Guide Medical Device Regulations: Global Overview and Guiding Principles

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Comparative Overview of Medical Device Regulatory Systems

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Github Facebook Google TwitterorFirst over-use product only be an shake? However, citizens often do not have the necessary skills to find and evaluate online health information and apply their knowledge to make health decisions. Digitally health literate citizens are empowered to play a more active role in their health self management, resulting in improved prevention, adherence to a healthier lifestyle and better health outcomes.

IC-Health project will provide support for the improvement of digital health literacy in Europe; in particular, the project will design 35 open access online courses MOOCs , in eight different national languages, for different population cohorts including for instance children, pregnant awomen, elderly and people affected by diabetes. Personalised medicine does not only concern medicines or medicinal products. A better understanding of the biological mechanisms and environmental interactions that govern health and disease will impact the entire health care continuum, from health research to patient care.

This report addresses the broader policy perspective and challenges by showcasing both integrated healthcare models in Member States and business approaches which involve patients more directly in their healthcare. Please find the full report in the attachments below. On May 25, , the Dutch Presidency of the Council of the European Union and the European Parliament have reached a draft agreement on the medical devices and in vitro diagnostic medical devices regulations. The Commission had considered a revision of the existing regulatory framework necessary to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative health care solutions.

Non-confidential information will be made available publicly through the central database European Databank on Medical Devices Eudamed. Another consequence will be the adoption of tighter rules for the notified bodies that are responsible for assessing medical devices, ensuring they have available qualified personnel to conduct factory inspections. The new regulation will also hold manufacturers responsible for continuous follow-up on the quality and safety of devices placed on the market, mandating manufacturers to monitor and act promptly in case emergencies arise.

Among the reactions, Serge Bernasconi, CEO of MedTech stresses the importance of collecting necessary funds from public and private stakeholders e. Governmental Health Agencies, Industry Representations to fully implement the agreement, and confirms that industry bodies EDMA and Eucomed will actively support their members in the challenging transition towards a new, less bureaucratic regulation.

The May 25 agreement still needs to be formally adopted by the Council and the Parliament to conclude the legislative process. It is also important to note the transition periods for the new rules, which will apply three years after publication of the medical devices regulation and five years after publication of the vitro diagnostic medical devices regulation. The regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics.

Patients with chronic conditions rely on medical devices to improve their health and quality of life. Patients have a fundamental right to expect that the devices they use are safe, after being authorised for use in the EU. As medical devices are produced and circulate all over the European Union, it is important to have common rules to ensure devices on the European market are safe and high quality.

In April , following several years of discussions, the EU adopted two new Regulations on medical devices, which replace the existing Directives. The new rules will apply from spring for medical devices and from spring for in vitro diagnostic devices. The new Regulations will bring important changes for patients, one of which is stronger safety requirements. There are three stages which are crucial for patient safety: clinical investigation, when the device is tested; conformity assessment, when the safety and performance of the device is assessed; and vigilance, which is the ongoing monitoring of risks and incidents once the device is on the market.

In our view patients should be empowered to play a role in each of these steps. Patients will be given information leaflets on their implanted devices. The summary document will be an important source of information for patients and healthcare professionals, and should enable them to make more informed decisions. Given that a centralised system for approving devices was not going to be an option, EPF called for stronger controls on the notified bodies which approve devices in the EU, to ensure they would not be able to compete by lowering the quality of the assessment procedure and therefore risk patient safety.

We believe it is vital that in future the Member States and Commission have control over the notified bodies, and that these are regularly evaluated. The capacity of notified bodies to deliver on the requirements of the Regulation must be ensured. We have developed materials for patient organisations to inform and enable them to participate in the implementation of the regulations and monitoring of their impact, and continue to work with our community to encourage patient participation at national level.

