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Summary
The Institute of Medicine (IOM) report To Err Is Human estimated
that 44,000-98,000 lives are lost every year due to medical errors in hos-
pitals and led to the widespread recognition that health care is not safe
enough, catalyzing a revolution to improve the quality of care.1 Despite
considerable effort, patient safety has not yet improved to the degree hoped
for in the IOM report Crossing the Quality Chasm. One strategy the nation
has turned to for safer, more effective care is the widespread use of health
information technologies (health IT).2 The U.S. government is investing
billions of dollars toward meaningful use of effective health IT so all Ameri-
cans can benefit from the use of electronic health records (EHRs) by 2014.
Health IT is playing an ever-larger role in the care of patients, and
some components of health IT have significantly improved the quality of
health care and reduced medical errors. Continuing to use paper records
can place patients at unnecessary risk for harm and substantially constrain
the country’s ability to reform health care. However, concerns about harm
from the use of health IT have emerged. To protect America’s health,
health IT must be designed and used in ways that maximize patient safety
while minimizing harm. Information technology can better help patients if
it becomes more usable, more interoperable, and easier to implement and
1 The IOM identified six aims of quality improvement, stating that health care should be
safe, effective, patient-centered, timely, efficient, and equitable.
2 Health IT can also be referred to as health information systems and health information
and communications technology, among others. This report employs the term health IT but
recognizes that these other, broader terms are also used.
1
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2 HEALTH IT AND PATIENT SAFETY
maintain. This report explains the potential benefits and risks of health IT
and asks for greater transparency, accountability, and reporting.
In this report, health IT includes a broad range of products, including
EHRs,3 patient engagement tools (e.g., personal health records [PHRs] and
secure patient portals), and health information exchanges; excluded is soft-
ware for medical devices. Clinicians expect health IT to support delivery of
high-quality care in several ways, including storing comprehensive health
data, providing clinical decision support, facilitating communication, and
reducing medical errors. Health IT is not a single product; it encompasses
a technical system of computers and software that operates in the context
of a larger sociotechnical system—a collection of hardware and software
working in concert within an organization that includes people, processes,
and technology.
It is widely believed that health IT, when designed, implemented, and
used appropriately, can be a positive enabler to transform the way care is
delivered. Designed and applied inappropriately, health IT can add an addi-
tional layer of complexity to the already complex delivery of health care,
which can lead to unintended adverse consequences, for example dosing
errors, failure to detect fatal illnesses, and delayed treatment due to poor
human–computer interactions or loss of data.
In recognition of the rapid adoption of health IT, the Office of the
National Coordinator for Health Information Technology (ONC) asked
the IOM to establish a committee to explore how private and public
actors can maximize the safety of health IT–assisted care. The committee
interpreted its charge as making health IT–assisted care safer so the nation
is in a better position to realize the potential benefits of health IT.
EVALUATING THE CURRENT STATE OF
PATIENT SAFETY AND HEALTH IT
The expectations for safer care may be higher in a health IT–enabled
environment as compared to a paper-based environment because the oppor-
tunity to improve patient care is much greater. The evidence in the literature
about the impact of health IT on patient safety, as opposed to quality, is
mixed but shows that the challenges facing safer health care and safer use
of health IT involve the people and clinical implementation as much as the
technology. The literature describes significant improvements in some as-
pects of care in health care institutions with mature health IT. For example,
the use of computerized prescribing and bar-coding systems has been shown
3 “Electronic health records” is used as the desired term because it is more inclusive
of the way electronic records are being used currently than “electronic medical records.”
EHRs include clinical decision support tools, computerized provider order entry systems, and
e-prescribing systems.
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3
SUMMARY
to improve medication safety. But the generalizability of the literature
across the health care system may be limited. While some studies suggest
improvements in patient safety can be made, others have found no effect.
Instances of health IT–associated harm have been reported. However, little
published evidence could be found quantifying the magnitude of the risk.
Several reasons health IT–related safety data are lacking include the
absence of measures and a central repository (or linkages among decen-
tralized repositories) to collect, analyze, and act on information related to
safety of this technology. Another impediment to gathering safety data is
contractual barriers (e.g., nondisclosure, confidentiality clauses) that can
prevent users from sharing information about health IT–related adverse
events. These barriers limit users’ abilities to share knowledge of risk-prone
user interfaces, for instance through screenshots and descriptions of poten-
tially unsafe processes. In addition, some vendors include language in their
sales contracts and escape responsibility for errors or defects in their soft-
ware (i.e., “hold-harmless clauses”). The committee believes these types of
contractual restrictions limit transparency, which significantly contributes
to the gaps in knowledge of health IT–related patient safety risks. These
barriers to generating evidence pose unacceptable risks to safety.
