THE SIGNIFICANT ROLE OF LEGAL REGULATIONS AND .
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)THE SIGNIFICANT ROLE OF LEGAL REGULATIONS AND STANDARDISATIONIN THE DEVELOPMENT OF TELEMEDICINE IN THE EUMikołaj MaślińskiAdam Mickiewicz University, Polandmikolaj.maslinski@amu.edu.plAbstractPurpose – The main aim of this article is to analyze and evaluate EU policies and legislationconcerning telemedicine. Therefore, the article aims to identify the legal instruments which could beimplemented to guarantee the development of telemedicine among the Member States of the EU,which will take place with respect to patient welfare and interoperability of healthcare systems.Design/methodology/approach – As for its methodology, this research focuses on the EUpolicies, legislation and a few recent initiatives that were undertaken by Poland and other EU MemberStates in the area of telemedicine. This research utilizes qualitative research methods. The textualanalysis method has been used to examine the content and meaning of legal texts and otherdocuments as well as their structure.Findings – The phenomenon of telemedicine is an extremely complex issue. This implies thatthe attempt to provide health services based on such solutions requires a comprehensive approach,taking into account not only the normative material related to the healthcare but also a number ofsectoral regulations relating to, for example, personal data protection and cybersecurity rules,patients’ rights, or to the provisions governing electronic commerce. On the other hand, mostregulations concerning directly telemedicine occur in the area of soft law. Due to this fact, there aresignificant differences in national regulations. Therefore, institutions involved in the EU legislationshould focus on implementing general standards in telemedicine, which would guarantee patientwelfare. Finally, the significant challenge is to provide interoperability between telemedicine solutionsavailable around the European Union. This is a sine qua non condition for a greater utilization oftelemedicine solutions by EU citizens.Research limitations/implications – The scope of the research covers the examination of theEU policies and legislation on telemedicine. This article does not cover wide and complex research onsectoral regulations relating to, for example, personal data protection and cybersecurity rules, patientrights, or finally to the provisions governing electronic commerce. It covers the comparative analysisof telemedicine in Poland and only general analyses concerning different countries, e.g. France or theUSA.Practical implications – The findings may give some reference to institutions involved in theEU legislation, especially to the European Commission. Therefore, they can be useful for improving theMember States’ legal frameworks on telemedicine.Originality/Value – Contrary to the majority of papers on telemedicine, this article does notconcentrate on the barriers and challenges for the successful implementation of telemedicine butfocuses on solutions. What is more, this research covers the latest regulations and publications.Finally, the article presents the current Polish legislation promoting telemedicine solutions, which mayprove an interesting case study for researchers from different countries.Keywords: telemedicine, telehealth, teleconsultations, healthcare, eHealth, interoperabilityResearch type: research paper.66
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)IntroductionThe development of Information and Communication Technologies (ICT) has createdhitherto unknown possibilities of providing health services at a distance. The above trend ledto the formulation of the term "telemedicine". According to the definition proposed by theEuropean Commission, “telemedicine is the provision of healthcare services, through use ofICT, 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, treatmentand follow-up of patients”1.The potential of telemedicine technologies is indisputable: it can provide new costeffective and efficient methods of delivering healthcare as well as improve health and qualityof life of thousands of patients (PWC, 2018). Furthermore, numerous studies have alreadydemonstrated improved clinical outcomes through the use of telemedicine applications (Khanand Driessen, 2018). Taking into account the dynamic development of new technologies aswell as the growing demand for medical services - which results even from the aging of thepopulation - it seems inevitable that telemedicine solutions will expand in current treatmentactivities. This tends to confirm the results of last research: he number of mHealth appsavailable in the market has increased substantially. In 2017 there was over 318,000 healthapps available on the top app stores worldwide, nearly double the number of apps available in2015 – with more than 200 apps being added each day (IQVIA, 2017). It is therefore notsurprising that the authors of the report on Global Markets for Telemedicine Technologiesanticipate the rapid