In their continuous efforts to improve health care, both the public and
private sectors have invested—and continue to invest—heavily in health
information technologies, collectively referred to as health IT. When designed
and used appropriately, health IT is expected to help improve the performance of
health professionals, reduce operational and administrative costs, and enhance
patient safety.
However, some products have begun being associated with increased safety
risks for patients. The Office of the National Coordinator for Health
Information Technology (ONC), the unit within the Department of Health and Human
Services (HHS) that is responsible for coordinating the development of a
national health IT infrastructure and promoting the use of health IT, asked the
Institute of Medicine (IOM) to evaluate safety concerns and to identify actions
that both government and the private sector can take to alleviate those actions.
The IOM appointed a study committee, which interpreted its charge as
recommending ways to make patient care safer using health IT so that the nation
will be in a better position to realize its potential benefits.
Critical Knowledge Gaps and Barriers
In its report, Health IT and Patient Safety: Building Safer Systems for
Better Care, the committee examines the safety of health IT products and
their effects on patient safety. Overall, the committee finds the literature
about health IT and patient safety to be inconclusive. Some health IT
applications are definitively successful at improving medication safety. For
example, the number of patients who receive the correct medication in hospitals
increases when these hospitals implement well-planned, robust computerized
prescribing mechanisms and use barcoding systems. But even in these instances,
the ability to generalize the results across the health care system may be
limited. For other products— including electronic health records, which are
being employed with more and more frequency— some studies find improvements in
patient safety, while other studies find no effect.
More worrisome, some case reports suggest that poorly designed health IT can
create new hazards in the already complex delivery of care. Although the
magnitude of the risk associated with health IT is not known, some examples
illustrate the concerns. Dosing errors, failure to detect life-threatening
illnesses, and delaying treatment due to poor human–computer interactions or
loss of data have led to serious injury and death.
Fostering a Systems Approach
In looking for ways to make health IT–assisted care safer, it is important to
recognize that the products are not used in isolation. Rather, they are part of
a larger sociotechnical system that also includes people—such as clinicians or
patients— organizations, processes, and the external environment. Safety emerges
from the interactions of these factors. Comprehensive safety analyses,
therefore, should not look for a single “root cause” of problems but should
consider the system as a whole in looking for ways to reduce the likelihood that
any given patient will experience an adverse health event.
Creating safer systems begins with usercentered design principles and
includes adequate testing and quality assurance assessments conducted in actual
or simulated clinical environments, or both. Designers and users of health IT
should work together to develop, implement, optimize, and maintain health IT
products. For most end users, an effective health IT product will provide easy
retrieval of accurate, timely, and reliable data; incorporate simple and
intuitive data displays; and yield evidence at the point of care to inform
decisions. Among other improvements, the product will
enhance workflow, perhaps by automating
mundane tasks or streamlining work, without increasing physical or cognitive
workloads;
allow easy transfer of information to and from other organizations and
providers; and
cause no unanticipated downtime.
Promoting Sharing of Safety Data
While the private sector, including health IT vendors, users, patients, and
professional societies, must play a major role in improving safety, the
government can help in various ways. As one step, HHS should ensure that vendors
support users in freely exchanging information about health IT experiences and
issues, including details relating to patient safety. The ability to generate,
develop, and share details of safety risks is essential to a properly
functioning market in which health care providers have the ability to choose
products that best suit their needs. Currently, many contracts with vendors
include clauses that could impede efforts to improve patient safety. For
example, nondisclosure clauses can discourage users from sharing information,
and limited liability clauses can essentially shift liability from the vendor to
the users when an adverse event occurs.
The ONC also should work with the private sector to make comparative user
experiences publicly available. In other industries, public product reviews
allow users to rate their experiences with products and share lessons learned. A
consumer guide for health IT safety could help identify safety concerns,
increasing system transparency.
Improving Standards, Measures, and Criteria for Safe Use
HHS also should take steps to help improve information gathering and
analysis. This includes promoting the development of new measures for reliably
assessing the current state of health IT safety and monitoring for improvements.
Currently, no entity is developing such measures. To lead, HHS should fund a new
Health IT Safety Council, within an existing voluntary consensus standards
organization, that would evaluate criteria for judging the safe use of health IT
and the use of health IT to enhance safety.
Promoting Transparency and Accountability
In addition, HHS should establish a mechanism for both vendors and users to
report health IT– related deaths, serious injuries, or unsafe conditions. This
effort would supplement current private-sector efforts and help quantify patient
safety risks. Reporting should be mandatory for vendors, while reporting by
users should be voluntary, confidential, and nonpunitive. Strategies also should
be developed to encourage reporting; such efforts might include removing any
perceptual, contractual, legal, and logistical barriers to reporting.
While improving reporting of patient safety incidents is critical, it is only
one part of a larger solution to maximize the safety of health IT– assisted
care. Another part is ensuring the ability to learn from and act on this
information. To this end, HHS should recommend that Congress establish an
independent federal entity—similar to the National Transportation Safety
Board—that would perform the needed analytic and investigative functions in a
transparent, nonpunitive manner. The entity would make nonbinding
recommendations to the Secretary of HHS, providing flexibility and allowing HHS,
health care organizations, vendors, and external experts to collectively
determine the best course forward.
These and other recommendations would comprise the first stage for action,
greatly advancing current understanding of the threats to patient safety.
However, because the private sector has not taken substantive action on its own,
the committee further recommends that HHS monitor and publicly report on the
progress of health IT safety annually, beginning in 2012. If progress is not
sufficient, HHS should direct the Food and Drug Administration (FDA) to exercise
its authority to regulate health IT. To be effective, the FDA will need to
commit sufficient resources and add capacity and expertise to carry this
out.
Conclusion
To achieve better health care, a robust infrastructure that supports
learning and improving the safety of health IT is essential. Proactive steps
must be taken to ensure that health IT is developed and implemented with safety
as a primary focus. If appropriately implemented, health IT can help improve
health care providers’ performance, better communication between patients and
providers, and enhance patient safety, which ultimately may lead to better care
for Americans.
, called upon developers to create a web-based application that could empower patients and caregivers to better navigate and manage a transition from a hospital.
