Treatment Advocacy Center's submitted comment to HHS on the proposed changes to the HIPAA Privacy Rule
February 17, 2021
The Treatment Advocacy Center supports the proposed modifications to 45 CFR § 164.502 and 45 CFR § 164.510-514 because they will improve patient care for people with severe mental illness (SMI). However, stronger language to encourage disclosure of information and foster dialogue between healthcare providers and family caregivers would lead to even better outcomes.
Importance of Two-Way Communication between Providers and Families
The Treatment Advocacy Center seeks to eliminate barriers to the timely and effective treatment of SMI. The Privacy Rule currently functions as one such barrier, most often arising when a family member or other caregiver needs information from a treating clinician who will not disclose it. The Treatment Advocacy Center works closely with families who dedicate their lives to securing treatment for their loved ones with SMI, too often losing them to suicide or unintended death resulting from the inability to meet their own basic needs and/or recognize their own need for treatment. Families often possess information about the person’s history that is highly relevant in medical decision-making, while clinicians possess information on the person’s current psychiatric condition. The person’s prospects for effective treatment often depend on the unrestricted flow of information between these parties. Although there is room for improvement in the proposed changes to the Privacy Rule, Section F of the Notice of Proposed Rule Making (NPRM) is a step in the right direction that will help facilitate critical communications.
Improvements to the Privacy Rule in NPRM
Replacing the current “professional judgment” standard to disclose PHI with a standard based on a healthcare provider’s “good faith belief” that they are acting in the patient’s best interest will improve the quality of care for SMI patients, particularly those in crisis who need immediate hospital care and a treatment plan upon discharge. Allowing a caregiver who is not already a personal representative of the patient to receive information from a provider will help the provider make better decisions about the patient’s psychiatric care as well as help caregivers better understand the implications of current treatment on their loved one’s overall condition.
Replacing the Privacy Rule’s requirement of “serious and imminent” threat of harm with “serious and reasonably foreseeable threat” to the health and safety of the patient or others is another welcome, life-saving change. To postpone action in a psychiatric crisis until the threat of harm is “imminent” is to invite tragedy. Once a threat to health or safety is reasonably foreseeable, any delay in communications to facilitate treatment will serve only to prolong the period of untreated psychosis, potentially leading to irreversible psychiatric harm and lower prospects for the person’s recovery.
Stronger Language Needed to Eliminate Privacy Rule’s Barriers to Care
The proposed modifications to 45 CFR §§ 164.502 and 164.510-514 would, if strictly interpreted, improve critical communications between caregivers and providers by allowing providers to share information more freely. But they would leave much of the current need for reform unmet, in that they would do very little to encourage such communications.
Since the inception of the Privacy Rule, a persistent frustration of many caregivers is the Rule’s emphasis on when communications are permitted, and the absence of provisions requiring essential communications between health care providers and family members who lack personal representative designation. Providers generally do not understand the extent to which they not only may—but should—disclose information that will facilitate vital dialogue and lead to better informed care. Unfortunately, the proposed modifications do not address this need, representing a missed opportunity.
Life-saving communications between clinicians and families will be limited until the Department amends the Privacy Rule to make it clear that clinicians should share any allowable PHI, under the proposed changes, that will improve patient care.
Responses to Specific Requests for Comments
In addition to the preceding general feedback on the proposed modifications, the Treatment Advocacy Center also has specific answers to (a), (c), (e), (f), and (i) of the Requests for Comments in Section F of the NPRM:
a. The proposed change from “professional judgment” to “good faith belief” will notdiscourage individuals with SMI in crisis from seeking care, and may in fact have the opposite effect. A person experiencing psychosis is not likely to consider technical changes to the Privacy Rule when deciding whether to seek care. In fact, many such individuals are brought to healthcare providers involuntarily. Family members, who are more likely to be aware of recent changes to the Privacy Rule, may in fact be encouraged to seek emergency evaluation of their loved ones if they believe the rule changes will lead to more productive dialogue with treating clinicians.
c. It is sometimes appropriate for a clinician to disclose PHI in a manner inconsistent with an individual’s known privacy preferences. There are times when “the totality of the facts and circumstances . . . outweigh an individual’s preferences, but do not rise to the level of posing a serious and reasonably foreseeable threat.” A person with SMI who is fully capable of rational decision-making when stable can completely lose that ability during a psychotic episode. The example given in the NPRM of a patient with substance use disorder behaving differently when under the influence of opioids is somewhat analogous. The loss of ability to make rational decisions is a common symptom of SMI.
e. The proposed “serious and reasonably foreseeable threat” standard will not discourage individuals from seeking treatment. See our comment to (a) above.
f. The proposed change will improve a covered entity’s ability to prevent potential harm. See our discussion of “imminence” above. The current standard is overly restrictive and fails at preventing harm by disallowing providers to share PHI before the threat of harm is “imminent.”
i. The Department should insulate some covered entities from liability and other negative consequences for disclosure of PHI to prevent harm. The fear of repercussions for violating the Privacy Rule is harming people with SMI by restricting communications between healthcare providers and family caregivers. It is not clear why this would require a change to the existing NPRM. We see nothing in the NPRM to prevent the Department from granting such protections.
Overall, the proposed changes to 45 CFR § 164.502 and 45 CFR § 164.510-514 will reduce but not eliminate barriers to care currently within the Privacy Rule. The Treatment Advocacy Center is encouraged by these proposals, but asks the Department to continue working with families and caregivers of people with SMI, as we continue to pursue the need for more thorough reform.
Download the PDF version, here.