William A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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Once again, we are assured that ONC wants to reduce the burdens they helped create. This time we learn of these desires (as mandated by the 21st Century Cures Act) in the draft “Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs” . This document is 74 pages with a healthy 132 references. It is open to public comment through January 28, 2019.
The strategy identifies several different areas for burden reduction, including:
- reducing the effort and time required to record information in EHRs for health care providers during care delivery,
- improving more generally the functionality and intuitiveness (ease of use) of EHRs, and
- reducing the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations.
A separate burden area identified is EHR certification, an ONC creation, which has now had three iterations. Note that items 1 and 2 relate to the actual use of the EHR while item 3 is regulatory burden. This is an interesting split in that the EHR portions relate to design issues in the EHR itself, although these are in part influenced by regulatory requirements. As the draft succinctly puts it “A disconnect exists between real-world clinical workflows and the design of health IT systems.” Design has been previously recognized as a major EHR problem through feedback from clinical users that have repeatedly reported that the products are too difficult to use, and that these difficulties not only demand excessive time to overcome, but also create dangers associated with data that is too hard to enter and too hard to access, even if it is actually there. These complaints, often associated with clinician sentiment that they hate their EHR, go beyond learning curve issues and they reflect attributes of products that would fail in the market place if their use wasn’t mandatory. The principle of the right data, easily entered, and retrieved in the right place, at the right time, and with the right presentation still alludes us. Note that such usability problems can be the difference between something that could possibly have been done and the likelihood that it would be done correctly by real users in the real environment of use. This invites a blame the user approach to EHR mishaps. Among many issues that are briefly addressed in the usability discussion is “copy-and-paste”. Here it is given a positive perspective as a time saver even though elsewhere copy-and-paste has been given a negative spin with regard to it representing a lack of diligence. As with so many things the answer is that properly used copy-and-paste is good, while bad copy-and-paste practices are bad.
The reporting burden arises from the classic regulatory challenge. How much reporting of what information is necessary for the government to achieve programmatic goals? Answering this question assumes that those goals have been clearly articulated and presumably of value, along with due consideration of how the reporting requirements can actually be used to measure progress against those goals. Meaningful Use (now Promoting Interoperability) is the type of program that has generated significant reporting requirements with “surrogate endpoints”. In this context a surrogate endpoint is something that can be measured but which isn’t what you really want to know. As I have noted previously a reduction in burden implies that the previous burden level was too high with respect to assuring program goals. On the other hand, the minimum reporting burden is none, but this is rarely if ever the level chosen, and it might not be appropriate. This perspective is not one of pure anti-regulation, but rather it is a concern for effective regulation against clear objectives.
Many times, the usability burden and the regulatory burden intersect. For example, a priority in reducing the burden of clinical documentation is identified as “Reduce regulatory burden around documentation requirements for patient visits”, ie we created this burden and now we are going to lower it.
The report concludes with four areas of recommendations containing 12 strategies and 42 recommendations. One characteristic of many of these recommendations is a lack of clarity on who it is that is going to be implementing them, and what are the incentives for their creation and adoption. There are many soft words in this regard such as consider, explore, continue, simplify, reduce, optimize, promote, coordinate, incentivize, partner, and harmonize. Good words all, but light on specific action items, and specific doers.
But lest we despair at burdens crated and then possibly relieved, we are assured by the National Coordinator for Healthcare Technology that “We are on the verge of realizing the incredible potential of health IT to interact with clinical care in a radically different way than what we have seen thus far.” But is radically different the same as radically better?