Three years ago, Dr. EMR finally decided to purchase an electronic health care (EHR) system for his dermatology office. He is not convinced that there is an economic benefit to doing so, but has been told that such a system will significantly lessen his medical legal liability because he will be able to better document his patient care. Recently, he has been sued for medical malpractice. Now, he is having trouble defending himself because of entries into the EHR that he contends he never made and resulted from a software glitch. What is his liability?
Although the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorized initial grants and incentives to promote “meaningful use” of electronic health records (EHRs) by providers, one of the potential risks that has not been given much discussion is the risk of medical malpractice liability.
By 2008, among physicians whose primary practice setting was not in a hospital, the number of EHR users was actually higher. Of those doctors, 21% had a basic system and six percent already had a comprehensive system in 2009. The number of installed systems has increased every year since those early days.
Disconcerting to many physicians is the fact that implementing new information systems may initially elevate, rather than decrease, providers’ malpractice risk. This issue was thoroughly looked at in a 2010 New England Journal of Medicine article.
The Health Insurance Portability and Accountability Act (HIPAA) specifically states that the healthcare provider is the sole covered entity responsible for maintaining the integrity of the patient's medical record -- not the EHR vendor, not the consultant, not the systems integrator.
A dermatologist can be held liable because most vendors' contracts essentially say, 'We do not practice medicine; it is up to the physician to make sure this EHR is being used correctly. Practices must understand what they're using and verify that the system is appropriately set up to document the care they provide."
If a dermatologist finds issues with his/her EHR, it is the dermatologist’s responsibility to contact the vendor and insist that the glitches be fixed, it is also important to document each attempt to get the vendor to fix the problem.
As with any new technology, the risk of error increases during the initial implementation phase, as providers move from their older familiar system of charting to a new much more comprehensive system. Several studies have already documented increases in computer-related errors, and in one case an increase in mortality, shortly after implementation of computerized provider-order entry systems. Medical errors and adverse events may result from individual mistakes in using EHRs (e.g., incorrectly entering information into the electronic record) or system wide EHR failures or “bugs” that create their own problems such as “crashes” that prevent access to crucial information.
The interface between “older paper” and “newer electronic” records may also create documentation gaps or other problems that impact on clinical care. As an illustration of such risks, one study showed a higher rate of failure to inform patients of abnormal test results in outpatient practices in which a hybrid of paper and electronic records was used than in practices in which either paper or electronic records alone were used. There is no reason to think such problems would not occur in a dermatology office.
Effective training and tailoring of new systems to existing technology can minimize the incidence of such errors, and organizations that have sufficient resources can monitor problems after implementation and adjust systems to minimize the persistence of errors. However, these measures may not prevent errors entirely, and system failures may recur long after implementation. Such a scenario would leave clinicians to “practice blind” until functioning is restored.
At least one legal case suggests that providers have a duty to minimize such risks during the transition period. A federal court held that a hospital that switched from a paper to an electronic system for delivering test results had a duty to “implement a reasonable procedure during the transition phase” to ensure the timely delivery of test results to doctors. The court did not elaborate on what the requirements were to constitute a reasonable procedure, but it found that the hospital had met its duty by establishing a training protocol for the period before all physicians had completed training on the new system.
Dr. EMR may not be able to avoid liability for the software glitch. He alone may be responsible for problems associated with his EHR.