Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Section 164.510(b) - Uses and Disclosures for Involvement in the Individual's Care and Notification Purposes

12/28/2000

Comment: A number of comments supported the NPRM's proposed approach, which would have allowed covered entities to disclose protected health information to the individual's next of kin, family members, or other close personal friends when the individual verbally agreed to the disclosure. These commenters agreed that the presumption should favor disclosures to the next of kin, and they believed that health care providers should encourage individuals to share genetic information and information about transmittable diseases with family members at risk. Others agreed with the general approach but suggested the individual's agreement be noted in the medical record. These commenters also supported the NPRM's proposed reliance on good professional practices and ethics to determine when disclosures should be made to the next of kin when the individual's agreement could not practicably be obtained.

A few commenters recommended that the individual's agreement be in writing for the protection of the covered entity and to facilitate the monitoring of compliance with the individual's wishes. These commenters were concerned that, absent the individual's written agreement, the covered entity would become embroiled in intra-family disputes concerning the disclosures. Others argued that the individual's authorization should be obtained for all disclosures, even to the next of kin.

One commenter favored disclosures to family members and others unless the individual actively objected, as long as the disclosure was consistent with sound professional practice. Others believed that no agreement by the individual was necessary unless sensitive medical information would be disclosed or unless the health care provider was aware of the individual's prior objection. These commenters recommended that good professional practice and ethics determine when disclosures were appropriate and that disclosure should relate only to the individual's current treatment. A health care provider organization said that the ethical and legal obligations of the medical professional alone should control in this area, although it believed the proposed rule was generally consistent with these obligations.

Response: The diversity of comments regarding the proposal on disclosures to family members, next of kin, and other persons, reflects a wide range of current practice and individual expectations. We believe that the NPRM struck the proper balance between the competing interests of individual privacy and the need that covered health care providers may have, in some cases, to have routine, informal conversations with an individual's family and friends regarding the individual's treatment.

We do not agree with the comments stating that all such disclosures should be made only with consent or with the individual's written authorization. The rule does not prohibit obtaining the agreement of the individual in writing; however, we believe that imposing a requirement for consent or written authorization in all cases for disclosures to individuals involved in a person's care would be unduly burdensome for all parties. In the final rule, we clarify the circumstances in which such disclosures are permissible. The rule allows covered entities to disclose to family members, other relatives, close personal friends of the individual, or any other person identified by the individual, the protected health information directly relevant to such person's involvement with the individual's care or payment related to the individual's health care. In addition, the final rule allows covered entities to use or disclose protected health information to notify, or assist in the notification of (including identifying or locating) a family member, a personal representative of the individual, or another person responsible for the care of the individual, of the individual's location, general condition, or death. The final rule includes separate provisions for situations in which the individual is present and for when the individual is not present at the time of disclosure. When the individual is present and can make his or her own decisions, a covered entity may disclose protected health information only if the covered entity: (1) obtains the individual's agreement to disclose to the third parties involved in the individual's care; (2) provides the individual with the opportunity to object to the disclosure, and the individual does not express an objection; or (3) reasonably infers from the circumstances, based on the exercise of professional judgement, that the individual does not object to the disclosure. The final rule continues to permit disclosures in circumstances when the individual is not present or when the opportunity to agree or object to the use or disclosure cannot practicably be provided due to the individual's incapacity or an emergency circumstance. In such instances, covered entities may, in the exercise of professional judgement, determine whether the disclosure is in the individual's best interests and if so, disclose only the protected health information that is directly relevant to the person's involvement with the individual's health care.

As discussed in the preamble for this section, we do not intend to disrupt most covered entities' current practices with respect to informing family members and others with whom a patient has a close personal relationship about a patient's specific health condition when a patient is incapacitated due to a medical emergency and the family member or close personal friend comes to the covered entity to ask about the patient's condition. To the extent that disclosures to family members and others in these situations currently are allowed under state law and covered entities' own rules, § 164.510(b) allows covered entities to continue making them in these situations, consistent with the exercise of professional judgement as to the patient's best interest. As indicated in the preamble above, this section is not intended to provide a loophole for avoiding the rule's other requirements, and it is not intended to allow disclosures to a broad range of individuals, such as journalists who may be curious about a celebrity's health status.

