In the last two years, the Federal Drug Administration (FDA) has received 260 reports of health IT malfunctions, some of which resulted in 44 reported injuries and six deaths. These numbers are prompting FDA officials to call for a federal framework and oversight to ensure patient safety.
An FDA official said the agency would require vendors to electronically register their EMRs and EHRs and submit regular reports. If the data indicates a trend that negatively impacts patient safety, the FDA would step in with recommendations for design controls for those systems.
Now Congress is getting involved. In February, Sen. Charles Grassley (R-Iowa), a member of the Senate Finance Committee, asked Health and Human Services Secretary Kathleen Sebelius how HHS is monitoring patient safety issues and what the FDA’s role is with regard to health IT regulation.
Some believe having the FDA involved would create unnecessary complexity and confusion. Some also believe the certification process should be responsible for that kind of oversight.
Let’s take a step back first and look at the big picture. Relatively speaking, health IT is a young industry and the federal office established to oversee it is also evolving. The Office of the National Coordinator for Health IT was established in 2004 and has had two interim and two appointed leaders in its six years. Thanks to the federal funds being distributed through the American Recovery and Reinvestment Act (ARRA) and the HITECH Act, ONC has taken on greater responsibilities and health IT has expanded in the industry.
EHR/EMR penetration has been slowly gaining ground. According to a 2008 Centers for Disease Control and Prevention survey, 17 percent of physicians participating reported having a basic EHR, with four percent having a fully functional EHR. In 2006, the percentage was 11.2 for basic and 3.1 for fully functional EHRs. Those numbers are rising every year.
It makes sense that as health IT implementations rise, the growing pains will reveal such problems as patient-safety errors. Yes, oversight is needed. But should it be through the FDA? Can the certification bodies address system issues and defects upstream? Can ONC shoulder that responsibility?
Between ONC and certification bodies the job can be done more efficiently than if another federal agency was brought in. The stakeholders in the EHR/EMR world are already familiar with ONC and certification. Why bring in another agency that may create discomfort, especially at a time when there are still many providers either unsure or sitting out altogether in the adoption of health IT?
The issue should be taken care of upstream. Give this approach a chance for a few years or more. If the number of reports rises, then perhaps the post-market approach may be introduced. But let’s try the upstream, less complicated approach first.