Patient safety is at the heart of our work for equitable access to high-quality, patient-centred healthcare. Patients across Europe deserve a regulatory system on medical devices that they can trust. Cancer is still the second leading cause of death in the EU and a major public health concern in terms of disease burden and economic and social cost.

There is a constant need for a robust, well informed response to it in order to contribute to the prevention, early detection, and adequate treatment. While responsibility for the delivery of health services lies with the Member States, the European Union contributes to tackling cancer with awareness-raising, guidance and investment in research and fostering cooperation.

Developed in cooperation with WHO, the European Code against Cancer is a set of 12 recommendations as to how people can reduce their cancer risk: it has been constantly updated since On December 15, an important anniversary in the fight against cancer has been celebrated in Europe: 30 years ago the first edition of the European Code Against Cancer ECAC was published at a time when cancer awareness was almost insignificant. Tobacco use remains the single biggest cause of chronic disease and avoidable death in the EU.

Statistics on deaths in the EU from lung cancer, the cancer most associated with smoking, show that in , there were deaths from lung cancer alone, too many. Somebody lost their child, parent, brother, sister or a friend. Lung cancer accounts for a fifth of all cancer-related deaths. On top of this, tobacco is also a major risk factor in many other forms of cancer, as well as other major diseases such as cardiovascular disease.

The Commission has been at the forefront of tackling risk factors, promoting screening to detect cancer early, and best practices to help EU countries improve the quality, effectiveness, resilience of health systems and to reduce inequalities in access to health services. Population-based cancer registries are the data providers that enable the monitoring of cancer frequency and collecting information on new cancer cases in well-defined populations. They are critical resources for the clinical and epidemiological investigation of cancer and for the planning and evaluation of cancer prevention and control programmes.

The European Cancer Information System ECIS application is a web-based tool conceived and developed by the JRC to report and disseminate cancer burden indicators at European level, on incidence, mortality and survival, from data submitted by around European cancer registries. It provides added value by allowing regional and national comparisons of harmonised cancer indicators, quantifying the burden of cancers and following its trends and changes over time.

It can help to understand the causes of certain types of cancer and compare best practices in prevention, diagnosis and treatment interventions. Regina Beets-Tan has been appointed as one of the Members of the Mission Board for Cancer, thus having the opportunity to represent the radiology community within this important body.

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  7. World Health Day is a chance to celebrate health and remind world leaders that everyone should be able to access the health care they need, when and where they need it. Access to healthcare for all is one of the major achievements of post-Second World War Europe bringing to reality the idea that all human beings, rich or poor, should benefit from quality medical care without worry that their illness would bankrupt their family.

    I have also met many inspiring healthcare professionals, scientists, researchers and social workers who make Universal Healthcare a reality on everyday basis — it strikes pride in my heart to be part of this wonderful union. The EU is also a leading global donor for health initiatives to boost research and provide support to fight major diseases across the world. For example, premature mortality rates from chronic diseases are at least twice as high as the EU average in Bulgaria, Hungary and Latvia.

    This is why building a fair and socially equal Europe is a key priority for the European Commission. These virtual networks facilitate access to specialised healthcare for patients suffering from rare and low prevalence complex diseases. Although the success of making healthcare available to all ultimately rests with the Member States who are responsible for defining and organising their health policy, services and budget, the Commission will continue to offer guidance in order to decrease the health gaps among EU countries.

    Together we will be able to make sure that we are doing our utmost so that universal health care is delivered to all, here in the EU and around the world. The UEMS contributed significantly to the improvement of Postgraduate Training through the development of European Curricula in each medical specialties as well as the elaboration of Training Standards. This document — renamed European Training Requirements — aims to provide the basic training criteria for each specialty and should be regularly updated by UEMS Specialist Sections and European Boards to reflect scientific and medical progress.

