TABLE 4.

Digital Therapeutics and Stakeholders—Opportunities and Issues Identified by Participants

Stakeholder	Needs and Issues
Patients and caregivers	Desired information may include user reviews, consumer reports, bloggers, patient associations, and clinician endorsements The types of information that patients will desire about a DTx will likely depend on patient factors, including age and health condition being treated Cost and coverage by third-party payers Ability to share data with health care providers, family members, or others to inform health care decision making Patients may share their data with others with the same condition through support groups and online communities Health literacy considerations Privacy of data
Payers	Need a credible authority to determine the burden of proof that is required for providing recommendations upon which coverage decisions can be based Need to identify which benefit is most appropriate for coverage of DTx products and how to integrate new products into existing utilization management programs Need the ability to validate whether a DTx is effective in the real world Similar to the function of a P&T committee, will need a process for internal assessment of DTx to evaluate each product and determine how it fits within the current treatment landscape Can use data from DTx to inform case management and expand care team outreach
Health care providers	Providers have low levels of awareness of DTx, and few continuing education programs address DTx Need education and training for both practicing providers and those currently in training Need to understand liability concerns and administrative burdens Determine how to incorporate DTx in practice Workflow, patient education, and delivery of the product to the patient Need to establish best practices for using products and integrate DTx in guidelines, recommendations, protocols, and references Need best practices for using data Determining how the DTx could interact with EHRs, which data should be highlighted to providers, and when should a response from the provider be triggered Identification of objective, actionable data that are presented in a useful format, such as a dashboard, that allows providers to improve care Should consider that many patients do not have a regular primary care provider—could use telehealth and DTx to deliver treatment, particularly for patients in rural or remote locations
Biopharmaceutical companies and product innovators	Likely will develop new paradigms for relationships among companies. Potential for many different financial arrangements among biopharmaceutical companies and software developers Different levels of interaction depending on culture and philosophy of the companies involved and the disease state that is targeted Companies will use data from DTx for value-based arrangements, ongoing quality improvement, and research Need to consider who owns the data, who has access, when data should be deidentified, and how to comply with HIPAA
Employers	Need to have a general understanding of the function of the DTx but do not require expertise Will rely on clinical experts to make recommendations Will be interested in the effect of the DTx on health, costs, and quality of life Patient engagement and satisfaction with the DTx based on objective data and patient-reported outcomes Availability of coverage through benefits including pharmacy or medical; options for coverage through HSA or FSA Data can inform risk sharing or value-based agreements

DTx = digital therapeutics; EHR = electronic health record; FSA = flexible spending account; HSA = health savings account; HIPAA = Health Insurance Portability and Accountability Act; P&T = pharmacy and therapeutics.