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Apr 07, 2014

In Developing Strategic Framework for HIT Regulation, HHS Continues to Focus on HIT Functionality

Published

Apr 07, 2014

On April 3, HHS released a draft report with proposed strategies and recommendations for health information technology (HIT) regulation.

The Food and Drug Administration Safety and Innovation Act (FDASIA)-mandated 2012 report was developed by FDA, the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC).  The authors based their regulatory strategy on recommendations by the FDASIA Committee, a workgroup of external stakeholders convened by HHS and tasked with developing a framework for HIT regulation.  

Recognizing the need to distinguish among different types and uses of HIT to avoid duplicative efforts and ensure appropriate regulation, these Agencies outlined three levels of HIT products:

Recognizing the need to distinguish among different types and uses of HIT to avoid duplicative efforts and ensure appropriate regulation, these Agencies outlined three levels of HIT products:

  • Level 1 - Administrative HIT Functionality: software that supports billing and claims processing, scheduling, practice and inventory management, data analysis, etc. The Agencies propose that there be no additional oversight on Level 1 products given the limited/low risk they pose to patient safety. They also propose no additional Level 3 oversight because FDA already oversees products falling into that category.  Instead, the report primarily focuses on Level 2 products, noting that the Agencies’ aim to promote innovation while also protecting patient safety.  

  • Level 2 - Health Management HIT Functionality: health information and data exchange, medication management, clinical decision support software, etc.
  • Level 3 - Medical Device HIT Functionality: bedside monitor alarms, radiation treatment, robotic surgical planning and control, etc.  

The four priority areas for their Level 2 HIT strategy call for: The Agencies’ flexible and limited regulatory approach will please developers of such Level 2 products, but is likely to upset some consumer and patient groups hoping for clearer regulations and definitive federal oversight.  Given the lack of clear definitional distinction for what constitutes “HIT” and how to determine which “level” a product falls into, additional clarity by the Agencies is likely next year.

  1. Promoting the use of quality management principles.
  2. Identifying, developing, and adopting standards and best practices.
  3. Leveraging conformity assessment tools.
  4. Creating an environment of learning and continual improvement.

The Agencies will host a public meeting on their report within 90 days of its release (but prior to July 2). They are also accepting comments; however, the Agencies specified no specific comment deadline.

View HHS’ HIT draft release.

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