Telemedicine: The legal framework (or the lack of it) in Europe

Raposo, Vera Lúcia

doi:10.3205/hta000126

Cited by 43 publications

(22 citation statements)

References 10 publications

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“…According to international studies, digital patient education has proven to be feasible, safe, efficient, and cost-effective and has been increasingly recommended and used during the COVID-19 pandemic [6,8]. This paper highlights the current standard in Europe and filters out concerns anaesthetists have about a telemedicine approach while pointing out the potential benefits.…”

Section: Discussionmentioning

confidence: 96%

“…European legislation considers telemedicine to be a health service on the one hand and an information service on the other and therefore is subject to different legislation [8]. Specific legal regulations for the use and handling of telemedicine are lacking in many countries, and harmonization across the EU is often described as unfeasible, for one, because of data protection problems [8].…”

Section: Discussionmentioning

confidence: 99%

“…Given the safety of remote education and informed consent, it is plausible that both the risk and potential anxiety and discomfort for the child caused by a hospital visit are vastly reduced. However, the use of technology in this context was highly restricted prior to the COVID-19 pandemic [8,9].…”

Section: Introductionmentioning

confidence: 99%

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Digital Online Anaesthesia Patient Informed Consent before Elective Diagnostic Procedures or Surgery: Recent Practice in Children—An Exploratory ESAIC Survey (2021)

Schleifer

Straßberger‐Nerschbach

Kamp

et al. 2022

JCM

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Background: One undisputed benefit of digital support is the possibility of contact reduction, which has become particularly important in the context of the COVID-19 pandemic. However, to the best of our knowledge, there is currently no study assessing the Europe-wide use of digital online pre-operative patient information or evaluation in the health sector. The aim of this study was to give an overview of the current status in Europe. Methods: A web-based questionnaire covering the informed consent process was sent to members of the European Society of Anaesthesia and Intensive Care Medicine (ESAIC) in 47 European countries (42,433 recipients/930 responses). Six questions related specifically to the practice in paediatrics. Results: A total of 70.2% of the respondents indicated that it was not possible to obtain informed consent via the Internet in a routine setting, and 67.3% expressed that they did not know whether it is in line with the legal regulations. In paediatric anaesthesia, the informed consent of only one parent was reported to be sufficient by 77.6% of the respondents for simple interventions and by 63.8% for complex interventions. Just over 50% of the respondents judged that proof of identity of the parents was necessary, but only 29.9% stated that they ask for it in clinical routine. In the current situation, 77.9% would favour informed consent in person, whereas 60.2% could imagine using online or telephone interviews as an alternative to a face-to-face meeting if regulations were changed. Only 18.7% participants reported a change in the regulations due to the current pandemic situation. Conclusion: Whether informed consent is obtained either online or on the telephone in the paediatric population varies widely across Europe and is not currently implemented as standard practice. For high-risk patients, such as the specific cohort of children with congenital heart defects, wider use of telemedicine might provide a benefit in the future in terms of reduced contact and reduced exposure to health risks through additional hospital stays.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

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Digital Online Anaesthesia Patient Informed Consent before Elective Diagnostic Procedures or Surgery: Recent Practice in Children—An Exploratory ESAIC Survey (2021)

Schleifer

Straßberger‐Nerschbach

Kamp

et al. 2022

JCM

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“…First, there is a significant heterogeneity among EU countries in terms of digital health funding, readiness and use (23). Moreover, in EU, there is no common regulatory framework for medical liability, since, despite some common legal principles, there are enormous legal differences among the juridical cultures of the Member States (e.g., in Italy medical errors can also be criminally persecuted) (24). That being said, privacy protection is guaranteed by the General Data Protection Regulation (GDPR), that applies when personal data are processed by a processor or controller in the context of the activities of its establishment in EU.…”

Section: Us and Eu Regulatory Frameworkmentioning

confidence: 99%

“…Telemedicine is having a significant impact on healthcare services like preventive medicine and follow-up of chronic conditions (24). In general, it is considered beneficial for both the healthcare institutions (that can offer their services also to distant people or to elder/physically impaired/sedentary persons who normally don't go to hospitals for non-urgent conditions) and for the patients (who can save more than 100 min per visit) (24,53). The main medico-legal issue of telemedicine is the so-called decoupling: the physician and patient are in different locations or even in different states (32).…”

Section: Medico-legal Issues Of Telemedicinementioning

confidence: 99%

Management of Medico-Legal Risks in Digital Health Era: A Scoping Review

et al. 2022

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Artificial intelligence needs big data to develop reliable predictions. Therefore, storing and processing health data is essential for the new diagnostic and decisional technologies but, at the same time, represents a risk for privacy protection. This scoping review is aimed at underlying the medico-legal and ethical implications of the main artificial intelligence applications to healthcare, also focusing on the issues of the COVID-19 era. Starting from a summary of the United States (US) and European Union (EU) regulatory frameworks, the current medico-legal and ethical challenges are discussed in general terms before focusing on the specific issues regarding informed consent, medical malpractice/cognitive biases, automation and interconnectedness of medical devices, diagnostic algorithms and telemedicine. We aim at underlying that education of physicians on the management of this (new) kind of clinical risks can enhance compliance with regulations and avoid legal risks for the healthcare professionals and institutions.

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Telemedicine practice guidelines in India: Global implications in the wake of the COVID‐19 pandemic

Venkatesh

Ananthan³

2022

World Med & Health Policy

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Telemedicine is the delivery of healthcare services from a distance, by use of information and communication technology. There have been no statutory regulations or official guidelines in India specific for telemedicine practice and allied matters so far. For the first time, the government of India released telemedicine practice guidelines for Registered Medical Practitioners on March 25, 2020, amid the COVID‐19 outbreak. This review would initiate the discussion on the features of the guidelines, their limitations, and their significance in times of the COVID‐19 pandemic. The guidelines are with a restricted scope for providing medical consultation to patients, excluding other aspects of telemedicine such as research and evaluation and the continuing education of healthcare workers. The guidelines have elaborated on the eligibility for practicing Telemedicine in India, the modes and types of teleconsultations, delved into the doctor‐patient relationship, consent, and management protocols, and touched upon the data security and privacy aspects of Teleconsultation. After releasing the guidelines, the telescreening of the public for COVID‐19 symptoms is being advocated by the government of India. COVID‐19 National Teleconsultation Centre (CoNTeC) has been initiated, which connects the doctors across India to All India Institute of Medical Sciences (AIIMS) in real‐time for accessing expert guidance on the treatment of the COVID‐19 patients.

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Telemedicine: The legal framework (or the lack of it) in Europe

Cited by 43 publications

References 10 publications

Digital Online Anaesthesia Patient Informed Consent before Elective Diagnostic Procedures or Surgery: Recent Practice in Children—An Exploratory ESAIC Survey (2021)

Digital Online Anaesthesia Patient Informed Consent before Elective Diagnostic Procedures or Surgery: Recent Practice in Children—An Exploratory ESAIC Survey (2021)

Management of Medico-Legal Risks in Digital Health Era: A Scoping Review

Telemedicine practice guidelines in India: Global implications in the wake of the COVID‐19 pandemic

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