Keywords: Digital Medicine; Digital Therapeutics; DTx; Digital Health; Digital Pharmacology
Digital therapeutics (DTx) are evidence-based software aimed to prevent, manage, or treat a broad spectrum of physical, mental and behavioural conditions. These interventions are typically subject to regulatory oversight and can be standalone or in combination with traditional drug therapies. DTx form an independent category of evidence-based products within the broader digital health landscape and are distinct from pure-play adherence, diagnostic, telehealth products.
Here we provide a review of current evidences and challenges regarding the possible use of DTx in family medicine practice.
Review until June 2019 of the DTx suitable for family medicine approved/under approval by FDA or under development according to the top 10 tech startups listed in order of funding.
reSET® is the first DTx approved by FDA (2017) as cognitive behavioral therapy (CBT) for the treatment of substance use disorder - abstinence rate improvement versus human performed CBT 40.3% vs 17.6%. Respimat® combines software and hardware program to improve asthma and COPD control and optimize healthcare utilization. Dthera Sciences delivers reminiscence therapy to Alzheimer’s patients in a scalable and personalized manner. Spleepio™ performs sleep improvement program featuring CBT techniques. KAIA delivers physical exercises and behavioral therapy for chronic back pain patients. Several companies have developed software which engage patients with Type 2 diabetes, hypertension and obesity to improve self-management and outcomes.
DTx have significant potential to affect primary care landscape thanks to the ability to empower patients, healthcare providers and payers through intelligent and accessible tolls for addressing a wide range of conditions via data-driven interventions. The role of GPs in the research, development and delivery of DTx is crucial but still to be determined as well as the contribute expected from European GPs to adapt and delivery DTx developed in US concerning regulatory, social and ethical point of view.
Points for discussion:
What is the role for GPs in the research, development and delivery of DTx?
What is the contribute expected form European GPs to adapt and delivery DTx developed in US concerning regulatory, social and ethical point of view?
How medical education regarding DTx (adverse effects, dose/response pharmacology, pharmacovigilance etc) should be implemented?