WOULD YOU LIKE TO INTRODUCE YOURSELF TO OUR READERS AND EXPLAIN THE WORK OF CONFINDUSTRIA WITH TELEMEDICINE?
I am Lorenzo Terranova, Director of Institutional Relations and coordinator of the ‘digital frontiers’ project of Confindustria Dispositivi Medici.
The ‘digital frontiers’ project starts from the observation that health has its foundation in human knowledge, but this must necessarily take into account what are/will be the transformations, the directions that will affect healthcare and the medical device sector in particular in the coming years.
Digitalisation is certainly the most important and most disruptive element in the last period. The change generated by digital implies a real cultural paradigm shift that must be understood and interpreted. Telemedicine is the most widespread and articulated declination of this change. In general, telemedicine encompasses a range of activities/services (e.g. telemonitoring). It should be remembered that current legislation classifies telemedicine as a medical device.
Medical device companies (i.e. also companies providing telemedicine services), precisely because they produce medical devices, are able to understand and interpret what clinicians’ and patients’ needs are. In other words, the technical and professional background enables them to understand the demand dimension and calibrate the supply. The medical device ‘telemedicine’, therefore, is a tool through which this mediation between supply and demand takes place.
Therefore, if we wanted to interpret the activities of Confindustria Dispositivi Medici on the subject of telemedicine, it could be said that, in the light of the profound changes, telemedicine represents a fundamental change in the way we treat and cure. Before entering into a detailed analysis of some of the considerations that have emerged within the industry on telemedicine, the need for clear and recognised terminology should be emphasised. It is not just a matter of wording, i.e. analytical investigation of the meaning of the word, but it becomes necessary to define punctually and homogeneously a whole series of services that fall under telemedicine. For this reason, we use what is defined in the agreement of 17/12/2020 of the State-Regions Conference (Repertory act no. 215/CSR).
WHAT HAS CHANGED IN TELEMEDICINE BETWEEN 2020 AND 2022?
The pandemic has contributed to a profound change in the very notion of telemedicine. Whereas telemedicine used to mean a sum (simplifying) of tele + something (telemonitoring, teleassistance, …), today it must be understood as a complex, integrated and articulated tool that is part of the care pathway in all terms.
In this case, it is appropriate that the change in telemedicine that has taken place in this three-year period can be shared by a number of subjects. I dwell several times on the wording, on the values, on the representation of telemedicine because when there are different meanings, the prerequisites for articulating reflections and proposals are different and lead to different (and relevant) considerations.
In addition to the topic of wording, we need to consider what telemedicine itself offered before COVID and after COVID. Using this perspective, we realise that the transformation has not only been numerical, i.e. an exponential increase in the use of telemedicine in the treatment and diagnosis of pathologies, but is itself becoming an enabling tool of a new approach to medicine itself. That is, it is not telemedicine that begins to be used as a simple improvement in what to do versus frontal treatment, but it is telemedicine itself that begins to offer specific courses of treatment and care. It begins to offer types of services that were not possible through a ‘traditional’ approach. For example, if telemonitoring shows a certain critical parameter, the procedures that follow may be profoundly different if the parameter had been found by an in-person visit.
This change had multiple effects. I reflect on how the relationship between the clinician and the patient changes. The clinician has had to revise the way in which he relates to the patient. From a model in which the clinician interpreted and represented the patient’s best needs, we have moved to a model in which the patient – depending on multiple variables – has begun to manifest autonomy with respect to the clinician, appropriating a range of choices. In this context, telemedicine – by enabling the patient to receive treatment at home – represents a further moment of enfranchisement of the patient vis-à-vis the clinician. Or rather: of strengthening the patient’s self-perception.
A second element, often considered on the sidelines, must be explored in the doctor-patient relationship. By cancelling (at least in several cases) the ‘place of performance’ element (i.e. not using – at least in the first instance) the health facility (thus in a condition of evident ‘difficulty’ for the patient), certain processes of autonomous assessment by the patient himself are modified. Similarly, the patient is identifying which dialectical tools within telemedicine services can improve the relationship with the clinician without obviously losing the advantage gained from the technology itself.
In these two years, it has also changed how the patient relates to telemedicine itself.
It must be emphasised that to talk about telemedicine, we must talk about a medical device, i.e. a product (e.g. a sensor or a wearable) or a service that must meet certain quality and communication standards. This is why, for example, one should never talk about the issue of using WhatsApp. This is not a medical device and should absolutely not be used as a tool for telemedicine (even if one recognises its ease of use).
I would like to remind you that using medical devices in the context of telemedicine means offering a number of guarantees that either harm or do not benefit the patient.
PNRR: HOW DOES IT APPLY? WHEN IS IT APPLICABLE AND WHEN IS IT UNTHINKABLE TO APPLY IT?
As we know, the PNRR points to telemedicine as a tool for that shift in clinical practice towards home and community-based activities.
Personally, I consider the use of telemedicine as a step forward in favour of the patient.
Having said that, it becomes necessary to think about the whole package of offers that is provided for the benefit of the patient.
We have to think of telemedicine associated with a complete system of health and social care delivery. If it were not associated, we would not be able to reflect on the great added value offered by telemedicine as (desired and) defined in the NRP.