development of telemedicine. As a comparison, in 2018 the globaltelemedicine market totalled 31.2 billion and is estimated to reach 72.5 billion by 2023,growing at a compound annual growth rate (CAGR) of 18.3% for the period between 2018and 2023 (BCC Research, 2018).On the other hand, the contemporary development of telemedicine among the MemberStates of the European Union leaves a lot to be desired. Although the concept of telemedicinehas been present in EU policies and strategies for over 15 years, the total EU market share ofthese services still remains marginal. According to a survey requested by the EuropeanCommission, in the last 12 months before March 2017, less than one in five respondents haveused health and care services provided online (18%), 5% have used these "once", 6% "twice"and 7% "three times or more". The majority (81%) have "never" used these services”(TNSPolitical & Social, 20172). One indication of this syptome is the European ParliamentResolution of 12 February 2019 on the Implementation of the Cross-Border HealthcareDirective. In this Resolution, the European Parliament pointed out that “the application of thedirective with regard to telemedicine – health services provided remotely – has led to acertain lack of clarity concerning reimbursement schemes, as some Member States doreimburse or provide consultation with general or specialised practitioners at a distance,while others do not”3. In this respect, the European Parliament calls upon the EuropeanCommunication of 4 November 2008 from the Commission to the European Parliament, the Council, theEuropean Economic and Social Committee and the Committee of the Regions on telemedicine for the benefit ofpatients, healthcare systems and society. COM (2008) 0689 final.2 This survey was carried out by TNS Political & Social network in the 28 Member States of the European Unionbetween 18th and 27th of March 2017. Some 27,901 EU citizens from different social and demographiccategories were interviewed face-to-face at home and in their native language on behalf of the DirectorateGeneral for Communications Networks, Content and Technology.3 European Parliament Resolution of 12 February 2019 on the Implementation of the Cross-Border HealthcareDirective. 2018/2108 (INI).167
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)Commission to “support the uptake of the reimbursement rules, in accordance with Articles7(1) and 4(1), so that they also apply to telemedicine, where appropriate”. Moreover, theEuropean Parliament pointed out that the European Commission should “encourage theMember States to align their approaches to the reimbursement of telemedicine”1.Furthermore, ensuring that patients have access to the convenience and benefitsafforded by telemedicine technologies is not enough. Telemedicine malpractice cases arelikely to increase the more widely it is used. Thus, there is a question of the legislativestrategy: do we need a law for regulating the use of telemedicine technologies in the practiceof medicine to guarantee the appropriate standards of care in the delivery of medical servicesdirectly to patients via telemedicine technologies? Or maybe the better solution is to dependon liberalisation and the free market.In light of these considerations, the question arises of what the EU legislation isconcerning telemedicine. Therefore, the article aims to identify the legal instruments whichcould be enforced to remove barriers to widespread appropriate adoption of telemedicinetechnologies for delivering care while ensuring the public health, patient welfare and safety.Definition and genesis of telemedicineOn the basis of the EU legal system, there is currently no legal definition of the conceptof telemedicine. Moreover, in many documents of the international organizations, as well as inthe literature, there is a noticeable terminological chaos concerning this issue. This isevidenced on the one hand by a multitude of concepts related to the aspects of modernhealthcare under development in recent years (e.g. telemedicine, telehealth, telecare, eHealth,mHealth, cybermedicine), and on the other hand, no consistency in their application(Mazurkiewicz and Klach, 2017; Botrugno C. 2018).The lack of a unified nomenclature is present also in the legislation of the United Statesof America. According to the research of the Center for Connected Health Policy (CCHP), thestates alternate between using the term “telemedicine” or “telehealth”. In some states, bothterms are explicitly defined in law and/or policy and regulations. ”Telehealth” is sometimesused to reflect a broader definition, while “telemedicine” is used mainly to define the deliveryof clinical services (CCHP, 2018). In addition, the authors of a Market study on telemedicinesuggestthat“telehealth is a more generic term that refers to health-related procedures, while telemedicinerefers more specifically to treating people from distance” (PWC, 2018). On the other hand,they pointed out that “eHealth and mHealth are terms that are as generic as telehealth interms of health services, but specific to the technologies used in delivering these services fromdistance: the Internet and mobile devices respectively” (PWC, 2018).Given the above, a lot of researchers describe “telemedicine” as “providing medical careat a distance”2. This definition derives from a combination of a prefix “tele”, (from AncientGreek τῆλε [têle], “at a distance”), which is a typical part of compound words that indicatetheir semantic connection with distance actions (e.g. telephone, teleoperator, telemarketer)Ibidem.See: Volkert S. E. 2000. Telemedicine: Rx for the Future of Health Care. Michigan Telecommunications andTechnology Law Review., Vol. 6. 