Comment: A large number of commenters objected to the application of the proposed "minimum necessary" standard for uses and disclosures of protected health information to uses and disclosures for treatment purposes. Some suggested that the final regulation should establish a good faith exception or safe harbor for disclosures made for treatment.
The overwhelming majority of commenters, generally from the medical community, argued that application of the proposed standard would be contrary to sound medical practice, increase medical errors, and lead to an increase in liability. Some likened the standard to a 'gag clause' in that it limited the exchange of information critical for quality patient care. They found the standard unworkable in daily treatment situations. They argued that this standard would be potentially dangerous in that it could cause practitioners to withhold information that could be essential for later care. Commenters asserted that caregivers need to be able to give and receive a complete picture of the patient's health to make a diagnosis and develop a treatment plan.
Other commenters noted that the complexity of medicine is such that it is unreasonable to think that anyone will know the exact parameters of the information another caregiver will need for proper diagnosis and treatment or that a plan will need to support quality assurance and improvement activities. They therefore suggested that the minimum necessary standard be applied instead as an administrative requirement.
Providers also emphasized that they already have an ethical duty to limit the sharing of unnecessary medical information, and most already have well-developed guidelines and practice standards in place. Concerns were also voiced that attempts to provide the minimum necessary information in the treatment setting would lead to multiple editions of a record or creation of summaries that turn out to omit crucial information resulting in confusion and error.
Response: In response to these concerns, we substantially revise the minimum necessary requirements. As suggested by certain commenters, we provide, in § 164.502(b), that disclosures of protected health information to or requests by health care providers for treatment are not subject to the minimum necessary standard. We also modify the requirements for uses of protected health information. This final rule requires covered entities to make determinations of minimum necessary use, including use for treatment purposes, based on the role of the person or class of workforce members rather than at the level of specific uses. A covered entity must establish policies and procedures that identify the types of persons who are to have access to designated categories of information and the conditions, if any, of that access. We establish no requirements specific to a particular use of information. Covered entities are responsible for establishing and documenting these policies and procedures. This approach is consistent with the argument of many commenters that guidelines and practice standards are appropriate means for protecting the privacy of patient information.
Comment: Some commenters argued that the standard should be retained in the treatment setting for uses and disclosures pertaining to mental health information. Some of these commenters asserted that other providers do not need to know the mental status of a patient for treatment purposes.
Response: We agree that the standard should be retained for uses of mental health information in the treatment setting. However, we believe that the arguments for excepting disclosures of protected health information for treatment purposes from application of the minimum necessary standard are also persuasive with respect to mental health information. An individual's mental health can interact with proper treatment for other conditions in many ways. Psychoactive medications may have harmful interactions with drugs routinely prescribed for other purposes; an individual's mental health history may help another health care provider understand the individual's ability to abide by a complicated treatment regimen. For these reasons, it is also not reasonable to presume that, in every case, a health care provider will not need to know an individual's mental health status to provide appropriate treatment.
Providers' comments noted existing ethical duties to limit the sharing of unnecessary medical information, and well-developed guidelines and practice standards for this purpose. Under this rule, providers may use these tools to guide their discretion in disclosing health information for treatment.
Comment: Several commenters urged that covered entities should be required to conspicuously label records to show that they are not complete. They argued that absent such labeling, patient care could be compromised.
Response: We believe that the final policy to except disclosures of protected health information for treatment purposes from application of the minimum necessary standard addresses these commenters' concerns.
Comment: Some commenters argued that the audit exception to the minimum necessary requirements needs to be clarified or expanded, because "audit" and "payment" are essentially the same thing.
Response: We eliminate this exception. The proposed exclusion of disclosures to health plans for audit purposes is replaced with a general requirement that covered entities must limit requests to other covered entities for individually identifiable health information to what is reasonably necessary for the purpose intended.
