On the Need for a Universal Health Record

In 1995, wheDr. Bruce Wildern the electronic health record (EHR¹) was a relatively novel concept², and a tool not widely adopted in medical practices and health care institutions, I wrote an article entitled, “The Medical Record of the Future.”³ At the time, I was mostly concerned about how we could maintain the privacy for patients and protect physician-patient communications. In other words, the discussion was mostly about preventing unauthorized access to the EHR as related to issues peculiar to electronically stored information (ESI), in addition to the concerns we already had about paper records.

The Health Insurance Portability and Accountability Act (HIPAA) followed in 1996. I also expressed concerns about the tendency toward acquiring massive amounts of information and verbiage without paying enough attention to how necessary information could be retrieved in an efficient way.

It is important to point out now that we were still wedded to the paradigm of the EHR being essentially a souped-up version of the paper chart. Since 1995, and especially since Executive Order 13335 in 2004, that aimed to have universal use of the EHR by 2014, the need for a new paradigm has become obvious. Just as the cellphone since that time has become a computer that happens to be able to make phone calls, the EHR has evolved into a system that is becoming integral and indispensable to meeting acceptable standards of delivery of medical care, and, unfortunately, contains an embedded tool for administration of payment for health care services.

When “meaningful use” was included in legislation⁴ designed to juice the widespread implementation of the EHR as a requirement to obtain funding for implementation, and later to avoid penalties for no implementation, it sounded innocent enough. But the regulatory process then seemed to take on a life of its own, and we all know the rest of the story. The “meaningful use” regimen has essentially shifted to providers the burden of structuring data for the benefit of payers, without regard for the cost in terms of physician labor that takes away from the application of clinical skills directed at patient care.

A recent study has attempted to quantitate this cost and its contribution to physician burnout.⁵ A more sensible approach, and one I believe we will eventually reach, given the appropriate innovative environment, is that data entries into the EHR will be driven only by patient care needs, structuring of data for administrative purposes will be automated and the burden of structuring data to fit a particular format will be placed upon those who desire it.

As recently put, “How about returning the record to the exclusive role of being a virtual clinical document that assists the health care team with the care of the patient?”⁶ While issues of how “meaningful use” requirements impede the efficiency and possibly the safety of medical care because of the distractions they may present, there are several other concerns facing physicians in the future, as outlined in a recent communication from the Pennsylvania Medical Society (PAMED).⁷

In addition, we continue to struggle with issues related to medical professional negligence, maintenance of certification (MOC) and patient safety. Not in any way meaning to ignore the importance of those issues, I present here a broader view of the future of medicine and the challenges physicians face in the coming years. In other words, much of the future of medical practice is bound up with the future of the EHR as it has evolved and will continue to evolve, not just as a “record,” but as a tool that is integral to the delivery of health care, the formulation of health policy, the ongoing evaluation of physician competence⁸ and the administration of public health measures.

The security of health information technology (HIT) continues to be problematic, and an adequate solution will require radical changes to the fundamental architecture of the EHR. We continue to struggle with maintaining the security of personal health information (PHI), and particularly electronic PHI (ePHI), as well as other personal information collected and stored in connection with delivery of health care. Breaches occur with regularity, and the increasing sophistication of hacking technology signals that concerns about protecting individual privacy will continue.

The need for interoperability is closely intertwined, in that, under our current paradigm of EHR architecture, more interoperability means increased risk of security vulnerabilities.

Another growing concern is that of ransomware, and there have been a number of instances of this in the news. Basically, a hacker can inject malicious code that can prevent the legitimate user from accessing the EHR and all the information contained therein, until ransom is paid, often using Bitcoin, a so-called cryptocurrency. Ironically, one approach to preventing seizure of information for ransom may lie in application of block-chain technology (the same technology that gave rise to Bitcoin) to HIT.⁹“

A blockchain is a kind of independent, transparent, and permanent database coexisting in multiple locations and shared by a community. This is why it’s sometimes referred to as a mutual distributed ledger (MDL).”¹⁰“The block validation system ensures that nobody can tamper with the records. Rather, old transactions are preserved forever and new transactions are added to the ledger irreversibly.

Anyone on the network can check the ledger and see the same transaction history as everyone else.”¹¹ Of course, restricting access to the network by hackers remains an issue that has to be dealt with separately, as discussed above.It is way past the time to consider the EHR, not only as a repository of data, but as a tool to use that data for artificial intelligence and machine learning.

To do so requires the creation of an environment that fosters innovation. Our present paradigm of protection of intellectual property in traditional ways, i.e., patent and copyright protection, in developing the EHR is deficient. What we need is an ecosystem of end-users who (with assistance from the technology community) collaborate by contributing to the development of an EHR, with the primary motivation of making the integral tool of medical care better for them and their patients – without the profit motive.

Such a model is akin to how surgical pedagogy has developed over centuries. That means open source EHR that is licensed appropriately. The EHR can and should be tooled to enable artificial intelligence (AI) and machine learning.

That we need artificial intelligence in the EHR can be illustrated by two phenomena: First, the general medical knowledge base is expanding geometrically, and we have probably reached a point where no human being can fully process all the data that is available to her, and bring it all to the bedside; Second, the amount of data accumulated on an individual patient is, again, too much for any human being to fully absorb and process.

