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Trusting telemedicine: A discussion on risks, safety, legal implications and liability of involved stakeholders
Open accessAbstract
Objectives The main purpose of the article is to raise awareness among all the involved stakeholders about the risks and legal implications connected to the development and use of modern telemedicine systems. Particular focus is given to the class of "active" telemedicine systems, that imply a real-world, non-mediated, interaction with the final user. A secondary objective is to give an overview of the European legal framework that applies to these systems, in the effort to avoid defensive medicine practices and fears, which might be a barrier to their broader adoption.Methods We leverage on the experience gained during two international telemedicine projects, namely MobiGuide (pilot studies conducted in Spain and Italy) and AP@home (clinical trials enrolled patients in Italy, France, the Netherlands, United Kingdom, Austria and Germany), whose development our group has significantly contributed to in the last 4 years, to create a map of the potential criticalities of active telemedicine systems and comment upon the legal framework that applies to them. Two workshops have been organized in December 2015 and March 2016 where the topic has been discussed in round tables with system developers, researchers, physicians, nurses, legal experts, healthcare economists and administrators.Results We identified 8 features that generate relevant risks from our example use cases. These features generalize to a broad set of telemedicine applications, and suggest insights on possible risk mitigation strategies. We also discuss the relevant European legal framework that regulate this class of systems, providing pointers to specific norms and highlighting possible liability profiles for involved stakeholders.Conclusions Patients are more and more willing to adopt telemedicine systems to improve home care and day-by-day self-management. An essential step towards a broader adoption of these systems consists in increasing their compliance with existing regulations and better defining responsibilities for all the involved stakeholders.
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“Scholars also commented on patients' need for assistance and education to navigate the new ways to get care and implications of using the services [34,[38], [39]].”
From REVISITING HEALTH INFORMATION TECHNOLOGY ETHICAL, LEGAL, and SOCIAL ISSUES and EVALUATION: TELEHEALTH/TELEMEDICINE and COVID-19 (2020) · cites this paper as [39]
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Schmitt, T., Habimana, K., Gottlob, A., Habl, C., Plomariti, C. S., Farmaki, A., Bogiatzidis, P., Leclercq, V., Delnord, M., & den Bulcke, M. V. (2026) · Health Economics Policy and Law · doi:10.1017/s1744133125100273 · Cited by 1
“…regulatory framework and digital infrastructure can be stated as a prerequisite for equitable telemedicine implementation and its possible acceptance by (cancer) patients (Kobeissi and Hickey 2023; Knudsen et al. , 2021; Parimbelli et al. , 2018; Payne et al. , 2024; Ricke and Bartelink 2000).”
Letsa, B. S., Oppong, J., Ahmed, H., Kubio, C., Adofo, A. O., Amu, H., & Baiden, F. (2026) · Frontiers in Digital Health · doi:10.3389/fdgth.2026.1864794 · Cited by 1
“However, it also highlights the need for ways to better engage male consumers, whose health-seeking behavior may be different or underrepresented (28).”
Taghipour, M. M., & Sepehri, M. M. (2020) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-020-01170-6 · Cited by 1
“Furthermore, the risks, safety, legal implications, and liability of involved stakeholders should be taken into account [13].”
BackgroundTelemedicine and Healthcare Ecosystem in India: A Review, Critique and Research Agenda
Shukla, P. S., & Shamurailatpam, S. D. (2022) · TELe-Health · doi:10.1007/978-3-030-99457-0_13 · Cited by 1
Policy Recommendation for Telemedicine Services after Covid-19 Pandemic
Budiyanti, R. T., Suryawati, C., Murni, M., & Hanifah, M. (2022) · BIO Web of Conferences · doi:10.1051/bioconf/20225400019 · Cited by 1
Iyendo, T. O., Uwajeh, P. C., & Bamisaye, A. (2022) · Lecture notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering · doi:10.1007/978-3-031-23116-2_4 · Cited by 1
SOG'LIQNI SAQLASHDA TELETIBBIYOT IMKONIYATLARI, XUSUSIYATLARI VA TO'SIQLARI
Karabayev, S., Xalilov, H., assistenti, T. T. A. N. V. P. F. K., Norberdiyev, S., Shadmanova, N., & t.f.n., T. T. A. N. V. P. F. K. A. (2023) · Eurasian Journal of Medical and Natural Sciences · doi:10.37547/ejmns-v03-i02-p2-46 · Cited by 1
“Bemorlar endi uzun navbatlarda turishga majbur bo‘lmaydilar va shifokorlar bemorlar haqidagi ma’lumotlarga elektron fayllar yordamida qulayroq va samarali kirishlari hamda umumiy kutish vaqtlarini yo‘qotmaydilar[2].”
