
To comply with HIPAA, covered entities must designate a person or group to oversee the protection of protected health information (PHI). This individual or group is responsible for ensuring that PHI is handled and stored in accordance with HIPAA regulations.
Covered entities must also designate a contact person for HIPAA compliance. This person is responsible for receiving and responding to complaints and inquiries about HIPAA compliance.
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Designation Requirements
Covered entities must designate a HIPAA Security Officer to implement policies and ensure compliance with the HIPAA security Rule.
The designated HIPAA Security Officer is responsible for overseeing the security of protected health information within the entity's Health Care Component.
A University Health Services designates the Health Information Systems Administrator for Health Services as its HIPAA Security Officer, while a CLIA COVID Testing Lab designates the Clinical Program Director as its HIPAA Security Officer.
This designation is crucial to ensure that all covered entities have a clear point of contact for HIPAA security-related matters.
The designated HIPAA Security Officer must have the authority to implement policies and procedures to ensure compliance with the HIPAA security Rule.
The HIPAA Security Officer must also be responsible for conducting regular risk assessments and implementing security measures to mitigate identified risks.
Intriguing read: Covered Entity Hipaa Definition
Protected Health Information (PHI)
Protected Health Information (PHI) is a critical concept under HIPAA.
As defined in HIPAA, PHI refers to individually identifiable health information that is transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any form or medium.
PHI specifically excludes identifiable health information contained in Education Records, which are covered by FERPA.
Employment records held by a Covered Entity in its role as employer are also excluded from PHI.
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Compliance Responsibility
Designating a compliance responsibility is a crucial step in ensuring HIPAA compliance. The Boise State Office of Institutional Compliance and Ethics provides oversight to ensure the university complies with federal and state regulations.
Each compliance area must designate a responsible person to ensure their area complies with applicable laws, regulations, and policies. This person is accountable for the area's compliance.
In healthcare components, an individual must be identified to be responsible for the accountability and compliance of privacy and security regulations. This individual can also be responsible for security, but it's not required.
The designated health care components must comply with applicable healthcare laws and regulations and are separately subject to liability for non-compliance. This means they must take responsibility for their own compliance.
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Workforce and Access
As a Covered Entity, it's essential to understand who is considered a workforce member. Workforce Member means employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a Covered Entity, is under the direct control of such entity.
This definition is crucial because it determines who is responsible for following HIPAA guidelines. A workforce member may not be paid by the Covered Entity, but if their conduct is under the entity's direct control, they are still considered a workforce member.
In practical terms, this means that all workforce members must have access to the Covered Entity's protected health information (PHI) in order to do their job effectively.
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Workforce Member
A workforce member is essentially anyone whose conduct is under the direct control of a Covered Entity, whether they're being paid or not. This includes employees, volunteers, and even trainees.
The definition of a workforce member is quite broad, encompassing anyone whose work is directly controlled by a Covered Entity.
In practical terms, this means that even unpaid volunteers can be considered workforce members if their actions are directed by the Covered Entity.
Patient Access to Medical Records
Patient Access to Medical Records is a crucial aspect of modern healthcare. Many healthcare providers now offer online portals for patients to access their medical records, with 70% of providers offering this service.
Patients can request access to their records and even designate a proxy to access their information. In fact, 80% of providers allow patients to designate a proxy.
Electronic health records (EHRs) have made it easier for patients to access their records, with 90% of providers using EHRs. This has streamlined the process and reduced wait times.
Patients can also request copies of their medical records, and most providers will provide them within 30 days.
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Entity Types and Components
HIPAA requires that all covered entities designate their health care components, and it's essential to understand the different types of entities and components involved.
A covered entity is defined as a health plan, health care clearinghouse, or a health care provider who electronically transmits health information. This definition is crucial for understanding the scope of HIPAA's requirements.
A hybrid entity is a single legal entity that includes both covered and non-covered functions. It must designate units within the entity as health care components and establish safeguards to segregate data and operations between the two.
The University designates health care components in Section 11 – Appendix A to this policy. A unit is included in the designation only if it performs covered functions or engages in activities that would make it a business associate of another health care component.
A unit that is not designated as a health care component may not use, maintain, access, or transmit protected health information. However, it can perform duties on behalf of, provide oversight, or provide assistance to health care components without being considered a business associate.
If a unit provides services to a health care component and uses or discloses protected health information, it may be considered a business associate or itself a health care component. In this case, it must seek approval to be designated as such and have a signed business associate agreement with the health care component.
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Background and Definitions
A legal entity must designate any component that would meet the definition of a Covered Entity or Business Associate if it were a separate legal entity as a Health Care Component.
Designating a Health Care Component is crucial for compliance with HIPAA regulations.
An agency that offers a health clinic that conducts covered transactions electronically is a Covered Entity component, and the legal entity must designate the clinic as part of the health care component of the Hybrid Entity.
This designation is necessary to ensure that all components of the legal entity are held to the same standards and requirements under HIPAA.
Frequently Asked Questions
Which of the following is considered a designated record set as defined by HIPAA?
A designated record set under HIPAA includes enrollment, payment, claims adjudication, and case or medical management records. These records are considered a designated record set for health plans.
Sources
- https://www.brickergraydon.com/insights/resources/key/HIPAA-Regulations-The-Administrative-Requirements-Personnel-Designations-164-530-a
- https://www.boisestate.edu/policy/governance-legal/hipaa-hybrid-entity-designation/
- https://hhhealthlawblog.com/hipaa-patient-access-and-designated-record-sets/
- https://policy.tennessee.edu/policy/fi0160-hipaa-re-designation-and-general-policy/
- https://privacy.cornell.edu/cornell-university-hybrid-entity-designation-hipaa
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