147 (2000). For more definitions see: Darkins A. W., Cary M. A. 2000.Telemedicine and Telehealth: Principles, Policies, Performances and Pitfalls. New York: Springer CompanyPublishing Inc. pp. 1-24; Maheu M.M., Whitten P., Allen A., E-Health, Telehealth, and Telemedicine: A Guide toStartup and Success, San Francisco 2001, pp. 2-4.1268
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)and a Latin term “medicina”1. As a result, the term telemedicine is defined as “healing from adistance”.It should be noted that Dr. K. Bird may be considered to be the author of the term“telemedicine” (Murphy and Bird). During his research in the 1960s he started to use the termtelemedicine. What is more, in their papers published in 1974, Bird and Murphy described thetelediagnosis as “system which utilizes diagnostic instrumentation to reproduce closely thenormal clinical setting wherein patient and doctor are in the same room”. What is interesting,the first example of using technology to deliver medical care from a distance wasimplemented in the early 1900s by a Dutch physiologist - Dr. Willem Einthoven. In 1903 W.Einthoven mastered the art of recording electrocardiogram among patients in a hospitallocated 1 km from the place where he read the results. This was done using a stringgalvanometer (the so-called Einthoven galvanometer) and telephone lines. As a result, W.Enithoven is considered to be the founder of the first electrocardiography, as well as the firstscientist-clinician, who on a relatively large scale applied technology of a similar purpose tothat used for the needs of modern telemedicine utilizing a string galvanometer that hedesigned and was the birth of clinical electrocardiography (Stowe and Harding, 2010). By the1960s, technology progressed to represent the modern form of telemedicine. Military andspace industries were the first to create and adopt the technology required to deliver thismodern care (WHO, 2010).The advancements and continued development of medical and communicationstechnology have had a profound impact on present understanding of telemedicine. As a result,the simplest definition of telemedicine (providing medical care at a distance) seems to be atoo far-reaching simplification. Therefore, the common idea is to limit the definition oftelemedicine by requiring utilisation of ICT. As Maurice and Caron rightly pointed out the “useof ICT or telecommunications to the definition of telemedicine limits the scope of activities butincorporates ICT-based activities that are not necessarily considered to be ‘telemedicine’”. Asan example, these authors quote the use of ‘telephone’ in clinical practice, which was reportedin the Lancet in 1879. Despite its slow uptake and early resistance from conservativephysicians, the telephone is now an integral part of medicine, for communication withcolleagues and patients, at a distance, to facilitate healthcare (Maurice and Caron, 2010).Because of that, the Federation of State Medical Boards (FSMB)2 in the Model policy for theappropriate use of telemedicine technologies in the practice of medicine, stated that“generally, telemedicine is not an audio-only, telephone conversation, e-mail/instantmessaging conversation, or fax”. Regardless of this policy, telemedicine “means the practice ofmedicine using electronic communications, information technology or other means between alicensee in one location, and a patient in another location with or without an interveninghealthcare provider ( ). It typically involves the application of secure videoconferencing orstore and forward technology to provide or support healthcare delivery by replicating theinteraction of a traditional encounter in person between a provider and a patient” ,[interactive].[accessed2019-05-04]. https://en.wiktionary.org/wiki/tele- .2 The Federation of State Medical Boards represents the 70 state medical and osteopathic regulatory boards—commonly referred to as state medical boards—within the United States, its territories and the District ofColumbia. It supports its member boards as they fulfill their mandate of protecting the public health, safety andwelfare through the proper licensing, disciplining, and regulation of physicians and, in most jurisdictions, otherhealthcare professionals. See: The Federation of State Medical Boards official website: https://www.fsmb.org/about-fsmb/ .169
