But the ability to provide medical services at a distance still lacks a legal framework. Without that, doctors and patients cannot be sure that the services offered are legal, safe and compliant with the required standards.
Telemedicine is not new. The first services that we would today call telemedicine appeared nearly 60 years ago, while the first reported successful transmission of medical data over telephone lines in Poland involved an ECG report sent from Lwów in 1935. Telemedicine developed rapidly during the space race of the 1960s. The health parameters of astronauts and cosmonauts were monitored via communications links using the technologies available at the time.
Telemedicine services have become widespread thanks to growth of the internet and digitisation of societies, and particularly the exceptionally rapid dissemination of smartphones, now joined by smart watches and other forms of wearable technologies, such as sensors installed in bracelets. Thousands of apps have been developed for these devices to apply or assist in prevention, diagnosis and treatment of illnesses, physiotherapy, rehabilitation and monitoring of users’ health condition.
Creating the legal framework
Medical services are a regulated activity in nearly every country in the world. This is one reason that new technologies are absorbed more slowly in medicine than in less-regulated sectors; it takes longer to create legal regulations to keep up with changes in technology.
A legal framework within which telemedicine can function as a full-fledged medical practice is a necessary condition for the spread of this method of delivering medical services. Regulations must clearly define the rights of patients who decide to use telemedicine services, and must provide patients with certain protective measures and right of redress should these regulations not complied be with. Above all, regulations should serve to increase the level of trust in such medical procedures. These are after all new-generation, digital services, provided without direct contact between doctor and patient. Patients – particularly older ones – may not have confidence in this form of examination, diagnosis or treatment. This is why it’s so important that society as a whole accept these services, directly governed by legal regulations, as legal, safe, and performed in accordance with the required standards.
In turn, medical professionals providing services at a distance also need the certainty offered by legal regulations, to know that they are operating legally, in compliance with codes of ethics, respecting the rights of patients and their privacy, complying with the requirements of the medical arts, based on standards and confirmed procedures, using electronic equipment that comply with these standards and procedures.
With increasingly broader acceptance and use of telemedicine services in various forms (tele-diagnosis, e.g. tele-radiology, tele-consultation with a doctor, tele-surgery using medical robots, tele-rehabilitation or tele-care with tele-monitoring), they should not be perceived as services that will drive out and one day replace the current model of treatment based on direct doctor/patient contact, but as services that support and augment the work of doctors, making their work easier, unburdening healthcare institutions and equalising access to healthcare.
The groundwork has already been laid
The adoption of the Cross-border Patients’ Rights Directive (2011/24/EU) marked a critical point in the creation of legal regulations for telemedicine.
The Directive establishes rules for ensuring citizens of EU member states access to cross-border healthcare, which should be safe and of high quality, with the costs reimbursable. The Directive applies to the provision of healthcare to patients regardless of how it is organised, delivered and financed.
One form for delivering healthcare is telemedicine. It is defined by the European Commission as “the provision of healthcare services, through the 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.”
The Directive expressly refers to telemedicine in two of its provisions. The Directive defines the concept of the “member state of treatment.” Generally, this would mean “the member state on whose territory healthcare is actually provided to the patient,” but in the case of telemedicine, “healthcare is considered to be provided in the member state where the healthcare provider is established”. The Directive also includes telemedicine as one of the forms of delivery of cross-border healthcare that entitles the patient to reimbursement of the costs of treatment, if the relevant conditions established by the law of the member state are met.
The Directive therefore confirms the status of telemedicine as a service which is covered by the EU Treaty principle of the free movement of services. This means that citizens of member states may take advantage of this form of delivering medical services, and that healthcare professionals may provide such services.
Telemedicine services are provided under the same rules as other healthcare services – by licensed physicians and other healthcare professionals. Reimbursement of treatment costs may be available, and the requirement to respect the rights of patients applies. These rules are established individually by the member states. This means that in practice, performance of certain services may be subject to limitations, for example with respect to reimbursement.
Because telemedicine employs ICT and involves provision of services for a fee, at a distance and upon the individual request of the recipient, telemedicine also constitutes an information society service. This makes it subject to numerous Directives, including the E-Commerce Directive and the Electronic Communications Directive (2002/58/EC).
In cross-border telemedicine services, transmission and processing of data concerning a patient’s health status – sensitive data – is unavoidable. Providers of these services must therefore ensure the security of such data using appropriate technologies and methods preventing unauthorised access to the data. The European Commission is still working on consolidation of the rules for protection of personal data across the EU and on the functioning of new IT solutions such as cloud computing. Without doubt, increased security standards and introduction of effective technical measures for protecting data are among the key conditions for growth of telemedicine services. Otherwise, the risks connected with leaking or loss of patient data, e.g. from hacking into IT systems, is too great for healthcare providers to develop broader telemedicine procedures, particularly across borders.
And how is it in Poland?
In Poland there are no regulations directly governing provision of healthcare services at a distance. Nor are there any express prohibitions in force in this area. Despite the gaps in the law and the conservative approach in Poland to regulating the practice of medical professions, some research institutions and universities have launched projects based on telemedicine solutions. But apart from a cardiology project (tele-consultation and tele-rehabilitation) and an audiology project (tele-consultation and tele-care), these projects are of local scope.
Another barrier to provision of telemedicine services is the major delay in implementing the Poland’s healthcare information system. The current target for launch is 2017.
The current proposal to amend the Healthcare Information System Act contains a major clarification of the method in which physicians practise their profession, specifying that they are permitted to carry out their work via ICT systems. The proposal would also introduce a provision in the Healthcare Activity Act concerning the ability to provide healthcare services via ICT systems. These changes would remove concerns that healthcare professionals now have about the legality of practising telemedicine.
This leaves the patient, who needs to be educated to accept telemedicine and also needs to be assured that the costs of such procedures will be reimbursed. The NFZ (national health fund) does not currently reimburse for these services. Because of the limited use of telemedicine in Poland, there is a lack of research on the effectiveness and conditions for use of telemedicine procedures among patients, particularly in tele-consultation and tele-surgery, and without a positive evaluation of the effects of such examinations the service cannot be included in the basket of healthcare services for which reimbursement is provided.
In the context of removing barriers to telemedicine, the recent changes to the Personal Data Protection Act should be mentioned. They make it easier to transfer personal data within a group of companies or to a provider of outsourcing services, based on approval by GIODO, Poland’s inspectorate-general for personal data protection, of binding corporate rules for the group, where the members of the group are in different member states. This solution should make it easier to provide cross-border healthcare services generally, including telemedicine services.
As legal uncertainties are gradually eliminated, the vision of broad use of telemedicine, including cross-border telemedicine, draws nearer. However, without reimbursement of healthcare expenses and without the use of adequately secure technologies, compatible with the relevant systems in other EU member states, telemedicine could remain but a small part of the healthcare picture despite its economic efficiency and other advantages.