In a 2009 Berkeley Technology Law Journal paper, E-Health Hazards: Provider Liability and Electronic Health Record Systems, Sharona Hoffman and Andy Podgurski argued that potential liability arising from the widespread use of electronic health records (EHRs) could end up burdening healthcare systems in a broad-reaching way. Therefore, a set of formal regulations governing EHR use should be implemented by care providers prior to widespread roll out of the technology in the clinical setting.
The core issue the authors anticipated was that “[h]istorically, medical innovations, such as anesthetics and x-rays, have generated increased tort litigation as patients quickly came to expect better care while physicians struggled to perfect their use of challenging technologies,” and that the same phenomenon may occur with EHR systems.
Despite the fact that the authors have to look forward in order to spot the issue, the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH), a component of the American Recovery and Reinvestment Act of 2009 (ARRA), effectively guarantees that malpractice lawsuits related to EHR miscues are going to increase exponentially by 2014. That is because HITECH’s goal of digitizing all Americans’ health records by 2014 necessitates a quintupling of our EHR capabilities by that time despite the fact that our current EHR technologies are far from optimally calibrated for active use in the caregiver context.
The argument for the ARRA’s allotment for health information technology focuses on efficiency and service gains that can be realized from the widespread adoption of EHRs. The required EHR technologies can now be brought into the offices of all American doctors due to the rise of smart mobile devices like the iPad. The arguments against are inverted reflections one another: that it must be the case either that the software itself is not mature enough to serve the needs of doctors or patients, or that the doctors do not have the necessary training to integrate the technology into their daily routines.
Hoffman and Podgurski say that either one or both of these concerns will lead to a host of liability concerns for healthcare providers. They identified seven likely origins of liability:
a) Physician time constraints and information overload
b) Reliance on others’ diagnosis and treatment decisions
c) Input errors
d) Challenges of decision support
e) Responsiveness to electronic communication
f) Patient access to personal health records (PHRs)
g) Product defects
The two underlying problems of all seven origins of potential liability is the lack of EHR standardization and software design.
So, how should Hoffman and Podgurski’s research be applied?
Hoffman and Podgurski’s cautious approach to wide-scale implementation of EHRs in even a sophisticated healthcare setting is a reason to give pause to the championing of EHRs and other mobile technologies as a miracle product for regions in the developing world. The United Nations has long recognized the threat that emerging technologies can pose to at-risk populations if their use and implementation is left unchecked, and it has a whole regulatory body that deals with these issues. Yet, the US does not have this type of regulatory body, though in May 2011, a widely circulated White House memo has shown that the newly created White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) is aware that time is of the essence in creating such a body. With new technologies poised to forever change the way healthcare is delivered in the United States, the faster that memos translate to concrete action, the better.
– For more on mobile technology regulation follow Damjan at Asia Healthcare Blog.