A newly released report(books.nap.edu) from the Institute of Medicine, or IOM, recommends that HHS take the lead on working to minimize patient safety risks associated with use of health information technology, or health IT.
According to the report, Health IT and Patient Safety: Building Safer Systems for Better Care, the agency should publish a plan within 12 months to reduce adverse events linked to use of health IT and should report annually on the plan's progress. HHS' plan should set a timeframe for the private sector to assess the impact of health IT on patient safety, the report notes.
"Just as the potential benefits of health IT are great, so are the possible harms to patient safety if these technologies are not being properly designed and used," says Gail Warden, chair of the IOM committee that developed the report, in a news release(www8.nationalacademies.org). "To protect patients, industry and government have a shared responsibility to ensure greater transparency, accountability and reporting of health IT-related medical errors," she adds.
If, after one year, the HHS secretary deems progress toward improving patient safety associated with the use of health IT is moving too slowly, the FDA should step in and regulate health IT, says the report. Accordingly, the report's authors further suggest that the FDA begin constructing a regulatory framework now in the event that FDA oversight is required in the future.
Among other recommendations included in the report:
- health IT vendors should support the free exchange of information about health IT experiences and issues;
- the Office of the National Coordinator for Health Information Technology, or ONC, should work to make comparative user experiences across vendors publicly available;
- HHS should fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT;
- all health IT vendors should be required to publicly register their products with ONC;
- HHS should specify the quality and risk management process requirements that vendors will be required to adopt;
- HHS should establish a mechanism for vendors and users to report health IT-related deaths, injuries and unsafe conditions; and
- HHS should recommend that Congress establish an independent federal entity to investigate deaths, injuries and unsafe conditions associated with health IT.