Comment: Many commenters argued that the proposed standard was unworkable as applied to "uses" by a covered entity's employees, because the proposal appeared not to allow providers to create general policy as to the types of records that particular employees may have access to but instead required that each decision be made "individually," which providers interpret as "case-by-case." Commenters argued that the standard with regard to "uses" would be impossible to implement and prohibitively expensive, requiring both medical and legal input to each disclosure decision.
Some commenters recommended deletion of the minimum necessary standard with regard to "uses." Other commenters specifically recommended deletion of the requirement that the standard be applied on an individual, case-by-case basis. Rather, they suggested that the covered entity be allowed to establish general policies to meet the requirement. Another commenter similarly urged that the standard not apply to internal disclosures or for internal health care operations such as quality improvement/assurance activities. The commenter recommended that medical groups be allowed to develop their own standards to ensure that these activities are carried out in a manner that best helps the group and its patients.
Other commenters expressed confusion and requested clarification as to how the standard as proposed would actually work in day-to-day operations within an entity.
Response: Commenters' arguments regarding the workability of this standard as proposed were persuasive, and we therefore make significant modification to address these comments and improve the workability of the standard. For all uses and many disclosures, we require covered entities to include in their policies and procedures (see § 164.530), which may be standard protocols, for 'minimum necessary' uses and disclosures. We require implementation of such policies in lieu of making the 'minimum necessary' determination for each separate use and disclosure.
For uses, covered entities must implement policies and procedures that restrict access to and use of protected health information based on the specific professional roles of members of the covered entity's workforce. The policies and procedures must identify the persons or classes of persons in the entity's workforce who need access to protected health information to carry out their duties and the category or categories of protected health information to which such persons or classes need access. These role-based access rules must also identify the conditions, as appropriate, that would apply to such access. For example, an institutional health care provider could allow physicians access to all records under the condition that the viewing of medical records of patients not under their care is recorded and reviewed. Other health professionals' access could be limited to time periods when they are on duty. Information available to staff who are responsible for scheduling surgical procedures could be limited to certain data. In many instances, use of order forms or selective copying of relevant portions of a record may be appropriate policies to meet this requirement.
Routine disclosures also are not subject to individual review; instead, covered entities must implement policies and procedures (which may be standard protocols) to limit the protected health information in routine disclosures to the minimum information reasonably necessary to achieve the purpose of that type of disclosure. For non-routine disclosures, a covered entity must develop reasonable criteria to limit the protected health information disclosed to the minimum necessary to accomplish the purpose for which disclosure is sought, and to implement procedures for review of disclosures on an individual basis.
We modify the proposed standard to require the covered entity to make "reasonable efforts" to meet the minimum necessary standard (not "all"reasonable efforts, as proposed). What is reasonable will vary with the circumstances. When it is practical to use order forms or selective copying of relevant portions of the record, the covered entity is required to do so. Similarly, this flexibility in the standard takes into account the ability of the covered entity to configure its record system to allow selective access to only certain fields, and the practicality of organizing systems to allow this capacity. It might be reasonable for a covered entity with a highly computerized information system to implement a system under which employees with certain functions have access to only limited fields in a patient records, while other employees have access to the complete records. Such a system might not be reasonable for a covered entity with a largely paper records system.
Covered entities' policies and procedures must provide that disclosure of an entire medical record will not be made except pursuant to policies which specifically justify why the entire medical record is needed.
We believe that these modifications significantly improve the workability of this standard. At the same time, we believe that asking covered entities to assess their practices and establish rules for themselves will lead to significant improvements in the privacy of health information. See the preamble for § 164.514 for a more detailed discussion.
Comment: The minimum necessary standard should not be applied to uses and disclosures for payment or health care operations.