Comments: A few comments supported the NPRM approach because it permitted the current practice of allowing someone other than the patient to pick up prescriptions at pharmacies. One commenter noted that this practice occurs with respect to 25-40% of the prescriptions dispensed by community retail pharmacies. These commenters strongly supported the proposal's reliance on the professional judgement of pharmacists in allowing others to pick up prescriptions for bedridden or otherwise incapacitated patients, noting that in most cases it would be impracticable to verify that the person was acting with the individual's permission. Two commenters requested that the rule specifically allow this practice. One comment opposed the practice of giving prescriptions to another person without the individual's authorization, because a prescription implicitly could disclose medical information about the individual.

Response: As stated in the NPRM, we intended for this provision to authorize pharmacies to dispense prescriptions to family or friends who are sent by the individual to the pharmacy to pick up the prescription. We believe that stringent consent or verification requirements would place an unreasonable burden on numerous transactions. In addition, such requirements would be contrary to the expectations and preferences of all parties to these transactions. Although prescriptions are protected health information under the rule, we believe that the risk to individual privacy in allowing this practice to continue is minimal. We agree with the suggestion that the final rule should state explicitly that pharmacies have the authority to operate in this manner. Therefore, we have added a sentence to § 164.510(b)(3) allowing covered entities to use professional judgement and experience with common practice to make reasonable inferences of an individual's best interest in allowing a person to act on the individual's behalf to pick up filled prescriptions, medical supplies, X-rays, or other similar forms of protected health information. In such situations, as when making disclosures of protected health information about an individual who is not present or is unable to agree to such disclosures, covered entities should disclose only information which directly relates to the person's involvement in the individual's current health care. Thus, when dispensing a prescription to a friend who is picking it up on the patient's behalf, the pharmacist should not disclose unrelated health information about medications that the patient has taken in the past which could prove embarrassing to the patient.

Comment: We received a few comments that misunderstood the provision as addressing disclosures related to deceased individuals.

Response: We understand that use of the term next of kin in this section may cause confusion. To promote clarity in the final rule, we eliminate the term "next of kin," as well as the term's proposed definition. In the final rule, we address comments on next of kin and the deceased in the section on disclosure of protected health information about deceased individuals in § 164.512(g).

Comments: A number of commenters expressed concern for the interaction of the proposed section with state laws. Some of these comments interpreted the NPRM's use of the term next of kin as referring to individuals with health care power of attorney and thus they believed that the proposed rule's approach to next of kin was inappropriately informal and in conflict with state law. Others noted that some state laws did not allow health care information to be disclosed to family or friends without consent or other authorization. One commenter said that case law may be evolving toward imposing a more affirmative duty on health care practitioners to inform next of kin in a variety of circumstances. One commenter noted that state laws may not define clearly who is considered to be the next of kin.

Response: The intent of this provision was not to interfere with or change current practice regarding health care powers of attorney or the designation of other personal representatives. Such designations are formal, legal actions which give others the ability to exercise the rights of or make treatment decisions related to individuals. While persons with health care powers of attorney could have access to protected health information under the personal representatives provision (§ 164.502(g)), and covered entities may disclose to such persons under this provision, such disclosures do not give these individuals substantive authority to act for or on behalf of the individual with respect to health care decisions. State law requirements regarding health care powers of attorney continue to apply.

The comments suggesting that state laws may not allow the disclosures otherwise permitted by this provision or, conversely, that they may impose a more affirmative duty, did not provide any specifics with which to judge the affect of such laws. In general, however, state laws that are more protective of an individual's privacy interests than the rule by prohibiting a disclosure of protected health information continue to apply. The rule's provisions regarding disclosure of protected health information to family or friends of the individual are permissive only, enabling covered entities to abide by more stringent state laws without violating our rules. Furthermore, if the state law creates an affirmative and binding legal obligation on the covered entity to make disclosures to family or other persons under specific circumstances, the final rule allows covered entities to comply with these legal obligations. See § 164.512(a).

