III. Analysis of, and Responses to, Public Comments on the Proposed Rules

We received approximately 2,350 timely public comments on the August 12, 1998 proposed rule. The comments came from professional associations and societies, health care workers, law firms, health insurers, hospitals, and private individuals. We reviewed each commenter's letter and grouped related comments. Some comments were identical. After associating like comments, we placed them in categories based on subject matter or based on the section(s) of the regulations affected and then reviewed the comments.

In this section of the preamble, we summarize the provisions of the proposed regulations, summarize the related provisions in this final rule, and respond to comments received concerning each area.

It should be noted that the proposed Security Rule contained multiple proposed “requirements” and “implementation features.” In this final rule, we replace the term “requirement” with “standard.” We also replace the phrase “implementation feature” with “implementation specification.” We do this to maintain consistency with the use of those terms as they appear in the statute, the Transactions Rule, and the Privacy Rule. Within the comment and response portion of this final rule, for purposes of continuity, however, we use “requirement” and “implementation feature” when we are referring specifically to matters from the proposed rule. In all other instances, we use “standard” and “implementation specification.”

The proposed rule would require that each covered entity (as now described in § 160.102) engaged in the electronic maintenance or transmission of health information pertaining to individuals assess potential risks and vulnerabilities to such information in its possession in electronic form, and develop, implement, and maintain appropriate security measures to protect that information. Importantly, these measures would be required to be documented and kept current. The proposed security standard was based on three basic concepts that were derived from the Administrative Simplification provisions of HIPAA. First, the standard should be comprehensive and coordinated to address all aspects of security. Second, it should be scalable, so that it can be effectively implemented by covered entities of all types and sizes. Third, it should not be linked to specific technologies, allowing covered entities to make use of future technology advancements. The proposed standard consisted of four categories of requirements that a covered entity would have to address in order to safeguard the integrity, confidentiality, and availability of its electronic health information pertaining to individuals: administrative procedures, physical safeguards, technical security services, and technical mechanisms. The implementation features described the requirements in greater detail when that detail was needed. Within the four categories, the requirements and implementation features were presented in alphabetical order to convey that no one item was considered to be more important than another. The four proposed categories of requirements and implementation features were depicted in tabular form along with the electronic signature standard in a combined matrix located at Addendum 1. We also provided a glossary of terms, at Addendum 2, to facilitate a common understanding of the matrix entries, and at Addendum 3, we mapped available existing industry standards and guidelines to the proposed security requirements.

A. General Issues

The comment process overwhelmingly validated our basic assumptions that the entities affected by this regulation are so varied in terms of installed technology, size, resources, and relative risk, that it would be impossible to dictate a specific solution or set of solutions that would be useable by all covered entities. Many commenters also supported the concept of technological neutrality, which would afford them the flexibility to select appropriate technology solutions and to adopt new technology over time.

1. Security Rule and Privacy Rule Distinctions

As many commenters recognized, security and privacy are inextricably linked. The protection of the privacy of information depends in large part on the existence of security measures to protect that information. It is important that we note several distinct differences between the Privacy Rule and the Security Rule. The security standards below define administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information. The standards require covered entities to implement basic safeguards to protect electronic protected health information from unauthorized access, alteration, deletion, and transmission. The Privacy Rule, by contrast, sets standards for how protected health information should be controlled by setting forth what uses and disclosures are authorized or required and what rights patients have with respect to their health information. As is discussed more fully below, this rule narrows the scope of the information to which the safeguards must be applied from that proposed in the proposed rule, electronic health information pertaining to individuals, to protected health information in electronic form. Thus, the scope of information covered in this rule is consistent with the Privacy Rule, which addresses privacy protections for “protected health information.” However, the scope of the Security Rule is more limited than that of the Privacy Rule. The Privacy Rule applies to protected health information in any form, whereas this rule applies only to protected health information in electronic form. It is true that, under section 1173(d) of the Act, the Secretary has authority to cover “health information,” which, by statute, includes information in other than electronic form. However, because the proposed rule proposed to cover only health information in electronic form, we do not include security standards for health information in non-electronic form in this final rule.

