Digital Health Care, Telemedicine, and Medicolegal Issues in Orthopedics: A Review.

The use of technologies in medicine has great potential to reduce the costs of health care services by making appropriate decisions that provide timely patient care. The evolution of telemedicine poses a series of clinical and medicolegal considerations. However, only a few articles have dealt with telemedicine and orthopedics. This review assesses the ethical and medicolegal issues related to tele-orthopedics. A systematic review was performed including papers published between 2017 and 2021 focusing on the main medicolegal and clinical-governance aspects of tele-orthopedics. Most of the articles were published during the COVID-19 pandemic, confirming the impetus that the pandemic has also given to the spread of telemedicine in the orthopedic field. The areas of interest dealt with in the scientific evidence, almost exclusively produced in the USA, Europe, the UK, and Canada, are quality, patient satisfaction, and safety. The impact of telemedicine in orthopedics has not yet been fully evaluated and studied in terms of the potential medicolegal concerns. Most of the authors performed qualitative studies with poor consistency. Authorizations and accreditations, protection of patient confidentiality, and professional responsibility are issues that will certainly soon emerge.

From COVID-19 Pandemic to Patient Safety: A New "Spring" for Telemedicine or a Boomerang Effect?

During the Covid-19 health emergency, telemedicine was an essential asset through which health systems strengthened their response during the critical phase of the pandemic. According to the post-pandemic economic reform plans of many countries, telemedicine will not be limited to a tool for responding to an emergency condition but it will become a structural resource that will contribute to the reorganization of Healthcare Systems and enable the transfer of part of health care from the hospital to the home-based care. However, scientific evidences have shown that health care delivered through telemedicine can be burdened by numerous ethical and legal issues. Although there is an emerging discussion on patient safety issues related to the use of telemedicine, there is a lack of reseraches specifically designed to investigate patient safety. On the contrary, it would be necessary to determine standards and specific application rules in order to ensure safety. This paper examines the telemedicine-risk profiles and proposes a position statement for clinical risk management to support continuous improvement in the safety of health care delivered through telemedicine.

Improving Risk Management by Learning from Adverse Events: Report on One Year of COVID-19 Vaccination Campaign in Verona (Northeastern Italy).

BACKGROUND: The COVID-19 mass vaccination campaign posed new challenges not only from a healthcare perspective, but also in terms of distribution, logistics, and organization. Managing clinical risk in off-site vaccination centers during a pandemic provided a new opportunity for the training and acquisition of competencies through continuous learning from adverse events. The aim of this report, based on a review of activity, was to identify the most recurrent and high-risk failures of the vaccination process in a mass vaccination center. METHODS: Adverse events and near misses reported during the first 11 months of activity (February 2021-January 2022) in the mass vaccination center of Verona (Italy) were evaluated. RESULTS: From 15 February 2021 to 17 January 2022 the center administered about 460,000 doses to the population and nine adverse events and one near miss were reported. Most of the events were errors in vaccine administration, either in principle, dosage, or timing with respect to the indicated schedule. All events had minor outcomes. Communication errors, inadequate training, and general organizational issues were the most recurrent factors contributing to the events. CONCLUSIONS: Risk mitigation during mass vaccination in temporary sites is an essential element of a successful vaccination campaign. The reporting of adverse events should be encouraged in order to obtain as much information as possible for a continuous improvement of the activity.

Health Management in Italian Prisons during COVID-19 Outbreak: A Focus on the Second and Third Wave.

The SARS-CoV-2 spread is a threatening and challenging issue for correctional systems worldwide because of many factors, particularly overcrowding and of the intrinsic characteristics of the population. The prevention measures adopted by the Italian Government were aimed to protect and preserve both inmates' and prison workers' health. The present study aimed to evaluate the efficacy of the adopted strategies. METHODS: Data regarding Italian prisons' occupation and prisoners' population from January 2019 to June 2021, as well as the cumulative weekly increase of confirmed cases and the number of doses of vaccine administered among the population of inmates, the prison workers, and Italian population from November 2020 to the end of June 2021, were collected. RESULTS: Prisons' occupation dropped from 120% to 106% after the beginning of the pandemics. The confirmed cases between inmates were consistently lower than among the Italian population and prison workers. A time-series chart showed a time lag of one week between the peaks of the different population. CONCLUSIONS: The containing strategies adopted by the Italian correctional system have proved their effectiveness in terms of the prevention and protection of both inmate and staff health.

From Syndemic Lesson after COVID-19 Pandemic to a "Systemic Clinical Risk Management" Proposal in the Perspective of the Ethics of Job Well Done.