Comments: A number of commenters supported the proposal to limit disclosures to family or friends to the protected health information that is directly relevant to that person's involvement in the individual's health care. Some comments suggested that this standard apply to all disclosures to family or friends, even when the individual has agreed to or not objected to the disclosure. One commenter objected to the proposal, stating that it would be too difficult to administer. According to this comment, it is accepted practice for health care providers to communicate with family and friends about an individual's condition, regardless of whether the person is responsible for or otherwise involved in the individual's care.

Other comments expressed concern for disclosures related to particular types of information. For example, two commenters recommended that psychotherapy notes not be disclosed without patient authorization. One commenter suggested that certain sensitive medical information associated with social stigma not be disclosed to family members or others without patient consent.

Response: We agree with commenters who advocated limiting permissible disclosures to relatives and close personal friends to information consistent with a person's involvement in the individual's care. Under the final rule, we clarify the NPRM provision to state that covered entities may disclose protected health information to family members, relatives, or close personal friends of an individual or any other person identified by the individual, to the extent that the information directly relates to the person's involvement in the individual's current health care. It is not intended to allow disclosure of past medical history that is not relevant to the individual's current condition. In addition, as discussed above, we do not intend to disrupt covered entities' current practices with respect to disclosing specific information about a patient's condition to family members or others when the individual is incapacitated due to a medical emergency and the family member or other individual comes to the covered entity seeking specific information about the patient's condition. For example, this section allows a hospital to disclose to a family member the fact that a patient had a heart attack, and to provide updated information to the family member about the patient's progress and prognosis during his or her period of incapacity.

We agree with the recommendation to require written authorization for a disclosure of psychotherapy notes to family, close personal friends, or others involved in the individual's care. As discussed below, the final rule allows disclosure of psychotherapy notes without authorization in a few limited circumstances; disclosure to individuals involved in a person's care is not among those circumstances. See § 164.508 for a further discussion of the final rule's provisions regarding disclosure of psychotherapy notes.

We do not agree, however, with the suggestion to treat some medical information as more sensitive than others. In most cases, individuals will have the opportunity to prohibit or limit such disclosures. For situations in which an individual is unable to do so, covered entities may, in the exercise of professional judgement, determine whether the disclosure is in the individual's best interests and, if so, disclose only the protected health information that is directly relevant to the person's involvement with the individual's health care.

Comment: One commenter suggested that this provision should allow disclosure of protected health information to the clergy and to the Red Cross. The commenter noted that clergy have ethical obligations to ensure confidentiality and that the Red Cross often notifies the next of kin regarding an individual's condition in certain circumstances. Another commenter recommended allowing disclosures to law enforcement for the purpose of contacting the next of kin of individuals who have been injured or killed. One commenter sought clarification that "close personal friend" was intended to include domestic partners and same-sex couples in committed relationships.

Response: As discussed above, § 164.510(a) allows covered health care providers to disclose to clergy protected health information from a health care facility's directory. Under § 164.510(b), an individual may identify any person, including clergy, as involved in his or her care. This approach provides more flexibility than the proposed rule would have provided.

As discussed in the preamble of the final rule, this provision allows disclosures to domestic partners and others in same-sex relationships when such individuals are involved in an individual's care or are the point of contact for notification in a disaster. We do not intend to change current practices with respect to involvement of others in an individual's treatment decisions; informal information-sharing among persons involved; or the sharing of protected health information during a disaster. As noted above, a power of attorney or other legal relationship to an individual is not necessary for these informal discussions about the individual for the purpose of assisting in or providing a service related to the individual's care.

We agree with the comments noting that the Red Cross and other organizations may play an important role in locating and communicating with the family about individuals injured or killed in an accident or disaster situation. Therefore, the final rule includes new language, in § 164.510(b)(4), which allows covered entities to use or disclose protected health information to a public or private entity authorized by law or its charter to assist in disaster relief efforts, for the purpose of coordinating with such entities to notify, or assist in the notification of (including identifying or locating) a family member, an individual's personal representative, or another person responsible for the individual's care regarding the individual's location, general condition, or death. The Red Cross is an example of a private entity that may obtain protected health information pursuant to these provisions. We recognize the role of the Red Cross and similar organizations in disaster relief efforts, and we encourage cooperation with these entities in notification efforts and other means of assistance.