    The curriculum is periodically amended and the last version has been revised in February , endorsed by the Section on October 06, and by the UEMS Council on October 20, This revised version of the Curriculum outlines a five-year training period consisting of Level I fundamentals over the first three years, followed by a more flexible Level II with potential special interest rotations during the last two years. Level III is dedicated to the subspecialisation path. In order to keep pace with the increasing complexity of medical imaging and growing training needs, they also request that the minimum years of training laid down in the European Directives be increased from four to five years.

    The Section of Radiology is particularly engaged in the field of education and postgraduate specialist training. The EDiR — European Diploma in Radiology — is an international benchmark for radiologists and is currently a unique and differential advantage over other candidates for a job or fellowship. Created in , it serves the standardisation and accreditation of radiologists across European borders. The examination is open to radiologists and radiology residents in their fifth year of training in compliance with the requirements indicated below.

    The application for the EDiR examination can be carried out individually or as a group through hospital heads of department or the corresponding national society. Supplemental to any other national qualifications, the EBIR also aims to facilitate the free movement of Interventional Radiologists across and beyond Europe. The EDiR is the European examination offered by EBR — European Board of Radiology and open to radiologists and radiology residents in their fifth year of training in compliance with the requirements.

    EDiR candidates must be certified radiologists or at least be in their fifth year of national radiology training at the time of the examination. In cases where the radiology training is less than five years, experience as a supervised staff radiologist will be considered. The total of training and supervised practical experience must be four years or more at the time of application. The EDiR is recognised as an equivalent of the Polish exit training examination, the first part of the Turkish board examination and the image interpretation part of the Finnish national examination.

    Moreover, in order to practice radiology in The Netherlands, trainees must either pass their national board examination or the EDiR. It has significant value in many other countries and it is expanding its role beyond Europe. The committees that form the EDiR Scientific Board follow a structured workflow to prepare each examination, ensuring an adequate peer review system for quality assurance.

    As such, it is an accurate test of general knowledge of the specialty. An ever-increasing number of heads of department are encouraging their final year residents to take the examination. Taking the EDiR is therefore an excellent opportunity for radiologists to test their excellence and compare themselves to their colleagues overseas. Designed to facilitate professional mobility across different countries, the diploma is an asset for radiologists both in and outside Europe. Diploma holders will have an advantage if they are looking for a job. It proves that this person wants to compare him or herself to international competition.

    As Prof. Krajewski and Dr. To the present date, more than 30 European Examinations have been appraised, as marks of excellence in medical specialties.

    Medical Device Regulations - Global Overview and Guiding Principles (Electronic book text)

    While the European Examinations organised under UEMS aegis are not to be considered as formal qualifications, their quality and renown have increased significantly over the past few years. As a result, some countries recognize European examinations as part of their national examination more information available in a specific box dedicated to EDiR. In March it was agreed to shift the project to the EBR. The revised version — European Training Assessment Programme 2.

    The new ETAP 2. Three EBR members and three UEMS members will also perform the role of assessor on a rotating basis one lead assessor and co-assessor per assessed institution. A third junior assessor European Junior Doctors and ESR Radiology Trainees Forum Subcommittee representatives will perform an advisory role as residents or junior doctors supporting the assessors.

    Dicle EBR member: V. Koen EBR member: L. Oleaga EBR member: F. Pizzini EBR member: P. Montvila — European Junior Doctors. Phase 1 : evaluation of the documentation. The ETAP Scientific Committee verifies compliance with the eligibility criteria and the centre receives its access credentials for the platform. The centre and trainees complet etheir respective questionnaires and provide the necessary information.

    Phase 2: video and report. The centre sends a video of its facilities and equipment. No high-quality professional video is required. This verifies the information relating to the facilities and equipment required in the questionnaires, which are filled in by the head of training report on equipment, including manufacturer, model, year, etc. Phase 3: online interviews. Online interviews with the people who fulfil the following functions adapted to each institution according to their training department structure :. The final outcome of the certification of the relevant training departments is determined using a weighting system for the different areas of evaluation based on the material provided by the institution; namely the questionnaires and information provided by the head of training and the residents, the video of the institution facilities and equipment, and the online interviews.

