The meaningful use movement is here to stay, whether we like it or not. The benefits electronic health records (EHRs) can bring are unquestionable, but with those benefits come many potential burdens and legal questions.
Inevitably, complications will arise throughout EHR-related input, delivery, and reception procedures. Such complications could include: data breaches, software glitches, physician confusion, lack of harmony and uniformity between software, inaccurate analytics, or user error. Arguably, the most pressing issue in all of this is the matter of who is to be held accountable once such problems are realized.
One potential solution is tort-based accountability. This method would focus heavily on provider’s complying with a set standard of care. Such an approach would allow for precise accountability by forcing courts to look at the full scope of the matter, assessing all potential direct and indirect causes. The big issue here would be establishing a clear and consistent standard of care. Evaluating a claim from a medical standpoint might not present such a problem; the more complicated issue is weaving IT standards into current medical criteria. IT industry standards tend to be less-user friendly and many argue that uniform standards are virtually non-existent when it comes to technology. [1] Moreover, relying on a tort-based system would appear to indicate that the government seeks another channel to attack providers. The legislative intent is rather clear, the ultimate goal of healthcare technology is to ease the pressures and burdens for both patients and physicians, not increase them. [2] Meaningful use is intended to improve physician workflow and allow more time for patient care, such benefits would be eliminated under a tort-based system. [3] Providers would be living under a continuous cloud of fear, having to worry about being held responsible for software-based problems, an issue that is not and should not be their primary concern.
An obvious solution, one that is already being implemented to some degree, is contract-based accountability. With contract-based accountability, liability would be outlined in the terms and conditions of the contract between the vendor and provider. Although such an avenue may seem appealing, a contract-based approach is far from perfect. Small physician practices would be at a huge disadvantage, lacking the bargaining leverage of a multi-hospital system. [4]
Furthermore, EHR digitalization is a necessity; the vendors understand this fact and use it to their advantage during the negotiation process. Many vendors will build “hold harmless” clauses into their contracts; such clauses essentially call for the provider to accept any liability for technology related defects, which could endanger patient safety. [5] Vendors have taken even greater steps to dodge liability, some contracts go as far as preventing healthcare organizations from even reporting any design flaws, defects, or other problems associated with the software. [6] Even in the event that a provider has sufficient bargaining power, it is unreasonable to assume that they will be able to account for the majority of potential scenarios that could develop. Meaningful use is a “new science” that is in a transitional phase, issues that have yet to be addressed or even considered are bound to arise.
A strong argument can be made in favor of creating an EHR “trust fund.” Such a system would not only be feasible, but also efficient. The major benefit of a trust fund approach is that the schematics for such a system already exist; this is a proven method that has been successfully implemented with the National Vaccine Injury Compensation Program (NVICP). A comparable method could be copied and applied to the matter of EHR accountability. By implementing a small federal tax, the government could establish a trust fund specifically devoted to payouts and legal fees for EHR –related injuries (The NVICP is funded by a small $0.75 excise tax which is placed on vaccines). [7] The injured party would file a claim and go through the necessary legal processes with the U.S. Court of Federal Claims. Regardless of whether or not a claim is paid, legal fees and other relevant costs would be covered, similar to the NVICP. [8]
A trust-fund program would put minimal strain on our healthcare system, while allowing for flexibility and accuracy. Such a solution would not only ease burdens for both vendors and providers, but it would also empower the patient. Contract and tort-based solutions neglect to address the consumer side of the spectrum.
Here, patients would be free to bring forth claims without having to worry about the costs typically associated with trials. Most importantly, such a model would support the notion of a fair, transparent, and equal healthcare system. Factors such as the size of the provider, the software they use, the location, or budget would not matter; all healthcare organizations would be provided an equal level of protection. Such a solution balances interests and, in turn, allows providers and vendors to focus their efforts on providing reliable and efficient healthcare.
References:
[1] Matthew T. Wimberley, D.C. in Action: An Early Look at Meaningful Use, the Government Practice of Medicine, and Tort Reform, 62 Ala. L. Rev. 207, 217-18 (2010)
[2] Id.
[3] H. Stephen Lieber, As Electronic Health Record Implementations Rise ... So Will Disputes, Disp. Resol. J., 46, 48 (2011).
[4] Id. at 49-50.
[5] Id.
[6] Id.
[7] National Vaccine Injury Compensation Fund, Health Resources and Services Administration,http://www.hrsa.gov/vaccinecompensation/index.html.
[8] Id.