Health Information Technology Advisory
Bulletin
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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