An Italian Law for Digital Health?
How? When? Who?
The digital transformation of health, medicine and healthcare is in progress and will significantly change the way health is managed and health services are delivered. While it is clear that this transformation will affect all countries, its speed will depend on national initiatives to support the training and organisational interventions needed to integrate digital health and medicine into health processes.
For the speed of adoption of digital technologies in health systems, the leading role of national governments, through specific legislative initiatives, becomes crucial.
The 21st Century Cures Act, a law approved in the United States in December 2016 to accelerate the development of medical products and bring new innovations and advances to patients more quickly and efficiently, identifies digital technologies (medical apps) as key tools for saving lives and creating development opportunities. The approval in 2017 of the first Digital Therapeutic by the FDA and the subsequent acceleration of the development of Digital Therapeutics by US start-ups is one of the first effects of this law.
In Europe, the “Law to Improve Healthcare Delivery through Digitisation and Innovation“, approved on 7 November 2019 by the Bundestag of the Federal Republic of Germany and adopted on 29 November 2019 by the Bundesrat, intends to achieve its goal through prescription apps, user-friendliness of online video consultations and access to a secure health data network for treatment everywhere. The most important changes envisaged by this law affect the following activities:
1. Patients will be able to use health apps more quickly
2. Promotion of the innovative strength of the health system
3. Creation of a mandatory digital network for the health sector
4. Online video consultations will become routine
5. End of paper chaos
6. Better results in health services research
7. Secure IT for doctors and dentists
8. Equal participation in digitisation
9. Networking the healthcare system
In October 2021, France anticipated its willingness to adopt – in a manner very similar to Germany – the same reimbursement procedure for digital therapeutics.
The United Kingdom has already introduced for some years in its National Health Service the use of medical devices in the form of digital applications both to provide measurements and to deliver treatments. Scotland’s National Health Service approved in October 2021 the reimbursement of two digital therapeutics for the whole eligible population.
Not surprisingly, Italy has not taken any significant steps to date to catch up with these countries. As a country among the lowest-ranked countries in Europe in the DESI 2021 ranking, we certainly need more time to close the digital competence and maturity gap with these countries.
Now, however, we believe that the time has come.
As Nello Martini has authoritatively reminded us, “institutions codify a process of change, they do not anticipate it, and consequently it is essential that working groups and think tanks encourage perception and indicate solutions that can then be ratified at an institutional and regulatory level“. Although bills may be proposed within our institutions as well as elsewhere, it is now necessary for think tanks and actions to set in motion a process that will quickly lead to the drafting of a bill to be presented to government authorities for their consideration, discussion and conversion into law.
Using the experience already gained in countries with greater vision and ability to adapt to the rapid digital transformation of health, medicine and healthcare, we believe that these should be some of the fundamental aspects to be followed in drafting the bill:
– Inspired by the Digitale Versorgung Gesetz (Digital Health Law) of Germany
– Incorporated into Italian health legislation
– Adapted to the Italian National Health Service
– Drafted by experts in constitutional law and digital medicine, patients, doctors, pharmacists and others
– Discussed with all stakeholders
– Open to contributions from all social partners
– Supported by a network of institutions, universities, associations, companies
– Presented in time for discussion by the end of the current legislative period.
It is an ambitious goal, but certainly within our reach and we believe it should be a key element of the recovery and resilience pathway that our country is now embarking on.
21st Century Cures Act. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
FDA permits marketing of mobile medical application for substance use disorder. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder
France adopting Germany’s approach to digital health apps https://www.mobihealthnews.com/video/emea/france-adopting-germanys-approach-digital-health-apps
NICE – National Institute For Health And Care Excellence. Deprexis for adults with depression. 2018 https://www.nice.org.uk/media/default/about/what-we-do/nice-advice/iapt/iab-deprexis.pdf
Digital therapeutics part of NHS Scotland services in ‘world-first’ deal https://www.digitalhealth.net/2021/10/digital-therapeutics-part-of-nhs-scotland-services-in-world-first-deal/
The Digital Economy and Society Index – DESI 2021. https://digital-strategy.ec.europa.eu/en/policies/desi 
G.Recchia, Terapie Digitali, una Opportunità per l’Italia Una Call to Action per l’adozione nella pratica medica. Tendenze Nuove 1, 13-20, 2021