2 minutes
Ready for the December 31, 2024 ONC HTI-1 deadline?
Insights from an Industry Veteran
The Last-Minute Rush
As a seasoned professional with 13 years of experience at a leading ONC Authorized Certification Body and Authorized Test Lab, I’ve witnessed firsthand the tendency of vendors to delay ONC compliance until the last possible moment. It’s a pattern I’ve observed consistently throughout my career. Understandably so, there are several reasons why vendors might postpone compliance efforts:
- Resource allocation: Compliance work often competes with product development and other priorities.
- Evolving standards: Sometimes, vendors hope for clarifications or changes to the requirements.
- Complexity: The certification process can be more involved than initially anticipated.
While the last-minute approach is common, it’s not without risks. Rushing compliance can lead to oversights, stress, and potential delays in product release or certification.
Delivering Intervention Risk Management for Predictive Decision Support Interventions
The ONC’s HTI-1 Final Rule outlines intervention risk management practices that must be applied for each predictive DSI supplied by the health IT developer as part of its Health IT Module. Over the past year and a half, I’ve been deeply involved in researching solutions and participating in industry workgroups to address these new requirements. My work has included:
- Actively engaging in key industry initiatives such as the Coalition for Health AI (CHAI) and the NIST AI Safety Consortium.
- Contributing to the CHAI Assurance Standards Guide, specifically the NIST CSF and Privacy profile.
- Researching tools to help developers streamline their compliance processes.
How can I help?
Need help with AI governance? I can assist with:
- Creating NIST AI RMF and ISO 42001 compliant policies
- Classifying predictive Decision Support Interventions (DSI) for ONC HTI-1 rule compliance
- Analyzing risks and impacts
- Exploring test tools for risk mitigation controls