    Continuing Medical Education CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. Continuing Professional Development CPD is a structured approach to learning to help insure competence to practice, taking in knowledge, skills and practical experiences. It can be defined as the systematic maintenance, improvement and continuous acquisition or reinforcement of the lifelong knowledge, skills and competences of health professionals.

    At EU-level, the role of CPD to help safeguard patient safety within the context of cross border mobility has been addressed in several legal instruments: e. With 40 member countries, 60 specialist bodies, and well-established partnerships across Europe, the UEMS represents around 1. CME-CPD should be free from commercial influence, meaningful during the entire professional life, affordable and — as far as possible — harmonised at national and European level. Number of credits required per year? How is it supported and promoted by the healthcare system?

    The data for each country 30 NMAs have answered our survey have been collected, analysed and summarised in some thematic maps below and in a table of results on the left column. No answer. This was to be achieved through the international accreditation of CME events, and the establishment of a system for the international acceptance of CME points. ACI started its activities in January and now has a leading position in Europe and beyond. Today, radiology — together with oncology and cardiology — is one of the UEMS specialties with the largest number of applicants for event accreditation.

    Since 04 March , Prof. In particular: Prof. Aronen and Dr. Demuth in Reviewing Committee. Recognising the globally emerging generation shift not only in radiology, but also in the generation-dependent level of readiness to use current and future technologies in radiology and education, the ACI conducted a new survey in June on the future of Continuing Medical Education CME and Continuing Professional Development CPD. The overall results indicate that most respondents know how to earn CME credits We can see a slight shift among Generation Y respondents, together with a slight but observable increasing trend in earning more CME credits through ELM among the younger generation groups, indicating an easy and slow generational shift towards ELM.

    Please note that the current website will close on December 31, One of its main goals is to assist in harmonising radiological education in Europe. Eurorad — a project of the European Society of Radiology — is the largest peer-reviewed databse for radiological case reports, containing more than 7. Celebrating its 20th anniversary, the brand-new website of Eurorad includes a fast and efficient search engine, Editors Selection of cases, teaching cases with quiz questions and much more.

    Starting this fall, ESR Connect will offer exclusive live streaming events, an extended and constantly growing on-demand library and premium topic packages from the European Congress of Radiology. The current framework of Interventional and diagnostic Neuroradiology in Europe still presents significant differences in training and practice. The results of the inquiry have been summarised in the table and in the conceptual maps on the left column.

    Francesca B. Paolo Ricci- President, Section of Radiology. Question 4 — Neuroendovascular procedures performed by Interventional Radiologists. On January 25, , the European Parliament and the European Council have adopted a first draft proposal for the regulation of sensitive personal data with particular regard to their processing, movement or distribution. After prolonged discussions, a revised agreement on data protection has been adopted by the European Parliament in April and officially published in the EU Official Journal on May 04, To summarise, the new regulation provides a more balanced approach between protecting privacy and making sensitive data available for research projects, where grounds of public interest e.

    The processing of personal data concerning health may still be necessary for reasons of public interest in the areas of public health, without consent of the data subject. This in the consideration of the fact that sensitive data could be used to:. Once again, the new regime does not entirely rule out the relevance of national provisions. The following are included:. The data subject may always revoke the given consent at any time and without justification. This will impede further processing, but not making past operations retrospectively unlawful.

    The Privacy Directive does not require the consent to be in written form. Since the new rules will come into force on May 25, , the ESR — European Society of Radiology has prepared a paper on The EU General Data Protection Regulation: what the radiologist should know includeing an overview of the most relevant legislation applicable to radiologists, a glossary and concrete examples of the impact of GDPR on clinical practice. EU Proportionality Directive on the regulation of professions. On December 19 , the European Commission first published a proposal for a revision of the previous Professional Qualifications Directive based on the outcome of the various consultation processes.

