Patient rights, safety at the heart of EHR track changes debate

The electronic health record (EHR) is a constantly evolving digital chronicle of a patient's health--data is placed in the EHR, data is deleted or changed for various reasons. This ongoing process, though, has caught the eye of legislators in California who want to make it more difficult for healthcare providers to surreptitiously make changes in EHRs--especially when bad or poor patient outcomes might occur.

As in many other parts of the country, the use of EHRs among providers is growing quickly throughout the state. The California Healthcare Foundation, for instance, estimated earlier this year that nearly half of the state's physician practices have EHR systems--up from 14 percent in 2008.

But among those users, several high profile cases have emerged over whether data was deleted or changed in the EHR when problems arose. One case in particular was that of a 70-year-old woman who died of a bowel obstruction after knee replacement surgery in 2007 at a prominent Northern California hospital.

In the lawsuit, according to the San Francisco Chronicle, the woman's family maintained that efforts to destroy some records and file late entries were part of a cover-up that eventually led to her death. However, the hospital said in a statement later that "no permanent records" about the patient had been deleted. Instead, "rough, contemporaneous notes"--which were not supposed to be part of the permanent EHR file--were removed.

To address this issue of EHR add/delete, state Sen. Mark Leno (D-San Francisco) introduced a bill (SB 850) earlier this year requiring state providers to log EHR changes or deletions--which specifically include the identity of the individual making the changes.

"Without these requirements and protections, there could be real concern for the well-being of the patient," Leno said at a state senate hearing on the bill last month. He added that changes to EHRs sometimes can go unnoticed--and can be harder to trace than changes made to paper records, according to California Healthline.

In addition, the bill would allow patients who request access to their EHRs to view the modifications when they occur.

Consumer groups have been pleased by the legislation. Paloma Perez, the associate legislative counsel for the Consumer Attorneys of California (which sponsored SB 850), said the measure could prevent situations in which patients' medical data is lost because of data entry errors.

However, provider groups have expressed their displeasure with the bill's provisions--specifically because of added complexities and costs. The California Hospital Association said in a letter to Leno that use of EHRs provides "new challenges to documentation," and that the frequency of the problem addressed in the bill is not cost-justified "when hospitals are focused on achieving sustainable health information exchange and in demonstrating federally defined meaningful use of clinical data."

CHA cautioned that making the patient's medical information accessible upon request could not be supported under the current level of reporting existing for EHRs. The costs to revise vendor systems to meet the proposed requirement "will result in millions of dollars of programming changes to systems already installed in California's hospitals and will result in major delays to hospital EHR system projects awaiting implementation."

The California Medical Association also raised concerns--citing that the bill could end up creating two standards for EHRs--one that addresses the federal law and one that answers to the state.

The bill appears likely to continue through the State Assembly; it passed the Senate, 21-15, two weeks ago, and now is on its way to the Assembly for committee hearings.

While the legislation is confined to California, it does bring up issues that patients in many states are likely to bring up as EHRs become part of the healthcare delivery landscape. Because EHRs already contain functions to audit changes, will patients be asking for more details to make sure the EHRs are working for them as well? Now--rather than later--may be the time to ask this at the national level. - Janice