EXAMINING THE CURRENT STATE OF
THE ART IN SYSTEM SAFETY
Software-related safety issues are often ascribed to software coding
errors or human errors in using the software. It is rarely that simple. Many
problems with health IT relate to usability, implementation, and how soft-
ware fits with clinical workflow. Focusing on coding or human errors often
leads to neglect of other factors (e.g., usability, workflow, interoperability)
that may increase the likelihood a patient safety event will occur. Further-
more, software—such as an EHR—is neither safe nor unsafe because safety
of health IT cannot exist in isolation from its context of use. Safety is an
emergent property of a larger system that takes into account not just the
software but also how it is used by clinicians.
The larger system—often called a sociotechnical system—includes tech-
nology (e.g., software, hardware), people (e.g., clinicians, patients), pro-
cesses (e.g., workflow), organization (e.g., capacity, decisions about how
health IT is applied, incentives), and the external environment (e.g., regula-
tions, public opinion). Adopting a sociotechnical perspective acknowledges
that safety emerges from the interaction among various factors. Compre-
hensive safety analyses consider these factors taken as a whole and how
they affect each other in an attempt to reduce the likelihood of an adverse
event, rather than focusing on eliminating one “root cause” and ignoring
other possible contributing factors.
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4 HEALTH IT AND PATIENT SAFETY
OPPORTUNITIES TO BUILD SAFER SYSTEMS FOR HEALTH IT
Merely installing health IT in health care organizations will not result
in improved care. Together, the design, implementation, and use of health
IT affect its safe performance. Safer implementation and use of health IT is
a complex, dynamic process that requires a shared responsibility between
vendors and health care organizations.
Features of Safer Health IT
Safely functioning health IT should provide easy entry and retrieval of
data, have simple and intuitive displays, and allow data to be easily trans-
ferred among health professionals. Many features of software contribute to
its safe use, including usability and interoperability. Although definitive evi-
dence is hard to produce, the committee believes poor user-interface design,
poor workflow, and complex data interfaces are threats to patient safety.
Similarly, lack of system interoperability is a barrier to improving clini-
cal decisions and patient safety, as it can limit data available for clinical
decision making. Laboratory data have been relatively easy to exchange
because good standards exist such as Logical Observation Identifiers Names
and Codes (LOINC) and are widely accepted. However, important informa-
tion such as problem lists and medication lists are not easily transmitted and
understood by the receiving health IT product because existing standards
have not been uniformly adopted. Interoperability must extend throughout
the continuum of care; standards need to be developed and implemented to
support interaction between health IT products that contain disparate data.
Opportunities to Improve the Design and Development of Technologies
Application of quality management practices needs to be a high priority
for design and development activities. Creating safer systems begins with
user-centered design principles and continues with adequate testing and
quality assessments conducted in actual and/or simulated clinical environ-
ments. Vendors should not only create useful functions in their software
but also understand how user-interface design affects the clinical setting
and workflow where the applications are to be used, as well as support for
activities within a health professional’s scope of practice.
Opportunities to Improve Safety in the Use of Health IT
Safety considerations need to be embedded throughout the implementa-
tion process, including the stages of planning and goal setting, deployment,
stabilization, optimization, and transformation. Selecting the right software
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SUMMARY
requires a comprehensive understanding of the data and information needs
of the organization and the capabilities of the system. Vendors take primary
responsibility for the design and development of technologies, ideally with
iterative feedback from users. Users assume responsibility for safe imple-
mentation and work with vendors throughout the health IT implementation
process. The partnership to develop, implement, and optimize systems is a
shared responsibility where vendors and users help each other achieve the
safest possible applications of health IT.
It is important to recognize that health IT products generally cannot
be installed out of the box. Users need to customize products judiciously
to appropriately match their needs and capabilities—in both functional-
ity and complexity of operation. The process of implementing software is
critical to optimizing value and mitigating patient safety risks. A constant,
ongoing commitment to safety—from acquisition to implementation and
maintenance—is needed to achieve safer, more effective care. Testing at
each of these stages is needed to ensure successful use of health IT.
