The EHR Debacle: Has Organized Medicine Failed Us?

By now, it should be no secret that physicians in the United States, although largely receptive to the idea of electronic health records (EHRs), are widely dissatisfied with the current state of the art, and with the way that EHR adoption is being implemented.[1] Indeed, Congress[2] has shown continuing – but sometimes seemingly perfunctory – interest in the concerns of physicians and other health care providers, and I am at this point pessimistic about seeing any results of its efforts in the near future unless a more fundamental change is made in our approach. As Einstein noted, “We cannot solve our problems with the same thinking that created them.”

So where did Congress go wrong? It took a wrong turn when it dropped provisions in HR 6898 of 2008, that would have provided a low-cost, open source EHR (for example, the VA’s VistA[3] to any provider, in conjunction with a governing authority that would include physicians, IT experts and legal experts. In my view, this would be the ideal catalyst for innovation if physician-user input is properly enabled.

When HR 6898 was introduced in 2008, Health Information Management Systems Society (HIMSS) strongly opposed these provisions.[4] In a letter dated 9/25/08, not two weeks after HR 6898 was introduced, HIMSS wrote, “The private sector makes significant investments in research and development for healthcare IT products. Healthcare IT is available via a competitive market in which vendors compete on the basis of price, quality, and functionality of a product. The development, routine updating, and provision of an open source ‘healthcare information system’ is not the role of the federal government and such product development should remain in the private sector.”[5]

The letter implied the standard argument that a company in the business of producing something, whether it be pharmaceuticals, genetic tests, EHR systems, etc., has to make a considerable investment in developing its product, and therefore premium – and sometimes exorbitant – prices are justified, else there will be no development of a needed product. This is sometimes a valid argument, but sometimes not. It really depends upon the circumstances, and details matter. As argued by the petitioners who prevailed in a unanimous decision of the U.S. Supreme Court,[6] too much patent protection can result in limited access to the benefit that the invention was designed to produce, and actually stifle innovation.

It is not clear – to me at least – what, if any, input was provided by organized medicine on the issue of the proposed “nominal cost” open source EHR included in this legislation. Nor is it clear what input was provided on the subsidies and penalties for EHR adoption that were enacted within HITECH (part of ARRA) in 2009. What is clear is that HIMSS, representing an industry that did not need rescue from the financial calamity that occurred in 2008, and for which the American Recovery and Reinvestment Act (ARRA) was primarily intended, was able to piggy-back its own agenda at a cost of tens of billions of dollars in taxpayer money.[7]

So here we are six years later: minimal interoperability (a problem that has been around for two decades), cost overruns, frequent security breaches, widespread physician dissatisfaction because of “meaningful use” requirements, loss of productivity, and issues of patient safety, among other things.

The so-called “meaningful use” requirement to receive subsidies, and subsequently to avoid penalties, quickly became far more than what the plain language of the term suggests. It is an intrusion by government upon the practice of medicine: required documentation standards imposed, not by peers, but by governmental agency. An intrusion that has embittered legions of physicians who must spend hours providing required documentation, mainly in the form of structured data entry, significant amounts of which have little to do with the care of the individual patient – hours taken away from the physician’s practice.

The EHR should be considered an integral part of medical practice, and as such never should have been allowed to be outsourced to government and proprietary EHR vendors. If it is integral to the practice of medicine, it ought to be primarily controlled by physicians: clinicians, researchers and public health physicians, with input from the hospital, payer, regulator and allied health professional sectors. With a properly licensed open source system, those entities would be able to make modifications that would be shared, and when found to have widespread appeal and utility, be included in distribution updates. Medical record systems for public health agencies, nursing homes and sub-specialty practices would obviously have different requirements, and systems with the same architecture could be individualized for the type of practice in which they are used, but general features, such as security, data-sharing, etc., would be common to all.

An unanticipated side effect of the immense bureaucratic burdens imposed by HITECH is that it is making solo and small group practices unsustainable – a phenomenon that would not need to occur with the low-cost, interoperable system proposed in HR 6898, using shared support services. With such a system, solo and small group practices could fully participate in accountable care organizations from the standpoint of quality and efficiency of care without becoming economically dependent on those institutions.

