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Electronic Health Records and the National Health
Information Infrastructure
By Paul
Smith
[Sept. 2004]
The federal government, buoyed by private initiatives, has taken
up the challenge of electronic health records. On July 21, 2004
the National Coordinator for Health Information Technology published
a Framework for Strategic Action to guide the nation toward
adoption of widespread, interoperable Electronic Health Records
(EHRs) within 10 years. This is the most ambitious goal of a
broad-based public and private initiative that is gathering
momentum. Besides the Framework:
- The federal Consolidated Health Informatics Initiative,
part of the President's E-Government Strategy, has announced
standards in 20 areas for the electronic exchange of clinical
health information to be adopted across federal government.
- The Medicare Prescription Drug, Improvement and Modernization
Act of 2003 requires the Secretary of Health and Human Services
(HHS) to adopt standards and conduct pilot projects for electronic
prescribing, and establishes a limited safe harbor under the
anti-kickback laws for hospitals and other organizations providing
information technology to physicians for e-prescribing projects.
- The final "Stark" regulations published in March,
2004, which generally prohibit referrals for Medicare-sponsored
hospital and other services among providers with mutual financial
relationships, established a new exception for relationships
arising from participation in community-wide health information
systems.
- At the request of the Department of Health and Human Services,
Health Level Seven, an ANSI-accredited standards developing
organization, has published a draft standard for a functional
model of an electronic health record system.
- The HHS Secretary has entered into an agreement with the
College of American Pathologists to make SNOMED Clinical Terms
available to U.S. users at no cost through the National Library
of Medicine's Unified Medical Language System. SNOMED-CT is
said to be the most comprehensive clinical terminology available.
A standard terminology is crucial to the development of a
unified electronic health record system.
- The Foundation for eHealth Initiative, funded by the Health
Resources and Services Administration Office for the Advancement
of Telehealth, has announced grants totaling more than $2
million for nine community health information sharing initiatives.
Implementation Challenges
Implementation of a national health information infrastructure
faces daunting obstacles - technological, financial and legal.
These begin with the individual provider's acquisition of an
electronic health record. EHR systems are expensive, and the
installation can be disruptive. While an EHR may save costs
in the long run, many practitioners are unwilling to make the
initial outlay of capital, particularly when there is no assurance
that any particular brand of EHR will meet whatever standards
are ultimately developed. And then, a large proportion of technology
implementations fail for one reason or another.
More complex issues attend the implementation of community
health records, which allow providers and health plans access
to one another's records. The promise of the EHR is not just
the facility for manipulating data in the way that computers
can, but also the ability to share and aggregate data. Giving
providers access to more complete information than they maintain
in their own records will improve their decision-making and
prevent errors, as will systems that eliminate handwriting errors
and check drug doses. Giving consumers ready access to their
own health records will help them manage their health and their
health care services. And aggregated health information will
improve public health monitoring, research and bioterror surveillance.
Issues to be explored more closely
All this requires interoperability among EHRs. There is no
settled model as of yet, but much of the discussion is about
distributed data that can be assembled on demand. This requires
standards both for data structure within EHRs and for communications
among them. There is no plan for mandatory standards like the
HIPAA standards for payment-related electronic transactions;
instead, the government will use economic incentives to foster
the private development and adoption of standard technologies.
The plan also requires financial investment, not just in standards
development but in technology acquisition. This is particularly
true for smaller providers, where expense and technological challenges
have impeded adoption of EHRs. The initiative must find ways to
compensate clinicians over the short term for the costs of this
technology.
There are also very substantial legal and ethical hurdles. Over
the forthcoming weeks, DWT will issue a series of bulletins examining
some of these barriers in detail, and suggesting approaches to resolving
them. We plan bulletins on some of the following topics:
- Form and Governance of Local Health Initiatives.
The goal is to create a national health information infrastructure
(NHII) by fostering regional collaborations of providers,
health plans and public health authorities, and providing
them with a set of common intercommunication tools. These
local collaborations would be self-governing and reflect the
needs of the local population. What form might these local
collaborations take? Who should participate? What should the
decision-making process be?
- Regulatory Barriers to Health Information Networks.
Participation in a health information sharing network will
create complex financial and other relationships among providers.
Financial dealings among providers are heavily regulated by
the Stark law, the anti-kickback prohibitions, the False Claims
Act, and, for many, prohibitions on private inurement and
the gifting of public funds. What are the regulatory implications
of how community health records are funded? How does a collaborative
avoid creating financial relationships among providers that
would prevent them from making referrals to one another or
expose them to sanctions if they do? Are the existing exceptions
and safe harbors to the laws prohibiting self-interested referrals
and kickbacks adequate? What are the implications to a tax-exempt
organization of funding community health information exchanges?
- Individual Rights over Health Information in EHR Networks.
Current regulatory schemes place ownership of the health record
with the provider, and give consumers limited rights to see,
copy and amend their health records. In discussions about
the NHII, there is a strong theme of consumer involvement
and empowerment. What does ownership of the health record
mean? What rights do consumers have today? Should they have
stronger rights over information in a shared EHR - for example,
the right to keep their health records out of the system,
or to exclude certain information, such as mental health records,
genetic information and the like? Should they be able to restrict
access to their records by certain providers, or by non-providers,
such as public health authorities?
- Health Information Privacy and Security in EHR Networks.
Can regional and national health information sharing networks
function within the complicated matrix of federal and state
laws affecting health information privacy and security, including
HIPAA? How can responsibility for privacy and security be
assigned in a widely distributed, shared system? How would
consumers approach the system to exercise rights with respect
to their health information, and how would these requests
be implemented?
- Liability of Providers Participating in EHR Networks.
Providers are concerned about professional responsibilities
and liabilities. How will they judge the reliability of health
information in a shared system? Will participation in a community
health record become part of community standards of care?
Will they be liable if they rely on inaccurate or incomplete
information? And how will they be assured that, if their care
is later called into question, they can reconstruct the record
that they relied on when they provided the care?
- EHR Networks and Telemedicine. One strategy of the
plan for the NHII is to promote the use of telehealth systems
to provide services to people in remote and underserved areas
and to people moving among locations. What regulatory barriers
exist to telemedicine, particularly when it is practiced across
state borders?
- Acquisition of Technology for EHR Networks. Finally
(or perhaps not), what are the risks and pitfalls for those
acquiring EMR technology, and what practical steps can be
taken to avoid them?
As a leader in providing legal services to the health care
industry, DWT is taking an active part in identifying and addressing
these issues as the EHR initiative evolves. We hope readers
of our bulletins will find them useful.
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Additional
Contacts:
Gerry
Hinkley, San Francisco, (415) 276-6530, GerryHinkley@dwt.com
Thomas
E. Jeffry, Los Angeles, (213) 633-6882, TomJeffry@dwt.com
Kent
B. (Bernie) Thurber, Portland, (503) 778-5202, BernieThurber@dwt.com
Rebecca
L. Williams, Seattle, (206) 628-7769, BeckyWilliams@dwt.com
This
Advisory is a publication of the Health Information Technology
Department of Davis Wright Tremaine LLP. Our purpose in publishing
this Advisory is to inform our clients and friends of recent
developments in the health care industry. It is not intended,
nor should it be used, as a substitute for specific legal advice
as legal counsel may be given only in response to inquiries
regarding particular situations.
Copyright © 2004 |
Davis Wright Tremaine LLP.
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