by extension, to teledermatology.

The European directive that deals most comprehensively with the regulation of telemedicine is Directive 2011/24/EU of the European Parliament and of the Council, of 9 March 2011, on the application of patients’ rights in cross-border healthcare.1 That directive indicates that in the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established (Art. 3d). It also equates remote practice with in-person care: “the Member State of affiliation may impose on an insured person […] including healthcare received through means of telemedicine, the same conditions, criteria of eligibility and regulatory and administrative formalities […] as it would impose if this healthcare were provided in its territory” (Art. 7.7).

Since teledermatology is a form of healthcare, it is, by default, subject to all the laws regulating the general aspects of the provision of healthcare services (Table 1).

No specific references to telemedicine were found in Law 14/1986, of April 25, on General Public Health2 or in Law 41/2002, of November 14, the fundamental legislation regulating patient autonomy and rights and obligations relating to clinical information and documentation in Spain.3 All the provisions of this act relating to patient privacy and the confidential nature of healthcare (Art. 7), informed consent, (Art. 8) and the appropriate storage of medical records (Art. 19), as well as other issues, also apply to telemedicine.

In addition, Law 16/2003, of May 28, on the cohesion and quality of the National Health System4 includes provisions regarding new healthcare technologies, which are subject to an evaluation with particular attention to their safety, quality, efficacy, efficiency, and effectiveness (arts. 21 and 28). The same act also provides for the creation of Comprehensive Health Plans, which could include teledermatology services (Art. 64).

Finally, given that teledermatology uses new information and communication technologies to store and transmit personal patient data, the practice is also subject to the provisions of Law 34/2002, of July 11, on information society services and ecommerce5 and Organic Law 3/2018, of December 5, on the protection of personal data and guarantee of digital rights.6,7

The Code of Medical Ethics of the General Council of Official Spanish Medical Associations approved in 20118 includes specific provisions on the practice of telemedicine:

“The clinical practice of medicine through consultations exclusively by letter, telephone, radio, newspapers or the Internet is contrary to the ethical standards. Correct practice must of necessity involve personal and direct contact […]. In the case of a second opinion or medical follow-up, […] the practice is ethically acceptable provided that both parties are clearly identified to each other and the patient’s privacy is guaranteed. The use of such remote technologies to provide patient guidance […] is consistent with medical ethics provided it is used solely as an aid to decision making. The rules of confidentiality, security, and secrecy shall apply equally to telemedicine […] (Art. 26).

However, the draft of the new Code of Medical Ethics of the General Council of Official Spanish Medical Associations,9 a document already at an advanced stage, which has been going through the approval process since 2018, recognizes the incorporation into routine practice of new technologies and the need for adequate training in their use: “The physician must recognize the transformative impact of […] the available health technologies and health applications. It is the duty of physicians to continually improve their knowledge of and proficiency in the skills that will enable them to use new technologies that have been shown to be of use and of benefit to patients” (Art. 102). The use of these systems will be considered ethical when such use complies with all the requirements that apply to any medical act: “[…] such use is in accordance with medical ethics provided that all the parties involved are clearly identified, confidentiality is guaranteed, and the means of communication used ensures the highest level of security available” (Art. 103): “[…] all the ethical precepts established in this Code relating to the doctor-patient relationship, the defense of the patient’s rights and safety, and respect for health professionals also apply” (Art. 104). Healthcare professionals must also assume liability for any harm resulting from healthcare services delivered via teledermatology systems just as they do for services delivered in person and face-to-face: “When physicians use communication systems, they must be aware of the implications of their actions and of the direct or indirect damages that may result from the service and they must accept legal and ethical responsibility for any such damage” (Art. 105).

In short, the practice of teledermatology has advanced and moved beyond its specific legal framework, giving rise to numerous ethical and legal issues that continue to give rise to controversy.

Some authors consider the restrictive view of telemedicine enshrined in the codes of ethics to be too strict and advocate for the broader use of this modality to complement in-person care, for planning and prioritization and any other purpose that can improve the delivery of care.7 This is the prevailing view in our country’s public health systems. The new draft Code of Medical Ethics and Deontology is sensitive to this shift and introduces new provisions for the ethical regulation of teledermatology appropriate to the current situation.