Response: Commenter's arguments for exempting these uses and disclosures from the minimum necessary standard were not compelling. We believe that our modifications to application of the minimum necessary standard to internal uses of protected health information, and to routine disclosures, address many of the concerns raised, particularly the concerns about administrative burdens and the concerns about having the information necessary for day-to-day operations. We do not eliminate this standard in part because we also remain concerned that covered entities may be tempted to disclose an entire medical record when only a few items of information are necessary, to avoid the administrative step of extracting the necessary information (or redacting the unnecessary information). We also believe this standard will cause covered entities to assess their privacy practices, give the privacy interests of their patients and enrollees greater attention, and make improvements that might otherwise not have been made. For this reason, the privacy benefits of retaining the minimum necessary standard for these purposes outweigh the burdens involved. We note that the minimum necessary standard is tied to the purpose of the disclosure; thus, providers may disclose protected health information as necessary to obtain payment.
Comment: Other commenters urged us to apply a "good faith" provision to all disclosures subject to the minimum necessary standard. Commenters presented a range of options to modify the proposed provisions which, in their view, would have mitigated their liability if they failed to comply with minimum necessary standard.
Response: We believe that the modifications to this standard, described above, substantially address these commenters' concerns. In addition to allowing the covered entity to use standard protocols for routine disclosures, we modify the standard to require a covered entity to make "reasonable efforts," not "all" reasonable efforts as proposed, in making the "minimum necessary" disclosure.
Comments: Some commenters complained that language in the proposed rule was vague and provided little guidance, and should be abandoned.
Response: In the preamble for § 164.504 and these responses to comments, we provide further guidance on how a covered entity can develop its policies for the minimum necessary use and disclosure of protected health information. We do not abandon this standard for the reasons described above. We remain concerned about the number of persons who have access to identifiable health information, and believe that causing covered entities to examine their practices will have significant privacy benefits.
Comment: Some commenters asked that the minimum necessary standard should not be applied to disclosures to business partners. Many of these commenters articulated the burdens they would bear if every disclosure to a business partner was required to meet the minimum necessary standard.
Response: We do not agree. In this final rule, we minimize the burden on covered entities in the following ways: in circumstances where disclosures are made on a routine, recurring basis, such as in on-going relationships between covered entities and their business associates, individual review of each routine disclosure has been eliminated; covered entities are required only to develop standard protocols to apply to such routine disclosures made to business associates (or types of business associates). In addition, we allow covered entities to rely on the representation of a professional hired to provide professional services as to what information is the minimum necessary for that purpose.
Comment: Some commenters were concerned that applying the standard in research settings will result in providers declining to participate in research protocols.
Response: We have modified the proposal to reduce the burden on covered entities that wish to disclose protected health information for research purposes. The final rule requires covered entities to obtain documentation or statements from persons requesting protected health information for research that, among other things, describe the information necessary for the research. We allow covered entities to reasonably rely on the documentation or statements as describing the minimum necessary disclosure.
Comment: Some commenters argued that government requests should not be subject to the minimum necessary standard, whether or not they are "authorized by law."
Response: We found no compelling reason to exempt government requests from this standard, other than when a disclosure is required by law. (See preamble to § 164.512(a) for the rationale behind this policy). When a disclosure is required by law, the minimum necessary standard does not apply, whether the recipient of the information is a government official or a private individual.
At the same time, we understand that when certain government officials make requests for protected health information, some covered entities might feel pressure to comply that might not be present when the request is from a private individuals. For this reason, we allow (but do not require) covered entities to reasonably rely on the representations of public officials as to the minimum necessary information for the purpose.
Comment: Some commenters argued that requests under proposed § 164.510 should not be subject to the minimum necessary standard, whether or not they are "authorized by law." Others argued that for disclosures made for administrative proceedings pursuant to proposed § 164.510, the minimum necessary standard should apply unless they are subject to a court order.
Response: We found no compelling reason to exempt disclosures for purposes listed in the regulation from this standard, other than for disclosures required by law. When there is no such legal mandate, the disclosure is voluntary on the part of the covered entity, and it is therefore reasonable to expect the covered entity to make some effort to protect privacy before making such a disclosure. If the covered entity finds that redacting unnecessary information, or extracting the requested information, prior to making the disclosure, is too burdensome, it need not make the disclosure. Where there is ambiguity regarding what information is needed, some effort on the part of the covered entity can be expected in these circumstances.
