Ricardo Costa Macedo and Diana Mâncio da Costa, of Caiado Guerreiro, Sociedade de Advogados, discuss the needed reinvention of medical care and how it is redefining the relationship between healthcare services providers and patients.
In the context of the COVID-19 pandemic and the numerous problems that came with it, outpatient visits had to be cancelled and patients faced the fear of visiting hospitals and physicians' practices. Medical care simply had to be reinvented; technology and already in motion programs for e-health proved to be a true ally of healthcare systems all over the world. In fact, technology has been an essential part of the strategy adopted to face the challenges posed by this pandemic, especially at a time when national health systems are facing real difficulties in providing healthcare services to their citizens.
Although telemedicine and e-health are not new concepts, a new wave has brought them to the epicentre of the debate, being that the effects of the recent urge to use them are here to stay.
The concepts of E-Health and Telemedicine
E-Health may be defined as the use of information and communication technologies (ICT) for health, and telemedicine as the provision of healthcare services where traditional face-to-face patient- doctor interaction is replaced by over distance interaction through use of ICT.
E-health and telemedicine are having an undeniable impact on healthcare. As it is expected, the technologic developments the world has been witnessing are also widespread to the medical area, not only to the realm of medical devices but also in the way patients and doctors interact.
Such technological advances however are not necessarily being followed by the development of an adequate regulatory framework. The legislation surrounding telemedicine is actually quite delayed, as countries have only issued general recommendations, as it is the case of the EU with the publication of the Green Paper on Mobile Health.
Telemedicine services form a rather complex web, where multiple aspects are interconnected, from patients' sensitive data to reimbursement. Consequently, it is hard for national legislators to draw up a general framework that will encompass the numerous factors emerging from the use of telemedicine services.
Notes on the EU perspective on telemedicine
For the last decades, the European Union has been perceiving e-health and telemedicine as steps towards better quality of healthcare.
The EU has shown great interest in the development of e-health platforms, as these may serve to alleviate the heavy financial burden of public health systems, to stimulate the economic development of the EU regions (due to the technological innovation) and to allow for an easier access to cross-border medical assistance by EU citizens.
Article 14 (1), on "eHealth", of the Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011, establishes the need for the support, cooperation, and exchange of information among Member States working within a voluntary network, with the goal of connecting national authorities responsible for eHealth designated by the Member States. Said Directive, concerning the application of patients' rights in cross-border healthcare, is considered relevant for the regulatory framework of e-health provided by the EU.
Moreover, the Directive establishes objectives for said eHeath network, such as the preparation of guidelines on different matters and the need for the support to Member States in the development of measures that will facilitate transferability of data in cross-border health.
Nonetheless, when addressing e-health services at an EU level, there are other significant legal instruments that should be taken in consideration, such as the EU legislation on Data Protection, E-commerce, Medical Devices, Consumers' Rights and Electronic Identification and Security of Network and Information Systems. A coherent set of rules to govern telemedicine and e-health services in all EU Member States may be hard to accomplish. In any case, and even though the development of eHealth solutions is a matter undertaken internally by Member States, the EU has been committed to providing funding and platforms for the collaboration of EU members on this matter.
An example of the enhancement of said collaboration is the "eHealth Digital Service Infrastructure" that is introducing two electronic cross-border health services in all EU countries: the ePrescription and the Patients Summaries, both of which are already available in Portugal.
More recently, Commission Implementing Decision (EU) 2020/1023 of 15 July 2020 regarding the cross-border exchange of data between national contact tracing and warning mobile applications with regard to combatting the COVID-19 pandemic was published. This may be perceived as a sign that the EU is interested in proposing the needed regulation for healthcare applications and in tackling the problems, for instance related with data protection, that said services may pose.
Portugal: Embracing Telemedicine
Well before the current COVID-19 pandemic came about, ambitious programs were already being put in place in Portugal, aiming at expanding the use of electronic means for the rendering of healthcare services.