In teledermatology, the prevailing opinion regarding professional liability is that the consulting physician is the professional ultimately responsible for decisions on the management of the case; however, this should not lead us to overlook the fact that Law 41/2002, of November 14,3 states that these actions are carried out without prejudice to the obligations of the other professionals who participate in the care of the patient, (Art. 3), which means that a dermatologist responsible for an erroneous recommendation in the context of a teleconsultation could be found responsible and be obliged to accept liability for the complaint, depending on the circumstances of the case.

Clear and specific legal guidelines are needed to ensure that specialists can practice teledermatology in a setting that is safe for both the patient and the clinician, with clear delimitation of the responsibilities of the professionals involved and respect for both patient rights and the value of the in-person doctor-patient relationship as the cornerstone of medical practice.

• 1

  At present, despite the growth in various forms of telemedicine, there is no specific legislation regulating these healthcare services in Spain, with the result that remote modalities are at present regulated by the provisions of non-specific legislation applied subsidiarily (Table 2).

  Table 2.

  Frequently Asked Questions About the Medical and Legal Aspects of Teledermatology in Spain.

  Is there a specific legal framework regulating teledermatology in Spain?	No. Teledermatology in Spain is regulated, by default or by extension, by general legislation (both Spanish and European) governing healthcare, data protection, and the use of electronic media.
  Do the codes of ethics recommend the use of teledermatology?	Teledermatology is a healthcare modality that complements and facilitates the delivery of in-person medical care. It is considered ethical provided that the practice complies with all the requirements applied to any medical act and the use of the modality is agreed between the patient and the medical professional.
  Who is the responsible physician in a teleconsultation?	The clinician requesting the consultation is the responsible physician, without prejudice to the responsibility and liability of the other professionals who participate in the care process.
  What precautions should be taken when transferring patient data and images over a teledermatology system?	Systems used to transmit patient data and images must use adequate encryption and processes designed to limit access to the data. Moreover they must be well maintained order to guarantee the safety of the data being transmitted. All such systems must be assessed on a regular basis and comply with Spanish and European legislation on the protection of personal data and digital rights.
  Is the provision of dermatological care via communications technologies covered by professional liability insurance policies?	Yes. Care delivered using new technologies is generally covered. Practitioners should, however, consult their insurer before undertaking teleconsultations outside of Spain or cases involving a patient or professional resident in another country.
  Is the patient’s written informed consent required when their case is the subject of a teleconsultation?	No. It is not necessary although we must always provide the patient with a clear explanation of the process. The patient’s consent is required for the publication of images used for educational or scientific purposes, if the image would allow the patient to be identified.
  Is direct interaction between specialist and patient permitted in teledermatology?	Yes. Direct interaction is permitted when a prior doctor-patient relationship exists. If no prior relationship exists, the specialist is responsible for ensuring continuity of care following the teleconsultation.
• 2

  The codes of ethics have evolved from a restrictive approach to the use of teledermatology to accepting its incorporation as an accessible, efficient, and safe tool that complements face-to-face care. Its use is now deemed ethical provided the patient is informed and agrees and his or her confidentiality and privacy are guaranteed.

• 3

  The concepts of informed consent and respect for patient autonomy apply to teledermatology in the same way as they do to any other form of care. The importance of protecting the confidentiality and privacy of patient data and images sent through computer systems is recognized as a requirement for the safe practice of teledermatology.

• 4

  The consulting physician, in accordance with the concept of responsible physician, is the professional ultimately responsible for the care provided through a teledermatology system.

• 5

  It is recommended that all professionals who participate in teledermatology systems should ensure that their liability or malpractice insurance covers healthcare services provided remotely.

• 6

  Teledermatology must be integrated into a health service delivery system that guarantees continuity of care after a teleconsultation. This issue is particularly relevant in the case of direct doctor-patient teledermatology consultations in private healthcare settings.

The authors declare that they have no conflicts of interest.