The DiMe Seal is a symbol of quality and trust, awarded to digital health software products that demonstrate compliance with the first comprehensive framework of standards and best practices across evidence, privacy & security, and usability.

Evaluating the 350,000+ digital health software products (DHSPs) is an exercise in confronting the wild west: 

• There are thousands of unknown developers and apps
• Users have limited, to no resources to review them
• There are as many sources of guidance for patients and providers to have to consider as there are risks in selection of a solution

With 41% of patients using digital apps weekly, this leaves caregivers and patients to continue in their struggle often remaining waiting for help or using unvetted, unsafe products instead.

To build the DiMe Seal platform’s evaluation framework, the Digital Medicine Society (DiMe) reviewed 1000+ scientific articles, examined 47 regulatory guidances, assessed 112 standards and quality programs, and engaged 150+ industry experts. DiMe then convened hundreds of cross-disciplinary experts from all corners of the digital health software ecosystem – including clinicians, developers, regulators, payers, and patient advocates – to create a comprehensive framework to define evidence-based best practices in evidence, privacy & security, and usability. 

• Review the publication on the development of the DiMe Seal framework here.

That framework developed by DiMe became the foundation for the DiMe Seal evaluation platform. Today, the DiMe Seal is able to scale evaluation of DHSPs for their compliance with the unifying criteria of evidence, privacy & security, and usability. As a result, the DiMe Seal functions to accelerate adoption of high quality and trustworthy products by patients and providers.

Eligible products must be seeking (or have) market access in the U.S. They are software applications built for a general-purpose computing platform and used for managing, maintaining, or improving health, used by a person/patient, a healthcare professional, or both. Telehealth services, EHR/EMR platforms, billing software, and products sold exclusively outside of the U.S. are not eligible to receive the DiMe Seal.

The DiMe Seal process walks software developers through an online, self-attestation workflow to measure their software product against the framework criteria. The online platform helps you with:

• Enrollment: Register your company and pay the platform fee.
• Determining your eligibility: The program focuses on digital health software products (excluding hardware components and services).
• Self-attestation: Upload documentation demonstrating your product meets framework criteria. Existing frameworks and certificates will be considered, so you won’t have to duplicate efforts.
• Approval: If your product meets the criteria, you’ll receive the DiMe Seal for use on your website and marketing materials. If your product is on the cusp of achieving the DiMe Seal, we provide educational content, guidance, and technical assistance to support you in achieving it. 
• Maintenance: An annual renewal process ensures ongoing compliance.

Through the platform, DiMe also provides educational content, guidance, and technical assistance to support digital health software developers in achieving the DiMe Seal. We are committed to helping developers succeed and delivering good products to market to improve lives.

On average it takes DHSP developers approximately 5-7 hrs to complete the self-attestation workflow, usually over the course of a week.

DiMe Seal evaluates privacy and security, in addition to domains of evidence and usability for the broad category of digital health software products. In addition, concepts such as workflow integration and whether a product meets the needs of end users, which are commonly requested by physicians, are evaluated.

Developers pay a fee of $1,799 to be evaluated through our user-friendly, self-attestation platform and an annual renewal fee of $899. Proceeds from the DiMe Seal are reinvested into the maintenance of the platform and its ongoing efforts to accelerate adoption of high quality and trustworthy products by patients and providers.

The DiMe Seal is valid for 12 months from the date the product is awarded. After one year, it must be renewed against the current evaluation framework.

By obtaining the DiMe Seal, you differentiate your product, accelerate adoption, and build consumer confidence. Our rigorous, yet accessible evaluation process helps you demonstrate your commitment to high quality, responsibly developed products. 

DiMe Seal helps to enhance your market positioning, showcase your product as a trustworthy tool, increasing your likelihood of adoption, and builds trust and credibility by demonstrating your commitment across evidence, privacy & security, and usability.

DiMe Seal provides a rigorous, standardized evaluation of digital health software products. By adopting DiMe Seal-verified products, healthcare systems, providers, patients and payers can confidently select tools that meet standards for security, privacy, usability, evidence, and access. This not only enhances patient outcomes but also optimizes investment by reducing the risk and burden of technology selection, ultimately contributing to a more reliable and effective digital health landscape.

An independent governance committee, comprised of high-level industry leaders and innovators from across the digital health ecosystem, oversees the continued development of DiMe Seal. As guidelines and industry standards evolve, so will the framework.