HIPAA FAQ – Minimum Necessary
Yes. The HIPAA Privacy Rule explicitly permits a covered entity to reasonably rely on a researcher’s documentation of an Institutional Review Board (IRB) or Privacy Board waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is the minimum necessary for the research purpose. See 45 CFR 164.514(d)(3)(iii). This is true regardless of whether the documentation is obtained from an external IRB or Privacy Board or from one that is associated with the covered entity.
Covered entities are required to apply the minimum necessary standard to their own requests for protected health information. One covered entity may reasonably rely on another covered entity’s request as the minimum necessary, and then does not need to engage in a separate minimum necessary determination. See 45 CFR 164.514(d)(3)(iii).
However, if a covered entity does not agree that the amount of information requested by another covered entity is reasonably necessary for the purpose, it is up to both covered entities to negotiate a resolution of the dispute as to the amount of information needed. Nothing in the Privacy Rule prevents a covered entity from discussing its concerns with another covered entity making a request, and negotiating an information exchange that meets the needs of both parties. Such discussions occur today and may continue after the compliance date of the Privacy Rule.
No. The basic standard for minimum necessary uses requires that covered entities make reasonable efforts to limit access to protected health information to those in the workforce that need access based on their roles in the covered entity.
The Department generally does not consider facility redesigns as necessary to meet the reasonableness standard for minimum necessary uses. However, covered entities may need to make certain adjustments to their facilities to minimize access, such as isolating and locking file cabinets or records rooms, or providing additional security, such as passwords, on computers maintaining personal information.
Covered entities should also take into account their ability to configure their record systems to allow access to only certain fields, and the practicality of organizing systems to allow this capacity. For example, it may not be reasonable for a small, solo practitioner who has largely a paper-based records system to limit access of employees with certain functions to only limited fields in a patient record, while other employees have access to the complete record. In this case, appropriate training of employees may be sufficient. Alternatively, a hospital with an electronic patient record system may reasonably implement such controls, and therefore, may choose to limit access in this manner to comply with the Privacy Rule.
Yes, the Privacy Rule permits a provider who is a covered entity to disclose a complete medical record including portions that were created by another provider, assuming that the disclosure is for a purpose permitted by the Privacy Rule, such as treatment.
No. The Privacy Rule does not prohibit the use, disclosure, or request of an entire medical record; and a covered entity may use, disclose, or request an entire medical record without a case-by-case justification, if the covered entity has documented in its policies and procedures that the entire medical record is the amount reasonably necessary for certain identified purposes.
For uses, the policies and procedures would identify those persons or classes of person in the workforce that need to see the entire medical record and the conditions, if any, that are appropriate for such access. Policies and procedures for routine disclosures and requests and the criteria used for non-routine disclosures and requests would identify the circumstances under which disclosing or requesting the entire medical record is reasonably necessary for particular purposes.The Privacy Rule does not require that a justification be provided with respect to each distinct medical record.
Finally, no justification is needed in those instances where the minimum necessary standard does not apply, such as disclosures to or requests by a health care provider for treatment purposes or disclosures to the individual who is the subject of the protected health information.
No, because the Privacy Rule exempts from the minimum necessary standard any uses or disclosures that are required for compliance with the applicable requirements of the transactions standards, including disclosures of all data elements that are required or situationally required in those transactions. See 45 CFR 164.502(b)(2)(vi).
However, covered entities have significant discretion as to the information included in the transactions as optional data elements. Therefore, the minimum necessary standard does apply to the optional data elements. The transactions standard adopted for the outpatient pharmacy sector is an example of a standard that uses optional data elements. The health plan, or payer, currently specifies which of the optional data elements are needed for payment of its particular pharmacy claims. The health plan or its business associates must apply the minimum necessary standard when requesting this information. In this example, a pharmacist may reasonably rely on the health plan’s request for information as the minimum necessary for the intended disclosure. For example, as part of a routine protocol, the name of the individual may be requested by the payer as the minimum necessary to validate the identity of the claimant or for drug interaction or other patient safety reasons.
No. These disclosures must be authorized by an individual and, therefore, are exempt from the HIPAA Privacy Rule’s minimum necessary requirements. Furthermore, use of the provider’s own authorization form is not required. Providers can accept an agency’s authorization form as long as it meets the requirements of 45 CFR 164.508 of the Privacy Rule.
No. Uses and disclosures that are authorized by the individual are exempt from the minimum necessary requirements. For example, if a covered health care provider receives an individual’s authorization to disclose medical information to a life insurer for underwriting purposes, the provider is permitted to disclose the information requested on the authorization without making any minimum necessary determination. The authorization must meet the requirements of 45 CFR 164.508.
No. The definition of “health care operations” in the Privacy Rule provides for “conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers.” Covered entities can shape their policies and procedures for minimum necessary uses and disclosures to permit medical trainees access to patients’ medical information, including entire medical records.
No. Disclosures for treatment purposes (including requests for disclosures) between health care providers are explicitly exempted from the minimum necessary requirements.