Comment: One commenter recommended stating that individuals who are mentally retarded and unable to agree to disclosures under this provision do not, thereby, lose their access to further medical treatment. This commenter also proposed stating that mentally retarded individuals who are able to provide agreement have the right to control the disclosure of their protected health information. The commenter expressed concern that the parent, relative, or other person acting in loco parentis may not have the individual's best interest in mind in seeking or authorizing for the individual the disclosure of protected health information.

Response: The final rule regulates only uses and disclosures of protected health information, not the delivery of health care. Under the final rule's section on personal representatives (§ 164.502(g)), a person with authority to make decisions about the health care of an individual, under applicable law, may make decisions about the protected health information of that individual, to the extent that the protected health information is relevant to such person's representation.

In the final rule, § 164.510(b) may apply to permit disclosures to a person other than a personal representative. Under § 164.510(b), when an individual is present and has the capacity to make his or her own decisions, a covered entity may disclose protected health information only if the covered entity: (1) obtains the individual's agreement to disclose protected health information to the third parties involved in the individual's care; (2) provides the individual with an opportunity to object to such disclosure, and the individual does not express an objection; or (3) reasonably infers from the circumstances, based on the exercise of professional judgment, that the individual does not object to the disclosure. These conditions apply to disclosure of protected health information about individuals with mental retardation as well as to disclosures about all other individuals. Thus we do not believe it is necessary to include in this section of the final rule any language specifically on persons with mental retardation.

Comments: A few commenters recommended that disclosures made in good faith to the family or friends of the individual not be subject to sanctions by the Secretary, even if the covered entity had not fully complied with the requirements of this provision. One commenter believed that a fear of sanction would make covered entities overly cautious, such that they would not disclose protected health information to domestic partners or others not recognized by law as next of kin. Another commenter recommended that sanctions not be imposed if the covered entity has proper policies in place and has trained its staff appropriately. According to this commenter, the lack of documentation of disclosures in a particular case or medical record should not subject the entity to sanctions if the information was disclosed in good faith.

Response: We generally agree with commenters regarding disclosure in good faith pursuant to this provision. As discussed above, the final rule expands the scope of individuals to whom covered entities may disclose protected health information pursuant to this section. In addition, we delete the term next of kin, to avoid the appearance of requiring any legal determination of a person's relationship in situations involving informal disclosures. Similarly, consistent with the informal nature of disclosures pursuant to this section, we do not require covered entities to document such disclosures. If a covered entity imposes its own documentation requirements and a particular covered health care provider does not follow the entity's documentation requirements, the disclosure is not a violation of this rule.

Comments: The majority of comments on this provision were from individuals and organizations concerned about domestic violence. Most of these commenters wanted assurance that domestic violence would be a consideration in any disclosure to the spouse or relatives of an individual whom the covered entity suspected to be a victim of domestic violence or abuse. In particular, these commenters recommended that disclosures not be made to family members suspected of being the abuser if to do so would further endanger the individual. Commenters believed that this limitation was particularly important when the individual was unconscious or otherwise unable to object to the disclosures.

Response: We agree with the comments that victims of domestic violence and other forms of abuse need special consideration in order to avoid further harm, and we provide for discretion of a covered entity to determine that protected health information not be disclosed pursuant to § 164.510(b). Section 164.510(b) of the final rule, disclosures to family or friends involved in the individual's care, states that when an individual is unable to agree or object to the disclosure due to incapacity or another emergency situation, a covered entity must determine based on the exercise of professional judgment whether it is in the individual's best interest to disclose the information. As stated in the preamble, we intend for this exercise of professional judgment in the individual's best interest to account for the potential for harm to the individual in cases involving domestic violence. These circumstances are unique and are best decided by a covered entity, in the exercise of professional judgment, in each situation rather than by a blanket rule.