We also found no compelling reason to limit the exemption for disclosures "required by law" to those made pursuant to a court order. The judgment of a state legislature or regulatory body that a disclosure is required is entitled to no less deference than the same decision made by a court. For further rationale for this policy, see the preamble to § 164.512(a).
Comment: Some commenters argued that, in cases where a request for disclosure is not required by law, covered entities should be permitted to rely on the representations by public officials, that they have requested no more than the minimum amount necessary.
Response: We agree, and retain the proposed provision which allows reasonable reliance on the representations of public officials.
Comment: Some commenters argued that it is inappropriate to require covered entities to distinguish between disclosures that are "required by law" and those that are merely "authorized by law," for the purposes of determining when the standard applies.
Response: We do not agree. Covered entities have an independent duty to be aware of their legal obligations to federal, state, local and territorial or tribal authorities. In addition, § 164.514(h) allows covered entities to reasonably rely on the oral or written representation of public officials that a disclosure is required by law.
Comment: The minimum necessary standard should not be applied to pharmacists, or to emergency services.
Response: We believe that the final rule's exemption of disclosures of protected health information to health care providers for treatment purposes from the minimum necessary standard addresses these commenters concerns about emergency services. Together with the other changes we make to the proposed standard, we believe we have also addressed most of the commenters' concerns about pharmacists. With respect to pharmacists, the comments offered no persuasive reasons to treat pharmacists differently from other health care providers. Our reasons for retaining this standard for other uses and disclosures of protected health information are explained above.
Comment: A number of commenters argued that the standard should not apply to disclosures to attorneys, because it would interfere with the professional duties and judgment of attorneys in their representation of covered entities. Commenters stated that if a layperson within a covered entity makes an improper decision as to what the minimum necessary information is in regard to a request by the entity's attorney, the attorney may end up lacking information that is vital to representation. These commenters stated that attorneys are usually going to be in a better position to determine what information is truly the minimum necessary for effective counsel and representation of the client.
Response: We found no compelling reason to treat attorneys differently from other business associates. However, to ensure that this rule does not inadvertently cause covered entities to second-guess the professional judgment of the attorneys and other professionals they hire, we modify the proposed policies to explicitly allow covered entities to rely on the representation of a professional hired to provide professional services as to what information is the minimum necessary for that purpose.
Comment: Commenters from the law enforcement community expressed concern that providers may attempt to misuse the minimum necessary standard as a means to restrict access to information, particularly with regard to disclosures for health oversight or to law enforcement officials.
Response: The minimum necessary standard does not apply to disclosures required by law. Since the disclosures to law enforcement officials to which this standard applies are all voluntary, there would be no need for a covered entity to "manipulate" the standard; it could decline to make the disclosure.
Comment: Some commenters argued that the only exception to the application of the standard should be when an individual requests access to his or her own information. Many of these commenters expressed specific concerns about victims of domestic violence and other forms of abuse.
Response: We do not agree with the general assertion that disclosure to the individual is the only appropriate exception to the minimum necessary standard. There are other, limited, circumstances in which application of the minimum necessary standard could cause significant harm. For reasons described above, disclosures of protected health information for treatment purposes are not subject to this standard. Similarly, as described in detail in the preamble to § 164.512(a), where another public body has mandated the disclosure of health information, upsetting that judgment in this regulation would not be appropriate.
The more specific concerns expressed about victims of domestic violence and other forms of abuse are addressed in a new provision regarding disclosure of protected health information related to domestic violence and abuse (see § 164.512(c)), and in new limitations on disclosures to persons involved in the individual's care (see § 164.510(b)). We believe that the limitations we place on disclosure of health information in those circumstances address the concerns of these commenters.
