Making AI Models in Healthcare Transparent One Bite at a Time – Regulatory Talk Series

This article is the third in the Healthcare Regulatory Talk series.
New data standards announced last December by the Office of the National Coordinator for Healthcare Technology (ONC) are an extraordinarily significant expansion of regulations around health IT and could hijack product roadmaps for years to come.
For EHRs faced with the daunting task of revamping platform technology and innovation roadmaps, the “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)” final rule is like the elephant in the old proverb: too hard to consume all at once, more doable bite by bite.
Let’s start with the “bite” that represents the most pressing change – namely, new guardrails for AI-driven clinical decision support intervention tools, or DSIs.
While the ONC extended some 21st Century Cures Act compliance deadlines, including requirements that EHR developers adopt improvements in information sharing and patient data access, they held firm on making AI models in healthcare transparent by the end of 2024. It’s no surprise that HTI-1’s first deadline in a four-year compliance timeline supports the ONC’s most ambitious regulatory action in more than a decade.
The challenge for health tech developers is to demystify the algorithms behind clinical-grade AI by the January 1, 2025, deadline. Deconstructing the black box that surrounds complex machine learning systems in under a year won’t be...

Source: EMR and HIPAA - March 4, 2024 Category: Information Technology Authors: Guest Author Tags: AI/Machine Learning Ambulatory C-Suite Leadership Health IT Company Healthcare IT Hospital - Health System Regulations 21st Century Cures Clinical Decision Support Clinical Grade AI DrFirst EHR Certification EHR Development EHR R Source Type: blogs