We received a number of comments that pertained to privacy issues. These issues were considered in the development of the Privacy Rule and many of these comments were addressed in the preamble of the Privacy Rule. Therefore, we are referring the reader to that document for a discussion of those issues.

2. Level of Detail

We solicited comments as to the level of detail expressed in the required implementation features; that is, we specifically wanted to know whether commenters believe the level of detail of any proposed requirement went beyond what is necessary or appropriate. We received numerous comments expressing the view that the security standards should not be overly prescriptive because the speed with which technology is evolving could make specific requirements obsolete and might in fact deter technological progress. We have accordingly written the final rule to frame the standards in terms that are as generic as possible and which, generally speaking, may be met through various approaches or technologies.

3. Implementation Specifications

In addition to adopting standards, this rule adopts implementation specifications that provide instructions for implementing those standards.

However, in some cases, the standard itself includes all the necessary instructions for implementation. In these instances, there may be no corresponding implementation specification for the standard specifically set forth in the regulations text. In those instances, the standards themselves also serve as the implementation specification. In other words, in those instances, we are adopting one set of instructions as both the standard and the implementation specification. The implementation specification would, accordingly, in those instances be required.

In this final rule, we adopt both “required” and “addressable” implementation specifications. We introduce the concept of “addressable implementation specifications” to provide covered entities additional flexibility with respect to compliance with the security standards.

In meeting standards that contain addressable implementation specifications, a covered entity will ultimately do one of the following:

1. (a) Implement one or more of the addressable implementation specifications;
2. (b) implement one or more alternative security measures;
3. (c) implement a combination of both; or
4. (d) not implement either an addressable implementation specification or an alternative security measure. In all cases, the covered entity must meet the standards, as explained below.

The entity must decide whether a given addressable implementation specification is a reasonable and appropriate security measure to apply within its particular security framework. This decision will depend on a variety of factors, such as, among others, the entity's risk analysis, risk mitigation strategy, what security measures are already in place, and the cost of implementation. Based upon this decision the following applies:

1. (a) If a given addressable implementation specification is determined to be reasonable and appropriate, the covered entity must implement it.
2. (b) If a given addressable implementation specification is determined to be an inappropriate and/ or unreasonable security measure for the covered entity, but the standard cannot be met without implementation of an additional security safeguard, the covered entity may implement an alternate measure that accomplishes the same end as the addressable implementation specification. An entity that meets a given standard through alternative measures must document the decision not to implement the addressable implementation specification, the rationale behind that decision, and the alternative safeguard implemented to meet the standard. For example, the addressable implementation specification for the integrity standard calls for electronic mechanisms to corroborate that data have not been altered or destroyed in an unauthorized manner (see 45 CFR 164.312(c)(2)). In a small provider's office environment, it might well be unreasonable and inappropriate to make electronic copies of the data in question. Rather, it might well be more practical and afford a sufficient safeguard to make paper copies of the data.
3. (c) A covered entity may also decide that a given implementation specification is simply not applicable (that is, neither reasonable nor appropriate) to its situation and that the standard can be met without implementation of an alternative measure in place of the addressable implementation specification. In this scenario, the covered entity must document the decision not to implement the addressable specification, the rationale behind that decision, and how the standard is being met. For example, under the information access management standard, an access establishment and modification implementation specification reads: “implement policies and procedures that, based upon the entity's access authorization policies, establish, document, review, and modify a user's right of access to a workstation, transaction, program, or process” (45 CFR 164.308(a)(4)(ii)(c)). It is possible that a small practice, with one or more individuals equally responsible for establishing and maintaining all automated patient records, will not need to establish policies and procedures for granting access to that electronic protected health information because the access rights are equal for all of the individuals.

a. Comment: A large number of commenters indicated that mandating 69 implementation features would result in a regulation that is too burdensome, intrusive, and difficult to implement. These commenters requested that the implementation features be made optional to meet the requirements. A number of other commenters requested that all implementation features be removed from the regulation.

