Digital therapeutics are re-writing our definition of medicine. As clinically-validated solutions, they can be used as standalone interventions or in association with other treatments to engage patients and improve the overall quality, cohesion, outcomes and value of healthcare delivery.
They represent a new generation of healthcare. It’s one that enhances, and in some cases replaces, current medical practices and treatments.
A number of digital therapeutics solutions have already demonstrated their safety and efficacy in randomised clinical trials. Some of the most advanced have received regulatory clearance for use as a medical device and are being integrated into clinical practice.
Pierre Leurent, chief executive of French digital therapeutics company Voluntis, explains: “Digital therapeutics are sometimes compared to medication therapies. While different in many ways, both of these interventions are designed to provide patients with positive clinical outcomes. Through randomised controlled trials and real-world evidence pilots, some digital therapeutics companies are achieving comparable results to medication therapies, yet with fewer side effects for patients.
“Instead, we are helping to extend it through these technologies, by providing better insights and interfaces for patients to engage with their healthcare team. These technologies are being designed to enhance, not replace human interaction.”
These tools are used in daily life to improve patient and provider visibility into complex treatment processes and simplify pathways to better outcomes. The hope is that they will significantly benefit individuals and communities by improving care and treatment for groups such as the elderly or those with chronic diseases.
“It is encouraging to see physicians and other members of the healthcare delivery team, including nurse practitioners, care managers and disease specialists, use these tools to monitor and treat patients between visits to the office,” says Pierre.
“Realising that physicians are not the only people managing interactions with patients, we are developing tools that bring patients together with their entire care team.”
The digital health explosion has seen many different segments of solutions emerge. For digital therapeutics, most to date have been positioned as consumer-facing solutions that see them provide interventions directly to patients. These types of solutions may then link to other systems, like electronic medical records in hospitals and clinics, to provide a more rounded and joined-up picture of care.
“While they are two very distinct systems, we are seeing increasing interoperability between digital therapeutic solutions and electronic medical records. It is important that these work synergistically to provide the maximum benefit for the patient,” Pierre says.
The barrier to entry for new companies and new solutions seems, at least at first glance, to be relatively low. Consequently, there are a lot of newcomers to the industry. But, Pierre says, appearances can be deceptive. “People do not necessarily realise what degree of investment and effort is needed to bring a digital therapeutic product to market.”
Now, supported by the growing levels of clinical evidence and outcomes, digital therapeutics are being increasingly recognised as a legitimate category and solution in the healthcare industry.
With founding members that include Akili Interactive, Propeller Health, Voluntis and WellDoc, the mission of the Alliance (DTA) is to broaden the understanding, adoption and integration of digital therapeutic solutions into mainstream healthcare through education, advocacy and research.
Voluntis’ Pierre Leurent, who also serves as chair of the DTA’s board of directors, says: “The DTA was founded by a group of digital health pioneers that represent different therapeutic areas and have achieved high levels of clinical validation for their solutions. These leaders are teaming up to share their expertise, learnings and experience to enable success for the broader ecosystem.
“Our goal is to interact with patients, providers, payers, manufacturers, academics and technology companies, in addition to policy makers and regulators.”
Following its formation, the DTA formed a strategic partnership with the Personal Connected Alliance – which Lilly signed up to earlier this year – to further establish digital therapeutics. A US non-profit organisation, the Personal Connected Alliance aims to make health and wellness an effortless part of daily life and also counts Voluntis and the Danish Health Data Authority among its members.
“In ten years, it will be natural for a healthcare provider to prescribe a digital therapeutic solution with, or in place of, a traditional drug therapy,” says Pierre. “Digital therapeutics will eventually be part of the routine healthcare delivery process, with clinically validated solutions being incorporated into clinical guidelines and delivery systems. We foresee this happening sooner than ten years.”