The health IT industry is preparing for the transformative role of AI and ML in healthcare as the Office of the National Coordinator for Health Information Technology (ONC) introduces new requirements for clinical decision support tools.
With a Dec. 31, 2024 deadline looming, electronic health record (EHR) vendors must decide soon on the solution that will help them achieve compliance.
We sat down with Dr. Doug Fridsma, Chief Medical Informatics Officer at Health Universe and former Chief Science Officer at the ONC, to discuss the upcoming B.11 compliance deadline. He unpacks its implications for EHR vendors, answers some common questions, and explains how Health Universe’s B.11 Compliance Wizard simplifies the path to ONC certification.
Q: Can you tell us about what’s required for B.11 compliance by the December 31st deadline?
Dr. Fridsma: The ONC is trying to learn more about how people are using clinical decision support tools, recognizing that the previous approach is somewhat antiquated in the era of ChatGPT and large language models. The industry is moving quickly, and the typical regulatory pattern of years or decades to incorporate changes may not be feasible.
In the most recent rule, there is a strict deadline for new compliance around B.11, which is an update to the previous clinical decision support rule and certification. B.11 expands the requirements for evidence-based decision support interventions to include information about predictive models, such as how they were trained, developed, and tested, as well as risk mitigation strategies and identified populations for use.
Q: What do the new B.11 requirements mean for EHR vendors?
Dr. Fridsma: EHR vendors have two ways of achieving compliance:
- They can retool their electronic health record to capture the required information, which may divert resources from patient-supporting activities.
- They can use relied-upon software, such as Health Universe, to provide the necessary functionality for B.11 compliance.
Given that this is likely the first of many regulations, EHR vendors must consider whether they want to invest significant time, money, and energy into building this infrastructure or outsource it to a dedicated relied upon software provider like Health Universe.
Q: How does Health Universe’s B.11 Compliance Wizard help EHR vendors achieve compliance?
Dr. Fridsma: Our goal at Health Universe is to make B.11 compliance simple and easy for EHR vendors. The B.11 Compliance Wizard provides a series of intuitive wizards that allow you to step through each clinical decision support rule in your EHR and add the necessary information. We curate this information and provide simple APIs that enable you to display the information and remain compliant. In addition to supporting evidence-based decision support, our wizards also accommodate predictive analytics.
We recognize that while many EHR vendors are trying to comply with these new regulations, they may not yet have a clear strategy for incorporating AI and ML models. Health Universe aims to help EHR vendors maintain compliance while also partnering with them to develop a strategy for using AI and ML models effectively.
Q: How can EHR vendors get started with Health Universe as relied-upon software?
Dr. Fridsma: Getting started is simple. Visit this page to learn more about the Health Universe platform and the B.11 Compliance Wizard. You can sign up for compliance directly on the website, and our team will work with you to ensure seamless integration and provide access to the necessary APIs.
Q: What else should EHR vendors know about B.11 compliance?
Dr. Fridsma: Having worked at the ONC, I understand that these certifications and requirements are designed to increase transparency around what have typically been black boxes. It doesn’t mean everything must be open source, but rather that the ONC is gathering information to better understand the challenges, potential problems, and applicable solutions.
I believe this B.11 compliance is just the beginning, and EHR vendors need to think beyond simply checking the box. They should consider a flexible, low-risk approach to deploying these systems, and that’s where Health Universe provides a unique opportunity. We can partner with EHR vendors to find out what works for their patient population, providers, and product, and then tailor a solution that meets their needs. Transparency is crucial not only from a regulatory perspective but also from a user perspective. A community that provides feedback, understands what works and what doesn’t, and shares best practices is essential for the efficient and safe deployment of this new technology. I’m excited for the future and hope that we can partner with many electronic health record vendors as they navigate this evolving landscape and embrace the potential of AI and ML in healthcare.
At Health Universe, we’re committed to supporting EHR vendors throughout this journey, offering a modular approach that allows for customization based on the unique needs of different specialties and practice settings.
By working together and leveraging the power of platforms like Health Universe, we can create a future where AI and ML seamlessly integrate into healthcare, empowering providers to deliver the best possible care to their patients. As we move forward, it’s essential to maintain an open dialogue and collaborate to ensure that these technologies are deployed safely, efficiently, and in a manner that truly benefits patients and providers alike. I’m confident that with the right partnerships and a shared commitment to innovation and transparency, we can revolutionize healthcare and unlock the full potential of AI and ML.