Response: Deleting the implementation specifications would result in the standards being too general to understand, apply effectively, and enforce consistently. Moreover, a number of implementation specifications are so basic that no covered entity could effectively protect electronic protected health information without implementing them. We selected 13 of these mandatory implementation specifications based on (1) the expertise of Federal security experts and generally accepted industry practices and, (2) the recommendation for immediate implementation of certain technical and organizational practices and procedures described in Chapter 6 of For The Record: Protecting Electronic Health Information, a 1997 report by the National Research Council (NRC). These mandatory implementation specifications are referred to as required implementation specifications and are reflected in the NRC report's recommendations. Risk Analysis and Risk management are found in the NRC recommendation title System Assessment; Sanction Policy is required in the Sanctions recommendation; Information system Activity Review is discussed in Audit Trails; Response and Reporting circumstances. In addition, a number of voluntary national and regional organizations have been formed to address HIPAA implementation issues and to facilitate communication among trading partners. These include the Strategic National Implementation Process (SNIP) developed under the auspices of the Workgroup for Electronic Data Interchange (WEDI), an organization named in the HIPAA statute to consult with the Secretary of HHS on HIPAA issues. Some of these organizations have developed white papers, tools, and recommended best practices addressing a number of HIPAA issues, including security. Covered entities may wish to examine these products to determine if they are relevant and useful in their own implementation efforts. A partial list of these organizations can be found at http://www.wedi.org/snip. We believe that these and other future industry-developed guidelines and/or models may provide valuable assistance to covered entities implementing these standards but must caution that HHS does not rate or endorse any such guidelines and/or models and the value of its content must be determine by the user.

b. Comment: Many commenters asked us to develop guidelines and models to aid in complying with the Security Rule. Several commenters either offered to participate in the development of guidelines and models or suggested entities that should be invited to participate.

Response: We agree that creation of compliance tools and guidelines for different business environments could assist covered entities to implement the HIPAA Security Rule. We plan to issue guidance documents after the publication of this final rule. However, it is critical for each covered entity to establish policies and procedures that address its own unique risks and circumstances.

In addition, a number of voluntary national and regional organizations have been formed to address HIPAA implementation issues and to facilitate communication among trading partners. These include the Strategic National Implementation Process (SNIP) developed under the auspices of the Workgroup for Electronic Data Interchange (WEDI), an organization named in the HIPAA statute to consult with the Secretary of HHS on HIPAA issues. Some of these organizations have developed white papers, tools, and recommended best practices addressing a number of HIPAA issues, including security. Covered entities may wish to examine these products to determine if they are relevant and useful in their own implementation efforts. A partial list of these organizations can be found at http://www.snip.wedi.org. We believe that these and other future industry-developed guidelines and/or models may provide valuable assistance to covered entities implementing these standards but must caution that HHS does not rate or endorse any such guidelines and/or models and the value of its content must be determined by the user.

4. Examples

Comment: We received a number of comments that demonstrated confusion regarding the purpose of the examples of security solutions that were included throughout the proposed rule. Commenters stated that they could not, or did not wish to, adopt various security measures suggested in examples. Other commenters asked that we include additional options within the examples. Some commenters referred specifically to the example provided in the proposed rule demonstrating how a small or rural provider might comply with the standards. One commenter asked for clarification that the examples are not mandatory measures that are required to demonstrate compliance, but are merely meant as a guide when implementing the security standards. Another commenter expressed support for the use of examples to clarify the intent of text descriptions.