Responsible use requires diligent surveillance for evolving needs, gaps,
performance issues, and mismatches between user needs and system per-
formance, unsafe conditions, and adverse events. The committee believes
certain actions are required by private and public entities to monitor safety
in order to protect the public’s health and provides the following recom-
mendations to improve health IT safety nationwide—optimizing their use to
achieve national health goals, while reducing the risks of their use resulting
in inadvertent harm.
Recommendation 1: The Secretary of Health and Human Services
(HHS) should publish an action and surveillance plan within 12 months
that includes a schedule for working with the private sector to assess
the impact of health IT on patient safety and minimizing the risk of its
implementation and use. The plan should specify:
a. The Agency for Healthcare Research and Quality (AHRQ)
and the National Library of Medicine (NLM) should ex-
pand their funding of research, training, and education of
safe practices as appropriate, including measures specifically
related to the design, implementation, usability, and safe use
of health IT by all users, including patients.
b. The Office of the National Coordinator for Health
Information Technology should expand its funding of pro-
cesses that promote safety that should be followed in the
development of health IT products, including standardized
testing procedures to be used by manufacturers and health
care organizations to assess the safety of health IT products.
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6 HEALTH IT AND PATIENT SAFETY
c. The ONC and AHRQ should work with health IT vendors
and health care organizations to promote postdeployment
safety testing of EHRs for high-prevalence, high-impact
EHR-related patient safety risks.
d. Health care accrediting organizations should adopt criteria
relating to EHR safety.
e. AHRQ should fund the development of new methods for
measuring the impact of health IT on safety using data from
EHRs.
PATIENTS’ AND FAMILIES’ USE OF HEALTH
IT: CONCERNS ABOUT SAFETY
Health IT products are also being developed to engage and support
patients and their families in decision making and management of their own
personal health information. Examples of electronic patient engagement
tools include PHRs (both integrated and freestanding), mobile applications,
and tools for assessing day-to-day health status (e.g., weight loss), and
continue to evolve rapidly. The increasing use of health IT by consumers,
patients, and families creates an urgent need for the development and sup-
port of a research agenda for these tools.
A SHARED RESPONSIBILITY FOR
IMPROVING HEALTH IT SAFETY
Health IT safety is contingent on how the technology is designed,
implemented, used, and fits into clinical workflow, requiring the coopera-
tion of both vendors and users. In the absence of a single accountable party,
policy makers need to act on behalf of the public good to promote and
monitor health IT safety. The committee believes this is best accomplished
through collaboration between the private and public sectors.
The private sector must play a major role in making health IT safer,
but it will need support from and close collaboration with the public sector.
Currently, there is no systematic regulation or sense of shared accountability
for product functioning, liability is shifted primarily onto users, and there is
no way to publicly track adverse outcomes. Therefore, when instances that
either cause or could result in harm occur, there is no authority to collect,
analyze, and disseminate learning. Lack of sufficient vendor action to build
safer products, or regulatory requirements to do so, threatens patient safety.
Access to details of patient safety risks is essential to a properly functioning
market where users identify the product that best suits their needs. Users need
to share information about risks and adverse events with other users and ven-
dors. Legal clauses shifting liability from vendors to users discourage sharing.
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7
SUMMARY
Recommendation 2: The Secretary of HHS should ensure insofar as
possible that health IT vendors support the free exchange of informa-
tion about health IT experiences and issues and not prohibit sharing
of such information, including details (e.g., screenshots) relating to
patient safety.
Once information about patient safety risks is available, comparative
user experiences can be shared. Currently, users cannot communicate effec-
tively their experiences with health IT. In other industries, product reviews
are available where users can rate their experiences with products and share
lessons learned. A consumer guide for health IT safety could help identify
safety concerns, increasing system transparency.
To gather objective information about health IT products, researchers
should have access to both test versions of software provided by vendors
and software already integrated in user organizations. Users should be able
to compare and share their experiences and other measures of safety from
health IT products.
Recommendation 3: The ONC should work with the private and public
sectors to make comparative user experiences across vendors publicly
available.
Another area necessary for making health IT safer is the development
of measures. Inasmuch as the committee’s charge is to recommend policies
and practices that lead to safer use of health IT, the nation needs reliable
means of assessing the current state and monitoring for improvement.
Currently, no entity is developing such measures; Recommendation 1 is for
AHRQ, the NLM, and the ONC to fund development of these measures.
