Despite the potential of mass benefits to the public, health IT also poses an equally great risk should it not be executed properly.
In response to legislation passed by Congress in 2012, the Food and Drug Administration, in consultation with the Federal Communications Commission and the Office of the National Coordinator for Health IT at the Department of Health and Human Services, released a report with a proposed strategy and recommendations for a health IT framework.
According to HHS, the draft framework promotes product innovation with an emphasis on maintaining patient protections and avoiding regulatory duplication.
“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” HHS Secretary Kathleen Sebelius said. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”
The report outlines three health IT categories based on the function they perform:
- The first category is products with administrative health IT functions that pose little to no risk to patient safety, and include software for billing and claims processing, scheduling, and practice and inventory management.
- The second category is made up of products with health management IT functions and includes software for health information and data management, medication management, provider order entry, electronic access to clinical results, knowledge management and most clinical decision support software.
- The third category is a more narrowly defined group — products with medical device health IT functions, and includes software for bedside monitor alarms, computer-aided detection software and radiation treatment software.
Of all these categories, the third poses the highest level of risk to patients should they fail to perform, which is why FDA will focus its oversight on this group.
“This proposed strategy will facilitate innovation, protect patients and support FDA’s focused oversight on higher risk technology, similar to medical devices that are currently regulated,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “FDA looks forward to additional stakeholder feedback on the proposed framework in this draft report.”
The framework also proposes the establishment of a public-private Health IT Safety Center to be created by ONC, in collaboration with the FDA, FCC, HHS’ Agency for Healthcare Research and Quality, and other stakeholders.
To get feedback from the public, the three agencies intend to have a public meeting to solicit comments on the draft, according to the release.
“ONC welcomes comment on the draft report and stands ready to collaborate with stakeholders to ensure that health IT is designed and used with both innovation and patient safety in mind,” said Karen DeSalvo, national coordinator for health IT.