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)An important point of reference in defining the concept of telemedicine is the acquis ofthe World Health Organization. For example, in its famous Report the WHO explains thattelemedicine is “the delivery of health care services, where distance is a critical factor, by allhealth care professionals using information and communication technologies for the exchangeof valid information for diagnosis, treatment and prevention of disease and injuries, researchand evaluation, and for the continuing education of health care providers, all in the interestsof advancing the health of individuals and their communities” (WHO, 1998).Another crucial definition, especially among the EU Member States, was proposed inCommunication of 4 November 2008 from the Commission to the European Parliament, theCouncil, the European Economic and Social Committee and the Committee of the Regions ontelemedicine for the benefit of patients, healthcare systems and society (further also:“Communication COM (2008) 689”). As mentioned before, in this document the EuropeanCommission described telemedicine as “the provision of healthcare services, through use ofICT, in situations where the health professional and the patient (or two health professionals)are not in the same location”. According to Communication COM (2008) 689 “it involvessecure transmission of medical data and information, through text, sound, images or otherforms needed for the prevention, diagnosis, treatment and follow-up of patients”. In thefurther part of the Communication, the Commission states that telemedicine encompasses awide variety of services. Those most often mentioned in peer-reviews are “teleradiology,telepathology, teledermatology, teleconsultation, telemonitoring, telesurgery andteleophthalmology”. Other potential services include call centers/online information centersfor patients, remote consultation/e-visits or videoconferences between health professionals.It is worth noting that the European Commission excludes from the telemedicine servicescatalogue “health information portals, electronic health record systems, electronictransmission of prescriptions or referrals (e-prescription, e-referrals)”.In conclusion, the definition of telemedicine, in spite of what may appear, is not just anobject of an academic dispute. The legal understanding of telemedicine may be crucial both in medical and legal practice. The regulation in this area may alter the scope of practice orauthorize the delivery of remote healthcare services. Such decisions may be also crucial for anumber of physicians and other medical professionals, as well as producers of medicaldevices. In consequence, the institutions involved in the EU legislation should take intoconsideration what is the expected model of telemedicine among the Member States. Thisdiscussion should deliver a proposition of telemedicine definition. Without the precise scopeof activities which are classified as telemedicine practice, there will be a wide range ofsystems among the 28 old EU countries. As a result, the telemedicine systems would be justlocal, limited to a maximum one or several states. Furthermore, it will be very difficult or evenimpossible to guarantee the interoperability of the telemedicine system around the EUMember States.Telemedicine in the light of EU policies and regulationsAlthough telemedicine has not yet been legally defined under EU law, this concept hasbeen present in the area of EU soft law acts for over 15 years1. Namely, for the first time itSome authors, among the initiatives that increase the use of telemedicine in Europe, present also olderEuropean acts. For example, Vera Lúcia Raposo cataloged among them Decision No 276/1999/EC of theEuropean Parliament and of the Council of 25 January 1999 adopting a multiannual Community action plan onpromoting safer use of the Internet by combating illegal and harmful content on global networks (OJ L 33,6.2.1999, pp. 1–11) and Communication from the Commission to the Council, the European Parliament, theEconomic and Social Committee and the Committee of the Regions - eEurope 2002: Quality Criteria for Health170
Social Transformations in Contemporary Society, 2019 (7)ISSN 2345-0126 (online)appeared in Communication of 30 April 2004 from the Commission to the Council, theEuropean Parliament, the European Economic and Social Committee and the Committee of theRegions e-Health - making healthcare better for E
telemedicine market totalled 31.2 billion and is estimated to reach 72.5 billion by 2023, growing at a compound annual growth rate (CAGR) of 18.3% for the period between 2018 and 2023 (BCC Research, 2018). On the other hand, the contemporary development of telemedicine among the Member States of the European Union leaves a lot to be desired.
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. Crawford M., Marsh D. The driving force : food in human evolution and the future.
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
