http://www.medscape.com/viewarticle/502875
Ten Steps to HIPAA Security Compliance
David C. Kibbe, MD, MBA
Fam Pract Manag. 2005; 12 (4): 43-49. ©2005 American Academy of Family
Physicians
Abstract and Introduction
Abstract
Protecting your patients' health information is more difficult and more
important than ever. The author's strategy will help you meet this
month's deadline.
The final rule adopting HIPAA standards for the security of
electronic health information was published in the Federal Register on
Feb. 20, 2003 [and goes into effect April 21, 2005]. This final rule
specifies a series of administrative, technical and physical security
procedures for covered entities to use to assure the confidentiality of
electronic protected health information. The standards are delineated
into either required or addressable implementation specifications.
- Statement on the Centers for Medicare & Medicaid Services Web site
regarding the Health Insurance Portability and Accountability Act[1]
Introduction
As family physician Dan Brewer, MD, once wrote on an e-mail discussion
list, "I believe I would rather eat live cockroaches than learn about
HIPAA security." Nothing, it seems, could be more boring and less
related to the practice of family medicine than computer security.
But don't be fooled into complacency. You and your patients are probably
more familiar with security risks and the costs or hassles associated
with inadequate protection than you realize.
Consider these examples:
* Have you ever been the victim of a computer virus, or do you know
someone who has?
* Are you concerned about what would happen if the computer hard
disk storing your patients' medical information failed?
* Do you worry that someone might eavesdrop on your wireless
communications?
* Were you concerned when a major pharmaceutical company
unintentionally distributed the e-mail addresses of hundreds of patients
taking an antidepressant medication?[2]
In addition to helping raise your awareness of what's at stake, this
article will make computer security more understandable and relevant to
your practice, and put you on the path toward complying with the HIPAA
security standards.
After reading through these 10 steps, you should be able to compare your
office's current computer security, or lack thereof, with that required
by HIPAA. This type of comparison is known as a "gap analysis" and is an
important component of meeting the HIPAA requirements.
Also be aware that HIPAA security compliance is like a clinical
encounter: If it's not documented, then it didn't happen. Therefore,
document everything and make it part of a security manual.
1. Understand Why Computer Security is Important
If you need a simple answer to the question, "Why is computer security
necessary and important?" the answer is "because everyone cares about
the privacy and integrity of their health information." In most cases,
the point of computer security is to prevent personal health information
from falling into the wrong hands or being inadvertently altered or
destroyed.
The HIPAA security standards apply to protected health information (PHI)
that is either stored or transmitted electronically. PHI is health
information in any form that personally identifies a patient. (For more
on PHI, see an earlier security article I wrote for FPM :
"A Problem-Oriented Approach to the HIPAA Security Standards,"
July/August 2001, page 37
http://www.aafp.org/fpm/20010700/37apro.html
.)
These security standards will apply to you on April 21 if any of these
situations exist in your practice:
* You use computers in the office to store and manage administrative
or clinical information;
* You have a computer or network connected to the Internet;
* You use e-mail or other forms of electronic messaging inside and
outside the practice.
The widespread use of computers, software and networks to exchange
digitized data creates new vulnerabilities. It also reveals new
dimensions to old risks. Much of the problem with computer security is
of our own making, the result of our love of convenience and our drive
to be more efficient. Computers automate routine, mundane tasks. By
storing compacted, bite-sized information inside machines, we are able
to collect data more easily and cut down on storage costs.
But computer storage devices can be broken or damaged, and the
information in them can be erased or corrupted, exposing the data to
unexpected change or loss. It is possible to steal thousands of medical
records by downloading them onto a small storage device, which can
easily be hidden in a pocket.
Similarly, we find networks of computers wonderfully convenient for
sending messages across any distance at almost the speed of light. We
delight in e-mail, file downloads and instant messaging. But the
Internet has no borders or natural boundaries, making it easy for
attackers to strike from a distance and to hide their whereabouts. Any
time we connect our computers to the Internet, we instantly become
vulnerable to new kinds of attacks, such as viruses and worms that can
literally get inside our computers and alter, destroy or release
confidential information.