As an example of the latter, imagine the flood of data accumulated on an ICU patient, and how frustrating it is for the physician who must not only access all the data (a daunting task in itself), but process it so that the most appropriate medical decisions are made in a timely fashion. In both of these instances, the need for AI and machine learning is clear, or certainly will be in just a few short years. Not only can algorithms process massive amounts of data, but they also can be designed to analyze it and come up with suggestions for diagnosis and treatment, which would serve as a starting point for the physician to develop a plan of care. As the EHR “learns,” from experience, such systems be-come more and more useful.

Moreover, links between the point of care and public health entities need to be facilitated, so that AI can process the mass of data that is accumulated at millions of points of care – an essential if we are to maximize the benefits of “big data,” to detect disease outbreaks, develop health policy, and prioritize research. Underlying these goals is the need for protection of ePHI, which will likely require major modifications in EHR architecture.

As alluded to above, the best way, at least in my view, to achieve the integration of the EHR into medical practice, is to provide for a universal EHR that is inexpensive, available to all and contributed to by all – with proper governance, of course. Ideally, the governance entity would be a consortium of health care providers, payers, government and information technology and AI experts.

In any discussion about the future of health care, there is always an elephant in the room, i.e., the paradox of scientific advances to preserve life, and in turn resulting in more care and cost. It is a cycle of more treatments for disease resulting in more living time, in turn resulting in more treatment, and more incentives to develop more treatments: a kind of positive feedback loop that will result in a geometric increase in costs for the few, and quite possibly with less left over, even for basic public health and preventive services, for the unlucky many. Whatever method we settle on for payment for health care, this paradox will not go away, and we need to address it now, full on – and not continue to ignore it.

I do not believe the problem of increasing health care costs will lie solely in tinkering with payment reform, even though we need such reform. One approach to the problem of increasing health care costs employs the notion that candid and (if necessary) lengthy discussions between physician and patient (or patient surrogate) in dealing with end-of-life decisions are a sine qua non. Toward this end, the concepts of predictive analytics and predictive modeling¹² will help. If patients or their surrogates can rely on predictions about their outcomes, and balance that information with the potential suffering that may occur as a result of treatment, they will better be able to make deci-sions about care, particularly when the patient is elderly, or high-risk due to co-morbidities.

Conclusion

The current path of progress of the EHR, with its concentration on “meaningful use,” and an intellectual property regime that does not fully exploit the capacity for innovation by end-users is approaching an evolutionary dead-end. It is time to treat the EHR as what it should be: an integral part of medical care that has limitless potential for maximizing the use of information acquired in the provision of health care, and not an impediment to optimal care and a bugaboo for the physician.

References

1. Some have chosen to make a distinction between the EHR and the EMR (electronic medical record), in that the EHR refers to an individual’s health record across all institutions and the EMR as being the record of care during an episode of care, akin to the hospital chart during a hospitalization. For purposes of this paper, the terms EHR and EMR may be considered interchangeable.

2. The electronic health record, along with its medical-legal implications, actually goes back much further. See, for example, Springer, E, Automated Medical Records and the Law, Health Law Center, Pittsburgh, PA, 1971.

3. The Medical Record of the Future, BULLETIN 1995;84:511-13 (9/9/95). Scanned version available at https://dl.drop-boxusercontent.com/u/26828547/Medi-cal%20Record%20of%20the%20Future.pdf (Access 12/11/16).

4. Health Information Technology for Economic and Clinical Health Act (HITECH), 2009. “To promote the adoption and mean-ingful use of health information technology.” https://www.hhs.gov/hipaa/for-professionals/special-topics/HITECH-act-enforcement-in-terim-final-rule/ (access 12/18/16).

5. Sinsky, C, et al, Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties, Ann Int Med, September 6, 2016, Abstract available at http://annals.org/aim/article/2546704/allocation-physician-time-ambulatory-prac-tice-time-motion-study-4-specialties (access 12/18/16).

6. McCanne, D, Physicians spend two hours on EHRs and desk work for every hour of direct patient care, http://pnhp.org/blog/2016/09/07/physicians-spend-two-hours-on-ehrs-and-desk-work-for-every-hour-of-direct-patient-care/ (access 12/18/16), a comment on Note 5, above.

7. For instance, Top Ten Health Care Issues From Pennsylvania’s 2015-2016 Legislative Session, https://www.pamedsoc.org/advocate/topics/general/Legislation2016? utm_source=MagnetMail&utm_medi-um=email&utm_term=Wilder&utm_cam-paign=Dose%20-%2012%2F8%2F16 (Access 12/18/16).

8. I suggest here that tools can be developed to assess physician competence in nearly real time, quite possibly obviating, or significantly reducing the time and expense requirements of, or the need of, independent testing for licensure renewal and maintenance of certification (MOC).

9. A Case Study for Blockchain in Health-care: “MedRec” prototype for electronic health records and medical research data [a white paper], Ekblaw A, et al, August 2016, https://www.healthit.gov/sites/default/files/5-56-onc_blockchainchallenge_mitwhitepaper.pdf (access 11/8/16).

10. What is a blockchain, and why is it growing in popularity, http://arstechnica.com/information-technology/2016/11/what-is-blockchain/ (access 12-11/16).11. Id.12. What is Predictive Modeling?, http://www.predictiveanalyticstoday.com/predic-tive-modeling/ (access 12/18/16).

Attribution: The Medical Record of the Future: Part II was authored by Dr. Bruce Wilder and published in the January 2017 issue of The Bulletin of the Allegheny County Medical Society. It is reprinted by Open Health News with permission.