Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. General Comments on Proposed § 164.510(f)

12/28/2000

Comment: Some commenters argued that current law enforcement use of protected health information was legitimate and important. These commenters cited examples of investigations and prosecutions for which protected health information is needed, from white collar insurance fraud to violent assault, to provide incriminating evidence or to exonerate a suspect, to determine what charges are warranted and for bail decisions. For example, one commenter argued that disclosure of protected health information for law enforcement purposes should be exempt from the rule, because the proposed regulation would hamper Drug Enforcement Administration investigations. A few commenters argued that effective law enforcement requires early access to as much information as possible, to rule out suspects, assess severity of criminal acts, and for other purposes. A few commenters noted the difficulties criminal investigators and prosecutors face when fighting complex criminal schemes. In general, these commenters argued that all disclosures of protected health information to law enforcement should be allowed, or for elimination of the process requirements proposed in § 164.510(f)(1).

Response: The importance and legitimacy of law enforcement activities are beyond question, and they are not at issue in this regulation. We permit disclosure of protected health information to law enforcement officials without authorization in some situations precisely because of the importance of these activities to public safety. At the same time, individuals' privacy interests also are important and legitimate. As with all the other disclosures of protected health information permitted under this regulation, the rules we impose attempt to balance competing and legitimate interests.

Comment: Law enforcement representatives stated that law enforcement agencies had a good track record of protecting patient privacy and that additional restrictions on their access and use of information were not warranted. Some commenters argued that no new limitations on law enforcement access to protected health information were necessary, because sufficient safeguards exist in state and federal laws to prevent inappropriate disclosure of protected health information by law enforcement.

Response: Disclosure of protected health information by law enforcement is not at issue in this regulation. Law enforcement access to protected health information in the first instance, absent any re-disclosure by law enforcement, impinges on individuals' privacy interests and must therefore be justified by a public purpose that outweighs individuals' privacy interests.

We do not agree that sufficient safeguards already exist in this area. We are not aware of, and the comments did not provide, evidence of a minimum set of protections for individuals relating to access by law enforcement to their protected health information. Federal and state laws in this area vary considerably, as they do for other areas addressed in this final rule. The need for standards in this area is no less critical than in the other areas addressed by this rule.

Comment: Many commenters argued that no disclosures of protected health information should be made to law enforcement (absent authorization) without a warrant issued by a judicial officer after a finding of probable cause. Others argued that a warrant or subpoena should be required prior to disclosure of protected health information unless the disclosure is for the purposes of identifying a suspect, fugitive, material witness, or missing persons, as described in proposed § 164.510(f)(2). Some commenters argued that judicial review prior to release of protected health information to law enforcement should be required absent the exigent and urgent circumstances identified in the NPRM in § 164.510(f)(3) and (5), or absent "a compelling need" or similar circumstances.

Response: In the final rule, we attempt to match the level of procedural protection for privacy required by this rule with the nature of the law enforcement need for access, the existence of other procedural protections, and individuals' privacy interests. Where other rules already impose procedural protections, this rule generally relies on those protections rather than imposing new ones. Thus, where access to protected health information is granted after review by an independent judicial officer (such as a court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer), no further requirements are necessary. Similarly, because information disclosed to a grand jury is vital to law enforcement purposes and is covered by secrecy protection, this rule allows disclosure with no further process.

We set somewhat stricter standards for disclosure of protected health information pursuant to administrative process, such as administrative subpoenas, summonses, and civil or authorized investigative demands. In these cases, the level of existing procedural protections is lower than for judicially-approved or grand jury disclosures. We therefore require a greater showing, specifically, the three-part test described in § 164.512(f)(1)(ii), before the covered entity is permitted to release protected health information. Where the information to be disclosed is about the victim of a crime, privacy interests are heightened and we require the victim's agreement prior to disclosure in most instances.

In the limited circumstances where law enforcement interests are heightened, we allow disclosure of protected health information without prior legal process or agreement, but we impose procedural protections such as limits on the information that may lawfully be disclosed, limits on the circumstances in which the information may be disclosed, and requirements for verifying the identity and authority of the person requesting the disclosures. For example, in some cases law enforcement officials may seek limited but focused information needed to obtain a warrant. A witness to a shooting may know the time of the incident and the fact that the perpetrator was shot in the left arm, but not the identity of the perpetrator. Law enforcement would then have a legitimate need to ask local emergency rooms whether anyone had presented with a bullet wound to the left arm near the time of the incident. Law enforcement may not have sufficient information to obtain a warrant, but instead would be seeking such information. In such cases, when only limited identifying information is disclosed and the purpose is solely to ascertain the identity of a person, the invasion of privacy would be outweighed by the public interest. For such circumstances, we allow disclosure of protected health information in response to a law enforcement inquiry where law enforcement is seeking to identify a suspect, fugitive, material witness, or missing person, but allow only disclosure of a limited list of information.

Similarly, it is in the public interest to allow covered entities to take appropriate steps to protect the integrity and safety of their operations. Therefore, we permit covered entities on their own initiative to disclose to law enforcement officials protected health information for this purpose. However, we limit such disclosures to protected health information that the covered entity believes in good faith constitutes evidence of criminal conduct that occurred on the premises of the covered entity.