The lack of measures and diversity of involved parties suggests a coordinat-
ing body is needed to oversee the development, application, and evaluation
of measures of safety of health IT use. Best practices will need to ensure
health IT is developed and implemented with safety as a priority.
Recommendation 4: The Secretary of HHS should fund a new Health
IT Safety Council to evaluate criteria for assessing and monitoring the
safe use of health IT and the use of health IT to enhance safety. This
council should operate within an existing voluntary consensus stan-
dards organization.
This function could be housed within existing organizations, such as the
National Quality Forum.
Because threats to health IT safety can arise before, during, and after
implementation, it is also useful to design methods to monitor health IT
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8 HEALTH IT AND PATIENT SAFETY
safety. Standards development organizations such as the American National
Standards Institute and the Association for the Advancement of Medical
Instrumentation could seek input from a broad group of stakeholders
when developing these standards, criteria, and tests. Additionally, vendor
attestation that they have addressed specific safety issues in the design and
development of their products can be important. Best practices for acquisi-
tion and implementation of health IT need to be developed. Development of
postimplementation tests would help users monitor whether their systems
meet certain safety benchmarks. Applying these tests is also a way for users
to work with vendors to ensure that products have been installed correctly;
accreditation organizations, such as The Joint Commission, could require
conduct of these safety tests as part of their accreditation criteria.
Finally, the committee found successful adoption of change requires
education and training of the workforce. Basic levels of competence, knowl-
edge, and skill are needed to navigate the highly complex implementation of
health IT. Because health IT exists at the intersection of multiple disciplines,
a variety of professionals will need training in a number of established dis-
ciplines such as health systems, IT, and clinical care.
The Role of the Public Sector: Strategic Guidance and Oversight
A shared learning environment should be fostered to the fullest extent
possible by the private sector, but, in some instances, the government needs
to provide guidance and direction to private-sector efforts and to correct
misaligned market forces. An appropriate balance must be reached between
government oversight and market innovation. To encourage innovation and
shared learning environments, the committee adopted the following general
principles for government oversight:
• Focus on shared learning,
• Maximize transparency,
• Be nonpunitive,
• Identify appropriate levels of accountability, and
• Minimize burden.
The committee believes HHS should take the following actions to improve
health IT safety.
First, to improve transparency and safety, it is necessary to identify the
products being used and to whom any actions need to be directed. Having
a mechanism to accomplish this is important so that when new knowledge
about safety or performance arises, other users and products that could also
be vulnerable can be identified. The ONC employed a similar mechanism
for EHR vendors to list their products in implementing the meaningful use
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9
SUMMARY
program. The committee supports continuation of the ONC’s efforts to list
all products certified for meaningful use in a single database as a first step
for ensuring safety.
Recommendation 5: All health IT vendors should be required to pub-
licly register and list their products with the ONC, initially beginning
with EHRs certified for the meaningful use program.
Second, by establishing quality management principles and processes
in health IT, vendors can improve the safety of their product lines. Experi-
ences from other industries suggest the best approach to proactively creat-
ing highly reliable products is not to certify each individual product but to
make sure organizations have adopted quality management principles and
processes in the design and development of products.
While many vendors already have some types of quality management
principles and processes in place, not all vendors do and to what standard
they are held is unknown. An industry standard is needed to ensure com-
prehensive industry adoption. To this end, the committee believes adoption
of quality management principles and processes should be mandatory for
all health IT vendors. The ONC, Food and Drug Administration (FDA),
and health IT certification bodies are examples of organizations that could
potentially administer this function.
Recommendation 6: The Secretary of HHS should specify the quality
and risk management process requirements that health IT vendors
must adopt, with a particular focus on human factors, safety culture,
and usability.
Third, to quantify patient safety risks, reports of adverse events need to
be collected, supplementing private-sector efforts. High-priority health IT–
related adverse events include death, serious injury, and unsafe conditions.
Analyses of unsafe conditions would produce important information that
could have a great impact on improving patient safety and enable adoption
of corrective actions that could prevent death or serious injury.
Regular reporting of adverse events is widely used to identify and
rectify vulnerabilities that threaten safety for the purposes of learning.
However, learning about safety of health IT is limited because there are
currently no comprehensive analyses available about health IT–related
adverse events, no consequences for failing to discover and report evidence
about harm, and no aggregation of data for learning. In other countries and
industries, reporting systems all differ with respect to their design, but the
majority employ reporting that is voluntary, confidential, and nonpunitive.