    On October 9, the European Parliament adopted the proposed legislation, which was followed by the adoption of the agreed text by the Council on November 15, As part of the value chain and their role as input to production processes as well as their output, services provided by professionals, such as engineers, architects, accountants, lawyers, are crucial to the functioning of the European economy more broadly and across sectors.

    Excessive regulatory barriers to professional entry have negative consequences for job creation, productivity, mobility and the consumer who is forced to pay higher prices by a less competitive market. Professional activities are regulated by Member States at national, regional or sometimes at local level.

    Securing the modernisation of the regulated professions and in particular the review of reserves of activities and the cumulative impact of measures requires that proper proportionality analysis be carried out at national level.

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    The key benefits of the EU Single Market include the freedom of establishment and the freedom to provide services. The proposal will introduce a general obligation for member states to carry out an ex-ante proportionality assessment before adopting new or modifying existing legislation restricting access to or the pursuit of regulated professions. It must be also considered that economic considerations can only partially affect the health professions, as patient safety and access to healthcare are equally important. Several health organisations have raised their voice concerned by the potential impact of the Directive on their practices: as an example, CPME, alongside other health stakeholders, in particular the Council of European Dentists CED and the Pharmaceutical Group of the European Union PGEU , have highlighted the fundamental difference of conceptual approach to regulation demonstrated by the draft Directive in comparison to the rationale for regulating doctors and other health professions.

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    On the crucial issue of the exemption of health professions from the Directive, the proposal was defeated by 20 votes to The European Parliament will therefore now go into negotiations with the Council without a clear mandate to exempt health professions. It builds on the principles of the Hippocratic Oath, and is now known as its modern version. Although important measures have been taken and radiology seems to be one of the few medical disciplines in which female and male academic physicians make the same salaries, incentives to combat gender bias in the radiology profession are still needed to encourage diversity and the inclusion of women among researchers, according to a recent study published on June 13 in Academic Radiology.

    While gender disparities in clinical practice have been deeply investigated in the last few years, but disparities in radiology research and publications have not been tracked as closely, according to the US team of NYU Langone Medical Center, who conducted the study. To investigate challenges to radiology research and publication for women in radiology, they sent an electronic survey to members of the American Association for Women Radiologists in September and October of The researchers received 89 surveys, for a response rate of Of the survey respondents, However, The findings suggest that a number of interventions are urgent to foster the research success of women radiologists, including dealing with conscious and unconscious bias among departmental and institutional leadership; establishing start-up and ongoing research time and access to department resources; putting work-life balance and child care policies in place; ensuring research tracks are available to both men and women in the department; and providing training in research methodology, negotiation skills, and leadership.

    If you want to find out more on this topic, do not miss the following articles published on Aunt Minnie. In the US and Canada, men still outnumber women in academic performances and leadership positions of nuclear medicine by almost 6-to-1, according to a recent study published in the January issue of the American Journal of Roentgenology.

    These results show the need for devising strategies to promote diversity in leadership roles and tackle gender disparity in academic and leadership positions across nuclear medicine specialists. A specific Women in Focus programme has been organised for ECR , and several topics such as female leadership in the medical class and the generational progression of women in medicine have been analysed. The International Day of Radiology is an annual event held with the aim of building greater awareness of the value that radiology contributes to safe patient care, and improving understanding of the vital role radiologists and radiological technologists play in the healthcare continuum.

    Initiatives targeting Radiographers at ECR Shape your Skills: Support Programme for Radiographers Radiological Technologists is financed exclusively by the ESR to support the continued professional development of radiographers. Selection will be based on establishing a good geopolitical spread. Presenting authors of accepted abstracts will be preferred. Decision notifications will be sent out in December This joint paper of the European Federation of Radiographer Societies and European Society of Radiology highlights the diverse areas that encompass patient safety in medical imaging, and the important roles of both radiographers and radiologists in this.