One problem merits special mention. Computers have made the issue of
identity much more problematic. People have always been able to use
someone else's identity for criminal purposes, but the problem is
exacerbated when we can't use a person's face, signature or other
physical means to confirm their identity. How do you know the person
sending you e-mail is truly the person he or she claims to be? How do
you know the person whose name is attached to an electronic health
record (EHR) entry really made it? It's difficult. Hackers use computer
viruses to get into e-mail programs and propagate their nastiness by
sending new e-mails that appear to come from a friend. As the public
does more online shopping, identity theft using computers has become a
common way for criminals to steal money and goods.
The bottom line is this: Computer security is a requirement for any
sound business, including your medical practice. Computer security is
needed to protect the privacy of those whose information you store and
manage. It is also needed to protect you and your practice from the risk
of penalty and legal liability if private information is used or
released by your practice.
You have two choices: Either delay learning about computer security and
risk playing catch-up when an attack or accident causes harm to a
patient or your practice, or be proactive and begin to install
protections that will allow you to detect and prevent trouble down the road.
2. Make Certain Your Colleagues and Staff Take Security as Seriously as
You Do
The HIPAA security standards require your practice to have written
security policies and procedures, including those that cover personnel
training and sanctions for security policy violations. Your office staff
and colleagues must truly understand basic security logic and take their
role in protecting patients' privacy very, very seriously. Most security
breeches occur when insiders - people working for the organization -
exercise faulty judgment or fail to follow protocols in which they've
been trained.
Consider two highly people-dependent areas of computer security:
physical access and password management.
Physical access to computers and software is a foundation of computer
security. Physical access means that someone can approach a computer or
monitor and see what's on the screen. Do you want everyone in the
office, including patients, family members or your cleaning crew to be
able see what is displayed on a computer screen? Of course not. But you
probably work in a busy, sometimes hectic, environment that makes it
difficult to closely monitor the flow of people and information at all
times.
This means two things. First, you should carefully consider the location
and design of display devices in your office. Don't place monitors in
busy corridors, and ensure that the display image has a 30-second
time-out feature. Second, employees and staff must have a heightened
awareness regarding access to computers, monitors, printers, fax
machines and other display devices. They should strive to avoid creating
insecure situations.
Password management is another area that requires staff to be security
conscious. Passwords and IDs allow computers to control access to
personal health information based on a person's role, authority or need
to know. They identify or authenticate a computer user via a secret
password. Obviously, passwords should be kept secret to avoid
unauthorized access to or manipulation of protected information. But
passwords are clumsy to use and difficult to remember, especially as
they become more complicated (thus increasing their secrecy). It's
tempting for users in small offices to share passwords or keep them
written on a piece of paper tucked into the top drawer next to the
computer station. I've even found passwords on sticky notes attached to
computer monitors!
These actions completely undermine the security system. Why pay for a
software system that uses passwords if you don't take the protection
they provide seriously?
So while it does make sense to worry about hackers and intrusions from
outside your office walls, remember that your co-workers pose the most
likely security risk. Your computer security is only as good as the
weakest human link in your office.
3. Catalog All the Information System Components That Interact With
Protected Health Information in Your Office
To assess your office's current security risk, you have to know, in
detail, the capabilities and weaknesses of your information systems. No
two medical practices have exactly the same information system
components, nor do they manage the flow of information precisely the
same way. Some practices still manage most information on paper and have
a single computer for billing and accounting purposes. However, most
practices, even small ones, have complicated information technology
environments that include multiple components. These might include the
following:
* Hardware - Computer workstations in the front office, tablet
computers in the clinical areas, printers in the back office, server in
the computer closet, personal digital assistants, scanning devices and
modems used to connect to the Internet.
* Software - Operating systems, billing software, practice
management software, browsers, e-mail client software, EHR software, and
database and office productivity software.
* Network components - Routers and hubs, dedicated phone or cable
lines, wireless systems, firewall software and firewall hardware.
