HHS Issues Proposed Rule to Update Health IT Regulations

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The United States Department of Health and Human Services (HHS) recently proposed a rule that would require HHS contractors to use health information technology (IT) that is certified or accepted by HHS. The proposal updates the Health and Human Services Acquisition Regulation (HHSAR) to implement requirements to procure health IT that meets standards and implementation specifications adopted by the Office of the National Coordinator for Health Information Technology (ONC).

Under the proposal, certain providers, health plans, and health insurance issuers that contract with HHS would be required to adopt ONC standards. Specifically, it would implement requirements in the HHSAR that would apply to all solicitations and contracts, issued by or on behalf of HHS entities, that involve implementing, acquiring, or upgrading health IT used (1) for the direct exchange of individually identifiable health information between agencies and non-Federal entities, or (2) by health care providers, health plans, or health insurance issuers.

The rule would mandate that health IT and electronic health record (EHR) systems comply with standards for interoperability, privacy and security. This would ensure that the systems can effectively communicate and share data across different platforms and health care providers. The rule also emphasizes the importance of data portability and patient access to health information. Facilities must continue to facilitate easy data sharing and allow patients secure access to their health records.

While acquiring and upgrading health IT may be easily understood, HHS defines “implementing” health IT as including a variety of activities that are distinct from acquiring or upgrading health IT. For instance, “implementing” health IT may include investments in health IT for its maintenance and upkeep, the use of health IT to collect, store, and share health information, and activities supporting the piloting, but not the acquisition, of health IT tools.

This regulation would not impact existing HHS authorities for standards adoption. In the proposed rule HHS notes that agencies under its umbrella are “committed to working together to ensure that standards under such authorities are aligned to advance interoperability for a nationwide health IT infrastructure.”

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