H I P A A L E R T Volume 1 No. 9 August 17, 2000
> From Phoenix Health Systems -- HIPAA Knowledge...HIPAA
Solutions <
HIPAAlert is published monthly as a service to the healthcare industry
to help managers and professionals stay on top of current issues
related to HIPAA security and privacy. Current subscribers total
just under 7000. Do you have interested associates? They can subscribe
free at: http://hipaalert.com
IF YOU LIKE HIPAALERT, YOU'LL LOVE HIPAAdvisory.com, the most comprehensive
HIPAA resource site on the web -- and THE industry "place" to begin
your HIPAA implementation efforts. http://www.HIPAAdvisory.com
T H I S I S S U E
1. From the Editors: Today the Clock Starts
2. HIPAAnews: Final Rule, Privacy Bills, NCVHS Report and More
3. HIPAAdvisor: E-mail Transmissions
4. What's So New About the Final Rule?
5. Announcing WEDI's Strategic National Implementation Process
1 / F R O M T H E E D I T O R S:
Per Bill Braithwaite of the Department of Health and Human Services
(DHHS), "The HIPAAs are coming, the HIPAAs are coming!" Finally,
late last Friday, word came that the Final Rule for Transactions
and Code Sets had been released to the Federal Register. Publication
occurred today, Thursday, August 17th. For most organizations, this
sets a compliance deadline of October 16, 2002. Small health plans
have 12 additional months to comply.
In response, the Healthcare Information and Management Systems
Society (HIMSS) has announced two Flash Web Audio Conferences next
week, focusing on the final rule. In addition to reviewing specifics
of the rule, Phoenix has been asked by HIMSS to analyze how the
final and proposed versions differ, and to offer specific compliance
planning recommendations. Don't miss this special opportunity to
jump-start Transactions and Code Sets compliance; just visit http://www.himss.org
to register online for either August 22nd or August 24th. Incidentally,
each 1-hour conference will offer the same content; if one date
won't work, the other surely will.
On other fronts, consumer concerns continue to drive additional
legislative and industry initiatives on information privacy and
security. Congress is considering no less than 16 bills that affect
privacy in the healthcare industry. Some of the bills deal exclusively
with electronic issues, while others do not draw distinctions. Read
more about two of these bills in HIPAAnews.
Also below: a recent report to DHHS that the government take a
leadership role in addressing standards issues... Steve Fox covers
encrypting e-mail transmissions in HIPAAdvisor... and read about
a centralized, national effort to support HIPAA compliance. Next
month, we will be conducting our quarterly HIPAA compliance progress
survey. If we can use your suggestions and ideas, we will - so let
us know now what issues are most important to you!
Diane Boettcher, Editor
dboettcher@phoenixhealth.com
D'Arcy Guerin Gue, Publisher
daggue@phoenixhealth.com
2 / H I P A A n e w s
*** Transactions and Codes Sets Final Rule Published. ***
The Final Rule on Transactions and Code Sets was published today
in the Federal Register. The rule will be final in sixty days; healthcare
industry organizations will have 24 months in which to comply (October
16, 2002).
We have published the full text of the rule, with keyword search
capability, at: http://www.hipaadvisory.com/regs/finaltrans/index.htm
See Section 4 below for our summary of the differences between
the proposed rule and the final rule on Transactions and Code Sets.
*** Internet Privacy Bill Introduced in Senate. ***
Introduced July 26th, the Consumer Internet Privacy Enhancement
Act (S- 2928), would require commercial web sites that collect personally
identifiable information to provide consumers with "clear and conspicuous
notice" about their information collection practices. Sites would
be required to describe entities collecting information via the
web site; how the information will be used; the types of information
collected; if the provision of information is required to use the
site; and the methods taken to secure personal information. The
bill would give consumers the option to limit the use of personally
identifiable information by commercial web sites. Senators McCain
(R-AZ), Kerry (D- MA), Abraham (R-MI) and Boxer (D-CA) are sponsoring
the bill.
*** Organizations Weigh in on Medical Financial Privacy Act. ***
The Medical Financial Privacy Act (HR-4585), which passed the
House Committee on Banking and Financial Services on July 20th,
proposes to prohibit financial institutions from sharing medical
financial records, and from using a consumer's medical information
in providing credit, without customer consent. This bill would not
limit or supersede medical privacy standards to be established under
HIPAA.
