Frequently asked questions and resources

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

DiMe identified 100+ guidelines, standards, and certifications for digital health software products (DHSPs), but no single tool existed (until now!) to establish that a product is built against these best practices. Without commonly accepted benchmarks of trustworthiness, users, and buyers of digital health software – healthcare systems, payors, and individual clinicians and patients – currently spend a disproportionate amount of time and resources vetting products and/or establishing their own evaluation criteria.

The DiMe Seal solves this by serving as the enduring model for quality digital health software products. It will build trust in the market, accelerate the adoption of digital health tools to improve health outcomes, and invite a continuous cycle of rigorous evaluation to elevate digital health practices. 

To build the platform’s evaluation framework DiMe reviewed 1000+ scientific articles, examined 47 regulatory guidances, assessed 112 standards and quality programs, and engaged 150+ industry experts. We 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 usability, accessibility, evidence, privacy, and security.

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 a 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.

The process timeline will vary depending on the amount and nature of data that a submitter will need to include for their respective product. Once your package is submitted, you will receive an immediate confirmation email. The review and Q&A process takes approximately 3-5 days. Once approved, our team will share a kit of marketing materials and guidance to help you promote your newly DiMe Seal-verified product. Your product will also be added to our DiMe Seal product library.

The DiMe Seal solves this by serving as the enduring model for quality digital health software products. It will build trust in the market, accelerate the adoption of digital health tools to improve health outcomes, and invite a continuous cycle of rigorous evaluation to elevate digital health practices. 

The DiMe Seal evaluates privacy and security, in addition to domains of evidence and usability for the broad category of digital health software products. Additionally, concepts such as workflow integration and whether a product meets the needs of diverse 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. As a nonprofit organization, DiMe re-invests proceeds from DiMe Seal into the maintenance of the program and its ongoing efforts to drive the adoption of digital approaches to redefine healthcare and improve lives.

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 quality, evidence, security, and usability. 

While many evaluation options focus primarily on a single criterion such as privacy, security, or regulatory compliance, DiMe Seal extends its criteria to include evidence of efficacy, usability, workflow integration, and the ability to meet the needs of diverse end users. This breadth of evaluation ensures that products with the DiMe Seal are not only high-quality and trustworthy, but also user-friendly, and truly beneficial in a variety of healthcare settings.

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

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 quality, evidence, security, and usability. 

While many evaluation options focus primarily on a single criterion such as privacy, security, or regulatory compliance, DiMe Seal extends its criteria to include evidence of efficacy, usability, workflow integration, and the ability to meet the needs of diverse end users. This breadth of evaluation ensures that products with the DiMe Seal are not only high-quality and trustworthy, but also user-friendly, and truly beneficial in a variety of healthcare settings.

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

DiMe Seal provides a rigorous, standardized evaluation of digital health software products. By adopting DiMe Seal-verified products, healthcare systems, providers, and payers can confidently select tools that meet stringent standards for security, privacy, usability, clinical evidence, and equity. 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.

We will maintain a publicly available library to help purchasers, providers, payors, and patients evaluate all the products with a DiMe Seal. Users will be able to search and filter products based on the attributes that are most relevant to their individual needs.

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