Digital therapeutics (DTx) are revolutionizing the landscape of patient care and health services delivery. They provide patients and clinicians with smart, accessible, and user-friendly interventions to address a wide range of health conditions.
DTx also create a great opportunity for healthcare decision-makers, policy makers, and payers to improve clinical care by integrating DTx into clinical settings. For these reasons, the popularity of DTx products is increasing.
The rapid growth of DTx then raises questions: “How should a healthcare decision-maker or payer decide to use or invest in a new DTx product?”; “How can we evaluate a DTx product to make sure it is safe and effective before integrating it into a clinical setting or recommending it to patients?”
In response, the Digital Therapeutics Alliance (DTA) has taken the responsibility for creating a reliable framework to assess DTx products. The framework is called DTx Value Assessment & Integration Guide.
The DTA guide provides healthcare decision-makers and DTx manufacturers with a common language and set of evaluations to assess DTx products. It also enables clinicians, policymakers, and payers to evaluate DTx products more consistently and confidently across national and local settings.
The guideline is a comprehensive document. In this Sidebar article, we review the DTx Product Evaluation Considerations of the guideline, which covers 18 considerations to evaluate a DTx product. To make it more digestible, we have grouped those into ten sections.
Covering all aspects of the DTA guideline in this short article is not possible. To solve this, we have created a list of questions divided by sections complementing this article, which you can download here. This article and the question list will make it possible for you to evaluate a DTx product more thoroughly and confidently.
DTx Product Evaluation Considerations
1. Product Basics
Digital therapeutics provide patients and clinicians with validated, evidence-based, and targeted interventions to treat, manage, or prevent a broad range of disorders. Evaluating a DTx product begins with a baseline framework that includes the following considerations.
- Name, target health condition, and patient population.
- Product use specifics such as approved indication, therapy duration and frequency, risks, and side effects.
- Product’s function in monitoring, managing, or preventing a disorder.
- Intended environments for starting the therapy and ongoing care.
- Product’s current stage of development, commercialization, and reimbursement.
2. Clinical Impact
Digital therapeutics affect patient care by delivering software-driven therapies directly to patients. They can provide new therapeutic options or support the existing ones for various health conditions. How they fit in the care pathway is then an area for assessment.
The guidelines suggest the following considerations to evaluate the clinical impact of a DTx product:
- Product’s ability to address patients’ needs.
- Product’s relationship with other therapies for a specific disease.
- Product’s position in the current standard of care and its alignment with current guidelines.
- Type of clinical measures used by the product and impact of product-generated data on patients’ treatment progress.
3. Technical Considerations
Digital therapeutics are generally considered medical devices. Therefore, they are subject to a variety of standards and regulations. Understanding the technical aspects of a DTx product will help healthcare decision-makers and product teams optimize a digital therapy for easier and more efficient use.
The guideline divides the technical aspects of a DTx product into product-specific and patient-related. Potential considerations to evaluate the product-specific technical elements include:
- Product’s ability to function as a standalone or part of a multi-product platform.
- Product’s core system to generate the intervention (i.e., static algorithms, artificial intelligence, or machine learning functionalities).
- Built-in processes to prevent bias and manage malfunctions.
- Product’s data infrastructure (i.e., data hosting and access, frequency of system updates, and cybersecurity improvements).
- Entities responsible for and hosting location of data storage.
Considerations to assess patient-related technical aspects include:
- Systems (hardware or software components) required by the DTx product to run the therapeutic intervention.
- Network connection required for the product to function.
- Product software compatibility with mobile operating systems.
- Types of technical support and customer service available to patients and clinicians.
4. Product Usability
Patients may not benefit from the full therapeutic values of a DTx product unless the product is user-friendly and appropriate for their needs. Following usability criteria will help healthcare decision-makers to identify patient populations that may benefit the most from a specific DTx product.
Identifying the appropriate end-user and ensuring they can use the DTx product correctly may improve clinical outcomes, prevent patients’ confusion, and reduce costs. Evaluating product usability includes reviewing:
- End-user characteristics needed for successful use of the product (i.e., language, age, literacy level, disability, and cultural aspects).
- Patient-centric usability aspects of the product (i.e., user-centric design and instruction, usability testing).
- Patient information security and data protection.
- End-user support (i.e., reliable product performance, methods of technical support).
- Type and quality of research done for testing the product design for human use.
Digital therapeutics are created to benefit patients and improve their care. Therefore, patients’ health needs and desired health outcomes should be the driving force behind the design and optimization of a DTx product.
The following considerations will guide healthcare decision-makers in evaluating the patient-centricity of a product. Understanding these may help them optimize the product use based on patients’ experiences and needs.
Factors to assess patient centricity of a product include:
- Patients’ requirements to use the product appropriately (i.e., hosting device, access to the internet, being digitally literate).
