“Digital health” is a new subject, the origin of which dates back only a few years ago and essentially concerns the interaction between a number of digital technologies and human health.
By way of example, all tools aimed at collecting and storing medical information concerning the patient, such as electronic medical records and telemedicine, belong to digital health.
All this allows doctors and health personnel to have useful data for diagnostic and therapeutic purposes very easily and quickly with a consequent improvement in health care for the single individual and therefore, ultimately, also for the whole company.
In this field there is no particular need to have rigorous validity tests and the reason lies in the fact that these devices have, in practice, a mere function of container and do not intervene directly in the actual treatment of the sick.
A further objective of this new discipline is to lower the costs of public health thanks to a more timely and accurate diagnosis and by virtue of the possibility of quickly implementing the appropriate therapies with more favorable prognosis and a shortening of treatment times and healing of patients.
The digital health landscape
Within digital medicine, two types of technologies can be distinguished.
On the one hand there are the devices that provide measures, in order to be monitored by the doctor or the patient himself for the collection of information and parameters, and can act passively (through sensors, ingestion of pills capable of sending signals, etc.) or actively (by filling in questionnaires, tests, clinical diaries, etc.).
On the other hand, there are the devices suitable for intervention, which in turn can be classified according to their action. These are divided into:
A DIGITAL SELF-MANAGEMENT AND EDUCATION, or tools for the self-management of diseases (for example, in patients with arterial hypertension, these technologies can provide information about their pathology by offering advice on nutrition, sports, habits, etc.).
B DIGITAL SUPPORT, applications and programs to optimize the effectiveness of a therapy (as in the pharmacological treatment carried out in non-hospital and uncontrolled conditions, or as information support provided by the doctor in order to make up for a visit carried out in a short time).
C DIGITAL REHABILITATION, for the recovery of motor function from home, in which the patient can, for example, benefit from a video game which, thanks to clothing equipped with sensors, allows him to identify with an avatar that offers a series of movements and exercises , useful for motor or physiotherapy rehabilitation.
D DIGITAL THERAPIES, that is software and programs that deliver a therapy that supports the pharmacological one, or that is independent of it.
An expanding market
A significant boost to digital health has been given in the last two years by the Covid-19 pandemic.
The huge number of cases of contagion, the need to carry out diagnostic tests with subsequent tracking of infected people, the processing and distribution of the so-called Green Passes have in fact considerably increased the demand for electronic tools of archiving and recording of clinical data.
The 2020 digital health market has thus exceeded 140 billion dollars, according to data from Global Market Inside. Furthermore, future projections see a further annual increase of over 17% through 2027 when that figure could reach $ 470 billion.
As far as Italy is concerned, the recent National Recovery and Resilience Plan (Pnrr) includes various interventions including the so-called “Mission 6 Health” in which 15.63 billion euros were assigned to digital health: 8.63 billions of euros for the digitization of the national health service, 7 invested in the construction of proximity networks, community hospitals and telemedicine. This is an overall figure that is certainly not insignificant.
Digital medicine, a sector that is part of digital health, represents a different situation: the digital tools available are in fact aimed directly at the treatment of diseases and are not limited to a mere collection of health data.
Digital therapeutics, defined with the acronym “DTx”, consist of technologies that allow the delivery of medical treatments in the strict sense. The heart of these new tools consists of increasingly sophisticated and precise software that offer guarantees on the reliability of the performance offered by digital equipment.
In order to be commercialized, these programs must be based on rigorous scientific evidence obtained from clinical studies conducted on the basis of precise scientific protocols.
All this is necessary considering that the purpose of digital therapeutics is to intervene directly, like traditional pharmacological interventions, in the therapeutic or preventive context of a considerable number of pathological situations of various kinds. These therapeutic tools can consist of devices that the patient can wear, or of applications, websites or even video games.
These are medical devices and therefore subject to Regulation (EU) 2017/745 in force since May 26, 2021. This regulatory provision has been updated precisely to respond to the massive changes and developments that have taken place in recent years in order to guarantee a high level of quality and safety of new products.
