Comment: Several commenters generally stated support for proposed § 164.510(k), which was titled "Uses and Disclosures in Emergency Circumstances." One commenter said that "narrow exceptions to confidentiality should be permitted for emergency situations such as duty to warn, duty to protect, and urgent law enforcement needs." Another commented that the standard "...based on a reasonable belief that the disclosures are necessary to prevent or lessen a serious and imminent threat to the health or safety of an individual" would apply in only narrow treatment circumstances. Some commenters suggested that the provision be further narrowed, for example, with language specifically identifying "imminent threats" and a "chain-of-command clearance process," or by limiting permissible disclosures under this provision to "public health emergencies," or "national emergencies." Others proposed procedural requirements, such as specifying that such determinations may only be made by the patient's treating physician, a licensed mental health care professional, or as validated by three physicians. One commenter recommended stating that the rule is not intended to create a duty to warn or to disclose protected health information but rather permits such disclosure in emergency circumstances, consistent with other applicable legal or ethical standards.
Response: We agree with the commenters who noted that the proposed provision would apply in rare circumstances. We clarify, however, that we did not intend for the proposed provision to apply to emergency treatment scenarios as discussed below. In the final rule, to avoid confusion over the circumstances in which we intend this section to apply, we retitle it "Uses and Disclosures to Avert a Serious Threat to Health or Safety."
We do not believe it would be appropriate to narrow further the scope of permissible disclosures under this section to respond to specifically identified "imminent threats," a "public health emergency," or a "national emergency." We believe it would be impossible to enumerate all of the scenarios that may warrant disclosure of protected health information pursuant to this section. Such cases may involve a small number of people and may not necessarily involve a public health emergency or a national emergency.
Furthermore, in response to comments arguing that the proposed provision was too broad, we note that under both the NPRM and the final rule, we allow but do not require disclosures in situations involving serious and imminent threats to health or safety. Health plans and covered health care providers may make the disclosures allowed under § 164.512(j) consistent with applicable law and standards of ethical conduct.
As indicated in the preamble to the NPRM, the proposed approach is consistent with statutory and case law addressing this issue. The most well-known case on the topic is Tarasoff v. Regents of the University of California, 17 Cal. 3d 425 (1976), which established a duty to warn those at risk of harm when a therapist's patient made credible threats against the physical safety of a specific person. The Supreme Court of California found that the therapist involved in the case had an obligation to use reasonable care to protect the intended victim of his patient against danger, including warning the victim of the peril. Many states have adopted, in statute or through case law, versions of the Tarasoff duty to warn or protect. Although Tarasoff involved a psychiatrist, this provision is not limited to disclosures by psychiatrists or other mental health professionals. As stated in the preamble of the NPRM, we clarify that § 164.512(j) is not intended to create a duty to warn or disclose protected health information.
Comment: Several comments addressed the portion of proposed § 164.510(k) that would have provided a presumption of reasonable belief to covered entities that disclosed protected health information pursuant to this provision, when such disclosures were made in good faith, based on credible representation by a person with apparent knowledge or authority. Some commenters recommended that this standard be applied to all permissible disclosures without consent or to such disclosures to law enforcement officials.
Alternatively, a group representing health care provider management firms believed that the proposed presumption of reasonable belief would not have provided covered entities with sufficient protection from liability exposure associated with improper uses or disclosures. This commenter recommended that a general good-faith standard apply to covered entities' decisions to disclose protected health information to law enforcement officials. A health plan said that HHS should consider applying the standard of reasonable belief to all uses and disclosures that would have been allowed under proposed § 164.510. Another commenter questioned how the good-faith presumption would apply if the information came from a confidential informant or from a person rather than a doctor, law enforcement official, or government official. (The NPRM listed doctors, law enforcement officials, and other government officials as examples of persons who may make credible representations pursuant to this section.)
Response: As discussed above, this provision is intended to apply in rare circumstances--circumstances that occur much less frequently than those described in other parts of the rule. Due to the importance of averting serious and imminent threats to health and safety, we believe it is appropriate to apply a presumption of good faith to covered entities disclosing protected health information under this section. We believe that the extremely time-sensitive and urgent conditions surrounding the need to avert a serious and imminent threat to the health or safety are fundamentally different from those involved in disclosures that may be made pursuant to other sections of the rule. Therefore, we do not believe it would be appropriate to apply to other sections of the rule the presumption of good faith that applies in § 164.512(j). We clarify that we intend for the presumption of good faith to apply if the disclosure is made in good faith based upon a credible representation by any person with apparent knowledge or authority--not just by doctors, law enforcement or other government officials. Our listing of these persons in the NPRM was illustrative only, and it was not intended to limit the types of persons who could make such a credible representation to a covered entity.
Comment: One commenter questioned under what circumstances proposed § 164.510(k) would apply instead of proposed § 164.510(f)(5), "Urgent Circumstances," which permitted covered entities to disclose protected health information to law enforcement officials about individuals who are or are suspected to be victims of a crime, abuse, or other harm, if the law enforcement official represents that the information is needed to determine whether a violation of law by a person other than the victim has occurred and immediate law enforcement activity that depends upon obtaining such information may be necessary.
Response: First, we note that inclusion of this provision as § 164.510(f)(5)(5) was a drafting error which subsequently was clarified in technical corrections to the NPRM. In fact, proposed § 164.510(f)(3) addressed the identical circumstances, which in this subsection were titled "Information about a Victim of Crime or Abuse." The scenarios described under § 164.510(f)(3) may or may not involve serious and imminent threats to health or safety.
Second, as discussed in the main section of the preamble to § 164.512(j), we recognize that in some situations, more than one section of this rule potentially could apply with respect to a covered entity's potential disclosure of protected health information. We clarify that if a situation fits one section of the rule (e.g., § 164.512(j) on serious and imminent threats to health or safety), health plans and covered health care providers may disclose protected health information pursuant to that section, regardless of whether the disclosure also could be made pursuant to another section (e.g., §§ 164.512(f)(2) or 164.512(f)(3), regarding disclosure of protected health information about suspects or victims to law enforcement officials), except as otherwise stated in the rule.
Comment: A state health department indicated that the disclosures permitted under this section may be seen as conflicting with existing law in many states.
Response: As indicated in the regulation text for § 164.512(j), this section allows disclosure consistent with applicable law and standards of ethical conduct. We do not preempt any state law that would prohibit disclosure of protected health information in the circumstances to which this section applies. (See Part 160, Subpart B.)
Comment: Many commenters stated that the rule should require that any disclosures should not modify "duty to warn" case law or statutes.
Response: The rule does not affect case law or statutes regarding "duty to warn." In § 164.512(j), we specifically permit covered entities to disclose protected health information without authorization for the purpose of protecting individuals from imminent threats to health and safety, consistent with state laws and ethical obligations.