Comment: Some commenters argued that disclosures to next of kin should be restricted to minimum necessary protected health information, and to protected health information about only the current medical condition.
Response: In the final regulation, we change the proposed provision regarding "next of kin" to more clearly focus on the disclosures we intended to target: disclosures to persons involved in the individual's care. We allow such disclosure only with the agreement of the individual, or where the covered entity has offered the individual the opportunity to object to the disclosure and the individual did not object. If the opportunity to object cannot practicably be provided because of the incapacity of the individual or other emergency, we require covered entities to exercise professional judgment in the best interest of the patient in deciding whether to disclose information. In such cases, we permit disclosure only of that information directly relevant to the person's involvement with the individual's health care. (This provision also includes limited disclosure to certain persons seeking to identify or locate an individual.) See § 164.510(b).
Some additional concerns expressed about victims of domestic violence and other forms of abuse are also addressed in a new section on disclosure of protected health information related to domestic violence and abuse. See § 164.512(c). We believe that the limitations we place on disclosure of health information in these provisions address the concerns of these commenters.
Comment: Some commenters argued that covered entities should be required to determine whether de-identified information could be used before disclosing information under the minimum necessary standard.
Response: We believe that requiring covered entities' policies and procedures for minimum necessary disclosures to address whether de-identified information could be used in all instances would impose burdens on some covered entities that could outweigh the benefits of such a requirement. There is significant variation in the sophistication of covered entities' information systems. Some covered entities can reasonably implement policies and procedures that make significant use of de-identified information; other covered entities would find such a requirement excessively burdensome. For this reason, we chose instead to require "reasonable efforts," which can vary according to the situation of each covered entity.
In addition, we believe that the fact that we allow de-identified information to be disclosed without regard to the policies, procedures, and documentation required for disclosure of identifiable health information will provide an incentive to encourage its use where appropriate.
Comment: Several commenters argued that standard transactions should not be subject to the standard.
Response: We agree that data elements that are required or situationally required in the standard transactions should not be, and are not, subject to this standard. However, in many cases, covered entities have significant discretion as to the information included in these transactions. Therefore, this standard does apply to those optional data elements.
Comment: Some commenters asked for clarification to understand how the minimum necessary standard is intended to interact with the security NPRM.
Response: The proposed Security Rule included requirements for electronic health information systems to include access management controls. Under this regulation, the covered entity's privacy policies will determine who has access to what protected health information. We will make every effort to ensure consistency prior to publishing the final Security Rule.
Comment: Many commenters, representing health care providers, argued that if the request was being made by a health plan, the health plan should be required to request only the minimum protected health information necessary. Some of these commenters stated that the requestor is in a better position to know the minimum amount of information needed for their purposes. Some of these commenters argued that the minimum necessary standard should be imposed only on the requesting entity. A few of these commenters argued that both the disclosing and the requesting entity should be subject to the minimum necessary standard, to create "internal tension" to assure the standard is honored.
Response: We agree, and in the final rule we require that a request for protected health information made by one covered entity to another covered entity must be limited to the minimum amount necessary for the purpose. As with uses and disclosures of protected health information, covered entities may have standard protocols for routine requests. Similarly, this requirement does not apply to requests made to health care providers for treatment purposes. We modify the rule to balance this provision; that is, it now applies both to disclosure of and requests for protected health information. We also allow, but do not require, the covered entity releasing the information to reasonably rely on the assertion of a requesting covered entity that it is requesting only the minimum protected health information necessary.
Comment: A few commenters suggested that there should be a process for resolving disputes between covered entities over what constitutes the 'minimum necessary' information.
Response: We do not intend that this rule change the way covered entities currently handle their differences regarding the disclosure of health information. We understand that the scope of information requested from providers by health plans is a source of tension in the industry today, and we believe it would not be appropriate to use this regulation to affect that debate. As discussed above, we require both the requesting and the disclosing covered entity to take privacy concerns into account, but do not inject additional tension into the on-going discussions.