HHS recently released a draft report that includes a proposed strategy and recommendations for a health information technology framework. The report was developed by FDA in consultation with the HHS ONC for Health IT, and the FCC. The strategy is to promote product innovation while maintaining appropriate patient protections while avoiding regulatory duplication.
The congressionally mandated report developed in consultation with health IT experts and consumer representatives proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use the product.
If health IT products are not designed, implemented, or maintained properly, they can pose varying degrees of risk to the patients that use the products. The safety of health IT relies not only on how a product is designed and developed, but how it is customized, implemented, integrated, and used.
As proposed in the draft report, there would be three health IT categories based on function and level of risk that focus on what the product does not on the platform on which it operates. For instance, this is important in the case of mobile medical devices, PCs, or for technology that is cloud-based.
The first category includes products with administrative health IT functions. The second category includes products that manage health including software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results, and most clinical decision support software. Both of these categories pose little or sufficiently low risk.
The third category however contains products with medical device health IT functions that could potentially pose greater risk to patients if they do not perform as intended. The draft report proposes that FDA continue regulating these products that includes computer-aided detection software and software for bedside monitor alarms and radiation treatment software.
Included in the framework is a proposal for ONC to create a public-private Health IT Safety Center in collaboration with FDA, FCC, and the HHS Agency for Healthcare Research and Quality along with other stakeholders. The Health IT Safety Center would work on best practices and provide a forum for the exchange of ideas and information focused on patient safety.
The three agencies also intend to announce a public meeting to solicit comments on the draft report and gather feedback on the outlined strategy and approach.
Go to www.hhs.gov/news/press/2014pres/04/20140403d.html to view the report.