A new online database from the Digital Medicine Society allows healthcare systems, providers, patients and the general public to learn which digital health products meet basic privacy, security and equity standards, and make better-informed decisions about which products to use to use.
Digital health developers can apply for the new Digital Medicine Society seal online through a series of attestations and questions covering industry standards such as SOC 2 Type II, HITRUST, Carin Code of Conduct, WCAG, ISO 27001 and more, the organization said.
WHY IT’S IMPORTANT
There are more than 400,000 health software applications available to consumers and 30,000 to providers, health care systems and other business organizations, DiMe said in a statement last week.
“Digital health software products are driving transformational innovation in healthcare,” said DiMe CEO Jennifer Goldsack Healthcare IT news. “However, the burden of discouraging software purchasing decisions remains unacceptably and unsustainably high for end users.”
Achieving the DiMe seal is intended to indicate that the software meets quality standards and is reliable. The standards were developed through a 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, according to the organization.
DiMe said it has also convened experts from across the digital health software ecosystem – including physicians, developers, regulators, payers and patient advocates – to help create the comprehensive framework.
“Until now, there has been no standard or efficient way to evaluate digital health software products,” John Brownstein, chief innovation officer at Boston Children’s Hospital and a member of the DiMe Seal board committee, said in the announcement.
Technologists at supplier 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 healthcare providers and patients who will benefit.”
More than 150 developers have already signed up more than 50 products – from glucose monitoring apps to platforms that integrate data and digital interventions to improve patient outcomes – for a DiMe Seal evaluation.
Defining “what good looks like with respect to digital health products” is a previously unmet need, says Grace Cordovano, co-founder of Unblock Health, patient-in-residence at DiMe and board committee member.
“There are resources available in the public domain to guide informed decision-making on things like cars, universities and home renovations,” she said. “We must prioritize providing the right tools to patients when they need them most, or as an industry we risk losing confidence in the transformative potential of digital health.”
DiMe Seal’s management committee includes:
- Dr. Jackie Gerhart, Epic’s vice president of clinical informatics
- Stephen Hughes, director of healthcare IT policy for the American Hospital Association
- Kate Berry, senior vice president of clinical affairs and strategic partnerships for America’s Health Insurance Plans
- Aneesh Chopra, Arcadia chief strategy officer
- Adrienne McFadden, vice president of Elevance Health and chief medical officer of Medicaid
- Kimberly McManus, deputy chief technology officer and deputy chief artificial intelligence officer at the Department of Veterans Affairs
DiMe said it will also launch a benchmarking database later this year to categorize product comparisons with details on regulatory status, common therapeutic areas and more.
THE BIG TREND
Providers and consumers struggle to assess which digital health tools will meet their needs and streamline regulatory compliance.
Recognizing the challenge posed by software developers embracing artificial intelligence in products, Epic Systems has released a tool to help hospitals and healthcare systems, which are often under-resourced Assess and validate AI models.
A healthcare AI validation tool that the electronic health records giant calls its “seismometer suite” is a Fairness Audit that organizations can use to assess any AI model, including homegrown ones, against local population data. It’s used to assess 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.
Of course, AI quality is just one issue healthcare decision makers should consider when considering software purchases. Cybersecurity is another challenge that brings with it a mountain of challenges, from the constant need to patch vulnerabilities to factors affecting human accountability within organizations.
While numerous tools exist to aid the exploding digital healthcare software industry – including various regulatory guidelines and government-driven healthcare IT certification programs – disruptions from healthcare cyber attacks are becoming increasingly common and thousands of medical devices and systems remain always safety risks.
To that end, the U.S. Health and Human Services has announced more than $50 million to develop tools that protect hospital operations from ransomware vulnerabilities, addressing the dramatic increase in the number of vulnerabilities being weaponized. The Universal Patching and Remediation for Autonomous DEfense, or UPGRADE, program announced earlier this year focuses on medical device security and continuity of patient care.
ON THE RECORD
“The DiMe Seal will give digital health innovators a shared language with their customers, allowing buyers to 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 complex, the value of a unifying framework for identifying high-quality, reliable solutions is of tremendous value to both the end users of digital health software products and to their developers looking to differentiate their products. ,” Goldsack said by email.
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.
The HIMSS Healthcare Cybersecurity Forum will take place from October 31 to November 1 in Washington, DC More information and registration.