Public Workshops on FDASIA Health IT Report: What Happens Next?

Posted by The Evidence Blog on May 27, 2014

As we mentioned in our previous blog post, on May 13-15, 2014, the Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communication Commission (FCC) held a 3-day public workshop seeking input on the FDASIA draft health IT report.

The session on May 15, 2014, focused on safety topics—reporting safety data, analyzing safety data, the proposed Health IT Safety Center, and collection and dissemination of evidence. Panelists agreed that to fully realize the benefits of health IT we need to do a better job reporting, analyzing, and disseminating health IT safety data. The most concerning issue, from our perspective, is that health IT events are not always reported. Why? Providers aren’t required to do so. And if it’s not mandated, it’s not going to happen. Moreover, providers need clarity with regard to what data they should report. Creating reporting parameters to improve the safety information that is captured is a necessary step. In addition, providers need to be able to discern which events are health IT-related and which are not. One panelist referred to an analysis in which 43% of health IT events were reported initially as medication errors when, in fact, these events occurred when software did not function as expected.

Two additional concerns with health IT safety reporting were confidentiality and the need for a nonpunitive structure so that providers are not penalized when they report health IT events. Panelists concurred with the notion of shared responsibility—everyone involved with health IT, whether developers, users, or patients, needed to take responsibility to ensure that health IT products did not put patients at risk and that evidence-based, high-quality healthcare be provided.

It was clear from the panelists’ responses that collecting safety data is not enough. We need collaboration between the people who develop, implement, and use health IT. The reality is that people use things in unanticipated ways. Health IT is no different. We need to understand how providers and consumers are using health IT in real life, analyze any problems that occur, and then disseminate that safety data in meaningful forms so that providers, manufacturers, and regulators will use the information to prevent future health IT safety events.

During this session, panelists also tackled the issue of mobile health applications. There was overwhelming agreement among panelists that mobile health applications can be misleading and inappropriate with regard to content. Another concern is that these applications are not secure and do not adequately protect patients’ healthcare information. Even though mobile health applications may be low risk, engaging and educating consumers about these concerns needs to be a priority.

Where do we go from here? The FDA, ONC, and FCC will incorporate the comments and input from this public workshop into a final report with recommendations on how to move forward to develop the proposed framework. Without engagement and buy-in from all health IT stakeholders, realizing the potential benefits of health IT will be difficult.

Topics: Hayes Blog

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