Health Is the Reason and Digital Is the Tool
Health systems across the world are increasingly adopting and integrating digital solutions to make healthcare more accessible, interconnected, and affordable. Given the widespread and rapid pace at which digital innovations are becoming available, deploying them safely and securely is essential for building trust throughout the entire health ecosystem.
Globally, organizations such as the United States Food and Drug Administration (FDA), the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the World Health Organization (WHO), and others are developing recommendations that focus on documenting best practices for clinical evidence generation for digital health solutions.1
These solutions require a fit-for-purpose evidentiary standard to evaluate the variety of information collected from clinical studies, real-world data, health economic and outcomes research (HEOR), and context-specific implementation.1
Evaluation frameworks that ensure consistency in digital health product assessment, regulation, reimbursement, and clinical scalability can help minimize delays and provide patients around the world with access to digital solutions that meet a broad range of unmet and under addressed medical needs.1
Quality and Evidentiary Standards
Strong Clinical Evidence Underscores the Impact of Digital Health Solutions.
Digital health solutions are software-based and are classified by the FDA as software as a medical device (SaMD). Because the software itself (and not the hardware) is classified as a medical device, it may be freely used on a smartphone or tablet.2
Many types of information are used to evaluate digital health solutions³:
• Clinical trials and real-world studies
• Regulatory approvals and certifications
• Expert opinions and professional recommendations
• User reviews
A fit-for-purpose evidentiary framework includes³:
• Intervention classifications
• Clinical outcome domains
• Participant selection
• Evidence endpoints
• Control arm considerations
The following domains provide evidence to assess the effectiveness of digital health solutions³:
• Safety and benefits
• The durability and duration of response
• Usability and accessibility
• User engagement
Professional guidelines highlight digital health solutions as an opportunity to redefine standards in care and have incorporated them into clinical practice guidelines.
The American Diabetes Association (ADA) Standards of Care in Diabetes 20234
Kidney Disease Improving Global Outcomes Guidelines for Diabetes Management in Chronic Kidney Disease5
American Heart Association (AHA)6
The Benefits of Digital Health Solutions Are Evident Across Multiple Quality Metrics.
As evidenced-based nonconventional assistive solutions, digital health solutions do far more than improve compliance—they help improve clinical and economic outcomes, which can be beneficial for plans.7-9
The Centers for Medicare & Medicaid Services (CMS) utilize a combination of measures to evaluate plan quality and performance, and quality bonus programs deliver plans up to $2.8 billion in incremental payments.1
Quality standards are evidence-based, and some digital health solutions show that they can address specific HEDIS measures.1
Quality domain affected
Managing chronic (long-term)
conditions beyond traditional real-world evidence experience
Member complaints about and
changes in the health/drug plan’s performance
Member experience with a
health/drug plan
Quality measure
C11: Blood Sugar Controlled
C12: Controlling Blood Pressure
C23: Complaints
about the Health Plan
C20: Rating of Health Care Quality
Select examples with supporting
peer-reviewed literature*
Digital outreach can positively affect A1c levels, systolic blood pressure, and glycemic control in poorly controlled diabetes
Digital intervention received
high satisfaction reports
Among 14 studies, digital health interventions resulted in higher QALYs with cost savings in 43% and gained QALYs at a higher cost at an acceptable incremental cost-effectiveness ratio in 57%
*Illustrative example, not meant to be representative.
HEDIS, Healthcare Effectiveness Data and Information Set; QALY, quality-adjusted life year.
Quality measurements are shifting toward patient-centered care.
With the increasing availability of digital health solutions, it is important to make them an integral part of your clinical quality programs; they can be beneficial when combined with conventional medicine.
Digital health and traditional pharmaceuticals are evaluated on different metrics.1
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Continuously testing, learning, and iterating is the key to increasing digital health retention—and revenue.
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To learn more about how Sanofi is using digital health solutions to help improve outcomes and reduce the costs of chronic conditions, please click below or contact your Sanofi Account Director.
Intended for use with payers, formulary committees, or other similar entities for purposes of population-based drug selection, coverage, and/or reimbursement decision-making, pursuant to FD&C Act Section 502(a).
REFERENCES: 1. Data on File. Sanofi US. 2. Huh KY, et al. Healthc Inform Res. 2022;28(3):188-197. 3. Digital Therapeutics Alliance. Setting the stage for a fit-for-purpose DTx evidentiary standard. Updated December 2022. Accessed April 26, 2023. https://dtxalliance.org/wp-content/uploads/2022/12/DTA-Clinical-Evidence-Paper_12.22.pdf 4. ElSayed, et al. Diabetes Care. 2023;46(Supplement_1):S1-S292. 5. de Boer, et al. Diabetes Care. 2022;45:3075-3090. 6. American Heart Association. Digital health lexicon and program/policy evaluation framework. Published February 2022. Accessed May 1, 2023. https://www.heart.org/-/media/Files/About-Us/Policy-Research/Policy-Positions/Telehealth/Digital-Health-Lexicon-Project-2022.pdf 7. Martin M, et al. JMIR Diabetes. 2021;6(2):e24981. 8. Jiang X, et al. J Med Internet Res. 2019;21(6):e13166. 9. Kaufman N, et al. Diabetes Technol Ther. 2016;S56-S68. 10. RTI Health Advance. The value of digital therapeutics: personalized, cost-effective care. Published January 05, 2023. Accessed April 26, 2023. https://healthcare.rti.org/insights/value-of-prescription-digital-therapeutics 11. Ahmed Z, et al. Database (Oxford). 2020:baaa010. 12. Mathews SC, et al. NPJ Digit Med. 2019;13;2:38. 13. Mercury Healthcare. How Patient Retention Translates into Lifetime Value. Updated February 22, 2022. Accessed April 19, 2023. https://www.mercuryhealthcare.com/blog/patient-retention-lifetime-value