- Product cost that patients need to pay and product coverage by insurance or other parties.
- Clinical, environmental, and social benefits of the product for patients.
6. Security and Data Privacy
Digital therapeutics gather and use sensitive data that belong to patients. Therefore, they must comply with international and national security standards, electronic Protected Health Information (PHI) policies, and sensitive data regulations.
Adhering to applicable regulations and laws reduces the risk of unethical use of data, security breaches, and users’ mistrust. Guideline-based criteria to evaluate product security and data privacy include:
- Manufacturer risk management procedures and frameworks to manage information security.
- Type, credibility, and scope of product cybersecurity certifications and credentials.
- Built-in strategies to ensure patient authentication, authorization, and data encryption.
- Product protocols and procedures to manage compromised data and privacy breaches.
- Product privacy protocols to gather, share, and use data.
- Consent processes of the product.
- Product insurance liability coverage.
- Policies and procedures related to data access and use by third parties.
7. Authorization and Distribution
DTx products deliver interventions to patients to help them better manage their diseases. Therefore, identifying the right individuals with the right disorder at the appropriate time to use the right DTx product is essential for successfully delivering digital therapies.
To make this possible, DTx products typically undergo an authorization process before distribution. Evaluating product authorization and distribution processes will help healthcare decision-makers to ensure appropriate use by the right groups of individuals.
Considerations to assess product authorization and distribution process include:
- Processes in place to grant access to digital therapy interventions.
- Procedures to authorize or terminate patient use.
- Delivery methods of the product.
- Distribution place of the product and authorized person to deliver the product.
8. Engagement and Implementation
DTx products fit into the care pathway to address patients’ needs or fill care gaps. As such, digital therapeutics expand clinicians’ abilities to make clinical decisions using DTx-generated data. In addition, digital therapeutics provide clinicians with more therapeutic options.
Since clinicians have an essential role in patient care, and evaluating how digital therapies fit in their workflow and benefit them may improve the appropriate use of the DTx products. Considerations to assess clinical team engagement of a product include:
- Ways clinicians can leverage DTx-generated data in improving clinical care.
- Ways clinicians are involved in DTx-related care.
- Degrees of clinical team involvement in the DTx product used by the patients.
- Type of clinicians who can authorize the product use and engage with the DTx-related therapy.
The DTA guideline also provides a framework for product decision-makers and manufacturers to assess their product-specific engagement and implementation processes. This framework suggests an “engagement chain” with five steps to target, outreach to, activate, engage with, and support end-users.
Reviewing each step of the engagement chain is out of the scope of this article. But, if you are interested, please visit the guideline.
Digital therapeutics play an important role in patient care. So, to ensure DTx products’ safety, effectiveness, appropriate real-world use, and optimization, they undergo several clinical evaluations throughout their life cycle. After successful clinical evaluation, regulatory bodies review DTx products to evaluate product claims, risks, efficacy, and use.
Assessing product clinical evaluations will help healthcare decision-makers better understand product safety, efficacy, and use by patients. In addition, evaluating the type and quality of jurisdiction the product has completed will allow them to integrate digital therapeutics into clinical care more confidently.
Potential considerations to review the product evaluations include:
- Type and quality of product design studies.
- Type, status, design, and clinical outcome of clinical studies to assess product clinical use.
- Quality of clinical evidence available for the product.
- Type of real-world studies (i.e., product performance, user and clinicians’ engagement studies).
- Type of product analyses and economic evaluations.
- Type of regulatory reviews and market authorizations completed by the product.
- Status of regulatory reviews and market authorizations processes of the product.
10. Real-World Data (RWD)
Once patients and clinicians start using DTx products, real-world data will be generated. Examples of real-world data include clinical measures used and clinical outcomes produced by the product, product performance, quality, and satisfaction measures. This data can then be used to improve DTx products and, eventually, patient care, and clinical outcomes.
Evaluating how the real-world data is gathered and who is responsible for analyzing it is critical to ensure that manufacturer policies comply with privacy and patient consent processes.
In addition to real-world data, conducting formal clinical trials is essential to assess product safety and efficacy. The outcomes of these studies provide real-world evidence to streamline digital therapies and create better-performing, lower-risk products.
Considerations to assess real-world evidence (RWE) studies include:
- Reasons for and benefits of conducting a RWE study.
- Entities responsible for conducting the study.
- Design and methodology of the study.
- Validity and reliability of the study results.
- Availability of the results to the public.
Digital therapeutics create an exciting field in healthcare to improve patient care and clinical outcomes. Since the popularity and number of DTx products are on the rise, assessing these DTx products based on a reliable framework by a reputable organization such as the DTA is essential.
This DTA framework will allow healthcare decision-makers, payers, policy makers, and patients to evaluate DTx products confidently and to integrate those into clinical care that are reliable, evidence-based, effective, and safe.