For the most part, Congress and organized medicine have accepted as almost axiomatic that we will not have widespread EHR adoption unless it is dominated by the proprietary vendors. Just how this idea came about is unclear. I will leave it to the reader to determine the agendas and motivations that have led to this state of affairs. So what can we do? Whether the 21st Century Cures Act, currently before Congress, will be effective in accomplishing its stated goals of interoperability, with “secure transfer,” and “complete access to health data” without “special effort” by the requestor, remains to be seen. It will not, however, address the physician concerns of “meaningful use” requirements, usability, efficiency and patient safety, however.

Substitutable Medical Applications & Reusable Technologies (SMART) is “an open, standards-based app platform.”[8] SMART may have the potential to make EHR more adaptable for particular requirements of a health care system or medical practice, and possibly solve the problem of interoperability – something that vendors have been teasing us with for more than a decade. It is almost a certainty, though, that there will be added costs, and that those costs will be borne by end users.

During a recent visit to Haiti, including a visit to Hospital Albert Schweitzer[9] in Deschapelles, I learned about OpenMRS,[10] an EHR system used by that and another hospital in Haiti, and by their satellite clinics, areas quite remote from them due to extreme travel limitations because of the geography of the region.[11] This system is used by health care institutions all over the world, and its use is growing rapidly,[12] at this time primarily operating in “very resource-constrained environments.” Although this system was developed and is being used by necessity in third world conditions, it has managed to become widely adopted, and to achieve the goals of interoperability and relative security against destruction by natural disasters, without the burdens of “meaningful use” requirements and excessive costs.

One would think that physicians who are concerned about their decreasing share of the health care dollar would be concerned about these added costs, and if for no other reason, consider adopting a workable system designed for “very resource poor environments.”[13] It’s time to recognize that the EHR is far more than simply an electronic version of the paper chart: If we consider its potential for clinical decision support, e-prescribing and patient safety measures, among other things, it should become clear that it is integral to medical practice. It’s time to break the mold and start over again. That means a reconsideration of the ideas embodied in HR 6898 with the hindsight afforded us from the past six years, including a governance that facilitates user input. Congress and organized medicine, please take note.

References

1. EHRs Going Against the Flow, http://www.healthdatamanagement.com/news/July-Feature-EHRs-Going-Against-the-Flow-50840-1.html (access 7/13/15). This is merely a recent example of an almost daily flood of such articles in the media.

2. http://www.help.senate.gov/hearings/achieving-the-promise-of-health-information-technology-what-can-providers-and-the-us-department-of-health-and-human-services-do-to-improve-the-electronic-health-record-user-experience (access 7/13/15).

3. The Veterans Affairs VistA is an open source medical record system in existence for decades, and “which grew organically over time with a fair amount of input from [its] end users.”

4. HIMSS Response to ‘Health-e Information Technology Act of 2008’ H.R. 6898, http:// www.himss.org/News/NewsDetail.aspx?ItemNumber=5229 (access 7/8/15).

5. Letter, http://s3.amazonaws.com/rdcms-himss/files/production/public/HIMSSorg/Content/files/Final_HIMSSResponsetoHR6898.pdf (access 7/13/15).

6. Association for Molecular Pathology v. Myriad Genetics, 569 U.S. (2013), 133 S.Ct. 2107 (2103).

7. The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records, http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667_pf.html (access 7/13/15).

8. EHR plug-and-play capabilities emerging from SMART on FHIR apps, 4/15/05, http://www.healthcareitnews.com/news/ehr-plug-play-capabilities-emerging-smart-fhir-apps  (access 7/13/15). Fast Health Interoperability Standard is an open healthcare data standard from HL7. In January 2014, FHIR® was officially designated as a Draft Standard for Trial Use.

9. The hospital was established by Dr. Larimer Mellon, originally from Pittsburgh, and his wife, Gwen, and has been in operation since 1956.

10. (access 7/13/15).

11. Internet access is extensive in Haiti – far more than in some rural areas in the U.S., where there is much better access by motor vehicle.

12. https://atlas.openmrs.org (access 7/13/15).

13. See supra.