BackgroundTelemedicine Acceptance in Malaysia's Healthcare System: Systems Quality and Users Behaviour Matter
Ramli, R. B., & Yahya, H. (2023) · International Conference on Information Management and Technology (ICIMTech) · doi:10.1109/icimtech59029.2023.10278060 · Cited by 1
Information and health literacy policies during pandemics: A narrative review
Mehrabad, S. D., Panahi, S., Sedghi, S., & Aryankhesal, A. (2024) · Health Information & Libraries Journal · doi:10.1111/hir.12544 · Cited by 1
Telemedicine in Italy: Healthcare authorization profiles in the modern medico-legal reading
Bolcato, V., Basile, G., Prevot, L. B., Fassina, G., Rapuano, S., Brizioli, E., & Tronconi, L. (2024) · International Journal of Risk & Safety in Medicine · doi:10.3233/jrs-240004 · Cited by 1
Alshaikhi, O. A., Aldarsi, L. A., Basfar, I. A. A., Alshehri, A., Shuqdar, R. M., Ghazy, R. M., & Elrggal, M. E. (2025) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2025.1426998 · Cited by 11
Mazaev, V. P., Komkov, A. A., Ryazanova, S. V., Samochatov, D. N., & Drapkina, O. M. (2020) · Современные проблемы науки и образования · doi:10.17513/spno.30478 · Cited by 1
“В последнее время интенсивно разрабатывается нормативно-правовая база новых правил применения ИИ в медицине [32, 33].”
Almatrooshi, H. (2022) · doi:10.46289/cs12lq29 · Cited by 1
Onlayn tibbiy xizmatlar va ularning o‘ziga xos xususiyatlari
Askarov, J. T. (2022) · Общество и инновации · doi:10.47689/2181-1415-vol3-iss6/s-pp293-300
Ramli, R. B., & Yahya, H. (2022) · IEEE/ACIS International Conference on Big Data, Cloud Computing, and Data Science (BCD) · doi:10.1109/bcd54882.2022.9900610
“From the literatures, poor acceptance of telemedicine initiative has been generally established to be stemmed from factors such as unconventional medical consultation process [13, 14, 15, 16] , privacy and liability issues [17, 15] , system quality [18, 19, 20, 15, 13, 21, 22], resistance to technology [15, 18] , unsu…”
BackgroundMaslyakov, V. V., Solovieva, V. A., Gerasimova, T. A., Bachaeva, A. T., Dudaev, D. M., Saidova, M. I., & Mudueva, M. U. (2023) · Spravočnik vrača obŝej praktiki (Journal of Family Medicine) · doi:10.33920/med-10-2302-02
Digital Health and Pharmacy: Evidence Synthesis and Applications
Hussain, R., Zainal, H., Noor, D. A. M., & Shakeel, S. (2023) · Springer eBooks · doi:10.1007/978-3-030-50247-8_80-1
Identifying the Challenges of Users in Using the Services of Electronic Health Platforms
salehnia, N., & Salehnia, F. (2023) · Journal of Health and Biomedical Informatics · doi:10.34172/jhbmi.2023.05
Digital Health and Pharmacy: Evidence Synthesis and Applications
Hussain, R., Zainal, H., Noor, D. A. M., & Shakeel, S. (2023) · Springer eBooks · doi:10.1007/978-3-030-64477-2_80
The Implications of Telemedicine in Pediatric Health: Integration of Technology into Medicine
Alrashdan, O. S., & Alshurfat, M. O. (2024) · Scholars Academic Journal of Pharmacy · doi:10.36347/sajp.2024.v13i01.005
A Comprehensive Analysis of: A Systematic Review
Lestari, D. E., Maulana, F. I., Purnomo, A., & Adi, P. D. P. (2024) · Lecture notes in electrical engineering · doi:10.1007/978-981-97-1463-6_30
Anesthesia Services Can be Provided via Telemedicine: An Assessment of the Readiness
Kohzadi, Z., Rahmatizadeh, S., Dabbagh, A., Emami, H., & Kohzadi, Z. (2024) · Journal of Biomedical Physics and Engineering · doi:10.31661/jbpe.v0i0.2311-1686
“However, the term “telemedicine” has different mean - ings over time, the majority of these meanings align with the fundamental principles outlined by the American Telemedicine Association, showing that telemedicine utilizes electronic communications to enhance patients’ clinical health [3].”
