A monumental initiative has emerged to address a critical need in the digital health ecosystem: the validation and standardization of digital health products. With the overwhelming number of digital health applications available today—over 400,000 for consumers and 30,000 for healthcare providers—navigating the space can be exceptionally challenging. The Digital Medicine Society (DiMe) seeks to streamline this process with its new online database and the introduction of the DiMe Seal. This ambitious project aims to offer health systems, providers, patients, and the general public a trusted platform to discern which digital health products meet essential standards for privacy, security, and equity, thereby fostering a more reliable and efficient healthcare landscape.
Addressing the Digital Health Dilemma
The surge in digital health applications has created a confusing landscape for patients, providers, and health systems alike. With such a vast array of options, determining which products are both effective and secure is no easy task. Healthcare institutions often spend countless hours assessing the risks associated with these tools, a time-intensive process that burdens resources. The proliferation of over 400,000 apps for consumers and 30,000 for healthcare providers complicates the decision-making process, often leaving end users to bear the brunt of risk assessment in purchasing digital health tools.
The new DiMe database offers a solution by providing a trusted source for evaluating digital health products based on their adherence to baseline privacy, security, and equity standards. This initiative aims to facilitate better decision-making processes for all stakeholders involved, ensuring that only high-quality, trustworthy digital health tools are utilized. By centralizing the vetting process, DiMe’s new platform helps streamline evaluations, offering peace of mind to healthcare institutions and patients alike. This effort not only conserves valuable time and resources but also elevates the standard of digital health offerings in the marketplace.
The DiMe Seal: A Symbol of Trust
A key component of this initiative is the DiMe Seal, which serves as a benchmark for trust and quality in digital health products. Developers can apply for the DiMe Seal by completing a series of attestations and questions covering a myriad of industry standards such as SOC 2 Type II, HITRUST, Carin Code of Conduct, WCAG, and ISO 27001. These rigorous standards ensure that products meet high benchmarks for privacy, security, and equity. The attainment of the DiMe Seal signifies that a product has undergone a thorough, evidence-based evaluation and has met stringent criteria established by industry experts.
The creation of the DiMe Seal involved extensive collaboration with over 150 industry leaders, including clinicians, developers, regulators, payers, and patient advocates. Together, they reviewed nearly 50 pieces of regulatory guidance, over 100 industry standards and quality programs, and more than 1,000 scientific articles. This collaborative effort has resulted in a comprehensive, evidence-based framework for evaluating digital health products. The process underscores the importance of interdisciplinary effort in setting a gold standard for digital health, ensuring that all voices in the ecosystem are considered and that the criteria for evaluation cover a broad and inclusive spectrum of concerns.
Streamlining Decision-Making in Health Systems
Health systems and organizations stand to benefit significantly from the DiMe Seal, as it addresses the inefficiencies inherent in the current vetting process for digital health products. John Brownstein, Chief Innovation Officer at Boston Children’s Hospital and a DiMe Seal governance committee member, highlighted the need for a standardized evaluation method. The DiMe Seal provides this much-needed standard, enabling more efficient innovation and adoption of digital health tools. By establishing a unified, trusted source for evaluation, the initiative significantly reduces the time and resources spent by healthcare institutions on vetting processes, allowing for quicker adaptation and implementation of reliable digital health solutions.
With more than 150 developers already signed up to have their products evaluated, the DiMe Seal has begun to make its mark. These products range from apps designed for glucose monitoring to integrated platforms aimed at improving patient outcomes. The stringent criteria ensure that only products meeting the highest standards are endorsed, thereby building trust among providers and patients. The widespread adoption of the DiMe Seal can potentially drive a culture of continuous improvement among developers, as they strive to meet the criteria and gain endorsement, further elevating the quality and reliability of digital health tools in the market.
The Challenge of Evaluating Digital Health Tools
Evaluating digital health tools has always posed a significant challenge due to the integration of artificial intelligence and ever-evolving cybersecurity threats. Epic Systems, a major electronic health record provider, has taken steps to assist hospitals and health systems in validating AI models. Their Fairness Audit, part of their “seismometer suite,” allows organizations to evaluate AI models against local population data, grading a model’s fairness across varying protected classes and demographic groups. This tool helps mitigate biases and ensures that AI-driven health solutions are equitable and fair, providing a more comprehensive approach to digital health validation.
Beyond AI validation, cybersecurity remains an ongoing concern. The dynamic nature of cybersecurity threats necessitates continuous patching of vulnerabilities. Additionally, maintaining human accountability across organizations adds layers of complexity. Many healthcare systems remain vulnerable to cyberattacks despite efforts to enhance security measures. These vulnerabilities underscore the importance of robust, standardized criteria like those set forth by the DiMe Seal, which ensure that products are not only functional and effective but also secure against emerging threats. This multifaceted approach to evaluation addresses various dimensions of digital health tools, making the DiMe Seal a comprehensive benchmark for quality.
Government Efforts and Industry Collaboration
Recognizing these challenges, the U.S. Health and Human Services (HHS) has announced more than $50 million in funding for tools aimed at protecting hospital operations from ransomware and other vulnerabilities. Programs like the Universal PatchinG and Remediation for Autonomous Defense (UPGRADE) specifically target the security of medical devices and the continuity of patient care. These government initiatives complement the efforts of organizations like DiMe to bolster the overall security and reliability of digital health tools. Government support and funding are crucial in addressing the burgeoning cybersecurity threats facing healthcare systems, reinforcing the efforts of industry-led initiatives like the DiMe Seal.
The introduction of the DiMe Seal is a significant step forward for the digital health industry. By setting a unified standard for evaluating digital health software products, the DiMe Seal simplifies the validation process and ensures only high-quality, trustworthy solutions are recommended. This standardized approach not only aids in building trust in digital health tools but also fosters an environment conducive to innovation. The collaborative efforts between government bodies and industry leaders highlight a shared commitment to enhancing the digital health landscape, ensuring that security, equity, and privacy remain paramount considerations in the development and deployment of digital health solutions.
Conclusion
A significant initiative is taking shape to tackle a critical need in the digital health landscape: the validation and standardization of digital health products. With today’s plethora of digital health apps—more than 400,000 for consumers and 30,000 for healthcare providers—navigating this space is exceedingly difficult. The Digital Medicine Society (DiMe) aims to simplify this process with their new online database and the introduction of the DiMe Seal. This ambitious project is designed to offer health systems, providers, patients, and the general public a trusted platform to evaluate which digital health products meet essential standards for privacy, security, and equity. By doing so, DiMe seeks to foster a more reliable and efficient healthcare environment. Not only does this initiative promise to streamline the selection process, but it also aspires to elevate the overall standard of digital health tools, making it easier for everyone to find dependable solutions in a crowded marketplace.
