Digital medicine, telemedicine, internet that help those with a chronic disease and need continuous checks, which today are done in the clinic (also extending the waiting lists). The pandemic has taught us that the web can be a valuable tool for not leaving the sick behind, especially those with chronic diseases, such as diabetes for example. Or those who live far from specialist centers.
Digital health, a journey to discover the medicine of the future
by Dario Rubino
By setting up, for example, digital treatment paths in which the drug will be only one of the protagonists and the doctor will be able to connect with the sick, promote healthy lifestyles, provide health and clinical services, from the choice of treatment to monitoring, up to the subsequent treatment. . A paradigm shift, made faster by Covid. And this is confirmed by the latest global macroeconomic data, which predict a growth in digital medicine, from 2020 to 2025, of 11.4%, reaching 3726.6 million dollars by 2025, compared to 2420.2 million dollars in the 2019.
A new era of medicine
Healthcare institutions around the world are working on planning this ‘new era’ of medicine, but there is no homogeneous regulation between the various European countries. Italy is also doing it and the opportunity could derive from the application of Mission 6 of the PNRR. In this context, the Lilly Foundation has launched a research project with the aim of both providing a proposal, aimed at systematizing the matter from a regulatory point of view, and designing innovative assessment procedures and new organizational models for taking care of patients. chronic, which allow access to Digital Medicine.
Digital health, “this is how we will predict emergencies”
by Barbara Orrico
Structured contribution on five key proposals: 1) a specific dossier for the evaluation of these products, 2) a National Observatory, 3) a new governance, 4) an ad hoc national regulation through a Framework Law and 5) an organizational model for the management of chronic patients, integrated with these new technologies. The project has just been presented in Rome.
Let’s start with diabetes
“Digital medicine is a great opportunity, especially for patients with chronic diseases – he explains Stefano Nervo, President of Diabete Italia -. Diabetes is one of the diseases for which ‘digital health‘ tools, I like to call them that, can do a lot, because the patient would have much more chance of being followed and treated by optimizing the quality of care and therapeutic treatment, by increasing the patient’s adherence to therapy thanks to the rapprochement with the territory and an improvement in the quality of life “.
Today the European regulation 2017/745 places Digital Medicine products among medical devices and, through the CE mark, ensures their marketing in Europe. But that’s not enough.
Digital medicine: what changes for doctor and patient?
by Barbara Orrico
Technological innovation must be therapeutic
“It is necessary to define the regulatory tools and ministerial structures through which to ensure the evaluation of the additional therapeutic value of the Digital Medicine tools and the reimbursement price within the NHS – he specifies Nello Martini, president of the RES Foundation (Research and Health) -. The technological innovation underlying the Digital Medicine tools does not coincide with the therapeutic innovation which, in terms of additional value compared to existing therapies, must be demonstrated by adequate clinical studies. But not only that, the commercialization of Digital Medicine tools, without reimbursement and price procedures, exposes these technologies to discretionary purchase by the Regions and ASLs, without ensuring uniformity of access for all citizens “.
Objective: inclusion in the Lea
Hence the need, expressed by the experts who participated in this research project, to define at national level the regulatory methods for evaluating these products (in terms of defining therapeutic innovativeness), for conducting the Health Technology Assessment (HTA) for inclusion in the essential levels of assistance (LEA), perhaps taking a cue from those European realities that have already activated reimbursement procedures and from which the experts have derived some aspects of potential transferability to the Italian health system.
Tele-health cooperation: this is how the Tor Vergata Multiple Sclerosis Center brings rehabilitation to patients’ homes
“In any case, in order for Digital Medicine products to find a correct implementation, it is not enough to solve the regulatory and structural reimbursement criticalities of our health system in the field of medical devices – he adds. Americo Cicchetti, president of ALTEMS Advisory – but it is necessary to implement a strong rethinking of their role within the Connected Care model. Hence a proposal for an organizational model, starting from the management of chronicity, in which the tools of Digital Medicine, in addition to acting as vehicles for innovation, generate an impact on the uniformity and equality of access to care on the national territory “.” technological innovation, personalization of care and integrated management of chronicity will be crucial elements of tomorrow’s healthcare “, he comments State of PeacePresident of the Lilly Italia Foundation.