You should make a detailed list of all of the components that play a
role in either storing patient health information or transmitting it
within the practice or to outside settings. You then need to create
either a flow diagram or a detailed description of how this collection
of hardware, software and network components collects, accesses, stores
and transmits patient health information.
This detailed examination of your entire system is an important step for
three reasons. First, it's required. HIPAA requires you to carry out
such a risk analysis and base your new computer security policies and
procedures on this analysis, which must be specific to your practice.
Second, it's the only reasonable way to assess your risk of security
breeches in your current systems and protocols. Finally, this exercise
can be valuable in the acquisition and use of EHR systems if your
practice is moving in that direction.
The HIPAA security standards require your practice to appoint someone as
the security manager, so you might want to assign these tasks to that
person. However, I can't stress enough the need for physicians to take
responsibility for understanding how health information technology is
used in their practice, especially small and independently owned ones.
4. Prepare for Disaster Before it Occurs
An important aspect of computer security involves protecting electronic
data from loss or corruption - that is, ensuring its integrity. Although
there are many ways data integrity can be affected, the most common is
loss of data from some sort of emergency or disaster, including human
error, mechanical hard disk failure, equipment damage due to flooding,
or computer virus infection.
A solid computer-system contingency plan is composed of a number of
steps, including performing backups, preparing for continued operations
in an emergency and recovering from a disaster.
The most important part of a contingency plan is having a backup system.
A backup system is a combination of hardware and software that lets you
retrieve exact copies of information if the originals become lost or
damaged. There are several kinds of commonly used backup systems,
including those that store data to tapes, compact discs or off-site
devices. The equipment and service can cost from hundreds to thousands
of dollars, and the best method for your practice can only be determined
after you know how much data needs to be backed up. Your choice also
will be influenced by cost, convenience and ease of use.
At a minimum, your practice's backup system should store all of the
critical data needed to run the practice in the event of a disaster.
Practices should conduct an analysis to identify these critical data.
5. Make Sure Your Network and Communications Safeguards are Intact and
Robust
It is increasingly difficult to find a computer that is not attached to
some sort of network. Most computers in your practice are connected to
the Internet, a particular kind of public network that has its special
risks. Although network security is a complex subdomain of computer
security, the basic threats and protective devices are not difficult to
understand.
Networks work by routing packets of information among and between users
at various computers. Generally, networks use devices known as routers
to send the packets to correct addresses. Therefore, networks need to
defend themselves against attacks from unauthorized users and from
infiltration of unauthorized information packets through the routers.
Firewalls are hardware and software devices that protect an
organization's network from intruders, such as hackers or data thieves.
Think of firewalls as sentries at the boundaries of private networks and
the public networks they are connected to: They check credentials,
permit passage of authorized parties and communications, and keep a
record of what crosses the boundary. Firewalls deny access to
unauthorized users and applications, and they create audit trails or
logs that identify who accessed the network and when. Firewalls may also
issue alarms when abnormal activity occurs, such as a repeated
unsuccessful attempt to enter the network.
6. Be Certain That You Have Anti-Virus Software and Keep it Up to Date
Even if you are in solo practice and use only one laptop computer for
all your data capture, storage and transmission - and therefore may not
require a network firewall - you probably connect to the Internet for
e-mail and Web browsing. In terms of risk to your computer's data,
connecting to the Internet is the most dangerous activity in which you
can engage.
Malicious software, sometimes called malware, has become a familiar form
of computer attack. Viruses, worms and "Trojan horses" are among the
most common forms of malware that your computer security must protect
against.
Viruses can attach themselves to e-mails, program files and data files.
They can infect all your hard disks and change or erase data while
spreading to floppy disks and e-mails to infect other machines. Worms
are self-replicating programs that attack networked computers. The now
infamous Nimda virus was a worm spread via e-mail attachments named
README.EXE. It affected a wide variety of operating systems, including
several versions of Windows. Nimda was responsible for tens of millions
of "denial of service" events throughout the Internet, in large part
because it was able to attack key Web servers that direct traffic across
the Internet. It is estimated that worms like the Nimda cost U.S.
companies billions of dollars each year in repairs and lost productivity.
