Digital Therapeutics Day 2021

Digital Therapeutics Day is the programme, launched in 2019 and now in its 3rd edition, to accompany Italy in the development and adoption by public healthcare of a new therapeutic option, Digital Therapeutics.

The 2021 edition, promoted by daVi Digital Medicine srl and Springer Healthcare Italia srl, aims to take stock of what happened in 2021 in Italy and worldwide and to anticipate the most significant initiatives and trends of the coming year.

The topics addressed in the 2021 edition of DTxDAY concern:

Confusion

Many people – in scientific societies, in the pharmaceutical industry, in institutions and in other sectors – have become familiar with the term “Digital Therapeutics” in the last 2 years. In many cases, however, the term Digital Therapeutics is used – sometimes intentionally – to refer to other categories of devices, e.g. for monitoring or self-management of the disease. An analysis of the clinical trials registered on ClinicalTrials.gov confirms this situation.
Confusion can only be governed and managed through the use of a correct taxonomy, constant training of healthcare professionals and expert patients, and information to citizens, institutions and associations.

Opportunities for Italy

2021 was the year of publication of the results of the project “Digital Therapies, an opportunity for Italy”, in Italian in January and in English in September. Thanks to this project, for the first time Italy has gained international visibility in the field of Digital Therapeutics.
However, the publication of the book is only a first step in the adoption of Digital Therapeutics in healthcare and medical practice.
Among the initiatives launched to foster the transfer of Digital Therapeutics into medical practice, the #DCTxITA project “Decentralised Clinical Trials for Italy” was launched in 2021.

Trial, Evaluate, Reimburse, Observe

Access to reimbursement for Digital Therapeutics requires managing confusion, informing and educating institutions, and ensuring proof of efficacy. All this must be placed within a regulatory framework that can guarantee the quality of the devices and the appropriateness of their use.
The National Observatory on Digital Therapeutics, currently in the planning stage, intends to represent this framework to support and guarantee the adoption of DTx by the National Health Service.

New Digital Therapeutics 2021

In 2021, the results of the controlled clinical trial of the first Digital Therapeutic for the treatment of high blood pressure were published, NHS Scotland approved the reimbursement of 2 Digital Therapeutics for insomnia and anxiety, the first Virtual Reality-based Digital Therapeutic for the treatment of lower back pain, and other therapeutics were approved and/or introduced to the market.

The Expert Patient and Digital Health Technologies

The patient using Digital Therapeutics does not have the characteristics of the patient of the last generation, who identified drugs by colour (blue pill, white pill…) without knowing any of their properties. It is a patient who “holds” the therapy, i.e. the smartphone on which the Digital Therapeutic software runs, who enters data, follows instructions, interacts in a conscious way. He is an informed patient, who in some cases – when he is also trained as an expert patient – participates in the development of Digital Therapeutics.
The EUPATI Expert Patient, already active in the field of drug clinical trials, is now entering the new therapeutic context of Digital Therapeutics and of digital health technologies more in general and represents a new primary actor in this scenario.

Towards the Italian Digital Health Law

First Germany in 2019, now France, will pass laws on Digital Health to introduce digital technologies in the processes of prevention, diagnosis, treatment and rehabilitation of patients. When Italy? A “Thought and Action Group” has launched an analysis of the German law to identify the most appropriate ways to adapt it to the Italian legislation. This is a process to be carried out within the current legislature, together with bodies and associations able to contribute both to the drafting of the law and to the creation of a broad consensus in support of its approval, necessary conditions for our country to close the gap that separates it from the most advanced countries.

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