Comment: Numerous commenters addressed directly or by implication the question of whether the provision permitting uses and disclosures of protected health information if required by other law was necessary. Other commenters generally endorsed the need for such a provision. One such commenter approved of the provision as a needed fail-safe mechanism should the enumeration of permissible uses and disclosures of protected health information in the NPRM prove to be incomplete. Other commenters cited specific statutes which required access to protected health information, arguing that such a provision was necessary to ensure that these legally mandated disclosures would continue to be permitted. For example, some commenters argued for continued access to protected health information to investigate and remedy abuse and neglect as currently required by the Developmental Disabilities Assistance and Bill of Rights, 42 U.S.C. 6042, and the Protection and Advocacy for Mentally Ill Individuals Act, 42 U.S.C. 10801.
Some comments urged deletion of the provision for uses and disclosures required by other law. This concern appeared to be based on a generalized concern that the provision fostered government intrusion into individual medical information.
Finally, a number of commenters also urged that the required by law provision be deleted. These commenters argued that the proposed provision would have undermined the intent of the statute to preempt state laws which were less protective of individual privacy. As stated in these comments, the provision for uses and disclosures required by other law was "broadly written and could apply to a variety of state laws that are contrary to the proposed rule and less protective of privacy. (Indeed, a lawrequiring disclosure is the least protective of privacy since it allows for no discretion.) The breadth of this provision greatly exceeds the exceptions to preemption contained in HIPAA."
Response: We agree with the comments that proposed § 164.510(n) was necessary to harmonize the rule with existing state and federal laws mandating uses and disclosures of protected health information. Therefore, in the final rule, the provision permitting uses and disclosures as required by other law is retained. To accommodate other reorganization of the final rule, this provision has been designated as § 164.512(a).
We do not agree with the comments expressing concern for increased governmental intrusion into individual privacy under this provision. The final rule does not create any new duty or obligation to disclose protected health information. Rather, it permits covered entities to use or disclose protected health information when they are required by law to do so.
We likewise disagree with the characterization of the proposed provision as inconsistent with or contrary to the preemption standards in the statute or Part 160 of the rule. As described in the NPRM, we intend this provision to preserve access to information considered important enough by state or federal authorities to require its disclosure by law.
The importance of these required uses or disclosures is evidenced by the legislative or other public process necessary for the government to create a legally binding obligation on a covered entity. Furthermore, such required uses and disclosures arise in a myriad of other areas of law, ranging from topics addressing national security (uses and disclosures to obtain security clearances), to public health (reporting of communicable diseases), to law enforcement (disclosures of gun shot wounds). Required uses and disclosures also may address broad national concerns or particular regional or state concerns. It is not possible, or appropriate, for HHS to reassess the legitimacy of or the need for each of these mandates in each of their specialized contexts. In some cases where particular concerns have been raised by legal mandates in other laws, we allow disclosure as required by law, and we establish additional requirements to protect privacy (for example, informing the individual as required in § 164.512(c)) when covered entities make a legally mandated disclosure.
We also disagree with commenters who suggest that the approach in the final rule is contrary to the preemption provisions in HIPAA. HIPAA provides HHS with broad discretion in fashioning privacy protections. Recognizing the legitimacy of existing legal requirements is certainly within the Secretary's discretion. Additionally, given the variety of these laws, the varied contexts in which they arise, and their significance in ensuring that important public policies are achieved, we do not believe that Congress intended to preempt each such law unless HHS specifically recognized the law or purpose in the regulation.
Comment: A number of commenters urged that the provision permitting uses and disclosures required by other law be amended by deleting the last sentence which stated: "This paragraph does not apply to uses or disclosures that are covered by paragraphs (b) through (m) of this section." Some commenters sought deletion of this sentence to avoid any inadvertent preemption of mandatory reporting laws, and requested clarification of the effect on specific statutes.
The majority of the commenters focused their concerns on the potential conflict between mandatory reporting laws to law enforcement and the limitations imposed by proposed § 164.510(f), on uses and disclosures to law enforcement. For example, the comments raised concerns that mandatory reporting to law enforcement of injuries resulting from violent acts and abuse require the health care provider to initiate such reports to local law enforcement or other state agencies, while the NPRM would have allowed such reporting on victims of crimes only in response to specific law enforcement requests for information. Similarly, mandatory reports of violence-related injuries may implicate suspected perpetrators, as well as victims, and compliance with such laws could be blocked by the proposed requirement that disclosures about suspects was similarly limited to a response to law enforcement inquiries for the specific purpose of identifying the suspect. The NPRM also would have limited the type of protected health information that could have been disclosed about a suspect or fugitive.
In general, commenters sought to resolve this overlap by removing the condition that the required-by-other-law provision applied only when no other national priority purpose addressed the particular use or disclosure. The suggested change would permit the covered entity to comply with legally mandated uses and disclosures as long as the relevant requirements of that law were met. Alternatively, other commenters suggested that the restrictions on disclosures to law enforcement be lifted to permit full compliance with laws requiring reporting for these purposes.
Finally, some comments sought clarification of when a use or disclosure was "covered by paragraphs (b) through (m)." These commenters were confused as to whether a particular use or disclosure had to be specifically addressed by another provision of the rule or simply within the scope of the one of the national priority purposes specified by proposed paragraphs (b) through (m).
Response: We agree with the commenters that the provision as proposed would have inadvertently interfered with many state and federal laws mandating the reporting to law enforcement or others of protected health information.
In response to these comments, we have modified the final rule to clarify how this section interacts with the other provisions in the rule.
