How the HITECH Act Impacts a Business Associate

HIPAA compliance requirements have been- Encryption of all electronic files. The HITECH Act
greatly changed with the American Recovery andhas made the use of encryption the one thing
Reinvestment Act (ARRA) and its Title XIII calledthat provides a "safe harbour" for not having a
the HITECH (Health Information Technology forbreach. Data that is not encrypted is considered
Economic and Clinical Health) Act. With theunsecured according to the law. While you may
introduction of this new law, business associatesalready be using encryption for data transfers,
are now accountable for the privacy and securitythis law also requires that information be
requirements that previously were required onlyencrypted while "at rest." This may require that
by covered entities. In addition, a businessyou add encryption to all electronic files that are
associate is now subject to civil and criminalstored anywhere on your system. If you are in
penalties. This also includes a provision that letsmedical transcription, remember that this will also
patients receive financial compensation for ainclude the voice files stored on any dictation
violation of their privacy.system. The Secretary of HHS will review these
This new federal law has added strength to thestandards annually for any changes.
enforcement portion of the law. The significant- Breach notifications. While HIPAA has always
changes include:required that a business associate notify their
- Employees and other workforce members,client of any breaches of  information, the law
including independent contractors, are now subjectnow makes you responsible for being sure the
to civil penalties. This means that individuals arenotification is done. A breach is defined as
also now accountable legally.acquisition, access, use or disclosure of unsecured
- There is a requirement for HHS to formallyPHI that is not permitted under HIPAA and that
investigate any complaints and to impose civilcompromises the privacy or security of the
penalties for violations of the rules if the violationinformation. Remember that unsecured data
is due to "willful" neglect.means unencrypted. Documentation of breech
- The law requires that any civil monetarynotifications must be kept for six years.
penalties or monetary settlements as a result of- Be sure you are compliant with both the privacy
a violation of the rules be sent to the Office ofand security rules. There are many points to
Civil Rights (OCR) for enforcement of the privacyconsider in these rules. You must have written
and security rules.policies and procedures. You must have a written
- Civil monetary penalties now have a tieredrisk analysis done. You also must have a
system ranging from $100 to $50,000 dependingcontingency plan in place for any kind of business
on the offense.disruption. Your systems also have to provide
- The Secretary of HHS is required to conductaudit trails for who accesses protected health
periodic audits to be sure that covered entitiesinformation.
and business associates are compliant with the- Realize you are responsible for the actions of
new rules.your workforce. The rules require training of the
- The State Attorneys General now have theworkforce, which must be done and documented.
authority to bring suit in district courts for anyIf you have remote workers, this can be more
violation on behalf of the residents of their state.of a challenge, but it is possible.
What Steps Should a Business Associate Take to- Another significant change is that business
be sure you are Compliant?associates are now responsible for trying to stop
The first step is being sure you are properlyany violations by the covered entity (their client).
classified. For example, if you are an independentThis includes things even up to canceling your
contractor working for a service and not directlycontract with a client who refuses to fix a
contracting with a covered entity, that probablyviolation or prefers to ignore the law. Both parties
means you are not a business associate, but anare responsible for doing this for the other, and
agent or subcontractor of a business associate. Itthis could very well change some of the
is important, however, for independentrelationships you currently have with your clients.
contractors to understand if your contract is- Documentation. Remember, it's all about being
directly with the covered entity, that makes yousure you have things documented. Use the rule of
a business associate and all of the new laws dothumb that says "if it's not documented, it wasn't
apply to you.done." It is no longer acceptable to just say you
Some things you need to consider include:are compliant. You must have written
- Assigning responsibility for compliance to onedocumentation to show that you have done all of
person. While you can have a team working onthe required steps.
compliance issues, one person must be named asThe changes that have come as a result of the
the compliance officer and be responsible. ThisHITECH Act certainly have a big impact on
does not have to be an employee and you canbusiness associates. The date for compliance is
use a consultant if that works best for you,past. If you haven't taken the required steps,
however, it is critical that you have this personnow is the time to do it.
identified.