The Digital Medicine Society (DiMe) is a global non-profit and the professional home for all members of the digital medicine community. The group tackles Digital Health Software Products (DHSP) challenges, develops clinical-quality resources on a technology timeline, and delivers these actionable resources to the field via open-source channels and educational programs.
Per the US FDA, digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products.
DiMe has launched the DiMe Seal, a new framework to evaluate digital health software products in the rapidly evolving market. The DiMe Seal intends to be a is a symbol of quality and trust granted to digital health software products demonstrating performance against a comprehensive framework of standards and best practices in privacy and security, usability, and evidence with equity woven throughout. It is a standard or efficient way to evaluate digital health software products. Under its Governance Committee comprised of industry experts, DiME is delivering clinical quality resources on a tech timeline to advance the safe, effective, ethical, and equitable use of digital medicine to optimize human health. The DiMe Seal will give digital health innovators a shared language with their customers to assist buyers easily validate their products’ security, usability, and clinical Return On Investment (ROI).
A developer can apply for the Seal for their digital health software products online through a series of attestations and questions incorporating complementary industry standards like SOC 2 Type II, HITRUST, Carin Code of Conduct, WCAG, ISO 27001, and others. If the product meets baseline criteria of evidence, privacy, and security standards, it is bestowed the DiMe Seal, a symbol the software is quality and trusted. Health systems, providers, patients, and the public can also access and search the freely available database of products on the DiMe Seal’s website to view which meet baseline standards. This will assist informing their decisions about which tools to use for their care and advance digital innovation and get the best products into the hands of the providers and patients who will benefit from them.
The DiMe Seal standards were developed in collaboration with more than 150 industry experts and after the review of nearly 50 regulatory guidances, over 100 industry standards and quality programs, and over 1,000 scientific articles. DiMe also 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 DiMe Seal’s comprehensive platform. DiME reports in October 2024, over 150 developers have signed up and over 50 products are being evaluated for the DiMe Seal, ranging from apps for glucose monitoring to platforms integrating data and digital interventions to improve patient outcomes! Sensibly, DiMe will launch a benchmarking database to compare categories of products and further meet the needs of end users by including details on regulatory status, common therapeutic areas, and more. The DiMe Seal process is described at http://dimesociety.org/dime-seal.