On January 20, 2016 the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) released a bipartisan discussion draft of a bill that would modify how the federal government regulates health information technology (IT). The discussion draft was released as one of seven proposed bills addressing biomedical innovation that the HELP Committee plans to consider during a February 9 executive session. The HELP Committee is accepting comments on the discussion draft through January 29. 

The bill includes several provisions from the Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, introduced last year by Senator Bill Cassidy (R-La), which would require the Secretary of the Department of Health and Human Services to establish a star rating system for federally certified health record (EHR) systems. The star ratings would be calculated using a methodology that includes criteria reported by developers of health IT as well as feedback from users of health IT on their experience related to security, usability and interoperability of specific health IT products. Each health IT developer that receives a one-star rating would be required to take action pursuant to a corrective action plan. The Secretary would be authorized to assess fines against an entity that does not satisfy the requirements of a corrective action plan or which does not actually improve, and could decertify the health IT. 

The bill is an attempt to address several significant challenges facing the health IT industry. For example, it includes provisions to deter information blocking practices that interfere with sharing electronic health information. The bill also includes several provisions that would encourage the interoperability of health IT. It would establish a Health IT Advisory Committee, which would combine and replace the current Health IT Policy Committee and the Health IT Standards Committee. In addition, the bill would reduce regulatory and administrative burdens related to the use of EHRs. For example, the bill would permit clinical documentation requirements to be delegated to non-physicians, as permitted under state law. 

The bill would require the National Coordinator to encourage, keep or recognize the voluntary certification of health IT for use in medical specialties for which no technology is available or where more technological advancement or integration is needed. It specifically requires the development of recommendations related to the voluntary certification of health IT for use by pediatric health providers. The bill also promotes patients’ access to their electronic health information. 

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Senate Releases Discussion Draft of Bill that would Change Federal Regulation of Health Information Technology