The American Bankers Association (ABA) has issued a statement opposing
the bill. The ABA has expressed general support for medical financial
privacy legislation. However, the current bill is considered "so
vague" that "a customer can demand that virtually every file in
the institution be searched."
The Independent Insurance Agents of America has endorsed the bill,
following inclusion of a change that clarified how it applied to
group health plans up for renewal or change.
*** NCVHS Report on Patient Medical Record Data Standards. ***
The National Committee on Vital and Health Statistics (NCVHS),
the Public Advisory Body to the Secretary of Health and Human Services,
has released its report on Uniform Standards for Patient Medical
Record Information (PMRI) to DHHS. NCVHS was directed by HIPAA to
report to DHHS on "issues related to the adoption of uniform data
standards for PMRI and the electronic exchange of such information."
The report addresses the protection of confidentiality of medical
records information; reducing barriers to the electronic exchange
of information caused by diverse state laws; increasing the participation
of underrepresented groups in the standards development process;
and coordinating the development of patient information standards
within the broader context of a National Health Information Infrastructure
(NHII).
It recommends that the government take the lead in addressing these
issues by accelerating the development, adoption and coordination
of PMRI standards. Further, it addresses the related issues of protecting
the confidentiality of PMRI, reducing barriers to the electronic
exchange of PMRI caused by diverse state laws, and coordinating
the development of PMRI standards within the broader context of
NHII.
To view the executive summary, go to: http://www.hipaadvisory.com/regs/ncvhsexecsum.htm
To view the full report in PDF format, visit: http://www.hipaadvisory.com/regs/Regs_in_PDF/hipaa000706.pdf
*** Privacy a Major Concern for Online Healthcare Consumers. ***
Successful development of the online healthcare field will depend
upon companies adequately handling consumers' concerns about privacy,
security and ethical issues, according to a new Cyber Dialogue Health
Practice report, "Protecting Consumer Privacy in Online Healthcare".
Among the 37 million online users who do not currently use online
health information, the report found that 6.3 million don't primarily
because of privacy and security concerns. The report, based partly
on a survey sponsored by the California HealthCare Foundation and
the Internet Healthcare Coalition, recommends that healthcare companies
build consumer loyalty and propel industry growth by responding
to consumer demand for a more trustworthy, ethically sound online
environment.
3 / H I P A A d v i s o r : Legal Q/A with Steve Fox, Esq.
*** E-MAIL TRANSMISSIONS ***
---------------------------
QUESTION: I work for a hospital that routinely sends patient records
to various third party contractors via email. To my knowledge, this
information is not encrypted or password protected. Does HIPAA forbid
these types of transmissions?
I keep reading about the HCFA Internet Security Policy; what is
HCFA and what relationship and/or relevance, if any, does it have
to HIPAA? Is there anything we should be doing relative to e-mail
communications while we wait for HIPAA regulations on the issue?
ANSWER: While the proposed HIPAA regulations do not forbid electronic
transmission of such information, they do require the information
to be encrypted.
The answer to your question has implications that extend far beyond
compliance with HIPAA's security standards. The broader and perhaps
more important issue is your hospital's patients' comfort level
with the hospital's current, rather lax, Internet security protocol
if it were made public. Even assuming that the hospital's current
approach is not uncommon, the hospital's patients may feel their
trust has been misplaced. What the hospital does when HIPAA takes
effect won't be able to repair the damage to the hospital's reputation.
One of the most important issues facing our society in this "electronic
information age" is how to reap the benefits of instant data transmission
and at the same time protect the privacy of the individual. There
are currently no fewer than 16 bills pending in Congress that address
this issue. In fact, a recent article cites consumer's enormous
privacy concerns as a hindrance to more widespread use of the Internet
for online health care and health education http://www.hipaadvisory.com/views/Patient/online071200.htm.
HIPAA confronts this issue by imposing minimum-security standards
on health care providers, clearinghouses, plans, and other entities
that electronically maintain or transmit health information (as
defined by the Act).
Electronic transmissions include, among others, transmissions over
the Internet and extranets (using Internet technology to link to
a business with information only accessible to collaborating parties).
