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The Department of Health and Human Services, through the Office of the National Coordinator for Health Information Technology, recently updated the health information technology certification process. Some of these modifications are intended to address the use of artificial intelligence in health IT systems. Certain programs require ONC certification, such as Healthcare IT for Medicare and Medicaid incentive programs. For everyone else it’s optional. Those who are already certified need to renew their certification. Those seeking new certification will be subject to a new process.
The certification process requires health IT developers to prove that their products meet certain standards. Demonstration can be accomplished through documentation or inspection, which must be approved by the Office of the National Coordinator for Health Information Technology. The updated certification process applies to health IT systems that use predictive models to assist decision-making (commonly referred to as “DSI”). Especially those who use training materials for modeling. Of particular concern, companies wishing to have their systems certified will need to demonstrate compliance with appropriate standards, while also demonstrating that they:
- Steps have been taken to ensure that users understand how DSI works. As part of this, it provides users with access to basic information about DSI design and development.
- Conduct an assessment of risk practices for health IT and publicly publish a summary of these practices.
If your health IT is already certified, you will need to update your products and certifications to ensure they meet the new standards. If you do not complete the necessary updates, you may lose your certification. Going forward, health IT developers incorporating predictive DSI will have until the end of 2024 to comply with the updated standards. That said, the rule excludes many other new requirements for several years.
Putting it into practice: Developers looking to become certified should review these requirements to assess whether their products comply with the new standards or require adjustments. Developers wishing to maintain certification should review these requirements and begin renewing their certification to avoid forfeiture.
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