FDASIA Health IT Report: Where Do We Go From Here?

Posted by The Evidence Blog on May 22, 2014

Whether you’re a patient, healthcare provider, or consumer, it’s nearly impossible to avoid health information technology (IT) these days. We are surrounded by products and technologies that enable us to electronically maintain, access, and exchange personal health information—and the number and types of health IT products will only continue to grow. If designed and implemented well, health IT can provide great benefits, such as preventing medical errors, increasing efficiency, and improving the quality of the care delivered to patients. On the other hand, health IT, when developed, maintained, or used improperly, can place patients, providers, and consumers at risk.

In April 2014, the Food and Drug Administration (FDA), Office of the National Coordinator (ONC) for Health Information Technology, and the Federal Communication Commission (FCC) released a draft health IT report that presented a strategy for oversight of health IT products that would promote product innovation, protect patient safety, and avoid regulatory duplication. The draft report, known as the FDASIA health IT report, is one mandated outcome of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012.

The draft report proposes 3 categories of health IT that are based on function and level of risk rather than the platform on which the product operates.

  1. Products with administrative health IT functions. This category includes software to manage billing and process claims, for scheduling, and for practice and inventory management. These products pose little or no risk to patient safety and will require no additional FDA oversight.
  2. Products with health management health IT functions. This category includes software to manage data, health information, and medications; provider order entry; knowledge management; electronic access to clinical results; and most clinical-decision-support software. These products are considered low risk. If they meet the statutory definition of a medical device, the FDA does not intend to focus its oversight on them. Oversight would be managed by activities coordinated by the ONC and private sector capabilities that highlight quality management principles, industry standards, and best practices.
  3. Products with medical device health IT functions. These are products such as radiation treatment software, software for bedside monitor alarms, and computer-aided detection software that could potentially pose greater risks to patients if they do not perform as intended. The FDA proposes continued regulation of these products.

The draft report also proposed the creation of a public-private Health IT Safety Center in collaboration with the FDA, FCC, HHS’ Agency for Healthcare Research and Quality (AHRQ), and other stakeholders. Its purpose would be to develop best practices and provide a forum for the exchange of ideas and information focused on patient safety.

Last week, the FDA, ONC, and FCC held a 3-day public workshop seeking input on this draft report. In a subsequent post, we’ll discuss some of the key takeaways from that meeting.

The health IT report and the framework proposed are an important first step in the management of the health IT products that are flooding the market. But in order to benefit from health IT products, we need collaboration between the people who develop, implement, and use them to ensure that the products being created aren’t just new and innovative. Health IT products need to improve healthcare delivery and not cause harm. Getting to that point may not be as easy as we hope.

Topics: Hayes Blog

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