The solution to malware is installing and updating anti-virus software,
available from specialized software companies, on all of your computers.
Anti-virus software works by scanning digital data, such as incoming
e-mails, files, hard disks and CDs, and then automatically deleting or
isolating viruses. Anti-virus software programs are great at detecting
known viruses but not so good at detecting new ones. New malware appears
all the time, so anti-virus software needs to be updated frequently.
Viruses, especially e-mail worms, are the price we pay for universal
connectivity and communications over open networks, especially over the
Internet. There is no single solution to the problem of computer
viruses, and the problem seems to be getting worse as more information
is delivered over the Internet all the time. Vigilance is essential.
7. Understand What Encryption Will Do and When it is Necessary
Contrary to what many people are saying, the HIPAA security standards do
not require e-mails, or any other transmission from a doctor's office,
to be encrypted. The standards do require your practice to assess
whether its unencrypted transmissions of health information are at risk
of being accessed by unauthorized entities. If they are, you should
consider some form of encryption.
The basic idea behind cryptography, of which electronic data encryption
is a branch, is that a group needs to keep a message secret from
everyone else and therefore encrypts it. Encryption is the
transformation of a message from plain text into nonsensical cipher text
before the message is sent. Anyone who steals the cipher text message
will not be able to understand it. Only those who have the code used to
encrypt the message can convert it back from cipher to plain text and
reveal its meaning.
For several reasons, encryption is generally not employed for
information stored on a computer's hard disk or transferred within an
office's local area network. First, the risk of disclosure to
unauthorized parties is small in the closed environment. Second,
encrypting data is costly. Third, encryption generally slows down the
movement of information within software applications and databases.
Here is a list of electronic data transfers and communications commonly
used in a medical office that could be considered for encryption:
* Patient billing and administrative information exchanged with
payers and health plans;
* Utilization and case management data, including authorizations and
referrals that are exchanged with payers, hospitals and utilization
management organizations;
* Patient health information gathered from or displayed on a Web
site or portal;
* Lab and other clinical data electronically sent to and received
from outside labs;
* Word-processing files used in transcription and other kinds of
patient reports that are transferred electronically;
* E-mails between physicians and patients, and between attending and
referring physicians and their offices.
Encryption of e-mail messages merits special attention because e-mail is
so common. Many patients enjoy direct online communications with their
physicians via e-mail. The problem, of course, is that e-mail is the
digital equivalent of a postcard. Anyone handling the message can easily
read its contents. It doesn't even have an envelope! And e-mails are
susceptible to forgery. How do you know for sure that the person listed
in the "from" field of an e-mail is the person who actually mailed the
message?
The problem with encrypting e-mail is that both parties of the e-mail
exchange need to be using compatible e-mail encryption products. This is
clumsy and, so far, rarely used. More commonly, encrypted e-mail message
exchanges occur when both parties agree to use a secure server or portal
system that requires both parties to use passwords and IDs to log on.
The AAFP has a partnership with Medfusion that permits AAFP members free
use of such a secure portal system for messaging with patients. For more
information, see
http://www.aafp.org/x23273.xml
http://www.aafp.org/x23273.xml
.
8. Consider Chains of Trust and Your Business Relationships
Your practice shares security concerns with any businesses that are
involved in the electronic transmission of your patients' information.
In effect, the security capability of insurance companies, transcription
and billing services, hospitals, labs and Internet service providers is
your concern.
"Chain of trust" is a concept used in the computer security field to
describe the contractual agreements made between parties to assure that
the confidential information they share remains secure throughout its
journey. There is no standard set of obligations for chain-of-trust
agreements. However, such agreements obligate both parties to adopt a
form of strong authentication such that data transmissions are
attributable and nondeniable. (Otherwise, one party or the other could
claim not to have received an important piece of information sent
electronically.)
The HIPAA security standards require your practice to obtain assurances
from business associates that they will implement the necessary
safeguards to protect the confidentiality, integrity and availability of
the electronic health information they create, maintain or transmit on
behalf of the practice.
