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How
Do You Know if HIPAA Applies to You?
The regulations define the “covered
entities” - those that must comply
- to be:
-Healthcare providers (hospitals,
doctor offices)
-Health plans (insurers, HMOs, group
health plans)
-Healthcare clearinghouses (service
organizations that submit claims for
providers)
Even
if you are not one of these organizations,
you still may be required to comply
with HIPAA. If one of the covered
entities does business with another
organization, then that “business
associate” is required to have the
same level of security as the covered
entity. The reason is that security
is only as good as the weakest link.
If a highly secure organization sends
health data to a business associate
with weak security, then the security
of that data may be compromised. The
FAQ section of the Department of Health
and Human Services web site goes on
to state that a business associate
of a business associate has the same
duty of compliance to the covered
entity as the primary business associate!
The reach is far.
There are businesses that conduct
business with covered entities that
are not required to comply with HIPAA.
For instance, if you are a housekeeping
service that comes in and mops the
floors at a covered entity, then you
are not a business associate as defined
by the regulations. The standard for
whether you are a business associate
or not is that you transmit individually
identifiable health care information.
If you do not deal with healthcare
information, or if the health information
is not individually identifiable,
then you do not fall under the regulations.
A medical research organization that
only receives statistical medical
data with no personally identifiable
fields would not have to comply.
Since the HIPAA regulations are so
new, it is not yet clear exactly how
far the reach will be. There are some
consultants who believe that HIPAA
will eventually reach out into most
human resources departments because
employee files may contain health
information. Self-insured corporations
may have a greater need to be compliant.
The claims processor is a covered
entity, and therefore the self-insured
corporation would be a business associate
of the claims processor. At a minimum,
to the extent that individually identifiable
health data is transmitted to the
self-insured organization, that process
must be secure to HIPAA standards.
What
Do You Have to Do to Comply?
HIPAA has several components. The
part of the regulations that pertains
to business continuity is the “Administrative
Procedures”. The bulk of the Administrative
Procedures are concerned about protecting
access to personal health information.
Your security officer will be responsible
for implementing these portions. You,
the business continuity planner, will
be responsible for the part of the
regulations that demand that healthcare
information be “available.” The following
list contains the minimum requirements:
-You must conduct an “applications
and data criticality analysis” (business
impact analysis).
-You must have a data backup plan.
-You must have an emergency response
plan.
-You must have a contingency plan.
-You must be able to recover applications
and data in a reasonable amount of
time.
-You must have a plan testing and
revision program.
No
particular recovery technology is
required. No set recovery time objective
or recovery scope objective is demanded.
Your strategy and your plan simply
must be reasonable for your organization.
I expect that over the next several
years de facto standards will arise.
If you think your organization falls
under the HIPAA regulations, meet
with your security officer to discuss
an action plan. One of the first projects
required is a gap analysis. Your current
security and business continuity policies
and practices must be measured against
the standards in the regulations.
The result will be a HIPAA implementation
plan to fill in the gaps and move
toward full compliance before the
deadline.
How
Long Do You Have to Comply with HIPAA?
The start of the implementation period
will probably be this year (before
December 2001). Most organizations
have two years, until 2003 to implement
compliance. Some smaller organizations
have three years, until 2004. So,
by the time you read this the starting
gun will be ready to fire. The deadline
for completing your HIPAA security
and disaster recovery plan is already
set in federal regulations.
What
About Enforcement?
The Office of Civil Rights is given
authority to enforce HIPAA. But, there
will be no government auditors checking
your HIPAA program. There is no HIPAA
police. You must follow the necessary
steps to become compliant, and then
you simply self-certify that your
organization is in compliance. The
enforcement comes in several indirect
ways.
First, your attorney will be writing
your self-certification statement.
She will not put her name on the statement
unless she is satisfied that your
organization is indeed compliant.
Your own lawyer will be your first
auditor.
Second, before you can conduct healthcare-related
business with a covered entity or
a business associate, your organization
will be required to sign a Chain of
Trust Agreement. This ensures that
there is no weak link in the transmission
of healthcare data from one organization
to another. In the Chain of Trust
Agreement you will make a legally
binding statement that you are in
compliance. No corporate executive
will sign such an agreement unless
they are confident in their HIPAA
compliance.
Once the requests for Chain of Trust
agreements start flying between organizations
the completion of a business impact
analysis and business continuity plan
will become a top priority. There
is a risk of lost revenue because
a covered entity will no longer do
business with you.
The third inducement for compliance
is that the government sets civil
and criminal penalties for non-compliance.
Civil fines can be up to $25,000 per
calendar year per each provision that
is violated. The maximum criminal
penalty is 10 years in prison and
a $250,000 fine. The criminal penalties
are greatest for willful noncompliance
or an attempt to sell health information
for personal gain. Those news stories
of hackers breaking into computer
systems will now be followed with
news stories of fines levied against
the organization that was hacked.
What
Does HIPAA Mean to You?
From the point of view of the top
executives of your organization there
will be a good reason to combine security
and disaster recovery into one HIPAA
Compliance Department. To the executive
this is one big, expensive problem.
They will want one person to deal
with. That one person will be given
the title Privacy Officer, and they
will be tasked with ensuring compliance.
A significant amount of this person’s
time will be taken with giving HIPAA
training classes to his organization.
Every single employee, without exception,
must be trained at least once a year.
If you are a good consultant (more
business-oriented than technical-oriented),
and have a good relationship with
your CIO, then you are in line for
this position. If you have a strong
security officer, they are likely
to get this position, and you may
end up reporting to them.
The upshot is that we are entering
a new age for business continuity
planners. Once, the budget for your
planning projects could always be
put off to next year. Now (at least
for the healthcare industry) there
is an immutable deadline, just like
Y2K. But,Y2K went away after about
24 hours. HIPAA is here to stay.
For
More Information About HIPAA
There is a wealth of information available
on the web. Use any search engine
and type in “hipaa security”. Google.com
provides many hits. However, dogpile.com
will find additional sites that google.com
does not find. A full copy of the
regulation is available at
http://aspe.hhs.gov/admnsimp/.
The file is very large.
The North Carolina Healthcare Information
and Communications Alliance (www.nchica.org),
a privately funded, nonprofit organization
that promotes the advancement and
integration of information technology
into the healthcare industry, has
released EarlyView™ a HIPAA Gap Analysis
tool based on Microsoft Access 97
Version 7 SR2. The tool has over 500
audit questions and a variety of reports.
It should help you speed up the gap
analysis significantly. The tool can
be downloaded for $250 by nonmembers.
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