Creating a nonpunitive environment is essential for the success of voluntary
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10 HEALTH IT AND PATIENT SAFETY
reporting systems. Reports must be collected for the purpose of learning
and should not be used to address accountability.
The committee believes reports of health IT–related adverse events and
unsafe conditions that are verified and free of user-identifying information
should be transparently available to the public. The committee believes
reporting of deaths, serious injuries, or unsafe conditions should be man-
datory for vendors. Direction will need to come from a federal entity with
adequate expertise, capacity, and authority to act on reports of health
IT–related adverse events. The Secretary of HHS should designate an entity
and provide it with the necessary resources to do so.
Current user reporting efforts are generally not coordinated with one
another and not collected in a systematic manner; a more streamlined
reporting system is needed. AHRQ has developed a common format that
precisely defines the components of a field report for health IT–related
adverse events or risks. Reports by users should remain voluntary and the
identities of reporters should not be discoverable under any circumstance.
Patient Safety Organizations are examples of entities that can protect this
information from discovery. User-reported health IT–related adverse events
should be collected by a central repository and also be sent to the appropri-
ate vendor.
Recommendation 7: The Secretary of HHS should establish a mecha-
nism for both vendors and users to report health IT–related deaths,
serious injuries, or unsafe conditions.
a. Reporting of health IT–related adverse events should be
mandatory for vendors.
b. Reporting of health IT–related adverse events by users should
be voluntary, confidential, and nonpunitive.
c. Efforts to encourage reporting should be developed, such
as removing the perceptual, cultural, contractual, legal, and
logistical barriers to reporting.
However, reports of patient safety incidents are only one part of a
larger solution to maximize the safety of health IT–assisted care. The power
to improve safety lies not just with reporting requirements, but with the
ability to act on and learn from reports. To this end, two distinct functions
are also needed: (1) aggregating and analyzing reports and (2) investigat-
ing the circumstances associated with safety incidents to determine the
conditions that contribute to those incidents. Through these processes,
lessons learned can be developed so similar incidents will be less likely to
occur in the future. To maximize the effectiveness of reports, the collection,
aggregation and analysis, and investigation of reports should be coupled as
closely as possible.
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SUMMARY
Ideally, all reports of health IT–related adverse events would be aggre-
gated and analyzed by a single entity that would identify reports for im-
mediate investigation. Reports to this entity have to include identifiable
data to allow investigators to follow up in the event the reported incident
requires investigation. The entity would investigate two categories of
reports: (1) reports that result in death or serious injury and (2) reports
of unsafe conditions. Prioritization among the reports should be deter-
mined on a risk-based hazard analysis. In keeping with the principle of
transparency, reports and results of investigations should be made public.
A feedback loop from the investigatory entity back to both vendors and
users is essential to allow groups to rectify systemic issues found that
introduce risk.
The committee considered a number of potential organizations that
could objectively analyze reports of unsafe conditions, as well as conduct
investigations into health IT–related adverse events in the way the com-
mittee envisions, including FDA, the ONC, AHRQ, and the private sector.
The committee concluded that investigating patient safety incidents does
not match the internal expertise of any existing entity, as the needed func-
tions are under the jurisdiction of multiple federal agencies and efforts are
generally uncoordinated and not comprehensive.
The committee believes development of an independent, federal entity
could perform the needed analytic and investigative functions in a transpar-
ent, nonpunitive manner. It would be similar in structure to the National
Transportation Safety Board, an independent federal agency created by
Congress to conduct safety investigations. The entity would make non-
binding recommendations to the Secretary of HHS. Nonbinding recommen-
dations provide flexibility, allowing the Secretary, health care organizations,
vendors, and external experts to collectively determine the best course
forward. Because current federal agencies do not have this as their charge,
nor the baseline funding to take on these activities, the committee believes
an independent, federal entity is the best option to provide a platform to
support shared learning at a national level.
Recommendation 8: The Secretary of HHS should recommend that
Congress establish an independent federal entity for investigating
patient safety deaths, serious injuries, or potentially unsafe conditions
associated with health IT. This entity should also monitor and analyze
data and publicly report results of these activities.
When combined, removing contractual restrictions, promoting public
reporting, and having a system in place for independent investigations can
be a powerful force for improving patient safety.