Legal and ethical considerations in medical records management within emergency cardiology
Almanna, M. A., Alanazi, D. M., Alaujan, B. S., Zamzami, B. A., Almarzouq, Y. F., Ababtain, H. A., Alenizi, E. S., Alshaibani, . S., Alowaidan, . R., Alharbi, L. F., et al. (2019) · International Journal of Health Sciences · doi:10.53730/ijhs.v3ns1.15059
Audiophonologopedic Telerehabilitation: Advantages and Disadvantages from User Perspectives
Lauriello, M., Angelone, A. M., Iannotti, S., Nardecchia, E., Scopano, B., Fioretti, A. B., Ciancarelli, I., & Eibenstein, A. (2024) · Children · doi:10.3390/children11091073
“The chance of a “tailored” therapy based on the patient’s needs and preferences, combined with the flexibility of a remote therapeutic approach, contributes to the effectiveness of the rehabilitation process [26,27].”
BackgroundMirasghari, F., Ayatollahi, H., & Velayati, F. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-30168-1.00025-6
A Study on Telemedicine Facility at a Tertiary care hospital in South India
Pushpilata, A. S., Pillai, J. S. K., & Mondal, R. (2024) · Asian Journal of Management · doi:10.52711/2321-5763.2024.00051
Remote Consultation Appropriateness: Legal Issues and Ethical Concerns
Suzuki, E. C. (2025) · TELe-Health · doi:10.1007/978-3-031-89661-3_4
Bioethics in information technologies in telehealth: a systematic review
dos Santos, W. O. M., Gonçalves, I. C. D. M., Duarte, G. G., Osis, S. L., de Farias, A. S., Santos, D. M., & Sachett, J. D. A. G. (2025) · Revista Bioética · doi:10.1590/1983-803420253475en
Bioética en las tecnologías de la información en telesalud: una revisión sistemática
dos Santos, W. O. M., Gonçalves, I. C. D. M., Duarte, G. G., Osis, S. L., de Farias, A. S., Santos, D. M., & Sachett, J. D. A. G. (2025) · Revista Bioética · doi:10.1590/1983-803420253475es
Schmitt, T., Habimana, K., Gottlob, A., Habl, C., Rosińska, M., Frydensberg, M. S., Jensen, C., Leclercq, V., Delnord, M., & den Bulcke, M. V. (2025) · Journal of Health Organization and Management · doi:10.1108/jhom-01-2025-0048
Policies and Practices of Cross-border Teleconsultation in Japan
Yan, Y., & Naito, T. (2025) · Juntendō Igaku/Juntendo igaku · doi:10.14789/ejmj.jmj25-0016-p
“As in other countries, concerns about legal liability and the risk of malpractice may cause Japanese doctors to hesitate in offering medical opinions or recommendations 8 ) .”
Silven, A. V., van Peet, P. G., Boers, S. N., Tabak, M., de Groot, A., Hendriks, D., van Os, H. J. A., Bonten, T. N., Atsma, D. E., de Graaf, T. J., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19094149
Metadata
- Authors
- Parimbelli, E., Bottalico, B., Losiouk, E., Tomasi, M., Santosuosso, A., Lanzola, G., Quaglini, S., & Bellazzi, R.
- Affiliations
- University of Pavia (IT)
- Free University of Bozen-Bolzano (IT)
- Corresponding author
- Parimbelli, E.
- Venue
- International Journal of Medical Informatics
- Publisher
- Elsevier BV
- Published
- 2018-04
- Volume
- 112
- Pages
- 90-98
- ISSN
- 1386-5056 (ISSN-L)
- OpenAlex
- W2794434368
- Cited by
- 110
- References
- 61
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 18 · 2023: 14 · 2022: 21 · 2021: 11 · 2020: 13 · 2019: 7 · 2018: 5
- FWCI
- 8.57
- Type
- journal article
- Language
- en
- Open access
- Licence
- cc-by-nc-nd
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- Locations
- International Journal of Medical Informatics (publishedVersion)
- PubMed (publishedVersion)
- Iris (University of Trento) (submittedVersion, cc-by-nc-nd)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- European Union’s Seventh Framework Programme (287811, 247138)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Social Sciences › Law › Medical Malpractice and Liability Issues
- Social Sciences › Law › Medical and Health Sciences Research
- Keywords
- telemedicine, risk mitigation, legal framework, liability, stakeholder responsibility, home care, self-management, European regulation, telehealth adoption
- MeSH terms
- Stakeholder Participation, Delivery of Health Care, Europe, Humans, Risk Management, Liability, Legal, Telemedicine, Patient Safety
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