The important issue here is to "know thy business partner." Every entity
with which you share information electronically is an extension of your
practice, whether you want them to be or not.
9. Demand That Your Vendors Fully Understand the HIPAA Security Standards
As you become better informed about computer security and the HIPAA
security standards, you will realize the extent to which compliance
makes you dependent on hardware, software, network and other information
technology (IT) vendors. Their products and services, whether
out-of-the-box computer hardware or hands-on-in-the-office IT services,
will enable you to meet many of the security standards - or not.
A good example is the requirement for audit controls. Audit controls
that permit you to record and examine activity in information systems
can require a combination of hardware, software, network and procedural
mechanisms to act in concert. If these components have been purchased
from separate vendors, it might be necessary to coordinate their setup
and configuration to meet the audit control requirement of the HIPAA
security standards. Who will perform this coordination in your office?
It might be a fortunate coincidence that the HIPAA security standards
have been mandated just as many family physicians are acquiring EHRs for
their practices. Many are choosing integrated EHR systems - that is,
products that include billing, scheduling and clinical information
software from the same vendor. This integration can greatly simplify
meeting the HIPAA security challenge - if you select the right EHR
vendor. (To see EHR reviews by your colleagues, check out the AAFP's
Center for Health Information Technology (CHiT) Web site at
http://www.centerforhit.org/x290.xml
http://www.centerforhit.org/x290.xml
.)
A single-vendor solution for small and medium medical practices allows
you to work more closely with the vendor to ensure that all the facets
of your computer system satisfy your practice's HIPAA security plan.
Some EHR vendors will even help you do a gap analysis as part of their
purchase program. But because most EHR vendors don't install the
hardware and networking components, your choice of a local contractor
for these services should be made with HIPAA in mind. Be certain that
your local contractor is fully aware of the HIPAA security standards and
is willing to assist you before you proceed.
10. Start With a Plan - and the End - in Mind
My hope is that after reading to this point you have a much better idea
of the breadth and scope of the HIPAA security standards, and that you
are better prepared to tackle the task of assessing your practice's
current state of computer security. There are some excellent tools that
can assist you in performing a gap analysis for this purpose without
having to hire a consultant. (One place to start is the Needs Assessment
page on the CHiT Web site, available at
http://www.centerforhit.org/x69.xml
http://www.centerforhit.org/x69.xml
.)
Remember that there is no cookbook or one-size-fits-all approach for
computer security. What counts is being "reasonable and appropriate"
when matching security measures with the level of risk that pertains to
your situation. These 10 steps should help you recognize a number of
places where your organization's computer security could be improved and
where some deficiencies might be easily addressed.
Send comments to
fpmedit@...
fpmedit@...
.
Editor's note: For more information about the Health Insurance
Portability and Accountability Act, visit FPM 's collection of HIPAA
articles at
http://www.aafp.org/x20098.xml
http://www.aafp.org/x20098.xml
.
CME Information
The print version of this article was originally certified for CME
credit. For accreditation details, contact the publisher. American
Academy of Family Physicians, 11400 Tomahawk Creek Parkway, Leawood, KS
66211-2672.
References
1. Available at:
http://www.cms.hhs.gov/hipaa/hipaa2/regulations/security/default.asp.
Accessed March 4, 2005.
2. O'Harrow R Jr. Prozac maker reveals patient e-mail addresses.
Washington Post. July 4, 2001:E1.
Sidebar: Key Points
* Practices will need to ensure that their current computer security
complies with the HIPAA standards that take effect April 21.
* Physicians should take responsibility for understanding how health
information technology is used in their practice
* By taking a proactive approach to your computer security now, you
will be able to detect and prevent trouble later.
* There is no one-size-fits-all approach for computer security.
Acknowledgements
He thanks Steven E. Waldren, MD, CHiT's assistant director, for his
assistance on this article.
Dr. Kibbe is director of the AAFP's Center for Health Information
Technology (CHiT).
Conflicts of interest: none reported.