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12 HEALTH IT AND PATIENT SAFETY
Next Steps
Achieving transparency and safer health IT products and safer use of
health IT will require the cooperation of all stakeholders. Without more
information about the magnitude and types of harm, other mechanisms will
be necessary to motivate the market to correct itself. The committee offers
a two-stage approach, with its recommended actions as the first stage to
provide a better understanding of the threats to patient safety.
The current state of safety and health IT is not acceptable; specific ac-
tions are required to improve the safety of health IT. The first eight recom-
mendations are intended to create conditions and incentives to encourage
substantial industry-driven change without formal regulation. However,
because the private sector to date has not taken sufficient action on its
own, the committee believes a follow-up recommendation is needed to
formally regulate health IT.4 If the actions recommended to the private and
public sectors are not effective as determined by the Secretary of HHS, the
Secretary should direct FDA to exercise all authorities to regulate health IT.
The committee was of mixed opinion on how FDA regulation would
impact the pace of innovation by industry but identified several areas of
concern regarding immediate FDA regulation. The current FDA framework
is oriented toward conventional, out-of-the-box, turnkey devices. However,
health IT has multiple different characteristics, suggesting that a more
flexible regulatory framework will be needed in this area to achieve the
goals of product quality and safety without unduly constraining market
innovation. For example, as a software-based product, health IT has a
product life cycle very different from that of conventional technologies.
These products exhibit great diversity in features, functions, and scope of
intended and actual use, which tend to evolve over the life of the product.
Taking a phased, risk-based approach can help address this concern. FDA
has chosen to not exercise regulatory authority over EHRs, and contro-
versy exists over whether some health IT products such as EHRs should be
considered medical devices. If the Secretary deems it necessary for FDA to
regulate EHRs and other currently nonregulated health IT products, clear
determinations will need to be made about whether all health IT products
classify as medical devices for the purposes of regulation. If FDA regulation
is deemed necessary, FDA will need to commit sufficient resources and add
capacity and expertise to be effective.
The Secretary should report annually to Congress and the public on the
progress of efforts to improve the safety of health IT, beginning 12 months
from the release of this report. In these reports, the Secretary should make
4 One member disagrees with the committee and would immediately regulate health IT as
a Class III medical device, as outlined in Appendix E.
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13
SUMMARY
clear the reasons why further oversight actions are or are not needed.
In parallel, the Secretary should ask FDA to begin planning the frame-
work needed for potential regulation consistent with Recommendations 1
through 8 so that, if she deems FDA regulation to be necessary, the agency
will be ready to act, allowing for the protection of patient safety without
further delay. The committee recognizes that not all of its recommendations
can be acted on by the Secretary alone and that some will require congres-
sional action.
Recommendation 9a: The Secretary of HHS should monitor and publicly
report on the progress of health IT safety annually beginning in 2012. If
progress toward safety and reliability is not sufficient as determined by
the Secretary, the Secretary should direct FDA to exercise all available
authorities to regulate EHRs, health information exchanges, and PHRs.
Recommendation 9b: The Secretary should immediately direct FDA
to begin developing the necessary framework for regulation. Such a
framework should be in place if and when the Secretary decides the
state of health IT safety requires FDA regulation as stipulated in Rec-
ommendation 9a above.
FUTURE RESEARCH FOR CARE TRANSFORMATION
The committee identified a number of research gaps during its infor-
mation gathering. Research is needed to continue to build the evidence to
determine how to develop and adopt safer health IT most effectively. A
greater body of conclusive research is needed to fully meet the potential of
health IT for ensuring patient safety.
Recommendation 10: HHS, in collaboration with other research groups,
should support cross-disciplinary research toward the use of health IT
as part of a learning health care system. Products of this research should
be used to inform the design, testing, and use of health IT. Specific areas
of research include
a. User-centered design and human factors applied to health
IT,
b. Safe implementation and use of health IT by all users,
c. Sociotechnical systems associated with health IT, and
d. Impact of policy decisions on health IT use in clinical practice.
Creating an infrastructure that supports learning about and improving
the safety of health IT is needed to achieve better health care. Proactive
steps must be taken to ensure that health IT is developed and implemented
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14 HEALTH IT AND PATIENT SAFETY
with safety as a primary focus through the development of industry-wide
measures, standards, and criteria for safety. Surveillance mechanisms are
needed to identify, capture, and investigate adverse events to continually
improve the safety of health IT. Transparency and cooperation between the
private and public sectors are critical to creating the necessary infrastruc-
ture to build safer systems that will lead to better care for all Americans.