Malcolm Rivera
The Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996 to prohibit transactions intended to induce or reward referrals for items or services reimbursed by federal healthcare programs. It also aims to improve care coordination between primary care physicians, hospitals, specialists, and public or private health payers, and to standardize healthcare transactions and protect the privacy and security of health information. HIPAA's Administrative Simplification provisions require the Secretary of HHS to adopt standards to ensure that covered entities maintain safeguards for the security of individually identifiable health information. The Security Rule defines confidentiality as data or information not being made available or disclosed to unauthorized persons or processes. This rule supports the Privacy Rule's prohibitions against improper uses and disclosures of PHI.
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What You'll Learn
Health Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes federal standards to protect sensitive health information from disclosure without a patient's consent. The US Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule to implement HIPAA requirements. The Privacy Rule standards address the use and disclosure of individuals' protected health information (PHI) by entities subject to the rule. These entities are called "covered entities" and include health plans, health care clearinghouses, and health care providers who conduct standard health care transactions. The Privacy Rule also contains standards for individuals' rights to understand and control how their health information is used.
The Administrative Simplification provisions of HIPAA require the Secretary of HHS to adopt standards to ensure that covered entities maintain appropriate administrative, physical, and technical safeguards for the security of certain individually identifiable health information. This includes ensuring the integrity and confidentiality of the information, protecting against reasonably anticipated threats or hazards to the security or integrity of the information, and protecting against unauthorized uses or disclosures of the information. The Security Rule defines "confidentiality" as ensuring that data or information is not made available or disclosed to unauthorized persons or processes.
The HIPAA Security Rule, published on February 20, 2003, protects a subset of information covered by the Privacy Rule. This subset includes all individually identifiable health information that a covered entity creates, receives, maintains, or transmits in electronic form, known as electronic protected health information (ePHI). To comply with the HIPAA Security Rule, covered entities must ensure the confidentiality, integrity, and availability of all ePHI, protect against reasonably anticipated threats to the security of the information, and protect against anticipated impermissible uses or disclosures that are not allowed by the rule.
HIPAA also includes provisions to improve the efficiency and effectiveness of the health care system, such as requiring HHS to adopt national standards for electronic health care transactions and code sets, unique health identifiers, and security. Additionally, HIPAA aims to improve care coordination between primary care physicians, hospitals, specialists, and public or private health payers, standardize health care transactions, and prohibit transactions intended to induce or reward referrals for items or services reimbursed by federal healthcare programs.
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Privacy Rule
The Privacy Rule, as part of the Health Insurance Portability and Accountability Act (HIPAA), provides guidelines for safeguarding individuals' confidential health information. It outlines the conditions under which protected health information (PHI) can be used and disclosed, with the aim of protecting individuals' privacy. This rule applies to health plans, healthcare providers, and their business associates.
The Privacy Rule allows individuals to request alternative means or locations for receiving their PHI. For instance, they can ask for communications to be sent to a designated address or phone number or request that sensitive information be sent in a sealed envelope rather than on a postcard. Health plans are required to accommodate these requests if the individual expresses that disclosing their PHI could put them in danger.
In terms of research, the Privacy Rule permits covered entities to use and disclose PHI for research purposes without obtaining individual authorizations in certain cases. An Institutional Review Board (IRB) or a Privacy Board can grant a "waiver" for a specific research protocol if they determine that the use or disclosure of PHI poses minimal risk to individuals' privacy.
The Privacy Rule also has provisions for de-identifying information. The "safe harbor" method involves removing 18 specified personal identifiers, allowing data to be considered de-identified. Additionally, covered entities must ensure the confidentiality, integrity, and availability of electronic PHI (ePHI). This includes implementing appropriate administrative, physical, and technical safeguards to protect ePHI from unauthorized access or disclosure.
Furthermore, the Privacy Rule grants individuals the right to access their PHI. This includes the ability to request access through Certified EHR Technology portals or direct electronic addresses. However, there are exceptions to this right, such as when the PHI was obtained under a promise of confidentiality or when granting access could reveal the source of the information.
In summary, the Privacy Rule under HIPAA establishes important guidelines for protecting individuals' confidential health information. It ensures that PHI is only used and disclosed under specific conditions, provides individuals with rights to access and control their PHI, and mandates appropriate safeguards to protect ePHI. These measures help maintain the privacy and security of sensitive health information.
