The Institute of Medicine is recommending that the federal government create a new agency to investigate the safety of health IT systems rather than give such authority to FDA, iWatch News reports (Leonard, iWatch News, 11/7).
IOM is scheduled to release a new report -- titled, "Health IT and Patient Safety: Building Safer Systems for Better Care" -- on Nov. 10, but iWatch News received an advance copy (Daly, Modern Healthcare, 11/8). Findings from the report were presented to HHS and its agencies on Oct. 28.
Currently, no federal agency investigates the safety of health IT systems and no individuals or entities are required to report health IT-related safety issues.
FDA receives voluntary reports of health IT-associated incidents, but it does not have the authority or the resources to take action.
Advising Against FDA Oversight
The IOM report states that FDA lacks the funds, investigative capabilities and human resources to investigate health IT tools such as:
- Electronic health records;
- Health information exchanges; and
- Personal health records.
In addition, IOM notes that FDA investigations could restrict innovation in the health IT industry, which could negatively affect patient safety. The report states that strict regulations "can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers' flexibility to address complex issues."
In the report, IOM calls for HHS to create and fund a new, independent watchdog agency to conduct investigations of health IT safety issues and develop recommendations for health care organizations, health IT vendors and government officials. The agency would not have enforcement power.
The report also states that health IT vendors should be required to report adverse events associated with their products. Health care providers could voluntarily report health IT-related safety issues, according to IOM.
IOM also recommends that:
- All health IT vendors be required to publicly register and list their products with the Office of the National Coordinator for Health IT;
- Another study be conducted to quantify health IT-related deaths, injuries and unsafe conditions;
- Officials establish and enforce criteria for EHR safety;
- The federal government fund a new Health IT Safety Council to set safety standards; and
- The HHS secretary release an annual public report on health IT safety issues.
FDA Declines To Comment
FDA representatives declined to respond to the report's recommendations, saying that HHS is taking the lead on the issue (iWatch News, 11/7).