The syndemic framework proposed by the 2021-2030 World Health Organization (WHO) action plan for patient safety and the introduction of enabling technologies in health services involve a more effective interpretation of the data to understand causation. Based on the Systemic Theory, this communication proposes the "Systemic Clinical Risk Management" (SCRM) to improve the Quality of Care and Patient Safety. This is a new Clinical Risk Management model capable of developing the ability to observe and synthesize different elements in ways that lead to in-depth interventions to achieve solutions aligned with the sustainable development of health services. In order to avoid uncontrolled decision-making related to the use of enabling technologies, we devised an internal Learning Algorithm Risk Management (LARM) level based on a Bayesian approach. Moreover, according to the ethics of Job Well Done, the SCRM, instead of giving an opinion on events that have already occurred, proposes a bioethical co-working because it suggests the best way to act from a scientific point of view.

Comportment Management in the Hospital: Where Is Patient's Health Care Station?

This article analyzes the factors that explain the increased use of special reports by hospital facility auditors, such as the structured interview, wondering if they look like evaluation studies. It examines their training, impact, and the institutional use implicit in the performance audit. From an anthropological perspective, the audit could traditionally be considered as "Rituals of Verification," recognizing the procedure and the evaluation of social effects, in public management. Therefore, sampling represents an effective and efficient tool for carrying out the statutory audit activity in the health care facilities where the coronavirus disease (COVID-19) virus is treated. However, the performance established a regulatory dimension compared to the concept of verification. In addition, auditing practices may often seem "trivial, inevitable part of a bureaucratic process," but taken together and over time, they are probably part of a distinct cultural artifact. As we have seen, the reasons that justify the activation of a clinical audit can be numerous: patient complaints, occurrence of adverse events such as the case of COVID-19, performance with inadequate results, publication of new guidelines; however, the "bet" is that in the future the awareness that auditing is an irreplaceable part of professional practice will mature among professionals.

The Difficult Balance between Ensuring the Right of Nursing Home Residents to Communication and Their Safety.

The COVID-19 epidemic has had a profound impact on healthcare systems worldwide. The number of infections in nursing homes for the elderly particularly is significantly high, with a high mortality rate as a result. In order to contain infection risks for both residents and employees of such facilities, the Italian government passed emergency legislation during the initial stages of the pandemic to restrict outside visitor access. On 30 November 2020, the Italian President of the Council of Ministers issued a new decree recognizing the social and emotional value of visits to patients from family and friends. In addition, it indicated prevention measures for the purposes of containing the infection risk within nursing homes for the elderly. This article comments on these new legislative provisions from the medicolegal perspective, providing indications that can be used in clinical practice.

Take-Home Messages from the COVID-19 Pandemic: Strengths and Pitfalls of the Italian National Health Service from a Medico-Legal Point of View.

The World Health Organization (WHO) declared the outbreak of the Coronavirus disease-2019 (COVID-19) infection a pandemic on 11 March 2020. As of the end of October 2020, there were 50 million cases of infection and over one million deaths recorded worldwide, over 45,000 of which occurred in Italy. In Italy, the demand for intensive care over the course of this pandemic crisis has been exceptionally high, resulting in a severe imbalance between the demand for and availability of the necessary resources. This paper focuses on elements of preventive medicine and medical treatments in emergency and non-emergency situations which, based on the international scientific literature, may prove to be useful to physicians on a behavioral level and avert professional liability problems. In order to achieve this objective, we have performed a search on MEDLINE to find published articles related to the risks associated with the pandemic that contain useful suggestions and strategies for mitigating risks and protecting the safety of the population. The results have been collocated in line with these specific study areas.

Liability of clinical oncologists and the COVID-19 emergency: Between hopes and concerns.

To contain COVID-19 spread, Italy is under a global lockdown since February 21, 2020, except for health services and food supply. In this scenario, growing apprehension concerning legal consequences is rising among health professionals due to several ethical and legal questions. Even if medical ethicists may approve patients' prioritization protocols, hospitals and health professionals remain highly exposed to liability. The so-called smart-working may be very useful, but it may harbor potential legal harms for health personnel and patients and safety. Moreover, personal umbrella policies also often exclude liability arising out of the transmission of a communicable disease, especially a pandemic state, is declared. Under the pressure of medical associations, Italian Government political forces have very recently presented an amendment to the recently released ordinances for the COVID-19 emergency aimed to reduce medical liability. Presumably, similar epidemics or other wide-scale similar events may happen again in an unpredictable future. Therefore, more articulated legal regulations are strongly needed starting from lessons learned from this epidemic.