Uses of protected health information for treatment are not exempt from the minimum necessary standard. However, the Privacy Rule provides the covered entity with substantial discretion with respect to how it implements the minimum necessary standard, and appropriately and reasonably limits access to identifiable health information within the covered entity. The Rule recognizes that the covered entity is in the best position to know and determine who in its workforce needs access to personal health information to perform their jobs. Therefore, the covered entity may develop role-based access policies that allow its health care providers and other employees, as appropriate, access to patient information, including entire medical records, for treatment purposes.
The HIPAA Privacy Rule requires a covered entity to make reasonable efforts to limit use, disclosure of, and requests for protected health information to the minimum necessary to accomplish the intended purpose. To allow covered entities the flexibility to address their unique circumstances, the Rule requires covered entities to make their own assessment of what protected health information is reasonably necessary for a particular purpose, given the characteristics of their business and workforce, and to implement policies and procedures accordingly. This is not an absolute standard and covered entities need not limit information uses or disclosures to those that are absolutely needed to serve the purpose. Rather, this is a reasonableness standard that calls for an approach consistent with the best practices and guidelines already used by many providers and plans today to limit the unnecessary sharing of medical information.
The minimum necessary standard requires covered entities to evaluate their practices and enhance protections as needed to limit unnecessary or inappropriate access to protected health information. It is intended to reflect and be consistent with, not override, professional judgment and standards. Therefore, it is expected that covered entities will utilize the input of prudent professionals involved in health care activities when developing policies and procedures that appropriately limit access to personal health information without sacrificing the quality of health care.
Yes. Where a covered entity is a party to a legal proceeding, such as a plaintiff or defendant, the covered entity may use or disclose protected health information for purposes of the litigation as part of its health care operations. The definition of “health care operations” at 45 CFR 164.501 includes a covered entity’s activities of conducting or arranging for legal services to the extent such activities are related to the covered entity’s covered functions (i.e., those functions that make the entity a health plan, health care provider, or health care clearinghouse). Thus, for example, a covered entity that is a defendant in a malpractice action, or a plaintiff in a suit to obtain payment, may use or disclose protected health information for such litigation as part of its health care operations.
The covered entity, however, must make reasonable efforts to limit such uses and disclosures to the minimum necessary to accomplish the intended purpose. See 45 CFR 164.502(b), 164.514(d). In most cases, the covered entity will share protected health information for litigation purposes with its lawyer, who is either a workforce member or a business associate. In these cases, the Privacy Rule permits a covered entity to reasonably rely on the representations of a lawyer who is a business associate or workforce member that the information requested is the minimum necessary for the stated purpose. See 45 CFR 164.514(d)(3)(iii)(C). A covered entity’s minimum necessary policies and procedures may provide for such reasonable reliance on the lawyer’s requests for protected health information needed in the course of providing legal services to the covered entity.
In disclosing protected health information for litigation purposes, the lawyer who is a workforce member of the covered entity must make reasonable efforts to limit the protected health information disclosed to the minimum necessary for the purpose of the disclosure. Similarly, a lawyer who is a business associate must apply the minimum necessary standard to its disclosures, as the business associate contract may not authorize the business associate to further use or disclose protected health information in a manner that would violate the HIPAA Privacy Rule if done by the covered entity. Depending on the circumstances, this could involve de-identifying the information or stripping direct identifiers from the information to protect the privacy of individuals, and may in some cases limit disclosures more significantly than would be required to meet a “relevance” standard. Further, whether as workforce members or business associates, lawyers may consider availing themselves of the protections routinely afforded to similarly confidential information within the litigation forum, such as protective orders on the use of the information in public portions of the proceedings.
No. The Privacy Rule is not intended to impede the flow of health information to those who need it to process or adjudicate claims, or coordinate care, for injured or ill workers under workers’ compensation systems. The minimum necessary standard generally requires covered entities to make reasonable efforts to limit uses and disclosures of, as well as requests for, protected health information to the minimum necessary to accomplish the intended purpose. For disclosures of protected health information made for workers’ compensation purposes under 45 CFR 164.512(l), the minimum necessary standard permits covered entities to disclose information to the full extent authorized by State or other law. In addition, where protected health information is requested by a State workers’ compensation or other public official for such purposes, covered entities are permitted reasonably to rely on the official’s representations that the information requested is the minimum necessary for the intended purpose. See 45 CFR 164.514(d)(3)(iii)(A).
For disclosures of protected health information for payment purposes, covered entities may disclose the type and amount of information necessary to receive payment for any health care provided to an injured or ill worker.
The minimum necessary standard does not apply to disclosures that are required by State or other law or made pursuant to the individual’s authorization.
A covered entity’s contract with a business associate may not authorize the business associate to use or further disclose the information in a manner that would violate the HIPAA Privacy Rule if done by the covered entity. See 45 CFR 164.504(e)(2)(i). Thus, a business associate contract must limit the business associate’s uses and disclosures of, as well as requests for, protected health information to be consistent with the covered entity’s minimum necessary policies and procedures. Given that a business associate contract must limit a business associate’s requests for protected health information on behalf of a covered entity to that which is reasonably necessary to accomplish the intended purpose, a covered entity is permitted to reasonably rely on such requests from a business associate of another covered entity as the minimum necessary.