We shape the rule's provisions with respect to law enforcement according to the limited scope of our regulatory authority under HIPAA, which applies only to the covered entities and not to law enforcement officials. We believe the rule sets the correct standards for when an exception to the rule of non-disclosure is appropriate for law enforcement purposes. There may be advantages, however, to legislation that applies the appropriate standards directly to judicial officers, prosecutors in grand juries, and to those making administrative or other requests for protected health information, rather than to covered entities. These advantages could include measures to hold officials accountable if they seek or receive protected health information contrary to the legal standard. In Congressional consideration of law enforcement access, there have also been useful discussions of other topics, such as limits on re-use of protected health information gathered in the course of health oversight activities. The limitations on our regulatory authority provide additional reason to support comprehensive medical privacy legislation.

Comment: A few commenters cited existing sanctions for law enforcement officials who violate the rights of individuals in obtaining evidence, ranging from suppression of that evidence to monetary penalties, and argued that such sanctions are sufficient to protect patients' privacy interests.

Response: After-the-fact sanctions are important, but they are effective only when coupled with laws that establish the ground rules for appropriate behavior. That is, a sanction applies only where some other rule has been violated. This regulation sets such basic ground rules. Further, under the HIPAA statutory authority, we cannot impose sanctions on law enforcement officials or require suppression of evidence. We must therefore rely on rules that regulate disclosure of protected health information by covered entities in the first instance.

Comment: Several commenters argued that disclosure of protected health information under § 164.510(f) should be mandatory, not just permitted. Others argued that we should mandate disclosure of protected health information in response to Inspector General subpoenas. A few commenters argued that we should require all covered entities to include disclosure of protected health information to law enforcement in their required notice of privacy practices.

Response: The purpose of this regulation is to protect individuals' privacy interests, consistent with other important public activities. Other laws set the rules governing those public activities, including when health information is necessary for their effective operation. See discussion of § 164.512(a).

Comment: Some commenters questioned whether the Secretary had statutory authority to directly or indirectly impose new procedural or substantive requirements on otherwise lawful legal process issued under existing federal and state rules. They argued that, while the provisions are imposed on "covered entities," the rule would result in law enforcement officials being compelled to modify current practices to harmonize them with the requirements this rule imposes on covered entities. A number of state law enforcement agencies argued that the rule would place new burdens on state administrative subpoenas and requests that are intrusive in state functions. At least one commenter argued that the requirement for prior process places unreasonable restrictions on the right of the states to regulate law enforcement activities.

Response: This rule regulates the ability of health care clearinghouses, health plans, and covered health care providers to use and disclose health information. It does not regulate the behavior of law enforcement officials or the courts, nor does it prevent states from regulating law enforcement officials. All regulations have some effects on entities that are not directly regulated. We have considered those effects in this instance and have determined that the provisions of the rule are necessary to protect the privacy of individuals.

Comment: One commenter argued that state licensing boards should be exempt from restrictions placed on law enforcement officials, because state licensing and law enforcement are different activities.

Response: Each state's law determines what authorities are granted to state licensing boards. Because state laws differ in this regard, we cannot make a blanket determination that state licensing officials are or are not law enforcement officials under this regulation. We note, however, that the oversight of licensed providers generally is included as a health oversight activity at § 164.512(d).

Relationship to Existing Rules and Practices

Comment: Many commenters expressed concern that the proposed rule would have expanded current law enforcement access to protected health information. Many commenters said that the NPRM would have weakened their current privacy practices with respect to law enforcement access to health records. For example, some of the commenters arguing that a warrant or subpoena should be required prior to disclosure of protected health information unless the disclosure is for the purposes of identifying a suspect, fugitive, material witness, or missing persons, did so because they believed that such a rule would be consistent with current state law practices.

Response: This regulation does not expand current law enforcement access to protected health information. We do not mandate any disclosures of protected health information to law enforcement officials, nor do we make lawful any disclosures of protected health information which are unlawful under other rules and regulations. Similarly, this regulation does not describe a set of "best practices." Nothing in this regulation should cause a covered entity to change practices that are more protective of privacy than the floor of protections provided in this regulation.

This regulation sets forth the minimum practices which a covered entity must undertake in order to avoid sanctions under the HIPAA. We expect and encourage covered entities to exercise their judgment and professional ethics in using and disclosing health information, and to continue any current practices that provide privacy protections greater than those mandated in this regulation.

Comment: Many commenters asserted that, today, consent or judicial review always is required prior to release of protected health information to law enforcement; therefore, they said that the proposed rule would have lessened existing privacy protections.

Response: In many situations today, law enforcement officials lawfully obtain health information absent any prior legal process and absent exigent circumstances. The comments we received on the NPRM, both from law enforcement and consumer advocacy groups, describe many such situations. Moreover, this rule sets forth minimum privacy protections and does not preempt more stringent, pre-existing standards.

