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Background and objective: Telemedicine or telehealth services has been increasingly practiced in the recent years. During the COVID-19 pandemic, telemedicine turned into and indispensable service in order to avoid contagion between healthcare professionals and patients, involving a growing number of medical disciplines. Nevertheless, at present, several ethical and legal issues related to the practice of these services still remain unsolved and need adequate regulation. This narrative review will give a synthesis of the main ethical and legal issues of telemedicine practice during the COVID-19 pandemic. Material and Methods: A literature search was performed on PubMed using MeSH terms: Telemedicine (which includes Mobile Health or Health, Mobile, mHealth, Telehealth, and eHealth), Ethics, Legislation/Jurisprudence, and COVID-19. These terms were combined into a search string to better identify relevant articles published in the English language from March 2019 to September 2021. Results: Overall, 24 out of the initial 85 articles were considered eligible for this review. Legal and ethical issues concerned important aspects such as: informed consent (information about the risks and benefits of remote therapy) and autonomy (87%), patient privacy (78%) and confidentiality (57%), data protection and security (74%), malpractice and professional liability/integrity (70%), equity of access (30%), quality of care (30%), the professional–patient relationship (22%), and the principle of beneficence or being disposed to act for the benefit of others (13%). Conclusions: The ethical and legal issues related to the practice of telehealth or telemedicine services still need standard and specific rules of application in order to guarantee equitable access, quality of care, sustainable costs, professional liability, respect of patient privacy, data protection, and confidentiality. At present, telemedicine services could be only used as complementary or supplementary tools to the traditional healthcare services. Some indications for medical providers are suggested.

The establishment of criteria for a European categorisation will have to serve most of the needs of all parties involved: health professionals, drug regulatory agencies, drug manufacturers and patients. Clear warnings and symbols are needed so patients use their medicines in the most optimal (and safest) way possible The DRUID WP4 expert group established and agreed that, according to its influence on the ability to drive, a medicine could, regarding to driving, be categorized as followed: • category 0 (no or negligible influence on fitness to drive), • category I (minor influence on fitness to drive), • category II (moderate influence on fitness to drive), • and category III (severe influence on fitness to drive). The DRUID methodology on categorisation/labelling on medicines and driving. In summary, categorisation of a medicine on driving includes several steps of evaluation after taken into account the conditions of use of the medicine on the European Union market: 1. Pharmacodynamic and pharmacokinetic data 2. Pharmacovigilance data (including prevalence of unwanted effects reported in the SmPC) 3. Experimental and epidemiological data 4. Additional data derived from the Patient Information Leaflet (PIL) and existing categorisation systems 5. Synthesis Básically conditions of use of the medicine, pharmacodynamics, pharmacokinetic data, and pharmacovigilance data (including prevalence of unwanted effects) were derived from the SmPC, while section 3 was based on a scientific literature serach. Additional data step consisted of reviewing section 4.7 of the SmPC "Effects on ability to drive and use machines" and the PIL section on "driving and using machines" as well as reviewing the previous categorisations (if available) of the medicine in Belgium, France, Spain as well as to the ICADTS list. After evaluating all the available data, a provisional category was assigned to each active substance. The provisional category was proposed and discussed during WP4 meetings where a final and definitive category was assigned and approved by all WP4 partners. ; Biología Celular, Histología y Farmacología