A new online database from the Digital Medicine Society enables health systems, providers, patients and the general public to learn about which digital health products meet baseline privacy, security and equity standards, and make more informed decisions about which ones they use.

Digital health developers can apply for the new Digital Medicine Society Seal online through a series of attestations and questions that cover industry standards, such as SOC 2 Type II, HITRUST, Carin Code of Conduct, WCAG, ISO 27001 and more, according to the organization. 

WHY IT MATTERS

There are more than 400,000 health software applications available to consumers and 30,000 for providers, health systems and other enterprise organizations, DiMe said in a statement last week.

"Digital health software products are driving transformational innovation in healthcare," DiMe CEO Jennifer Goldsack tells Healthcare IT News. "However, the burden of derisking software purchase decisions remains unacceptably and unsustainably high for end users."

Gaining the DiMe Seal is meant to connote the software meets quality standards and is trustworthy. Its standards were developed through a collaboration with more than 150 industry leaders who reviewed nearly 50 pieces of regulatory guidance, more than 100 industry standards and quality programs and 1,000+ scientific articles, according to the organization.

DiMe said it also convened experts from across the digital health software ecosystem – including clinicians, developers, regulators, payers and patient advocates – to help create the comprehensive framework.

"Until now, there was no standard or efficient way to evaluate digital health software products," John Brownstein, chief innovation officer at Boston Children's Hospital and member of the DiMe Seal governance committee, said in the announcement.

Technologists at provider organizations "spend countless hours vetting products," he noted. "We need a new way to advance digital innovation and get the best products into the hands of the providers and patients who will benefit from them."

More than 150 developers have already signed up to have more than 50 products – from apps for glucose monitoring to platforms that integrate data and digital interventions to improve patient outcomes – for a DiMe Seal evaluation. 

Determining "what good looks like with respect to digital health products" is a previously unmet need, said Grace Cordovano, cofounder of Unblock Health, patient-in-residence at DiMe and governance committee member.

"There are resources available in the public domain to help guide informed decision-making about things like cars, colleges and home renovations," she said. "We must prioritize getting the right tools to patients when they need them most or we as an industry risk losing trust in the transformative potential of digital health."

The DiMe Seal governance committee also includes, among others: 

• Dr. Jackie Gerhart, Epic's vice president of clinical informatics.
• Stephen Hughes, the American Hospital Association's director of healthcare IT policy.
• Kate Berry, America's Health Insurance Plans' senior vice president of clinical affairs and strategic partnerships.
• Aneesh Chopra, Arcadia's chief strategy officer.
• Adrienne McFadden, Elevance Health's vice president and chief medical officer of Medicaid.
• Kimberly McManus, deputy chief technology officer and deputy chief artificial intelligence officer for the Department of Veterans Affairs.

DiMe said that it will also launch a benchmarking database to categorize product comparisons with details on regulatory status, common therapeutic areas and more later this year.

THE LARGER TREND

Providers and consumers struggle to evaluate which digital health tools will meet their needs and streamline regulatory compliance.

Recognizing the challenge presented by software developers embracing artificial intelligence across products, Epic Systems released a tool to help hospitals and health systems, which often lack resources, to properly assess and validate AI models. 

One healthcare AI validation tool the electronic health record giant calls its "seismometer suite" is a Fairness Audit that organizations can use to evaluate any AI model, including homegrown models, against local population data. It's used to score a model's fairness across different protected classes and demographic groups, Corey Miller, Epic's VP of research and development, explained to Healthcare IT News in May.

AI quality, of course, is just one issue healthcare decision-makers need to think about when they consider software purchases. Cybersecurity is another that presents a mountain of challenges, from the constant need to patch vulnerabilities to factors of human accountability across organizations.

While myriad tools exist to help the exploding digital health software industry – including various pieces of regulatory guidance and government-directed health IT certification programs – healthcare cyberattack disruptions are becoming more frequent and thousands of medical devices and systems still pose security risks.

To that end, the U.S. Health and Human Services announced more than $50 million for the development of tools that protect hospital operations from ransomware vulnerabilities to address the drastic uptick in vulnerabilities being weaponized. The Universal PatchinG and Remediation for Autonomous DEfense, or UPGRADE, program announced earlier this year targets medical device security and patient care continuity.

ON THE RECORD

"The DiMe Seal will give digital health innovators a shared language with their customers that helps buyers easily validate their products," Annie Collins, Bio + Health investment partner at a16z and DiMe governance committee member, said in a statement.

"As the market for these products becomes increasingly crowded and complicated, the value of a unifying framework to identify high-quality, trustworthy solutions holds enormous value for both the end users of digital health software products as well as their developers seeking to differentiate their products," Goldsack said by email.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

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