Healthcare-industry stakeholders — including associations, vendors, practitioners and providers — have raised two major concerns relating to implementation of Stage 2 and 3 meaningful use criteria: problems with interoperability and a regulatory failure to assess value added from implementation of meaningful use criteria to date.

The American Medical Association (AMA) recommended the creation of a public-private partnership that would include those stakeholders and the government to develop consensus standards that could be adopted broadly across the healthcare system concerning the design and implementation of electronic health records (EHR) systems to ensure interoperability. Stakeholders have also expressed concerns about the government regulatory failure to fund and conduct an independent comprehensive external progress evaluation of the meaningful use program to date and the adoption of incentives to encourage industry assessment of successes or failures in implementation. Additionally, they have expressed concern that individual providers are so involved in the adoption of technology that little effort is being directed toward assessment of whether care, quality and efficiency have been enhanced.

HIT was intended to establish an informational backbone for accountable care, and for patient safety and healthcare reform. Stage 1 of the meaningful use guidelines was intended to promote EHR adoption and infrastructure development. Unfortunately, it was not designed with sufficient forethought so as to require that design implementation and evolution of existing systems and infrastructure meet the goals of Stages 2 and 3. While Stage 1 barely scratched the surface of interoperability, Stage 2 requirements include stiff criteria in this area. Under Stage 2 rules, which take effect next year, healthcare organizations must provide a summary-of-care record in at least 50 percent of transactions and referrals, with a portion of those communications occurring between certified EHRs or indirectly through health information exchange. The two goals of HIT have always been the interoperability and usability of EHR systems that allow secure and responsible information exchange.

While commentators have expressed concerns about HITECH implementation for many years, original research by various respected medical organizations was published earlier this year on successes and challenges that have come to light from the implementation of HITECH, as perceived by the medical community. Concerns relate to the failure of the Office of the National Coordinator for Health Information Technology (ONC) to emphasize the need for interoperability in the implementation of Stage 1 requirements, resulting in the design, marketing and sale of EHR systems that cannot talk to each other; a lack of vendor regulation and oversight to ensure the design and sale of compatible systems, usability, and the lack of a means to ensure ongoing assessment of the implementation of EHR systems.

Difficulty in the perceived ease of use reflects widespread criticism of the usability of these tools. While ONC is making progress in this area, significant progress must be made before such systems are perceived to be usable by most physicians. Using EHR as a simple replacement for paper records will not result in the gains in quality and efficiency or reduction in cost that EHR has the potential to achieve.

The American College of Physicians (ACP) recently published original research on the effect of EHR on healthcare costs. The ACP noted that empirical evidence has not yet resolved the question of whether EHR will result in lower healthcare costs but that EHR use has resulted in strong savings in certain areas of medicine, such as radiology. The authors appear to express cautious optimism that EHR will produce true savings.

Presently, more than 700 vendors produce approximately 1,750 distinct certified EHR products. This certification, however, has historically not been focused on the ultimate goals of meaningful use.

The exploding electronic records industry is largely unregulated. Notwithstanding this growth, a few companies control much of the market and remain entrenched in legacy approaches. The lack of progress relating to interoperability has led some to speculate that major IT vendors are opposed to this goal.Commercial contracts between users and vendors often prohibit frank discussion about problems with a given system even in published medical literature. Concern also exists that such discussion of problems with EHRs may lead to malpractice lawsuits against the healthcare provider or product liability lawsuits against vendors. These communications are clearly not adequately protected from the legal community at this time.
Many have commented that although HIT use has increased, the quality and efficiency of patient care has, at best, improved only marginally. Others have suggested that EHR adoption has resulted in medical errors, causing harm and even death. Worse yet, annual aggregate expenditures on healthcare have increased from approximately $2 trillion dollars in 2005 to $2.8 trillion dollars in 2013, a far cry from the rosy future that HIT supporters promised.

Despite governmental encouragement to increase interoperability among HIT systems, ONC reported last year that only 19 percent of hospitals suggested successful exchange of clinical information electronically with providers outside their system.

A major reason for the low level of interoperability, according to ONC, was the expense of interconnecting disparate EHR systems. No one state or organization has sufficient influence over the community of vendors to reduce design variability in available EHR systems. While national interoperability standards have recently been published, regulation and enforcement remains an issue.

Because of the shortcomings in the design and implementation of HIT systems, many providers are reluctant to invest the considerable time and effort required to master difficult user technology and to implement process changes required to fully realize HIT potential. The most recent data available suggests that only about 27 percent of hospitals are using basic EHR. Fear of rapid obsolescence and uncertainty about the future regulatory environment are cited as reasons for delay in HIT adoption. While there has been convincing evidence that federal incentives have accelerated HIT adoption, most of this adoption has been among providers that had already planned improvements in this area, as opposed to small, rural and nonteaching institutions.

This can also be partly attributed to a failure to deliver quantifiable gains in productivity and patient safety and may, in part, be due to a failure to engage doctors and healthcare providers early in the HIT development process.

Several specialty groups (emergency room physicians and pediatricians) have noted that usability issues impair the advancement of EHR use in the healthcare community. System functionality varies greatly and affects physician decision making, clinical workflow, communication and, ultimately, the overall quality of care and patient safety. EHR safety concerns arising from use of inferior EHR products or suboptimal execution of such products in the clinical environment include: (a) communication failure; (b) wrong order/wrong patient errors; (c) poor data display; and (d) alert fatigue. As HIT products become more intimately involved in the delivery of care, the potential for HIT-induced medical errors causing harm or death has increased significantly. Authors have cited dosing errors, delays in diagnosis and delays in treatment issues because of poor human-computer interaction or loss of data as HIT evolves. EHR errors are often attributed to user experience level and training but may occur due to human errors secondary to poor design of products.

Usability concerns include violation of common interface design, heuristic rules such as presenting consisting models of function or usable, legible workflow mismatching related to lack of consistency between provider modeling of work, and design models inscribed into EHR. Deficiencies in IT system designs can inhibit provider discovery of error and efforts to correct such error.

Problems in the implementation of meaningful use standards to ensure usability and interoperability to promote the goals of HITECH have plagued the healthcare system. These issues arguably have contributed to a failure of the majority of healthcare providers and institutions to adopt EHR designed to meet Stages 1 and 2 meaningful use criteria. Design evolution to meet existing use criteria by 2014 is further impeded by the reticence of stakeholders and vendors to exchange information on successes and failures in the implementation of EHR systems. The industry and regulators have started to confront roadblocks adversely affecting the evolution of the program. However, these efforts have historically neither been adequately planned nor coordinated to ensure success.

ONC should consider delay in implementation of Stage 2 and 3 criteria pending implementation of controls to ensure interoperability and usability, as well as measures to honestly evaluate progress in a systematic way to ensure cost efficiencies and improved care.