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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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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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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