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Fact Sheet
FOR IMMEDIATE RELEASE
Monday, April 14, 2003 |
Contact: HHS Press Office
(202) 690-6343 |
PROTECTING THE PRIVACY OF PATIENTS'
HEALTH INFORMATION
Overview: The
first-ever federal privacy standards to protect patients' medical
records and other health information provided to health plans,
doctors, hospitals and other health care providers took effect on
April 14, 2003. Developed by the Department of Health and Human
Services (HHS), these new standards provide patients with access to
their medical records and more control over how their personal health
information is used and disclosed. They represent a uniform, federal
floor of privacy protections for consumers across the country. State
laws providing additional protections to consumers are not affected by
this new rule.
Congress called on HHS to issue
patient privacy protections as part of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). HIPAA included
provisions designed to encourage electronic transactions and also
required new safeguards to protect the security and confidentiality of
health information. The final regulation covers health plans, health
care clearinghouses, and those health care providers who conduct
certain financial and administrative transactions (e.g., enrollment,
billing and eligibility verification) electronically. Most health
insurers, pharmacies, doctors and other health care providers were
required to comply with these federal standards beginning April 14,
2003. As provided by Congress, certain small health plans have an
additional year to comply. HHS has conducted extensive outreach and
provided guidance and technical assistant to these providers and
businesses to make it as easy as possible for them to implement the
new privacy protections. These efforts include answers to hundreds of
common questions about the rule, as well as explanations and
descriptions about key elements of the rule. These materials are
available at
http://www.hhs.gov/ocr/hipaa.
PATIENT PROTECTIONS
The new privacy regulations ensure a
national floor of privacy protections for patients by limiting the
ways that health plans, pharmacies, hospitals and other covered
entities can use patients' personal medical information. The
regulations protect medical records and other individually
identifiable health information, whether it is on paper, in computers
or communicated orally. Key provisions of these new standards include:
- Access To Medical Records.
Patients generally should be able to see and obtain copies of
their medical records and request corrections if they identify
errors and mistakes. Health plans, doctors, hospitals, clinics,
nursing homes and other covered entities generally should provide
access these records within 30 days and may charge patients for
the cost of copying and sending the records.
- Notice of Privacy Practices.
Covered health plans, doctors and other health care providers must
provide a notice to their patients how they may use personal
medical information and their rights under the new privacy
regulation. Doctors, hospitals and other direct-care providers
generally will provide the notice on the patient's first visit
following the April 14, 2003, compliance date and upon request.
Patients generally will be asked to sign, initial or otherwise
acknowledge that they received this notice. Health plans generally
must mail the notice to their enrollees by April 14 and again if
the notice changes significantly. Patients also may ask covered
entities to restrict the use or disclosure of their information
beyond the practices included in the notice, but the covered
entities would not have to agree to the changes.
- Limits on Use of Personal Medical
Information. The privacy rule sets limits on how health plans
and covered providers may use individually identifiable health
information. To promote the best quality care for patients, the
rule does not restrict the ability of doctors, nurses and other
providers to share information needed to treat their patients. In
other situations, though, personal health information generally
may not be used for purposes not related to health care, and
covered entities may use or share only the minimum amount of
protected information needed for a particular purpose. In
addition, patients would have to sign a specific authorization
before a covered entity could release their medical information to
a life insurer, a bank, a marketing firm or another outside
business for purposes not related to their health care.
- Prohibition on Marketing. The
final privacy rule sets new restrictions and limits on the use of
patient information for marketing purposes. Pharmacies, health
plans and other covered entities must first obtain an individual's
specific authorization before disclosing their patient information
for marketing. At the same time, the rule permits doctors and
other covered entities to communicate freely with patients about
treatment options and other health-related information, including
disease-management programs.
- Stronger State Laws. The new
federal privacy standards do not affect state laws that provide
additional privacy protections for patients. The confidentiality
protections are cumulative; the privacy rule will set a national
"floor" of privacy standards that protect all Americans,
and any state law providing additional protections would continue
to apply. When a state law requires a certain disclosure -- such
as reporting an infectious disease outbreak to the public health
authorities -- the federal privacy regulations would not preempt
the state law.
- Confidential communications.
Under the privacy rule, patients can request that their doctors,
health plans and other covered entities take reasonable steps to
ensure that their communications with the patient are
confidential. For example, a patient could ask a doctor to call
his or her office rather than home, and the doctor's office should
comply with that request if it can be reasonably accommodated.
- Complaints. Consumers may
file a formal complaint regarding the privacy practices of a
covered health plan or provider. Such complaints can be made
directly to the covered provider or health plan or to HHS' Office
for Civil Rights (OCR), which is charged with investigating
complaints and enforcing the privacy regulation. Information about
filing complaints should be included in each covered entity's
notice of privacy practices. Consumers can find out more
information about filing a complaint at
http://www.hhs.gov/ocr/hipaa
or by calling (866) 627-7748.
