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On Health IT and Patient Safety: Protecting Patients Through Innovation

by Dan Haley, SVP and General Counsel

"The proper steps to improve the safety of health IT can only be taken if there is better information regarding health IT’s risks, harms, and impact on patient safety."

So reads the first sentence of the "Learn" section of the Health Information Technology Patient Safety Action & Surveillance Plan, which was released for public comment by the Office of the National Coordinator for Health Information Technology (ONC) in December 2012.

athenahealth recently submitted our comments on the ONC Plan, focusing on two core themes: (1) emphatic agreement with the statement above, emphasizing the pressing need for “better information” before moving to implement a regulatory scheme that could, if not based on credible data, potentially exacerbate problems it intends to fix; and (2) the importance of recognizing that any regulation of Health Information Technology (HIT) must be "risk-based," protecting patients while fostering innovation and avoiding unnecessary regulatory duplication.

Three core convictions underlie our comments:
1. Proper use of well-designed HIT enhances overall patient safety.
2. Regardless of the magnitude of risk to patient safety associated with HIT, all industry stakeholders should be united behind the proposition that improvement is always a goal to be aggressively pursued everywhere when it comes to patient safety.
3. Continued innovation is crucial to realizing HIT’s potential to improve patient safety (or, put another way, a regulatory scheme that stifles innovation will ultimately harm patients).

"The proper steps to improve the safety of health IT can only be taken if there is better information…"

Two things are true about the currently available data on HIT and patient safety. First, the available data is limited, largely gathered while providers’ adoption of HIT was still building. And second, the existing data strongly suggests that the risk to patients posed by HIT is quite low.

According to Institutes of Medicine (IOM), as cited in the ONC Plan, "a review of seven papers using large databases of reported errors found that health information systems were involved in less than 1 (one) percent of reported errors." The Plan also references a more recent advisory notice by the Pennsylvania Patient Safety Authority, which "found that only 3,900 of 1.7 million reports [of adverse patient safety events] were found to involve health IT." Of those, 81% "involved medication errors." In other words, the Pennsylvania PSA report underscored that HIT-related events comprise less than one percent of all adverse patient safety events.

A perfectly rational response to this might be "So what?" After all, any danger to patients specifically associated with the use of HIT is a problem that must be addressed. No argument here. I cite the current data not to argue that the problem is too small to merit a response, but to underscore the need for better data on the magnitude (and nature) of risk, to avoid implementing a regulatory scheme that inadvertently worsens the risk instead of mitigating it. If the baseline from which improvement will be measured remains unmeasured, how will we know whether a future regulatory scheme makes things better… or worse?

athenahealth enthusiastically supports the elements of the ONC Plan intended to support collection and analysis of patient safety information, with the laudable goal of a “learning system” that improves continuously, based on real data and substantive analysis. We applaud ONC for its active leadership in the effort to achieve that vision. There is much in the ONC plan to like.


The ONC Plan Needs Greater Focus on the Role of Innovation in Protecting Patients

As cloud-based innovators on the cutting edge of HIT, athenahealth appreciates that the ONC and its leadership consistently support private sector innovation. Indeed, ONC leadership often identifies empowering innovation as a core mission of the agency. Given that focus, the ONC Plan's lack of emphasis on innovation is all the more striking.

As we stated in our comments,

The ONC Plan responds directly and in great detail to a set of patient safety recommendations published in 2011 by the IOM. In contrast, the ONC Plan only passingly mentions the subsequent patient safety mandate issued by Congress in July 2012. In the FDA Safety and Innovation Act of 2012 (FDASIA) Congress instructed FDA, ONC, and FTC to collaborate within 18 months to propose a “risk-based regulatory framework” for HIT that: (1) protects patient safety, (2) fosters innovation, and (3) avoids unnecessary regulatory duplication. See Pub. L. No. 112-144 § 618, 126 Stat. 993, 1063 (2012).

Although the ONC Plan is intended only to fill the gap until the anticipated 2015 implementation of the framework mandated by Congress, in many important respects the Plan is itself a regulatory framework. It considers a certification structure, post-market surveillance, and an investigation and incident resolution process, for example. As a regulatory framework (that could very well form the foundation for a lasting structure) the Plan is subject presumably to Congress’s FDASIA instruction to foster innovation and avoid regulatory duplication while protecting patients. Our thinking: The Plan should be more explicit about those intertwined imperatives.

Again, from our comments:

Continued innovation is a necessary condition for continued improvement in patient safety… If fostering innovation and avoiding duplicative regulation are not explicit objectives of the ONC Plan, there is a risk that the central objective—continuous improvement of the safety of health IT—will be eventually undermined by insufficient attention to supporting the innovation required to power that continuous improvement.

Congress’s recognition of that danger is clearly reflected in the FDASIA. The second two prongs of the three-part mandate for a risk-based framework stand essentially as a Hippocratic Oath for would-be HIT regulators: “First, do no harm.” We strongly urge that this concept should be integrated more explicitly and fully into the ONC Plan.

The athenahealth Commitment
athenahealth is deeply committed to patient safety. We strive every day to be our clients’ most trusted service, a status we cannot hope to maintain without unflagging dedication to safety and continuous improvement. And, of course, we have first-hand interest, as we and our families are often patients ourselves.

That is why we have an athenahealth team dedicated 100% to patient safety. It is why we are actively involved in a patient safety collaboration under the auspices of the respected Bipartisan Policy Center (stay tuned for more on that soon). It is why we have committed publicly to affiliate with a Patient Safety Organization within a year.

While we strongly believe that our services significantly enhance patient safety—a belief that finds ample support in the ONC Plan—we strive always to improve that safety and recognize that, in a dynamic system, the impossibility of perfection maintains constant room for improvement.

The ONC Plan represents a good first step toward the much-needed goal of measuring the patient safety risks and benefits of HIT. Greater focus on that objective, and on the crucial need to foster innovation while mitigating risk, will ensure that the next steps taken are the "proper" ones.

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