Introduction
Digital therapeutics (DTx) deliver to patient’s evidence-based therapeutic interventions that are driven by high-quality software programs to treat, manage, or prevent a disease or disorder. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.
DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. They are certified or cleared by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
Digital therapeutics empower patients, clinicians, and payors with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions.
Are all digital health products are basically the same?
Just as medications serve different purposes, so do digital health products. Each digital health technology has a different purpose — such as health and wellness apps, digital diagnostics, remote monitoring, clinical support tools, and digital therapeutics. At Hello Sunrise one of our priorities is to make our digital products specific to the community it intends to serve in both design and content.
How are digital therapeutic app accessed?
Although patients may sometimes download the shell of a DTx product from an app store, they typically gain full access to the product’s content after they receive an authorization code from a clinician, payor, employer, or other entity and enter it into the product.
Do digital therapeutic products require a prescription to use?
Digital therapeutic products are provided to patients in a variety of ways, including:
- Clinician referral for a non-prescription product
- Direct authorization by an employer or payer for a non-prescription DTx product
- ‘Authorized clinical protocol’ established by a HCDM to authorize automatic patient access when necessary qualification requirements are met
- ‘Clinically-validated screening tool’ that patients utilize to determine whether they qualify for the therapy
- ‘Over-the-counter’ model where no form of third-party authorization is necessary
Individual countries often set different requirements for which products require a formal prescription.
Do Digital therapeutics protect patient data security and privacy?
Yes DTx products incorporate patient privacy and security protections according to each region and jurisdiction they are used within. Regulations that protect patient privacy and data rights include Health Insurance Portability and Accountability Act (HIPAA) in the United States and General Data Protection Regulation (GDPR) in Europe.
Additionally, types of third-party certifications that DTx products may undergo to protect the security of each product include ISO/IEC 27001, HITRUST, and SOC 2.
Do digital Therapeutics have to be used in a particular way?
DTx products are designed to deliver a therapy that is appropriate to patient needs and must therefore be appropriately engaging. Just as medications are used for specific durations and purposes, DTx products must be used according to product requirements in order to deliver the optimal therapeutic intervention at the right time, and for the right duration. Given their role in clinical therapy, digital therapeutics are not used in the same manner as non-clinical platforms, such as social media, gaming, and entertainment sites.
How do Digital therapeutics improve traditional therapies?
Digital therapeutics introduce an entirely new degree of product scalability and patient access. Payors and policymakers are now able to deliver care to entire populations that have previously been outside the reach of traditional care – either due to geographic limitations, cultural and language boundaries, well-documented disparities, or health condition severity. Patients who have previously not received care now have the opportunity to receive personalized therapeutic interventions based on their specific needs and abilities, in an engaging way, with familiar languages and cultural references, in the privacy and safety of their own environment, with access to actionable insights that convey patient movement toward clinical improvement, and often through the use of patient-owned smartphones or devices.
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