The (expected) boom in digital therapeutics
Regarding the market value of digital therapeutics, Insider Intelligence has revised its forecasts for the next few years. In fact, if in 2020 the estimate reached a global value of about 9 billion dollars by 2025, now the figure expected by that date is around 56 billion dollars worldwide.
A crucial turning point for this drastic change in orientation may have been the $ 18.5 billion merger carried out in the summer of 2020 between two US groups: Teladoc Health, a company providing telemedicine services, and Livongo, a company that deals with management programs for patients with chronic diseases, such as diabetes.
Pharmaceutical companies are also likely to play an active role in acquiring digital therapy providers.
In fact, the pharmas have already invested sums of money in the companies that deal with DTx and will probably continue to do so, even to a greater extent, in consideration of the positive attitude shown by the FDA which has granted a green light to various treatments of this kind.
In our country, it is news these days that Polifarma and the digital health technology startups daVinci Digital Therapeutics and daVi DigitalMedicine have started a collaboration to develop – and commercialize – digital drug supports and digital therapeutics associated or combined medical prescription solutions. with drugs, for the treatment of chronic diseases.
Approval only after trials
The path that digital therapies must follow before being authorized and placed on the market is completely comparable to that of traditional pharmacological treatments.
The methodology used is therefore the same: controlled and randomized clinical trials with the aim of verifying safety, efficacy, side effects and benefits on individual health validated with the appropriate measurements. After the experimental process, the manufacturing companies must submit an application for approval to the competent regulatory bodies, such as Fda or Ema.
The authorities examine and evaluate the digital product in the same way as for drugs and, if the requisites are met, they issue the authorization for the marketing and therefore for the use of these tools.
Digital therapeutics are accompanied by a leaflet that contains instructions for use, product characteristics, indications, contraindications and any adverse effects that may occur, exactly as if it were a standard medicine.
How digital therapies work
The fundamental purpose of digital therapeutics is to actively involve the patient in the treatment of his disease by positively influencing his behavior.
Digital treatments, in fact, try to eliminate the poor therapeutic adherence, the lack of attention on the part of the patient and also try to modify his attitudes of refusal towards therapy.
The set of these counterproductive behaviors is often part of the clinical picture of various chronic diseases including, for example, diabetes, hypertension, obesity, anxiety, depression, addictions.
Unlike drugs, which, once taken, exert their action under the biological aspect independently of the patient’s behavior, which therefore has a completely passive role, digital therapies act on people’s behaviors and creative processes, involving them in actively through appropriate attractive programs to follow and share, for example on social platforms.
To date, the medical disorders that can benefit from digital therapies are still few, but they concern a wide spectrum of diseases, including chronic, mental, metabolic and oncological ones, for example:
- occasional and chronic insomnia
- syndrome of hyperactivity and lack of attention in children
- addiction to cigarette smoking
- substance addiction
- symptoms associated with chemotherapy
- irritable colon
- autism spectrum disorders
- high blood pressure (pending)
The list of authorized digital treatments already includes a good number of tools available, especially abroad (see box).
Historically, the first digital therapy was marketed in 2009, under the name of Deprexis, and it is a platform that acts on a cognitive-behavioral level to combat depression. The effectiveness of this device was good and is now used in Germany and Switzerland where it is also reimbursed and recognized by health insurers.
As for Italy, however, things are proceeding slowly. There are numerous obstacles to face and, in order to try to deepen the issue by addressing the doubts, perplexities and questions raised by these new therapeutic tools, various initiatives have been undertaken especially by the Higher Institute of Health (ISS) and by the Italian Medicines Agency (Aifa).
In addition, the project called “Digital therapies for Italy” was launched a couple of years ago. A group made up of heterogeneous personalities from the clinical sector, entrepreneurship, economics and other fields, edited a weighty report entitled “Digital therapies: an opportunity for Italy“, with the aim of raise awareness and promote the dissemination of digital therapeutics throughout the country, as already happened for digital health and telemedicine during the Covid-19 pandemic.
A significant obstacle to the diffusion of DTx also derives from a not yet mature knowledge of digital therapies by the experts themselves.