    The paper can be accessed at the link below:. The examination is open to fully qualified radiographers who have completed their radiography education and training. Candidates must be officially recognised to practice in their country. The ESR is increasing the membership benefits for North American radiologic technologists and offers radiographer a tailor-made Shape your Skills initiative for the continued professional development of radiographers.

    Two different exams will be available: an examination in medical imaging incluidng nuclear medicine or the combined examination for medical imaging including nuclear medicine and radiotherapy. The examination is open to fully qualified radiographers who have completed their radiography education and training and are officially recognised to practice in their country. The ESR is the first medical specialty to successfully launch a professional-patient body that gathers patient representatives from various disease-specific fields and the ESR-PAG will become a group of committed patient advocates aimed at strongly embedding the patient perspective within radiology in full collaboration with the ESR.

    This thematic network seeks to explore the connection between education and professional development with enhanced patient safety. With the amount and quality of technological capabilities, scientific studies and available data increasing exponentially, it has become increasingly difficult for healthcare professionals to keep abreast of the latest developments, and to treat their patients according to the latest medical evidence. Creating a truly European healthcare labour force through university education and continuing medical education CME-CPD is therefore particularly important, yet many legal and political barriers remain for healthcare professionals that move to different countries.

    The goal of the ESR-PAG is to bring together patients, the public, and imaging professionals in order to positively influence advances in the field of medical imaging to the benefit of patients in Europe. The last ECR in Vienna featured two well-attended sessions organised by the ESR-PAG which enjoyed high interest by the congress delegates and featured lively discussions between panellists and the audience.

    Participants from 77 different countries attended the Conference, whose main outcome has certainly been a proposal on incoming priorities regarding radiation protection in the next decade. This specific outcome has been called Bonn Call for Action. Member States had time until the 6 February to complete the process of transposition into their national regulations.

    The Directive laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation introduced specific articles relating to two different areas:. The directive clearly states any equipment used for interventional radiology and CT, as well as any new x-ray machine, must have a device or a feature informing the practitioner at the end of the procedure of relevant parameters for assessing the patient dose.

    The device or feature must also have the capacity to transfer this information to the record of the examination. Uniform basic safety standards are established for the protection of individuals subject to occupational exposures, besides the medical and public exposures against the dangers arising from ionising radiation.

    Sources of ionising radiation can be processed radioactive materials, nuclear installations, natural radionuclides, x-ray machines and cosmic radiation. The Directive applies inter alia to the manufacture, production, processing, handling, disposal, use, storage, holding, transport of radioactive material and certain radiation emitting installations as well as the exposure of workers to radiation.

    The new Directive entails substantial innovative requirements in several different areas, as the protection of patients in medical applications, improving the protection of workers, and enhancing the protection of the public from natural radiation sources. The mission of EuroSafe Imaging is to support and strengthen medical radiation protection across Europe following a holistic, inclusive approach. The EuroSafe Imaging Stars initiative was launched in with the goal of establishing a worldwide network of imaging departments committed to best practice in radiation protection.

    To participate in this initiative, imaging facilities have to perform a simple self assessment according to a list of 21 criteria on the topics optimisation, justification, quality and safety, education, research, and regulatory compliance. After successful evaluation, applicant facilities are awarded a number of stars from one to five, depending on the criteria fulfilled.

    The project is led by the European Society of Radiology and started in August The first edition of a strategic research agenda SRA for medical radiation protection has been published in July In late , AI luminary — Prof. Although specific tasks can be done with software, AI has not delivered on all its early promise, according to many observers, and it is not replacing radiologists. Some radiologists, however, argue AI is launching its assault on radiologists.

    The term Artificial Intelligence AI is applied when a device mimics cognitive functions, such as learning and problem solving. It refers to a field of computer science dedicated to the creation of systems performing tasks that usually require human intelligence. Machine learning ML , a term introduced by Arthur Samuel in to describe a subfield of AI including approaches that allow computers to learn from data without being explicitly programmed, has been extensively applied to medical imaging. Among the techniques that fall under the ML umbrella, D eep learning DL has emerged as one of the most promising.

