Don’t Worry, You (Probably) Won’t Have To Deal With ONC: Algorithm Transparency Rule May Have Surprise Effects On Medtech Firms

Epstein Becker Green attorney Alaap Shah breaks down the HHS ONC’s 800-page rule on algorithm transparency and information blocking.

A drawing of a doctor consulting a patient online, wiht her medical records pulled up and floating outside of the screen.
• Source: Shutterstock

The Office of the National Coordinator for Health Information Technology’s (ONC) rule on algorithm transparency and information blocking may not directly affect medtech companies, but they may be subject to third-party liability consequences.

The ONC recently finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Digital Technologies

More from Medtech Insight

Altaviva Approval A Big Win For Medtronic And Millions Struggling With Bladder Control

 

The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.

Execs On The Move: September 8–12, 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

New Guidelines Support Early Intervention With Edwards TAVR Device Sapien

 

The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.