The U.S. Department of Health and Human Services (HHS) moved forward
today to strengthen the privacy and security protections for health
information established under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA).
The final omnibus rule greatly enhances a patient's privacy protections,
provides individuals new rights to their health information, and
strengthens the government's ability to enforce the law.
"Much has changed in health care since HIPAA was enacted over fifteen
years ago," said HHS Secretary Kathleen Sebelius. "The new rule will
help protect patient privacy and safeguard patients' health information
in an ever expanding digital age."
The changes in the final rulemaking provide the public with increased
protection and control of personal health information. The HIPAA Privacy
and Security Rules have focused on health care providers, health plans
and other entities that process health insurance claims. The changes
announced today expand many of the requirements to business associates
of these entities that receive protected health information, such as
contractors and subcontractors. Some of the largest breaches reported to
HHS have involved business associates. Penalties are increased for
noncompliance based on the level of negligence with a maximum penalty of
$1.5 million per violation. The changes also strengthen the Health
Information Technology for Econoic and Clinical Health (HITECH) Breach
Notification requirements by clarifying when breaches of unsecured
health information must be reported to HHS.
Individual rights are expanded in important ways. Patients can ask for a
copy of their electronic medical record in an electronic form. When
individuals pay by cash they can instruct their provider not to share
information about their treatment with their health plan. The final
omnibus rule sets new limits on how information is used and disclosed
for marketing and fundraising purposes and prohibits the sale of an
individuals' health information without their permission.
"This final omnibus rule marks the most sweeping changes to the HIPAA
Privacy and Security Rules since they were first implemented," said HHS
Office for Civil Rights Director Leon Rodriguez. "These changes not only
greatly enhance a patient's privacy rights and protections, but also
strengthen the ability of my office to vigorously enforce the HIPAA
privacy and security protections, regardless of whether the information
is being held by a health plan, a health care provider, or one of their
The final rule also reduces burden by streamlining individuals' ability
to authorize the use of their health information for research purposes.
The rule makes it easier for parents and others to give permission to
share proof of a child's immunization with a school and gives covered
entities and business associates up to one year after the 180-day
compliance date to modify contracts to comply with the rule.
The final omnibus rule is based on statutory changes under the HITECH
Act, enacted as part of the American Recovery and Reinvestment Act of
2009, and the Genetic Information Nondiscrimination Act of 2008 (GINA)
which clarifies that genetic information is protected under the HIPAA
Privacy Rule and prohibits most health plans from using or disclosing
genetic information for underwriting purposes.
The Rulemaking announced today may be viewed in the Federal Register at https://www.federalregister.gov/public-inspection.
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