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February 2005
Volume 69 |
Number 2 |
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Complying With the HIPAA Security Rule
Karin Bierstein, J.D.
Assistant Director of Governmental Affairs (Regulatory)
pril
20, 2005, is the deadline for compliance with
the Security Rule, part of the Administrative
Simplification provisions of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA).
The Security Rule is a much easier proposition
than either the Privacy Rule or the Transactions
and Code Sets Standards. Your practice management
and information technology staff have probably
done what is necessary to make you compliant already
— but let us make certain.
Protecting the security of electronically stored
and transmitted information is not just a HIPAA
mandate, it is good practice, period. The Security
Rule mandates preservation of the confidentiality,
integrity and availability of electronic
protected health information (e-PHI), breaches
of any of which could cause difficulties for the
anesthesiology group. Imagine discovering that
the patient information on which you depend has
been altered or destroyed by a computer virus
or in another unauthorized manner.
Without security there is no guarantee of privacy.
That is why your Privacy Rule activities have
likely satisfied some of the Security Rule standards,
too. For example the Privacy Rule states that
you must “reasonably safeguard” PHI
from intentional or unintentional disclosures
for improper purposes. That is one of the standards
of the Security Rule as well. One major difference
between the two is that the Privacy Rule applies
to all forms of PHI: verbal or paper as well as
electronic. The Security Rule only covers e-PHI.
The goal of this article is to give ASA members
enough information that they can feel comfortable
in delegating responsibility for compliance, not
to spell out the 18 standards or 36 “Implementation
Specifications” of the Security Rule. Anesthesiology
group leadership should know that the rule is
intended to be flexible, “scalable”
and technology-neutral. Each group’s security
program should be based on that group’s
risk level and should be proportionate to the
risks. Size, complexity and capabilities of the
practice are all relevant in choosing how to satisfy
the specific standards. As stated by the Workgroup
on Electronic Information (WEDI), “Don’t
build a $5,000 fence for a $3,000 horse.”
WEDI does spell out the standards and how they
can be met in a free monograph that should be
in your possession. It is titled “Small
Practice Security Implementation White Paper”
and is available at <www.wedi.com>.
Information for the Anesthesiology Group’s
CEO or COO
The Security Rule requires “covered entities,
which include all physician practices that transmit
or store patient information electronically, to
adopt safeguards to protect the privacy of protected
health information [PHI].” One of the first
standards mandates the designation of one person
as the security official. This could be an anesthesiologist
or the practice administrator, and in smaller
anesthesiology groups, it might easily be the
same individual who serves as the privacy official.
The security official is responsible for developing
and implementing the policies and procedures required
by the rule. By now, this individual will undoubtedly
have conducted the requisite risk assessment and
gap analysis, identified and prioritized measures
to reduce vulnerabilities and developed a budget
to manage risks. Between now and April 20, the
security official, together with the practice
administrator and information systems vendor,
should complete any outstanding steps among those
outlined in Table 1.
Table 1. Implementation Action
Plan for the Security Official
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October
- November 2004
1.
Develop a plan
• Determine tasks and resources
you need to become HIPAA Security
Rule-compliant. Use the Security
Standards Matrix published by CMS
and reproduced in the WEDI Implementation
White Paper.
• Determine a timetable for
plan development and review.
• Ask vendors about security
features included in your information
system.
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November
2004 - January 2005
2. Develop policies and procedures
• Document how you plan to
implement each security standard.
• Study and evaluate budget
as you evaluate specifications.
• Identify security controls
to meet policy requirements. Discuss
technical safeguards with vendors.
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February
2005
3. Implement administrative,
physical and technical controls
• Plan enough time to install,
test and certify any vendor upgrades.
• Document procedures, develop
necessary forms to accompany new
controls.
• Manage budget through implementation.
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March
- April 2005
4. Develop and present Security
Training, Awareness and Ongoing Reminders
• Provide all staff with
security awareness training.
• Determine who needs specific
training and at what level.
• Develop an ongoing security
reminder plan.
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April
2005 - Ongoing
5. Develop an ongoing monitoring
process
• Determine how often you
will conduct regular audits. Conduct
audits when an incident occurs and
your policies require it.
• Integrate privacy complaints
and security incidents when appropriate.
• Monitor regulations and
changes.
• Refer to the Security Rule
when you have questions. You may
also ask specific questions at <askhipaa@cms.hhs.gov>
or <www.cms.hhs.gov/hipaa/hipaa2/default.asp>
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This table is adapted from the HIPAA
Security Implementation Action Plan
available on the Physicians EHR Web
site <www.physiciansehr.com>.
The suggested time frames are in the
original. |
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To make those steps more meaningful, those ultimately
responsible for the practice’s compliance
need to understand the basic anatomy of the Security
Rule. There is a hierarchy consisting of three
types of safeguards that the practice must put
in place: administrative, physical and technical,
and their associated standards and implementation
specifications. Each implementation specification
is either “required” or “addressable.”
The term “required” is self-explanatory.
“Addressable” means that the security
official will assess whether the specification
is reasonable and appropriate for the practice
and either implement it or not, documenting the
decision. “Addressable,” it should
be noted, does not mean “optional.”
Administrative safeguards include:
• The security management
process (Implementation specifications: implementing
security measures; establishing systems of audit
logs, patient record access reports and security
incident reports and procedures; setting and enforcing
sanctions, etc. These are all required.)
• Workforce security (employee
authorization and supervision, clearance and termination)
• Security awareness and training
(login monitoring, security reminders and other
specifications in this group are all addressable.)
• Backup and contingency planning
• Business associate agreements
(update your Privacy Rule business associate agreements
to require the outside party to notify the practice
of any security incidents; include business associate’s
duty to implement safeguards to protect e-PHI,
etc.)
Physical safeguards include:
• Facility and equipment
access controls (facility security plan;
workstation security; data backup, storage and
disposal, access and accountability records, etc.)
Technical safeguards include:
• Access control
(unique user identification, automatic log-off,
emergency access, etc.)
• Transmission security (encryption)
• Audit controls (hardware and
software and/or procedural mechanisms to examine
e-PHI activities)
The Security Rule is fairly prescriptive with
respect to documentation. In addition to policies
and procedures, it requires the documentation
of the rationale for many of the practice’s
security decisions and for specific events such
as security incidents and their outcomes.
Finally, what are the risks of noncompliance?
Although the statute refers to “ensuring”
protection for e-PHI, the Centers for Medicare
& Medicaid Services (CMS) acknowledged in
the introduction to the security regulations that
there is no such thing as a totally secure system.
The regulations did not establish any particular
penalties for breaches of security. Enforcement
is going to be complaint-driven, and there is
every indication that CMS’ attitude will
be educational, not punitive, as has been the
case with enforcement of the Privacy Rule.
The more realistic risks of noncompliance are
the potential costs of losing patient data, finding
your claims corrupted or having servers go down.
The Security Rule is a roadmap for preventing
such losses.
Source Material:
• Small Practice Implementation White Paper
Version 2.0. Workgroup on Electronic Data Interchange/Strategic
National Implementation Program. April 2004. <wedi.org/cmsUploads/pdfUpload/WhitePaper/pub/2004-04-20SmallPractice.pdf>.
• Security 101 for Covered Entities and
other papers in CMS’ Security Series, <www.cms.hhs.gov/hipaa/hipaa2/education/Security%20101_Cleared.pdf>.
• HIPAA Security Rule Action Plan. Physicians
EHR, <www.physiciansehr.com>.
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