The proposed rules require protection of electronically transmitted
health information so that it cannot be, "intercepted [or] interpreted
by parties other than the intended recipient and [can be] protect[ed]...
from intruders trying to access systems through external communication
points." The proposed HIPAA regulations recognize that information
transmitted over the Internet is especially vulnerable to compromise
and interference, and accordingly require such information to be
encrypted.
It is advisable for the hospital to follow the Health Care Financing
Administration (HCFA) Internet Security Policy guideline until the
final HIPAA security regulations are released. HCFA is the DHHS
agency responsible for Medicare and parts of Medicaid. HCFA's Internet
Security Policy applies to HCFA contractors, state agencies acting
as HCFA agents, other government organizations, and any entity that
has been authorized by HCFA to access HCFA information resources.
HCFA's policy authorizes use of the Internet for transmission of
individually identifiable and other sensitive information as long
as:
- Covered entities use an acceptable method of encryption that
insures the confidentiality and integrity of the information being
transmitted; and
- There is an authentication/identification procedure to verify
the identity of the sender and the intended recipient.
The HCFA Internet Security Policy is relevant to HIPAA because
it lists acceptable approaches to complying with the authentication
and identification requirements of the policy. DHHS is likely to
take these approaches into account and could potentially use them
as a model when making final determinations on the comparable HIPAA
regulation.
This article was co-authored by Rachel H. Wilson, an associate
at Pepper Hamilton.
---------------------------
Steve Fox, Esq. is a partner in the Washington, D.C. office of
Pepper Hamilton LLP. Pepper Hamilton LLP is a multi-practice law
firm with more than 400 lawyers in ten offices. A specialist in
healthcare, Steve is a frequent writer and speaker on healthcare
information management and technology issues.
http://www.pepperlaw.com/
Disclaimer: Steve's responses offer information that is general
in nature and should not be relied upon as legal advice. Only your
attorney is qualified to evaluate your specific situation and provide
you with customized advice.
4 / What's So New about the Final Rule?
Gaining a better understanding of the final Transactions and Code
Sets rule is a critical step towards compliance. Let's examine the
differences between the proposed rule and today's final rule, review
some key points that were clarified, and identify remaining unresolved
issues:
1. Elimination of the on-line interactive transaction exception
In the proposed rule, interactions between server and browser,
direct data entry, and fax back were exempt from the standards.
In the final rule, these transmissions must now comply with the
data content, but not with the data format. For example, with "dumb"
terminals, where the provider directly keys data into a health plan's
computer, the format need not comply with the standard, but the
data elements or content must comply. The final rule makes it clear
that a health plan may not offer an incentive for a healthcare provider
to conduct a transaction under the direct data entry exception.
2. Elimination of the exception for standard transactions within
a "corporate entity"
An exception in the proposed rule allowed non-standard transactions
to be used within a corporate entity, to minimize the burden of
change. The definition of a "corporate entity" caused considerable
confusion, especially given the rapid pace of change in the healthcare
industry. Under the final rule, covered entities must use a standard
transaction when transmitting to another covered entity, whether
the transmission is inside OR outside the entity. To help determine
when entities must use standard transactions, descriptions of each
transaction are now clarified in the final rule. In addition, the
preamble in the final rule provides examples of when a standard
transaction must be used. However, confusion remains on this issue
and further clarification is being sought.
3. Clarification of applicability to health plans
The proposed rule was unclear on whether a health plan must comply
with a standard if it doesn't currently support that standard electronically.
The final rule requires a health plan to accept and/or send a standard
transaction that it conducts but does not currently support electronically.
Therefore a health plan must be able to electronically transmit
a standard that it currently only transmits on paper. Health plans
may still choose to use a clearinghouse in order to comply.
4. Clarification of applicability to paper transactions and non-covered
entities
Many comments suggested that the final rule also cover paper transactions.
The decision was made not to include them at this point since many
paper forms do not support the data content required. Also, DHHS
indicates that applying the standards to both paper and electronic
transmission would not support HIPAA's overall objective to encourage
standard electronic transmission. Several commenters recommended
that the standards should apply to employers/sponsors who use electronic
data interchange (EDI), because of their major role in healthcare
administration. DHHS has responded that since HIPAA doesn't specifically
require employers/sponsors to use the transaction standards, DHHS
will not apply the regulation to them. However, health plans may
negotiate trading partner agreements with employers and sponsors
that require the use of standard transactions.