Since the 90's, Portugal has been developing a revolutionary approach to e-health, with the latest development being the launch of PENTS in 2019.
PENTS is the National Strategic Plan for e-Health. Its goal is to set a strategy for the enhancement of technologic and electronic health care in Portugal. This innovative program regards e-health as an opportunity to respond to the challenges posed by a society that is gradually aging.
PENTS is also a solution for the problems generated by the geographical isolation of some locations in Portugal and the difficult access to healthcare, also allowing for the remote group collaboration of various professionals.
In regard to the legislative framework for telemedicine in Portugal, it should be noted that already in 2013, Dispatch No. 3571/2013, of 6 March, was published. Said Dispatch determined that the services and establishments of the National Health Service (NHS) should intensify the use of information and communication technologies to promote and guarantee the provision of telemedicine services to NHS users.
Subsequently, and with the intent of reinforcing the implementation of the strategy for a Telemedicine Network in the National Health Service (NHS), Dispatch No. 8445/2014, of 30 June, was published. In said Dispatch, it was established the need for the general access to telemedicine, considering the technologic capacities of the institutions and the aim of increasing the accessibility to medical care and maximizing the installed capacity of the institutions of the NHS.
Lastly, it should be noted that the Regulation of Medical Ethics (Regulation 707/2016, of 21 July) extensively regulates the use of telemedicine services.
In accordance with the Portuguese Medical Association, there are some aspects that should be kept in mind when considering telemedicine services, such as the respect for the patient- doctor relationship, the independence of the doctor's opinion and the confidentiality and mutual confidence.
Particular attention should be paid to the fact that the regulatory framework provided by said Medical Association only appears to allow the use of e-health services when the conditions are similar to the ones of a face-to-face consultation and when the doctor has sufficient knowledge of the clinical situation of the patient. Moreover, physicians should only use telemedicine services after they ensure that the system used and its users guarantee the medical secrecy, namely through the encryption of names and other identifying data.
Closing notes
Although telemedicine is not new, it seems that its potential to facilitate the contact between patients and doctors had not been fully recognized until the COVID-19 pandemic started.
Even if telemedicine should not replace the so-called standard medicine, nor overrule the need of a personal contact between doctor and patient, it remains that by allowing the practice of medical acts and health procedures from a distance telemedicine is helping countries battling some of the biggest problems in the health sector such as the ageing population or difficult access to medical care in some regions.
From an EU regulatory perspective, the use of e-health services is regarded as generally regulated in legal instruments already available, as is the case of the EU legislation on Data Protection and on Medical Devices.
In this sense, although there is no specific legislation for e-health in the EU, it could be argued that there is already a set of rules that will play a relevant role in designing a future general framework for the use of e-health services and that the same already provides guidance for those dealing with e-health services and its applications.
Notwithstanding, there is room to say that the EU current regulatory framework is still insufficient to regulate, in a detailed and coherent manner, the phenomenon of e-health and telemedicine. Such regulation may be hard to conceive not only because EU Member-States retain internal relevant competences in matters related to healthcare but also because some topics, such as medical liability, may prove difficult to address.
As for the Portuguese scenario, and even before the pandemic stroke, there were already signs of investment in large programs that will enhance the use of telemedicine in the country, the PENTS program being one of them.
In addition, legislation has already been enacted to promote the use of telemedicine and the Portuguese Medical Association has specific guidelines for the use of telemedicine services.
What the future holds for e-health and telemedicine is still unknown, and even though the recent changes in the intense use of e-health services were not based on a choice of doctors and patients, but instead imposed by the COVID-19 pandemic, it is hard to conceive the future of medical care without these services.
E-health and telemedicine will require us to redefine the relationship between healthcare services providers and patients, setting a new measure for the protection of patients' rights and public health information systems and potentially even addressing medical liability and other issues that may emerge within an international environment of provision of medical care.
Originally Published by The Life Sciences Magazine.
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