LII:HIPAA Compliance - LII 007 05. Administration

Previous lessons in the Laboratory Informatics Institute HIPAA Compliance series have dealt with explaining what HIPAA is, who it applies to, what data are protected and how the Protected Health Information (PHI) of individuals must be handled, according to HIPAA generally and the Privacy Rule. Implications for administration of HIPAA and how it applies to and affects healthcare organizations and administrative departments are also important to understand.

Requirements and Recommendations

Administratively, there are a few things to keep in mind when seeking to comply with HIPAA, according to the HHS:

Privacy Policies and Procedures

A covered entity (CE) must develop and implement written privacy policies and procedures that are consistent with the Privacy Rule. This is discussed in detail in Lesson 4, under Patient Notification and Rights.

Privacy Personnel

CEs must designate a "Privacy Official", who is responsible for developing and implementing its written privacy policies and procedures. It must also provide a contact person or contact office responsible for receiving complaints and providing individuals with information on the covered entity’s privacy practices. There isn't anything preventing these being the same person/office.

Workforce Training and Management

Workforce requirements are two-fold: privacy, and breach procedures. Workforce members include employees, volunteers and trainees, and may also include other persons whose conduct is under the direct control of the CE (whether or not they are paid by the CE). CEs must train all workforce members on privacy policies and procedures - but only as necessary and appropriate for them to carry out their functions. In addition, the CE must have and apply appropriate sanctions against workforce members who violate privacy policies and procedures or the HIPAA Privacy Rule. The information to do this is contained in this course and at the HHS website, as well as in the HIPAA law itself.

Mitigation

Sometimes HIPAA regulations and/or CE privacy policies are broken, either accidentally or intentionally. In such cases, a CE must mitigate (to the extent practicable) any harmful effect it learns was caused by that use or disclosure of PHI by its workforce or its business associates.

Data Safeguards

Per the HIPAA Security Rule, a CE must maintain reasonable and appropriate administrative, technical, and physical safeguards to prevent either intentional or unintentional use or disclosure of PHI in violation of the Privacy Rule, and to minimize its incidental use and disclosure in the process of providing otherwise allowed or required use or disclosure. For example, such safeguards could include shredding documents containing PHI before discarding them, securing medical records with lock and key or pass code, and limiting access to keys or pass codes. More suggestions can be had at the HHS website.

Complaints

To comply with HIPAA, a CE must have procedures for individuals to complain about problems with its compliance with privacy policies and procedures and the Privacy Rule. As stated above, the CE must provide those procedures in its privacy practices notice. In the notice, among other things, the CE must let individuals know where they can submit complaints to, and let them know that complaints can also be submitted to the Secretary of HHS.

Retaliation and Waiver

Under HIPAA, a CE may not retaliate against a person for:

• Exercising rights provided by the Privacy Rule
• Assisting in an investigation by HHS or another appropriate authority
• Opposing an act or practice that the person believes in good faith violates the Privacy Rule

A covered entity may not require an individual to waive any right under the Privacy Rule as a condition for obtaining treatment, payment, and enrollment or benefits eligibility.

Documentation and Record Retention

As a HIPAA CE, all actions, activities and designations that the Privacy Rule requires to be documented must be maintained until six years after the later of the date of their creation or last effective date. This includes CE privacy policies and procedures, privacy practices notices and disposition of any complaints, along with any other required documentation as outlined in this course and at HHS or in the HIPAA law available from the US Government Publishing Office.

Fully-Insured Group Health Plan Exception

The only administrative obligations with which a fully-insured group health plan that has no more than enrollment data and summary health information is required to comply are the

1. Ban on retaliatory acts and waiver of individual rights, and
2. Documentation requirements with respect to plan documents if such documents are amended to provide for the disclosure of PHI to the plan sponsor by a health insurance issuer or HMO that services the group health plan.

Organizational Options

Despite the guidance on who is actually required to comply (covered in Lesson 2: LII:HIPAA Compliance - LII 007 02. Who Needs to Comply?), there are subtle variations on the way entities are organized, departmentalized and the like, that require clarification on how HIPAA Privacy and Security rules apply. These are addressed here:

Hybrid

The Privacy Rule permits a covered entity that is a single legal entity and that conducts both covered and non-covered functions to elect to be a “hybrid entity.” (The activities that make a person or organization a covered entity are its “covered functions.”) To be a hybrid entity, the covered entity must designate in writing its operations that perform covered functions as one or more “health care components.” After making this designation, most of the requirements of the Privacy Rule will apply only to the health care components. A covered entity that does not make this designation is subject in its entirety to the Privacy Rule.

Affiliated

Legally separate covered entities that are affiliated by common ownership or control may designate themselves (including their health care components) as a single covered entity for Privacy Rule compliance. The designation must be in writing. An affiliated covered entity that performs multiple covered functions must operate its different covered functions in compliance with the Privacy Rule provisions applicable to those covered functions.

Organized Healthcare Arrangement

The Privacy Rule identifies relationships in which participating covered entities share protected health information to manage and benefit their common enterprise as “organized health care arrangements.” Covered entities in an organized health care arrangement can share protected health information with each other for the arrangement’s joint health care operations.

Covered Entities With Multiple Covered Functions

A covered entity that performs multiple covered functions must operate its different covered functions in compliance with the Privacy Rule provisions applicable to those covered functions. The covered entity may not use or disclose the protected health information of an individual who receives services from one covered function (e.g., health care provider) for another covered function (e.g., health plan) if the individual is not involved with the other function.

Group Health Plan disclosures to Plan Sponsors

A group health plan and the health insurer or HMO offered by the plan may disclose the following protected health information to the “plan sponsor”—the employer, union, or other employee organization that sponsors and maintains the group health plan:

Enrollment or disenrollment information with respect to the group health plan or a health insurer or HMO offered by the plan. If requested by the plan sponsor, summary health information for the plan sponsor to use to obtain premium bids for providing health insurance coverage through the group health plan, or to modify, amend, or terminate the group health plan. “Summary health information” is information that summarizes claims history, claims expenses, or types of claims experience of the individuals for whom the plan sponsor has provided health benefits through the group health plan, and that is stripped of all individual identifiers other than five digit zip code (though it need not qualify as de-identified protected health information).

PHI of the group health plan’s enrollees for the plan sponsor to perform plan administration functions. The plan must receive certification from the plan sponsor that the group health plan document has been amended to impose restrictions on the plan sponsor’s use and disclosure of the protected health information. These restrictions must include the representation that the plan sponsor will not use or disclose the protected health information for any employment-related action or decision or in connection with any other benefit plan.