A fresh online database hosted by the Digital Medicine Society enables health systems, providers, patients and the public to learn which digital health products meet basic standards of privacy, security and equity, and to make more informed decisions about the ones they apply.
WHY IT’S IMPORTANT
DiMe said in a statement last week that there are more than 400,000 health apps available to consumers and 30,000 to providers, health systems and other corporate organizations.
“Digital health software is driving transformational innovation in healthcare,” says DiMe CEO Jennifer Goldsack. “Yet the burden of mocking software purchasing decisions remains unacceptably and unsustainably high for end users.”
Obtaining the DiMe seal confirms that the software meets quality standards and is trustworthy. According to the organization, its standards were developed in collaboration with more than 150 industry leaders who reviewed nearly 50 regulatory guidelines, more than 100 industry standards and quality programs, and more than 1,000 scientific articles.
DiMe said it also convened experts from across the digital health software ecosystem – including physicians, developers, regulators, payers and patient advocates – to lend a hand create a comprehensive framework.
“Until now, there has been no standard or effective way to evaluate digital health software,” John Brownstein, chief innovation officer at Boston Children’s Hospital and a member of the DiMe Seal management committee, said in the announcement.
He noted that technologists in supplier organizations “spend countless hours validating products.” “We need a new way to advance digital innovation and get the best products into the hands of providers and patients who will benefit from them.”
More than 150 developers have already signed up to have more than 50 products – from glucose monitoring apps to platforms that integrate data and digital interventions to improve patient outcomes – for DiMe Seal evaluation.
Determining “what good digital health products look like” is a previously unmet need, said Grace Cordovano, co-founder of Unblock Health, patient-in-residence at DiMe and member of the management committee.
“There are resources in the public domain to help you make informed decisions about things like cars, colleges and home renovations,” she said. “We must prioritize providing patients with the right tools when they need them most, otherwise, as an industry, we risk losing confidence in the transformative potential of digital health.”
The DiMe Seal management committee also includes:
- Jackie Gerhart, Ph.D., vice president of clinical informatics at Epic.
- Stephen Hughes, director of healthcare IT policy at the American Hospital Association.
- Kate Berry, senior vice president of clinical affairs and strategic partnerships at America’s Health Insurance Plans.
- Aneesh Chopra, Arcadia’s Chief Strategy Officer.
- Adrienne McFadden, Elevance Health vice president and medical director of Medicaid.
- Kimberly McManus, deputy chief technology officer and deputy director for artificial intelligence at the Department of Veterans Affairs.
DiMe said it will also launch a benchmark database later this year that will categorize product comparisons with details on regulatory status, common therapeutic areas and more.
A BIGGER TREND
Providers and consumers are struggling to assess which digital health tools will meet their needs and improve regulatory compliance.
Recognizing the challenge posed by software developers using artificial intelligence in their products, Epic Systems has released a tool that helps hospitals and health systems that often lack resources properly evaluate and verify artificial intelligence models.
One tool for validating AI in healthcare, which the electronic health records giant calls its “seismometer suite,” is an integrity audit that organizations can apply to evaluate any AI model, including home-grown models, against local data. population. It is used to assess the fairness of a model across different protected classes and demographic groups, Corey Miller, Epic’s vice president of research and development, explained in May.
Of course, AI quality is just one issue that healthcare decision-makers need to think about when considering software purchases. Cybersecurity is another challenge that presents many challenges, from the constant need to patch vulnerabilities to factors related to the responsibility of people in organizations.
While there are countless tools that can lend a hand the booming digital health software industry – including various regulatory guidelines and government-led healthcare IT certification programs – disruption in the form of cyberattacks in healthcare is becoming more common, with thousands of devices and systems medical facilities continue to pose a security risk.
To that end, the U.S. Health and Human Services announced more than $50 million in funding to develop tools to protect hospital operations from ransomware vulnerabilities to address the drastic enhance in weaponized vulnerabilities. The Universal Patching and Remediation for Autonomous Defense (UPGRADE) program, announced earlier this year, aims to ensure the safety of medical devices and continuity of patient care.
ON RECORDING
“The DiMe Seal will provide digital health innovators with a common language with their customers that will help buyers easily verify their products,” Annie Collins, Bio + Health investment partner at a16z and member of the DiMe management committee, said in a statement.
“As the market for these products becomes increasingly crowded and complex, the value of a unified framework for identifying high-quality, trusted solutions is of great value to both digital health software end users and developers looking to differentiate their products,” Goldsack told e- by e-mail.