HEALTH PLANS AND PROVIDERS
The privacy rule requires health plans,
pharmacies, doctors and other covered entities to establish policies
and procedures to protect the confidentiality of protected health
information about their patients. These requirements are flexible and
scalable to allow different covered entities to implement them as
appropriate for their businesses or practices. Covered entities must
provide all the protections for patients cited above, such as
providing a notice of their privacy practices and limiting the use and
disclosure of information as required under the rule. In addition,
covered entities must take some additional steps to protect patient
privacy:
- Written Privacy Procedures.
The rule requires covered entities to have written privacy
procedures, including a description of staff that has access to
protected information, how it will be used and when it may be
disclosed. Covered entities generally must take steps to ensure
that any business associates who have access to protected
information agree to the same limitations on the use and
disclosure of that information.
- Employee Training and Privacy
Officer. Covered entities must train their employees in their
privacy procedures and must designate an individual to be
responsible for ensuring the procedures are followed. If covered
entities learn an employee failed to follow these procedures, they
must take appropriate disciplinary action.
- Public Responsibilities. In
limited circumstances, the final rule permits -- but does not
require --covered entities to continue certain existing
disclosures of health information for specific public
responsibilities. These permitted disclosures include: emergency
circumstances; identification of the body of a deceased person, or
the cause of death; public health needs; research that involves
limited data or has been independently approved by an
Institutional Review Board or privacy board; oversight of the
health care system; judicial and administrative proceedings;
limited law enforcement activities; and activities related to
national defense and security. The privacy rule generally
establishes new safeguards and limits on these disclosures. Where
no other law requires disclosures in these situations, covered
entities may continue to use their professional judgment to decide
whether to make such disclosures based on their own policies and
ethical principles.
- Equivalent Requirements For
Government. The provisions of the final rule generally apply
equally to private sector and public sector covered entities. For
example, private hospitals and government-run hospitals covered by
the rule have to comply with the full range of requirements.
OUTREACH AND ENFORCEMENT
HHS' Office for Civil Rights (OCR)
oversees and enforces the new federal privacy regulations. Led by OCR,
HHS has issued extensive guidance and technical assistance materials
to make it as easy as possible for covered entities to comply with the
new requirements. Key elements of OCR's outreach and enforcement
efforts include:
- Guidance and technical assistance
materials. HHS has issued extensive guidance and technical
materials to explain the privacy rule, including an extensive,
searchable collection of frequently asked questions that address
major aspects of the rule. HHS will continue to expand and update
these materials to further assist covered entities in complying.
These materials are available at
http://www.hhs.gov/ocr/hipaa/assist.html.
- Conferences and seminars. HHS
has participated in hundreds of conferences, trade association
meetings and conference calls to explain and clarify the
provisions of the privacy regulation. These included a series of
regional conferences sponsored by HHS, as well as many held by
professional associations and trade groups. HHS will continue
these outreach efforts to encourage compliance with the privacy
requirements.
- Information line. To help
covered entities find out information about the privacy regulation
and other administrative simplification provisions of the Health
Insurance Portability and Accountability Act of 1996, OCR and HHS'
Centers for Medicare & Medicaid Services have established a
toll-free information line. The number is (866) 627-7748.
- Complaint investigations.
Enforcement will be primarily complaint-driven. OCR will
investigate complaints and work to make sure that consumers
receive the privacy rights and protections required under the new
regulations. When appropriate, OCR can impose civil monetary
penalties for violations of the privacy rule provisions. Potential
criminal violations of the law would be referred to the U.S.
Department of Justice for further investigation and appropriate
action.
- Civil and Criminal Penalties.
Congress provided civil and criminal penalties for covered
entities that misuse personal health information. For civil
violations of the standards, OCR may impose monetary penalties up
to $100 per violation, up to $25,000 per year, for each
requirement or prohibition violated. Criminal penalties apply for
certain actions such as knowingly obtaining protected health
information in violation of the law. Criminal penalties can range
up to $50,000 and one year in prison for certain offenses; up to
$100,000 and up to five years in prison if the offenses are
committed under "false pretenses"; and up to $250,000
and up to 10 years in prison if the offenses are committed with
the intent to sell, transfer or use protected health information
for commercial advantage, personal gain or malicious harm.
Note: All HHS press releases, fact
sheets and other press materials are available at
http://www.hhs.gov/news.
Last Revised: April
14, 2003
U.S. Department of
Health & Human Services • 200 Independence Avenue, S.W. •
Washington, D.C. 20201
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