How can Digital Therapeutics enter medical practice if Digital Medicine doesn’t?

Health, medicine and healthcare are all involved in digital transformation processes that started in the last decade and will see a first conclusive phase in the coming years.

Digital Health

The term Digital Health, referring to the application of digital technologies to the management of health and the processes that involve it, is generally used as a term embracing all technologies, which is why it is often perceived as vague and potentially confusing.

In fact, the field of digital health is not yet served by a shared lexicon and the many disciplines that comprise it are often divided by different languages. The definitions provided by WHO (1), FDA (2) and other institutions have not been able to overcome the uncertainty on the different terms used, such as Digital Medicine, Digital Health, Digital Healthcare, eHealth, mobile Health and others, often used as synonyms and interchangeable, causing confusion and sometimes distrust towards them.

Recently, the Digital Medicine Society and other international organisations have proposed a taxonomy and a new classification of digital technologies for health (Table 1) (3).

Digital Medicine

This classification identifies Digital Medicine as a subset of Digital Health. This in turn is defined as the set of all the digital technologies for health, mostly referring to the area of well-being and of the management and transmission of clinical data. These technologies generally do not require evidence to support their use or regulatory approval.

The new classification therefore defines Digital Medicine as the use of evidence-based software and hardware products that provide measurements and/or deliver interventions with the aim of treating and/or preventing diseases. The primary interest is therefore in the disease, the patient, the doctor and the healthcare professionals, not in well-being or health in general terms. Its products – like those used in the traditional context of medicine – are based on research, development and clinical trials.

Digital Medicine products

Digital Medicine comprises products that provide measurements and interventions, support health research and the practice of medicine more broadly, including treatment, recovery, disease prevention and health promotion for individuals and populations.

These products – divided into 2 categories, covering measurement and intervention – can be used independently or in conjunction with pharmaceuticals, medical devices or other interventions to optimise patient care and health outcomes.

1.        Measurement products

Through Digital Medicine products that measure biomarkers or clinical outcomes, it becomes possible to acquire new information for the diagnosis or monitoring of diseases and for their management, even at a distance.

This information is mainly generated in the context of the patient’s real life, which in many cases could not be obtained by traditional medical methods.

Recent product categories include:

Digital Inhalers

Inhalers for the treatment of asthma or chronic obstructive pulmonary disease (COPD) with a digital sensor attached through a device or inserted inside the device represent a new generation of inhalers capable of generating information relating both to use (opening and closing the lid) and in advanced products (as in the case of Amiko’s Respiro) also to the quality of inhalation of the drug.

Digital Pills

These are drug tablets (such as Abilify MyCite for the treatment of schizophrenia) inside which a sensor is inserted which, when exposed to the acid environment of the stomach in which the tablet is dissolved, sends out a signal. This is collected by a patch placed on the patient’s forearm and then transferred to an application on the patient’s smartphone. This is one of the most advanced ways of verifying that the patient is actually taking the therapy.

 2.       Intervention products

Digital Medicine products that deliver interventions can be used stand-alone or in conjunction with drugs, devices or other therapies to optimise patient care and health outcomes.

Digital Therapeutics

In the classification of the Digital Medicine Society and others (Table 1), Digital Therapeutics represent a subset of Digital Medicine, in particular of its intervention component and represent the third category of the taxonomy (4).

They are healthcare technologies driven by high-quality software programmes in the digital form of PC or smartphone applications or video games. They deliver evidence-based therapeutic interventions to patients through confirmatory clinical trials with the aim of preventing, managing or treating a medical disorder or disease. They are authorised for clinical use by regulatory bodies, reimbursed by public or private healthcare systems and prescribed by a physician. They can be used alone or, in the case of a shared therapeutic indication, in combination with other medicines (5).

Digital Supports

These are software, mainly in the form of an application, used by patients to optimise the therapy they are taking, whether pharmacological or otherwise. They represent the digital evolution of Patient Support Programmes – PSPs. Unlike DigitalTherapeutics, they do not deliver a therapeutic benefit directly, but operate in combination with a therapeutic intervention. Through reminders, information on the correct intake of the therapy, connections with the doctor or other patients and more, Digital Supports create the optimal conditions that allow to optimise the effectiveness of the therapeutic intervention.

As for all Digital Medicine products, they are developed through clinical research, of experimental or observational nature, to document their health value.

Digital Rehabilitation

Digital rehabilitation systems (motor, cognitive or other) deliver exercise sessions, driven by data collected from movement sensors worn by patients. The most advanced systems use serious games and immersive experiences to allow the patient to see himself inside the video game, in the form of an avatar, and to perform the exercises that the game proposes, whose duration and intensity is predefined by the physiotherapist. These systems make it possible to objectively document both the basic clinical situation and the results of the therapy sessions with regard to the patient’s motor functions.

Similar to Digital Therapeutics, they are developed through confirmatory clinical trials.

 DIGITAL HEALTHDIGITAL MEDICINEDIGITAL THERAPEUTICS
DEFINITIONDigital health includes technologies,
platforms, and systems that engage
consumers for lifestyle, wellness, and
health-related purposes; capture, store or transmit health data; and/or support life science and clinical operations.
Digital medicine includes evidence-based software and/or hardware products that measure and/or intervene in the service of human health.Digital therapeutic (DTx) products deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease
CLINICAL
EVIDENCE
Typically do not require clinical evidence.Clinical evidence is required for all digital medicine products.Clinical evidence and real world outcomes are required for all DTx products.
REGULATORY
OVERSIGHT
These products do not meet the regulatory definition of a medical device and do not require regulatory oversightRequirements for regulatory oversight vary.
Digital medicine products that are classified as medical devices require clearance or approval. Digital medicine products used as a tool to develop other drugs, devices, or medical products require regulatory
acceptance by the appropriate review
division.  
DTx products must be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use.
Table 1 – The Digital Medicine Society and other international organisations new classification of digital technologies for health

References

  1. Worl Health Organization. Digital Health. https://www.who.int/health-topics/digital-health#tab=tab_1
  2. US Food and Drug Administration. What is Digital Health? https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health
  3. Jennifer Goldsack. Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference? https://medium.com/digital-medicine-society-dime/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference-92344420c4d5 (2019)
  4. Digital Therapeutic Alliance. Digital Therapeutics: Combining Technology and Evidence-based Medicine to Transform Personalized Patient Care. https://dtxalliance.org/wp-content/uploads/2018/09/DTA-Report_DTx-Industry-Foundations.pdf (2018)
  5. Recchia G, Capuano DM, Mistri N, Verna R. Digital TherapeuticsWhat they are, what they will be. Acta Scientific Medical Sciences 2020.

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