Rules and challenges for digital health

Rules and challenges for digital health

The process of transformation of healthcare has been underway for years: from the legislation on the electronic health record to the emergence of telemedicine, now the challenge is to use the funds of the PNRR well

(Photo: IBM) * by Roberto Cursano - partner of the Baker McKenzie Associated Professional Firm

The digital transformation process in healthcare has been underway for several years: from the affirmation of the concept of mobile health with the appearance of the first medical applications, to online sales of drugs and medical devices, up to the legislation on electronic health records and electronic prescriptions and the progressive affirmation of telemedicine.

The spread of the pandemic has, however, accentuated the push towards innovation and the diffusion of these new tools, due both to the need to guarantee home care and to limit the movement of patients to a minimum, and to the familiarization of the latter with new digital technologies. According to official statistics, in the last year there has been a considerable increase in the use of digital platforms in the healthcare and pharmaceutical sector, with a 20% increase in telemedicine services such as television, which consists of a remote visit conducted by the doctor. on the patient, remote reporting (release and consultation of medical reports remotely), remote assistance (remote interaction between professional and patient via video call, in which data, reports or images are shared) and other tools.

Given this recent development of digitalization in healthcare, it is unfortunately necessary to note that in Italy these innovations are becoming more slowly established than in other European countries, such as the Scandinavian countries, France, the United Kingdom, Germany and France, both for reasons of a cultural nature (distrust of patients and resistance on the part of certain stakeholders), and for lack of public investment in this sector. A survey by the Digital Innovation Observatory of the Politecnico di Milano carried out in 2019 showed that Italian public structures have allocated investments in telemedicine services for 1.3 billion euros (equal to about 22 euros per citizen), ranking well beyond below the European average. Just think of the amount invested in the same sector by the Scandinavian countries (70 euros per capita Denmark), the United Kingdom (60 euros) and France (40 euros).

The opportunity for the NRP

A great opportunity to relaunch digitalisation in healthcare and, in particular, telemedicine, is now represented by the National Recovery and Resilience Plan (PNRR), whose the first item of expenditure, equal to 7 billion euros, is dedicated precisely to "Proximity networks, structures and telemedicine for territorial health care". Over half of this sum will be invested in the “home as the first place of care and telemedicine”. Furthermore, the text of the Pnrr promotes coordination between health and social services, which can make it possible to achieve "the full autonomy and independence of the elderly / disabled person in their own home, reducing the risk of inappropriate hospitalizations".

It will be crucial to encourage private investments and at the same time to implement procedures for awarding public contracts financed with the resources of the NRP that guarantee both an appropriate technical evaluation of the projects and the due speed in achieving the objectives and respecting the implementation times envisaged at European level. The Simplifications Decree bis, converted with law no. 108, which in some cases facilitates the possibility of resorting to the negotiated procedure even without the prior publication of a tender notice.

A further incentive for the development of digitalisation in healthcare and remote healthcare services to citizens and patients could be found in a more detailed definition of the applicable regulatory framework, which makes the relative rules clear and uniform at national level. the provision of these services and the repayment methods, thus favoring private investments. In this regard, if the recent Guidelines on telemedicine, published by the Ministry of Health in December 2020, have finally provided useful tools to operators for identifying the services that can be provided remotely and inserting them in the Essential Levels of Assistance, the implementation of these Guidelines is left to the Regions and Autonomous Provinces, without effective coordination at the national level.

Similarly, gaps at the regulatory level can also be found with reference to the innovative home delivery services for patients of prescription medicines (so-called last mile delivery service) through a growing number of digital platforms. The activity of these platforms - in the absence of a clear regulatory framework - in some cases could be carried out in ways similar to the online sale of medicines, which in Italy is only allowed for medicines not subject to medical prescription. In essence, the legislator's challenge is to keep pace with technological innovations and new services available.

There are undoubted advantages of remotely rendered health and pharmaceutical services, which eliminate the need to travel, guarantee more efficient access to quality care, reducing waiting times and simplifying the bureaucratic procedures related to the provision of such performance. Last but not least, these services could also allow a significant reduction in the cost of the National Health Service, avoiding the hospitalization of patients (especially if chronic), who can be followed from home. To ensure these advantages, it is necessary to proceed in parallel through two ways: the increase in public investments for digitalisation in health care, which would also allow a return in terms of cost savings for NHS, and a clear definition of the rules governing health services. digital and related sanctions framework.

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