Comment: Some commenters argued that health records should be entitled to at least as much protection as cable subscription records and video rental records.

Response: We agree. The Secretary, in presenting her initial recommendations on the protection of health information to the Congress in 1997, stated that, "When Congress looked at the privacy threats to our credit records, our video records, and our motor vehicle records, it acted quickly to protect them. It is time to do the same with our health care records" (Testimony of Donna E. Shalala, Secretary, U. S. Department of Health and Human Services, before the Senate Committee on Labor & Human Resources, September 11, 1997). However, the limited jurisdiction conferred on us by the HIPAA does not allow us to impose such restrictions on law enforcement officials or the courts.

Comment: At least one commenter argued that the regulation should allow current routine uses for law enforcement under the Privacy Act.

Response: This issue is discussed in the "Relationship to Other Federal Laws" preamble discussion of the Privacy Act.

Comment: A few commenters expressed concern that people will be less likely to provide protected health information for public health purposes if they fear the information could be used for law enforcement purposes.

Response: This regulation does not affect law enforcement access to records held by public health authorities, nor does it expand current law enforcement access to records held by covered entities. These agencies are for the most part not covered entities under HIPAA. Therefore, this regulation should not reduce current cooperation with public health efforts.

Relationship to Other Provisions of This Regulation

Comment: Several commenters pointed out an unintended interaction between proposed §§ 164.510(f) and 164.510(n). Because proposed § 164.510(n), allowing disclosures mandated by other laws, applied only if the disclosure would not fall into one of the categories of disclosures provided for in § 164.510 (b) - (m), disclosures of protected health information mandated for law enforcement purposes by other law would have been preempted.

Response: We agree, and in the final rule we address this unintended interaction. It is not our intent to preempt these laws. To clarify the interaction between these provisions, in the final rule we have specifically added language to the paragraph addressing disclosures for law enforcement that permits covered entities to comply with legal mandates, and have included a specific cross reference in the provision of the final rule that permits covered entities to make other disclosures required by law. See § 164.512(a).

Comment: Several commenters argued that, when a victim of abuse or of a crime has requested restrictions on disclosure, the restrictions should be communicated to any law enforcement officials who receive that protected health information.

Response: We do not have the authority to regulate law enforcement use and disclosure of protected health information, and therefore we could not enforce any such restrictions communicated to law enforcement officials. For this reason, we determined that the benefits to be gained from requiring communication of restrictions would not outweigh the burdens such a requirement would place on covered entities. We expect that professional ethics will guide health care providers' communications to law enforcement officials about the welfare of victims of abuse or other crime.

Comment: Some commenters argued against imposing the "minimum necessary" requirement on disclosure of protected health information to law enforcement officials. Some law enforcement commenters expressed concern that the "minimum necessary" test could be "manipulated" by a covered entity that wished to withhold relevant evidence. A number of covered entities complained that they were ill-equipped to substitute their judgment for that of law enforcement for what was the minimum amount necessary, and they also argued that the burden of determining the "minimum necessary"information should be transferred to law enforcement agencies. Some commenters argued that imposing such "uninformed" discretion on covered entities would delay or thwart legitimate investigations, and would result in withholding information that might exculpate an individual or might be necessary to present a defendant's case. One comment suggested that covered entities have "immunity" for providing too much information to law enforcement.

Response: The "minimum necessary" standard is discussed at § 164.514.

Comment: A few commenters asked us to clarify when a disclosure is for a "Judicial or Administrative Proceeding" and when it is for "Law Enforcement" purposes.

Response: In the final rule we have clarified that § 164.512(e) relating to disclosures for judicial or administrative proceedings does not supersede the authority of a covered entity to make disclosures under other provisions of the rule.

Use of Protected Health Information after Disclosure to Law Enforcement

Comment: Many commenters recommended that we restrict law enforcement officials' re-use and re-disclosure of protected health information. Some commenters asked us to impose such restrictions, while other commenters noted that the need for such restrictions underscores the need for legislation. Another argued for judicial review prior to release of protected health information to law enforcement because this regulation cannot limit further uses or disclosures of protected health information once it is in the hands of law enforcement agencies.

Response: We agree that there are advantages to legislation that imposes appropriate restrictions directly on the re-use and re-disclosure of protected health information by many persons who may lawfully receive protected health information under this regulation, but whom we cannot regulate under the HIPAA legislative authority, including law enforcement agencies.

Comment: A few commenters expressed concern that protected health information about persons who are not suspects may be used in court and thereby become public knowledge. These commenters urged us to take steps to minimize or prevent such protected health information from becoming part of the public record.

Response: We agree that individuals should be protected from unnecessary public disclosure of health information about them. However, we do not have the statutory authority in this regulation to require courts to impose protective orders. To the extent possible within the HIPAA statutory authority, we address this problem in § 164.512(e), Judicial and Administrative Proceedings.

Comment: Some commenters argued that evidence obtained in violation of the regulation should be inadmissible at trial.

Response: In this regulation, we do not have the authority to regulate the courts. We can neither require nor prohibit courts from excluding evidence obtain in violation of this regulation.