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The HIPAA Security Rule was introduced in 2005, but it wasn't until the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 that additional security measures were added.
The HITECH Act introduced new requirements for business associates, requiring them to implement similar security measures as covered entities.
This amendment also increased the fines for non-compliance, making it more crucial for healthcare providers to implement robust security measures.
The HITECH Act of 2009 is the key amendment that introduced additional security measures to HIPAA.
Breach and Security
The 2013 Amendments introduced significant changes to the definition of a breach under HIPAA. A breach is now presumed to be an impermissible use or disclosure of PHI, unless a four-part risk assessment shows a low probability that PHI has been compromised.
The risk assessment considers the nature and extent of the PHI involved, the unauthorized person who used the PHI, whether the PHI was actually acquired or viewed, and the extent to which the risk to PHI has been mitigated.
If the risk assessment fails to demonstrate a low probability that any PHI has been compromised, breach notification is required.
Administrative Safeguards
Administrative Safeguards were introduced in a HIPAA amendment to ensure the security of electronic Protected Health Information (ePHI). This includes implementing a security management process that includes risk analysis, risk management, internal sanctions, and information system activity reviews.
A designated official is responsible for assigning security responsibilities. This includes implementing workforce security measures such as authorization and/or supervision of workforce members who work with ePHI, clearance procedures, and termination procedures.
Information access management is also crucial, including isolating health care clearinghouse functions (if any), access authorization, and access establishment and modification. This helps to prevent unauthorized access to ePHI.
Security awareness and training is another key aspect of Administrative Safeguards, including measures to protect against malicious software, log-in monitoring, and password management.
Here are some key aspects of Administrative Safeguards:
- Implementation of a security management process
- Assignment of security responsibilities
- Workforce security measures
- Information access management
- Security awareness and training
- Security incident procedures
- Contingency planning
- Periodic security evaluation
- Business associate contracts
Sale of PHI
The sale of Protected Health Information (PHI) is a serious issue in the healthcare industry. The 2013 Amendments provide a general prohibition on any disclosure in exchange for remuneration of PHI by a covered entity or business associate without an authorization from the individual.
This prohibition applies to all types of remuneration, not just financial payments. The term "remuneration" is defined broadly to include any benefit received in exchange for PHI.
To comply with this rule, covered entities and business associates must obtain an authorization from the individual before disclosing PHI in exchange for remuneration. This authorization must state that the disclosure will result in remuneration.
There are several exceptions to this general authorization requirement, including disclosures for public health, treatment and payment purposes, and sale and merger transactions. These exceptions are designed to allow for necessary disclosures while still protecting individual privacy.
Administrative Safeguards
Administrative Safeguards are a crucial part of protecting electronic Protected Health Information (ePHI). This involves implementing a security management process that includes risk analysis, risk management, internal sanctions, and information system activity reviews.
A designated official is assigned security responsibilities, which helps ensure that security measures are taken seriously. This official is responsible for overseeing the entire security process.
Workforce security measures are also essential, including authorization and/or supervision of workforce members who work with ePHI. Clearance procedures and termination procedures are also necessary to prevent unauthorized access to sensitive information.
Information access management is critical, including isolating health care clearinghouse functions (if any), access authorization, and access establishment and modification. This helps prevent unauthorized access to sensitive information.
Security awareness and training are also vital, including issuance of periodic security reminders, measures to protect against malicious software, log-in monitoring, and password management. This helps educate workforce members on the importance of security and how to prevent security breaches.
Security incident procedures must be implemented, including response to, and reporting of, such incidents. This helps ensure that security breaches are handled promptly and effectively.
Contingency planning is also essential, including planning for data backup, disaster recovery, and emergency mode operation. This helps ensure that business operations can continue even in the event of a security breach or disaster.
Business associate contracts are also necessary, including written contracts or other arrangements. This helps ensure that business associates handle sensitive information securely.
Here is a list of key administrative safeguards:
- Risk analysis and risk management
- Assignment of security responsibilities
- Workforce security measures
- Information access management
- Security awareness and training
- Security incident procedures
- Contingency planning
- Business associate contracts
Changes and Overlap
The Security Rule was designed to incorporate some of the same concepts and terminology as the Privacy Rule.
The two rules differ slightly in focus, with the Privacy Rule addressing how Protected Health Information (PHI) should be controlled, and the Security Rule implementing safeguards to protect electronic PHI from unauthorized access.
The Security Rule specifically covers electronic PHI, not PHI held in paper records, and sets forth security-specific provisions that must be addressed in business associate agreements and group health plan/plan sponsor relationships.
Overlap with Privacy Rule
The Security Rule and the Privacy Rule are inextricably linked, which means they share some similarities.
The Security Rule incorporates concepts and terminology from the Privacy Rule, such as the idea of "business associate" agreements, which must be addressed in the Security Rule. These agreements are crucial for protecting electronic PHI.
The Security Rule also adopts the concepts of "hybrid entities" and "affiliated covered entities", which were first introduced in the Privacy Rule. This shows how the two rules are connected.
The focus of the two rules differs slightly, with the Privacy Rule addressing how PHI should be controlled, while the Security Rule implements safeguards to protect electronic PHI from unauthorized access.
Changes from 1998 Rule
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The 1998 proposed rule for the Security Rule had some key differences that were later addressed. The Security Rule introduced the concept of "addressable" implementation specifications, which allows covered entities to implement alternative measures if it's not reasonable or appropriate to do so.
This change was made to give covered entities more flexibility in meeting the security standards. The Security Rule also dropped the concept of a "chain of trust" agreement, opting instead for the "business associate" agreement used in the Privacy Rule.
The Security Rule abandoned several proposed requirements that were deemed unnecessary or duplicative. For example, the requirement for a "formal mechanism for processing records" was dropped due to its ambiguity and lack of necessity.
The Security Rule expanded on some proposed requirements, such as adding a requirement for removing electronic PHI from electronic media before re-use. This change ensures that sensitive information is properly handled and disposed of.
Sources
- https://www.duanemorris.com/alerts/overview_2013_amendments_to_HIPAA_privacy_security_breach_notification_enforcement_rules_4734.html
- https://natlawreview.com/article/ocr-proposes-sweeping-hipaa-security-rule-amendments
- https://www.crowell.com/en/insights/client-alerts/hhs-issues-new-hipaa-security-rule
- https://www.advancedmd.com/blog/congress-passes-amendment-hipaa-regulations/
- https://www.foley.com/insights/publications/2024/07/hipaa-amendments-protect-reproductive-health-care/
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