5. Clarification of "small health plan" definition
The proposed rule defined a small health plan as a health plan
with less than 50 participants. The final rule uses the Small Business
Administration's size standards, specifying a small health plan
as one with annual receipts totaling less than $5 million.
6. Addition of case management to regulation
In the proposed rule, case management was considered an "atypical
service" and therefore not subject to the standards. The final rule
reverses this exception. Case management is now considered a healthcare
service since it is directly related to the health of an individual
and is furnished by healthcare providers. Therefore, organizations
that have already set up HIPAA teams should re-think whether case
management should join them.
7. Addition of several definitions
Several new definitions are included to clarify applicability and
scope of the rule. These include trading partner agreement, covered
entity, workforce, business associate, and designated standard maintenance
organization (DSMO).
8. Addition of suggested implementation timelines
Timeline suggestions for implementation are included in the preamble.
Given the complex implementation sequencing issues that are anticipated,
health plans are encouraged not to require providers to use the
standards during the first year after the final rule's effective
date. Health plans are also encouraged to give providers at least
six months notice before requiring a standard transaction.
A number of issues remain unresolved. The final rule addresses
these comments, but is deferring resolution to the future. These
issues include:
1. Preemption by states
The proposed rules did not offer preemption requirements. The final
rule indicates that the preemption issue will be resolved in the
context of the HIPAA Privacy final rule. Amendments to the Transaction
and Code Set rule also will be made at that time.
2. Compliance assessment and enforcement
The issues of compliance, timing, appeals, self-assessment or certification
demonstrating compliance will be addressed in an enforcement Notice
of Proposed Rulemaking (NPRM), to be published next year.
3. Interaction with privacy
A statement concerning the importance of developing standards to
protect the privacy of individually identifiable health information
is included. DHHS states that if the privacy standards are substantially
delayed, or if Congress fails to adopt comprehensive privacy legislation,
it would seriously consider suspending application of the transaction
standards or withdrawing the rule. It appears that DHHS is concerned
that the public may view this rule as a new example of the lack
of privacy of their health information. DHHS may have re- emphasized
the importance of privacy legislation to encourage public support
and successful implementation of this first of the long awaited
final HIPAA rules.
5 / WEDI Sponsors HIPAA Implementation Support Initiative
Efforts are underway at a national level to systematically support
HIPAA implementation across the industry. Plans include identification
of major implementation issues, best practices, and model workflow
scenarios; and mitigation of national deployment obstacles. The
Workgroup for Electronic Data Interchange (WEDI) has established
the WEDI HIPAA Strategic National Implementation Process (SNIP)
Task Force.
SNIP's goals are to assess industry-wide HIPAA Administrative Simplification
implementation readiness and to help bring about the national coordination
necessary for successful compliance. SNIP's activities are centered
on three internal workgroups. The Transaction and Codes Sets Work
Group is focusing on testing implementation coordination deployment
protocols. The Security Work Group is working on implementation
issues and assessment of industry feedback on pilots such as Internet
Interoperability; and the Education Work Group is addressing training
objectives, industry awareness and readiness, information gaps and
proposed solutions.
The first SNIP Forum, held June 15-16 in Alexandria, VA, began
laying the groundwork for a long-term approach to collaboration
within the industry to address HIPAA. The workgroups are now preparing
white papers, best practice models and discussion forums. More information
is available at the WEDI web site at http://www.wedi.org.
BRING YOUR HIPAA QUESTIONS AND IDEAS TO LIFE AT...H I P A A l i
v e!
Join nearly 1700 other thinkers, planners, learners and lurkers
who are already members of our sister e-mail discussion list. We
almost make HIPAA fun! Almost. Subscribe now at: http://www.hipaadvisory.com/live/
COMMENTS? Email us at
SUBSCRIBE? Visit http://hipaalert.com
http://www.hipaadvisory.com/alert/newsarchives.htm
Copyright 2000, Phoenix Health
Systems, Inc. All Rights Reserved. Reprint by permission only.
|