Comment: A number of commenters sought expanded authority to use and disclosure protected health information when permitted by other law, not just when required by law. These comments specified a number of significant duties or potential societal benefits from disclosures currently permitted or authorized by law, and they expressed concern should these beneficial uses and disclosures no longer be allowed if not specifically recognized by the rule. For example, one commenter listed 25 disclosures of health records that are currently permitted, but not required, by state law. This commenter was concerned that many of these authorized uses and disclosures would not be covered by any of the national priority purposes specified in the NPRM, and, therefore, would not be a permissible use or disclosure under the rule. To preserve these important uses and disclosures, the comments recommended that provision be made for any use or disclosure which is authorized or permitted by other law.
Response: We do not agree with the comments that seek general authority to use and disclose protected health information as permitted, but not required, by other law. The uses and disclosures permitted in the final rule reflect those purposes and circumstances which we believe are of sufficient national importance or relevance to the needs of the health care system to warrant the use or disclosure of protected health information in the absence of either the individual's express authorization or a legal duty to make such use or disclosure. In permitting specific uses and disclosures that are not required by law, we have considered the individual privacy interests at stake in each area and crafted conditions or limitations in each identified area as appropriate to balance the competing public purposes and individual privacy needs. A general rule authorizing any use or disclosure that is permitted, but not required, by other law would undermine the careful balancing in the final rule.
In making this judgment, we have distinguished between laws that mandate uses or disclosures and laws that merely permit them. In the former case, jurisdictions have determined that public policy purposes cannot be achieved absent the use of certain protected health information, and we have chosen in general not to disturb their judgments. On the other hand, where jurisdictions have determined that certain protected health information is not necessary to achieve a public policy purpose, and only have permitted its use or disclosure, we do not believe that those judgments reflect an interest in use or disclosure strong enough to override the Congressional goal of protecting privacy rights.
Moreover, the comments failed to present any compelling circumstance to warrant such a general provision. Despite commenters' concerns to the contrary, most of the beneficial uses and disclosures that the commenters referenced to support a general provision were, in fact, uses or disclosures already permissible under the rule. For example, the general statutory authorities relied on by one state health agency to investigate disease outbreaks or to comply with health data-gathering guidelines for reporting to certain federal agencies are permissible disclosures to public health agencies.
Finally, in the final rule, we add new provisions to § 164.512 to address three examples raised by commenters of uses and disclosures that are authorized or permitted by law, but may not be required by law. First, commenters expressed concern for the states that provide for voluntary reporting to law enforcement or state protective services of domestic violence or of abuse, neglect or exploitation of the elderly or other vulnerable adults. As discussed below, a new section, § 164.512(c), has been added to the final rule to specifically address uses and disclosures of protected health information in cases of abuse, neglect, or domestic violence. Second, commenters were concerned about state or federal laws that permitted coordination and cooperation with organizations or entities involved in cadaveric organ, eye, or tissue donation and transplantation. In the final rule, we add a new section, § 164.512(h), to permit disclosures to facilitate such donation and transplantation functions. Third, a number of commenters expressed concern for uses and disclosure permitted by law in certain custodial settings, such as those involving correctional or detention facilities. In the final rule, we add a new subsection to the section on uses and disclosures for specialized government functions (§ 164.512(k), to identify custodial settings in which special rules are necessary and to specify the additional uses and disclosures of the protected health information of inmates or detainees which are necessary in such facilities.
Comment: A number of commenters asked for clarification of the term "law" and the phrase "required by law" for purposes of the provision permitting uses or disclosures that are required by law. Some of the commenters noted that "state law" was a defined term in Part 160 of the NPRM and that the terms should be used consistently. Other commenters were concerned about differentiating between laws that required a use or disclosure and those that merely authorize or permit a use or disclosure. A number of commenters recommended that the final rule include a definitive list of the laws that mandate a use or disclosure of protected health information.
Response: In the final rule, we clarify that, consistent with the "state law" definition in § 160.202, "law" is intended to be read broadly to include the full array of binding legal authority, such as constitutions, statutes, rules, regulations, common law, or other governmental actions having the effect of law. However, for the purposes of § 164.512(a), law is not limited to state action; rather, it encompasses federal, state or local actions with legally binding effect, as well as those by territorial and tribal governments.
For more detail on the meaning of "required by law," see § 164.501. Only where the law imposes a duty on the health care professional to report would the disclosure be considered to be required by law.
The final rule does not include a definitive list of the laws that contain legal mandates for disclosures of protected health information. In light of the breadth of the term "law" and number of federal, state, local, and territorial or tribal authorities that may engage in the promulgation of binding legal authority, it would be impossible to compile and maintain such a list. Covered entities have an independent duty to be aware of their legal obligations to federal, state, local and territorial or tribal authorities. The rule's approach is simply intended to avoid any obstruction to the health plan or covered health care provider's ability to comply with its existing legal obligations.
Comment: A number of commenters recommended that the rule compel covered entities to use or disclose protected health information as required by law. They expressed concern that covered entities could refuse or delay compliance with legally mandated disclosures by misplaced reliance on a rule that permits, but does not require, a use or disclosure required by other law.
Response: We do not agree that the final rule should require covered entities to comply with uses or disclosures of protected health information mandated by law. The purpose of this rule is to protect privacy, and to allow those disclosures consistent with sound public policy. Consistent with this purpose, we mandate disclosure only to the individual who is the subject of the information, and for purposes of enforcing the rule. Where a law imposes a legal duty on the covered entity to use or disclose protected health information, it is sufficient that the privacy rule permit the covered entity to comply with such law. The enforcement of that legal duty, however, is a matter for that other law.