Telemedicine in Spain today: regulatory and ethical challenges
Thursday 24 June 2021
Tereza Paz Ares
Uría Menéndez, Madrid
teresa.paz-ares@uria.com
Introduction
There is much discussion about the meaning of telemedicine, and the range of virtual - ‘tele’ - healthcare services available today is very broad: telediagnosis, teleradiology, telepathology, telesurgery, telemonitoring, telecare, among others. This article's focus on a very simple concept: telemedicine, which enables services normally performed by healthcare professionals to be accomplished by remote means with the support of information and communication technologies (ICT).1 Such ICTs can be very sophisticated (such as those enabling robotic surgery) or can be general-purpose (such as ICTs through which doctors communicate with their patients). The article considers the most common example: virtual medical consultation or e-visits.
Virtual healthcare services
The introduction of virtual consultations was a pivotal and disruptive moment in healthcare services provision. In a recent article2, Ricardo Ruiz, a pioneering Spanish dermatologist, refers to the fact that ‘Since Hippocrates, the doctor-patient relationship had hardly changed at all: the patient was at the doctor’s side and the doctor established a possible diagnosis and treatment. In recent years, for the first time this medical act has changed: the doctor can assess you and treat you remotely. This is what is called telemedicine.’
Though telemedicine has been available for several years, the Covid-19 pandemic proved to be a massive accelerator in this service. Telemedicine is no longer a residual medical act, which is why different stakeholders (and lawyers) are now wondering if and how virtual medical care can be delivered to patients.
In Spain, there is no nationwide regulation enabling telemedicine services. Does this mean that telemedicine is prohibited, or rather that it is unrestricted? The answer to both should be 'no'. It is true that the lack of regulation translates into a lack of legal clarity, but it should not be read either as a prohibition or as complete freedom to operate telemedicine services. Virtual services cannot be (or aspire to be) subject to fewer guarantees than the currently regulated in-person health services.[3]While we wait for a clearer, digital-based legal framework,4 we should use the current package of healthcare regulations to fill in the gaps. Thus, as is the case for in-person healthcare services:
- a telemedicine services provider should be an authorised health centre (including doctor-only consults);
- only qualified and registered health professionals should be allowed to render those services;
- continuous medical training should be guaranteed for those professionals;
- professional civil liability insurance must be in place;
- full details of the health services and the professionals providing them should be available;
- the patient’s rights (eg, informed consent) should be respected and clinical history duly documented and kept;
- the highest standards of patient safety should be ensured; and
- privacy should be guaranteed; and advertising of medical care should be accurate.
Medical ethics
The legality of telemedicine is not the only issue at play. Medical ethical principles must also be factored in. Does the provision of virtual medical care ensure respect for the basic ethical principles laid down in the Hippocratic Oath? Let’s consider the current medical deontological code - which was approved by the Spanish Medical Association in 2011 - and assess the compatibility of virtual medical services’ with it. Surprisingly, for a relatively recent set of rules, the 2011 Code of Medical Ethics presumes that a medical act involves personal and direct contact between the doctor and patient, except for second opinions. Patient orientation (ie, not a medical act) may be undertaken virtually if exclusively used to support a decision-making process.5
This would represent a major barrier (which some claim does exist) to the provision of virtual medical care in Spain. But is the 2011 Code setting the prevailing ethical standards today? It is not and, furthermore, it cannot.
On the one hand, in the wake of the recent pandemic, the Central Commission for Deontology of the Spanish Medical Association issued a communication6 stating that medical care offered through new ICT is a medical act. While it is true that in the context of the Covid-19 pandemic e-consultation has in some cases replaced (and in others completed) the in-person medical act, as a rule, it is generally considered complementary to a medical consultation where the doctor and patient are physically present. Emphasis is clearly put on the existence of consent by the patient/doctor.
On the other hand, a fair balance needs to be struck when interpreting the 2011 Code and this communication. Not only should the 2011 Code be considered as having overtaken, but the 2020 communication should be construed in such a way that it allows for the full range of virtual medical care, and not just follow ups of in-person consultations. For instance, it should be possible to prescribe medicines in an e-visit. Adopting a different position (for instance, if a medical association unjustifiably restricted the ability of its members to render virtual medical services) could easily be seen as conduct hindering fair competition (eg, a type of collective recommendation) that would likely draw the attention of the Spanish antitrust authorities if it persisted.
Conclusion
In conclusion, virtual medical care, properly delivered, is lawful and ethical in Spain.
Notes
[1] Communication 2008/689 from the Commission to the European Parliament, the European Council, the European Economic and Social Committee and the European Committee of the Regions on telemedicine for the benefit of patients, healthcare systems and society:
‘Telemedicine is the provision of healthcare services, through use of ICT, in situations where the health professional and the patient (or two health professionals) are not in the same location. It involves secure transmission of medical data and information, through text, sound, images or other forms needed for the prevention, diagnosis, treatment and follow-up of patients’
[2] Ricardo Ruiz Rodríguez, ‘The doctor will see you right away, but online’ (‘El doctor le atenderá enseguida, pero por internet’), El Confidencial, 13 April 2001.
[3] It would not only put in jeopardy patient care safety standards but also introduce unjustified discrimination between providers of the same service (ie, virtual and in-person medical care providers).
[4] Let’s hope that the small steps taken by some regions of Spain expressly acknowledging telemedicine services (eg, Catalonian Decree 151/2017, of 17 October, establishing the common technical-sanitary requirements and guarantees of health centres and services and the procedures for their authorisation and registration) are followed and developed by other regions and, most importantly, by the national health regulator.
[6] Communication of the Central Commission for Deontology commission of the Spanish Medical Association issued on 10 June 2020.