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Federal Agencies Release Health IT Framework for Patient Safety

April 3, 2014
by Gabriel Perna
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The Office of the National Coordinator for Health IT (ONC), the Federal Communications Commission (FCC), and the Food and Drug Administration (FDA) jointly released the strategy and recommendations for a health information technology (health IT) framework this week.

The purpose of the framework is to provide guidance on health IT products to help determine a) what it does and b) what risk it has to patients who will use it. The framework was developed as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).             

The three agencies will hold a public meeting in May to solicit comments on the draft report and gather feedback on the outlined strategy and approach. A docket will be available soon for the public to submit any additional comments.

The framework breaks the various types of health IT products into the three categories: administrative health IT functions, health management IT functions, and medical device health IT functions. The first category includes software for billing and claims processing, scheduling, and practice and inventory management and does not require oversight.

The second category is low risk and includes health information and data exchange, data capture and encounter documentation (such as an electronic health record), electronic access to clinical results, most clinical decision support, medication management, electronic communication and coordination, provider order entry, knowledge management, and patient identification and matching. Even if these products meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

Instead, the ONC will provide much of the oversight for these functionalities, with testing, certification and accreditation of this category of products. This oversight will include focus on interoperability standards and there will be best practices for implementation, customization, and maintenance. It will also work with the FCC, FDA, and the Agency for Healthcare Research and Quality (AHRQ) to leverage a newly created Health IT Safety Center, proposed as part of the most recent Department of Health and Human Services (HHS) budget, which will bring together various stakeholders for the purposes of identifying best practices and providing a forum for the exchange of ideas.  

The third category, medical device health IT functions, includes computer-aided detection, EKG monitoring, radiation treatment software, and similar types of products. The FDA is already providing oversight for these products and will continue to do so.

In addition, within the framework is an additional framework that includes four key proposed priority areas health management health IT functionality. Those areas include promoting the use of quality management principals; identifying, developing, and adopting standards and best practices; leveraging conformity assessment tools; and creating an environment of learning and continual improvement.



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