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Security Rule
The HIPAA Security Rule establishes national standards to protect individuals' electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.
The Security Rule defines "confidentiality" as data or information that is not made available or disclosed to unauthorized persons or processes. This means that only authorized persons should have access to the data or information. The rule also promotes the two objectives of maintaining the integrity and availability of ePHI. "Integrity" means that data or information has not been altered or destroyed without authorization, while "availability" means that data or information is accessible and usable on demand by an authorized person.
The Security Rule requires regulated entities to ensure the confidentiality, integrity, and availability of all ePHI they create, receive, maintain, or transmit. This includes protecting against reasonably anticipated threats to the security or integrity of the information, as well as impermissible uses or disclosures. Regulated entities must also consider factors such as their size, complexity, technical infrastructure, and the costs of security measures when selecting security measures that meet the Security Rule's requirements.
The Administrative Safeguards provisions in the Security Rule require regulated entities to perform a thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI as part of their security management processes. This helps entities identify potential risks and determine which security measures are reasonable and appropriate to implement. The risk analysis and risk management provisions of the Security Rule are essential for implementing the necessary safeguards to protect ePHI.
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Confidential Communications
The HIPAA Security Rule also plays a role in protecting confidential communications. It requires covered entities to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI). This includes protecting against reasonably anticipated threats or hazards and unauthorized uses or disclosures. The Security Rule defines "confidentiality" as ensuring that data or information is not disclosed or made available to unauthorized persons or processes.
In addition, the HIPAA Breach Notification Rule outlines the responsibilities of covered entities and business associates in the event of a breach of unsecured protected health information. Covered entities must notify affected individuals, the Secretary, and in some cases, the media, of any breaches. Business associates must also notify the covered entity of any breaches without unreasonable delay and no later than 60 days from the discovery of the breach.
Furthermore, confidential communications are important in the context of reproductive health care. Covered entities or business associates must comply with certain requirements when receiving requests for protected health information related to reproductive health care. This includes ensuring that the reproductive health care is lawful under state law or authorized by federal law.
Overall, confidential communications are a critical aspect of protecting an individual's health information. By ensuring that sensitive information is only shared with authorized individuals and that appropriate safeguards are in place, individuals can maintain their privacy and security while also having access to their health information.
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Breach Notification Rule
The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, requires HIPAA-covered entities and their business associates to notify relevant parties following a breach of unsecured protected health information. A breach is generally defined as an impermissible use or disclosure that compromises the security or privacy of protected health information.
Covered entities and business associates must notify individuals, the Secretary, and, in certain cases, the media, following a breach. They must also notify affected individuals if their unsecured protected health information has been accessed, acquired, used, or disclosed as a result of the breach. This notification should include:
- A brief description of the incident, including the date of the breach and its discovery.
- Details of the types of unsecured protected health information involved (e.g., full name, social security number, date of birth).
- Any steps individuals should take to protect themselves from potential harm.
- An overview of the entity's response to the breach, including investigation, mitigation, and preventative measures.
- Contact procedures for individuals seeking further information, including a toll-free phone number, email address, website, or postal address.
There are, however, three exceptions to the definition of a breach. The first is when a workforce member or person acting under the authority of a covered entity unintentionally acquires, accesses, or uses protected health information in good faith and within their scope of authority. The second exception is when an authorized person at a covered entity or business associate inadvertently discloses protected health information to another authorized person. The final exception is when the covered entity or business associate believes in good faith that the unauthorized person who gained access to the information would not have been able to retain it.
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Frequently asked questions
To prohibit transactions intended to induce or reward referrals for items or services reimbursed by federal healthcare programs, to improve care coordination between primary care physicians, hospitals, specialists, and public or private health payers, and to standardize healthcare transactions and rules that protect the privacy and security of health information.
The HIPAA Privacy Rule states that health plans and covered healthcare providers must allow individuals to request alternative means or locations for receiving communications of protected health information.
The Security Rule, also known as the Standards for Privacy of Individually Identifiable Health Information, was published on February 20, 2003. It applies to covered entities, requiring them to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of ePHI.
ePHI refers to electronic Protected Health Information.
An impermissible use or disclosure of protected health information is presumed to be a breach unless the covered entity or business associate demonstrates a low probability that the information has been compromised.
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