It is necessary, for example, to imagine a multiplicity of services at home that must be offered. These must, from a technical point of view, be a guarantee (of equivalence in terms of effectiveness and efficiency) for the patient compared with outpatient or hospital treatment; from a relational point of view, these services must necessarily guarantee constant dialogue between the patient, other family members, the caregiver and the clinicians. This contact not only has a purely social purpose (which in any case in a healthcare treatment also has its relevance in terms of the effectiveness of the therapy) but above all makes it possible to enhance all those elements which if missing would make the patient even more lonely in relation to the disease. Therefore, investments in technology (e.g.: apps, wearables, …) and in infrastructures (e.g.: 5G, fibre to the home, …) become necessary in a punctual analysis of all the implications required by telemedicine and which the PNRR indirectly assumes as a strategic commitment.
The NRP does not touch on a fundamental aspect of telemedicine: training.
This is not to be understood as merely the use of specific technologies or medical devices, but rather as a way of relating to the new technologies and, on the basis of these, of being able to understand how to relate to other categories and, above all, to identify other units of measurement in achieving the living objective of care.
The issue of training, in fact, concerns all actors: clinicians, patients, family members, caregivers.
With obviously different perspectives, a first aspect to be touched upon in training concerns the modalities of ‘communication’ with/among the actors. For example, if a patient is subjected to telemonitoring, and this identifies the occurrence of a criticality, the doctor-patient communication, but also the caregiver-patient communication, becomes very important.
Technical training is also necessary. On this aspect several criticalities insist, linked, at least as reported by some companies, not so much to the high average age of the Italian population as to the lack of confidentiality with the use of certain technologies, such as sensors, such as mobile phones, such as wearables, which lead to a basic insecurity on the part of the patient.
This aspect obviously needs to be studied in depth and is connected with the underlying criticality correlated with mistrust of science and the technologies it uses, which was well represented during the pandemic by the novax movements, by a priori scepticism towards technologies in healthcare.
The PNRR draws attention to certain critical issues and makes proposals for overcoming them.
What is needed, in fact, is a unified and homogeneous direction at the level of the health authority or, in any case, at the level of health planning, capable of making effective use of these telemedicine devices in a logic of a complete patient ‘monitoring-diagnosis-treatment-care’ pathway. In other words, it is necessary for the patient to be clear about the existence of a whole series of procedures, ‘what if’ hypotheses, and studies that can help optimise choices.
Another ambiguously defined element in the NRP concerns the question of remuneration for telemedicine services. To date, these services are not (at least at the central level) remunerated by the National Health Service, with the effect that they are not properly qualified. Telemedicine services may be cheaper or more expensive than the same traditional services. A lack of recognition results in a substantial blockage of the autonomy process of telemedicine described here.
HOW CAN MEDICAL DEVICES TAKE ADVANTAGE OF DIGITAL HEALTHCARE AND ARTIFICIAL INTELLIGENCE?
There are two parts to the answer: the evolution of digital health and the impact/integration on medical devices; and how artificial intelligence is able to transform the very notion of the medical device.
Regarding the first aspect, digital has already transformed the medical device. On the contrary, what has been argued above shows that digital health, using tools such as telemedicine, is capable of responding to increasingly articulated needs. This is only possible with the widespread use of medical devices that have already incorporated digital elements and these will determine digital health models.
Starting from a simple and well-established example, the wireless pacemaker, it is clear that the underlying process of controlling the device and the information on the device/that the device transmits is now well established and is itself changing the traditional process towards a definition of a new element of digital health. But the mode in the doctor-patient relationship is also changing.
As far as artificial intelligence is concerned, the subject is extremely complex and the ethical aspect should not be overlooked.
Today, there are several applications of artificial intelligence on devices.
A first element to consider concerns how a whole series of information is collected and processed by the medical device itself (which is now also equipped with artificial intelligence). Subsequently, the device is able to offer a series of possible clinical choices. The delicate point concerns how the clinical act (by the physician) is placed; that is, a whole series of data collection, activities (performed by the device) at what moment of the treatment are placed.
Therefore, it should be noted that the process of artificial intelligence is extremely challenging and full of opportunities, but each element must be considered in precise terms.
AS A PATIENT WHAT KIND OF HEALTHCARE DO YOU DREAM OF?
Personally, I believe that the path taken of healthcare that is increasingly closer to the home is the one that can best meet the needs of the patient or citizen and fulfil their expectations.
The notion of healthcare as an instrument of control and constraint for the citizen has long since been superseded, but this implies that the healthcare model should review a whole series of roles, but also functions, in a timely manner.
This implies a punctual passage on the role and function of the doctor (I would also add, restricted to the Italian case, that the relationship between the doctor and the nurse should be reviewed, giving the latter an increasing role and competence, and instead placing the doctor as an expert capable of performing a series of clinical acts). As part of this shift, digital health is and will be a major contributor to the change as described.
The patient must also change. The acquired capacity for greater interlocution with the clinician also implies understanding what his or her needs are (real and expected, and these need to be well selected) and communicating them to the outside world.
The healthcare governance model must also change, no longer a model still characterised by punctual and defined roles (in general terms, often with national standards) but the roles will have to be adapted according to individual realities. For example, the role of givers (who are not only caregivers, i.e. of health care, but also those providing social care services) must be considered. A new model of governance means a relationship of coordination with all those who perform activities with respect to the individual patient. In other words, we must go beyond a definition of personalised medicine, and talk about personalised healthcare where medicine (understood as a set of information, treatment, diagnosis of the patient) is associated with a ‘general’ model of care where the patient becomes the centre of a reality on which a model of governance of the entire system is built.