    You can find a comprehensive framework on AI and ML definitions and applicability in the interesting paper — Artificial intelligence in medical imaging: threat or opportunity? Radiologists again at the forefront of innovation in medicine, appeared on European Radiology Experimental in Although radiologists are not the only medical professionals to have their specialty modified by Artificial Intelligence, it is widely accepted that the radiological community is on the verge of a major revolution, and that AI will deeply affect the radiology specialty and the way clinical specialty and professional life have been conceived.

    While a good AI technology may potentially be helpful and valuable, bad or unethical use may be extremely dangerous, with proper regulation needed to ensure that software is used safely, ethically, and with appropriate protection of patient privacy. Patients, radiologists, and regulatory authorities must work together to prevent that from happening and a balance that provides security, privacy protection, and ethical use of sensitive information.

    To guarantee high quality radiological exams and reports, assistance from AI can be of great value. Pre-processing of radiological imaging and especially image quantification can help to substantially reduce time spent per read. We can thereby create more time for communicating results, for example, in multidisciplinary meetings and in direct contact with patients.

    Commercial imaging clinics show and explain results to their clients.

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    In routine clinical settings, radiologists do not have enough time to communicate directly with patients. The recent reform originated from the awareness that the existing directives, dating back to the s, are no more appropriate to deal with new, evolving technologies. On the other hand, the rise of AI generates several concerns relating to the way sensitive data are collected by the devices: as an example, data are threatened by cyberattacks addressed to those same bodies which collected them.

    The extended territorial scope and wider rights for data subjects in the GDPR make the regulation more suitable to regulate AI, while the Cybersecurity Directive delineates requirements for EU member states that aim to prevent cyberattacks and to limit their effects. Developers of AI for healthcare applications may have values that are not always aligned with the clinical values: there may be temptation, for example, to guide systems toward clinical actions that would improve quality metrics but not necessarily patient care. Or these algorithms may be able to skew data provided for public evaluation when being reviewed by potential hospital regulators.

    Furthermore, It is possible to program clinical decision-support systems in a manner that would generate increased profits for their designers or purchasers, such as by recommending tests, drugs, or devices in which they hold a stake, or by altering referral patterns. Virtual Reality, on the contrary, has already a long history of applicability in radiology, although it is still far from mainstream market adoption. Anyway, the idea of performing advanced visualization and complex image analysis for diagnosis in an open 3D space, with all the tools and functionalities available at the touch of a virtual button or voice commands, seem incredibly attractive to physicians today, much more than two decades ago, when Virtual Reality was implemented.

    With basic technology requirements far more accessible today in terms of costs, use of Virtual Reality VR and Augmented Reality AR in healthcare and clinical settings is starting to gain traction. However, other barriers must be overcome: for instance, policymakers and government agencies need to define the ground rules for clinical use and reimbursement; and end-users of the technology need to work closely with the industry to help develop it to fit the needs and customs of real-world clinics. As an intermediate step, AR for surgical applications and image-guided therapy, which layers 3D images from scanners, segmentations, and measurements on top of the patient directly in the interventional suite, could be adopted in the mainstream.

    Despite VR being very interesting for healthcare applications, quite a few hurdles need to be overcome from the business point of view, as reduceing the psychological barrier by increasing exposure in and around the healthcare segment, increasing the user-friendliness of VR and AR applications, and developing them in association with physicians and radiologist to directly target their needs and reduce the implementation burden and giving effective proofs VR and AR can help save time and money and increase accuracy in diagnosis.

    Assessing the impact of AI in radiology management:. Artificial intelligence AI can be a solution in many management scenarios, but leaders must address the enduring apprehension and define which tools are relevant when making the most of the new technology.