The AI for Health Alliance has released a draft framework for the responsible development and deployment of artificial intelligence in healthcare.
The framework — which includes standards guidance and a series of checklists — has been in development for more than two years, according to CHAI. The framework addresses the urgent need for consensus standards and practical guidance to ensure AI in healthcare benefits all populations, including those from underserved and underrepresented communities, CHAI said.
The bill is currently open for public review and comment for 60 days.
WHY IT MATTERS
CHAI, which launched in December 2021, previously released its Blueprint for Trustworthy AI in April 2023 as a consensus-based effort among experts from leading academic medical centers, regional health systems, patient advocates, federal agencies, and other stakeholders in health care and technology.
In a statement Wednesday, CHAI said the new guidance combines principles from the Blueprint with guidance from federal agencies while the checklist provides actionable steps to apply the assurance standards to everyday operating procedures.
Functionally, the Assurance Standards Guide outlines industry-agreed standards for implementing AI in healthcare and the Assurance Reporting Checklist can help identify use cases, develop healthcare AI products, and then deploy and monitor them.
According to CHAI, the basic principles in designing these documents align with the National Academy of Medicine’s AI Code of Conduct, the White House’s AI Bill of Rights plan, several frameworks from the National Institute of Standards and Technology, as well as the Department of Health and Human Services’ Cybersecurity Framework for Strategic Preparedness and Response.
Dr. Brian Anderson, executive director of CHAI, emphasized the importance of a public review and comment period to help ensure AI is effective, useful, safe, secure, fair, and equitable.
“This move will demonstrate that a consensus-based approach across the healthcare ecosystem can support innovation in healthcare and build trust that AI can serve us all,” he said in a statement.
The guidance will provide common language and understanding of the medical AI lifecycle, and explore best practices when designing, developing, and deploying AI in healthcare workflows while the draft checklist supports independent assessment of medical AI solutions throughout their lifecycle to ensure they are effective, valid, safe, and minimize bias.
This framework presents six use cases to demonstrate considerations and best practices:
- EHR Risk Prediction (Acute Asthma Exacerbation in Children)
- Diagnostic imaging (mammography)
- Artificial Intelligence (EHR query and extraction)
- Outpatient on Claims (Managed Care)
- Clinical Operations and Management (pre-authorized with medical coding)
- Genomics (precision oncology with genomic markers)
CHAI notes that making the results of the checklist application publicly available will ensure transparency.
The coalition’s editorial board reviewed the guidelines and checklist presented in May at a public forum at Stanford University.
One CHAI participant, Ysabel Duron, founder and CEO of the Latina Cancer Institute, said in a statement that collaboration and engagement with multiple patient voices from multiple sectors is needed to provide “safeguards against bias, discrimination, and unintended harmful outcomes.”
“AI can be a powerful tool in overcoming barriers and closing gaps in healthcare access for Latino patients and healthcare professionals, but it can also cause harm if we don’t all get involved,” she said in the CHAI announcement.
THE BIGGER TREND
First addressed by the House Energy and Commerce Committee’s Subcommittee on Health at a hearing on the U.S. Food and Drug Administration’s regulation of medical devices and other biological products last month, a growing number of lawmakers are now asking the FDA and the Centers for Medicare & Medicaid Services about the use and oversight of AI in health care.
Hill More than 50 lawmakers in both the House and Senate have called for increased oversight of artificial intelligence in Medicare Advantage coverage decisions while STATISTICAL said they had a letter from Republicans criticizing the FDA’s partnership with CHAI.
Dr. Mariannette Jane Miller-Meeks, R-Iowa, asked the FDA at a May 22 hearing whether it would transfer AI certification to CHAI, a group she said was not diverse and had “clear signs of a regulatory takeover effort.”
“It doesn’t pass the smell test,” she said.
Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, told Miller-Meeks that CDRH works with CHAI and other AI industry coalitions as a federal liaison and does not rely on the organization to review applications.
“We also told CHAI that they need more representation in the medical technology sector,” Shuren added.
ON PROFILE
“Common ways to quantify the usefulness of AI algorithms will help ensure we can realize the full potential of AI for patients and the health system,” said Dr. Nigam Shah, CHAI co-founder, board member and chief data scientist at Stanford Healthcare, in a statement. “This guidance represents the collective consensus of our 2,500-strong CHAI community of patient advocates, clinicians and technology experts.”
Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
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