HHS Proposes Rule Mandating Certified Health IT for Contractors

The Department of Health and Human Services (HHS) has proposed a new rule through its technology office, which mandates that healthcare entities contracting with HHS use government-certified health information technology (IT). This proposed rule, unveiled by the Office of the Assistant Secretary of Technology Policy (ASTP), could significantly extend the scope of HHS’s oversight, moving beyond electronic health records (EHRs) to encompass data systems used by public health entities and insurers. The rule could also impact the regulation of artificial intelligence and cybersecurity within the healthcare industry.

The proposed regulation, titled “Acquisition Regulation: Information Technology; Standards for Health Information Technology,” would require that health IT used by healthcare providers, health plans, or insurers under HHS contracts meet the standards set by the Office of the National Coordinator for Health Information Technology (ONC). This includes technology involved in exchanging individually identifiable health information (IIHI). The proposal aims to standardize health IT across the board, preventing the creation of isolated data silos that can undermine the efficiency and effectiveness of HHS programs. By aligning health IT requirements across various sectors, the rule seeks to reduce the burden on healthcare providers and technology developers.

However, the proposal has faced criticism from industry groups like the Health Innovation Alliance (HIA), which argues that the rule could be an overreach of ASTP/ONC’s authority. HIA’s Executive Director, Brett Meeks, expressed concerns that the rule could dramatically expand the scope of ASTP’s influence, affecting a wider range of health information systems beyond just EHRs. As stakeholders prepare to provide feedback within the 60-day comment period, the healthcare industry is cautiously evaluating the potential implications of this broad regulatory expansion.

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