Response: We wish to clarify that examples are used only as illustrations of possible approaches, and are included to serve as a springboard for ideas. The steps that a covered entity will actually need to take to comply with these regulations will be dependent upon its own particular environment and circumstances and risk assessment. The examples do not describe mandatory measures, nor do they represent the only, or even the best, way of achieving compliance. The most appropriate means of compliance for any covered entity can only be determined by that entity assessing its own risks and deciding upon the measures that would best mitigate those risks.

B. Applicability ([164.302])

We proposed that the security standards would apply to health plans, health care clearinghouses, and to health care providers that maintain or transmit health information electronically. The proposed security standards would apply to all electronic health information maintained or transmitted, regardless of format (standard transaction or a proprietary format). No distinction would be made between internal corporate entity communication or communication external to the corporate entity. Electronic transmissions would include transactions using all media, even when the information is physically moved from one location to another using magnetic tape, disk, or other machine readable media. Transmissions over the Internet (wide-open), extranet (using Internet technology to link a business with information only accessible to collaborating parties), leased lines, dial-up lines, and private networks would be included. We proposed that telephone voice response and “faxback” systems (a request for information made via voice using a fax machine and requested information returned via that same machine as a fax) would not be included but we solicited comments on this proposed exclusion.

This final rule simplifies the applicability statement greatly. Section 164.302 provides that the security standards apply to covered entities; the scope of the information covered is specified in [164.306] (see the discussion under that section below regarding the changes and revisions to the scope of information covered).

1. Comment: A number of commenters requested clarification of who must comply with the standards. The preamble and proposed § 142.102 and § 142.302 stated: “Each person described in section 1172(a) of the Act who maintains or transmits health information shall maintain reasonable and appropriate administrative, technical, and physical safeguards.” Commenters suggested that this statement is in conflict with the law, which defines a covered entity as a health plan, a clearinghouse, or a health care provider that conducts certain transactions electronically. The commentors apparently did not realize that section 1172(a) of the Act contains the definition of covered entities.

Response: Section 164.302 below makes the security standards applicable to “covered entities.” The term “covered entity” is defined at § 160.103 as one of the following: (1) A health plan; (2) a health care clearinghouse; (3) a health care provider who transmits any health information in electronic form in connection with a transaction covered by part 162 of title 45 of the Code of Federal Regulations (CFR). The rationale for the use and the meaning of the term “covered entity” is discussed in the preamble to the Privacy Rule (65 FR 82476 through 82477). As that discussion makes clear, the standards only apply to health care providers who engage electronically in the transactions for which standards have been adopted.

2. Comment: Several commenters recommended expansion of applicability, either to other specific entities, or to all entities involved in health care. Others wanted to know whether the standards apply to entities such as employers, public health organizations, medical schools, universities, research organizations, plan brokers, or non-EDI providers. One commenter asked whether the standards apply to State data organizations operating in capacities other than as plans, clearinghouses, or providers. Still other commenters stated that it was inappropriate to include physicians and other health care professionals in the same category as plans and clearinghouses, arguing that providers should be subject to different, less burdensome requirements because they already protect health information.

Response: The statute does not cover all health care entities that transmit or maintain individually identifiable health information. Section 1172(a) of the Act provides that only health plans, health care clearinghouses, and certain health care providers (as discussed above) are covered. With respect to the comments regarding the difference between providers and plans/ clearinghouses, we have structured the Security Rule to be scalable and flexible enough to allow different entities to implement the standards in a manner that is appropriate for their circumstances. Regarding the coverage of entities not within the jurisdiction of HIPAA, see the Privacy Rule at 82567 through 82571.

3. Comment: One commenter asked whether the standards would apply to research organizations, both to those affiliated with health care providers and those that are not.

Response: Only health plans, health care clearinghouses, and certain health care providers are required to comply with the security standards. Researchers who are members of a covered entity's work force may be covered by the security standards as part of the covered entity. See the definition of “workforce” at 45 CFR 160.103. Note, however, that a covered entity could, under appropriate circumstances, exclude a researcher or research division from its health care component or components (see [164.105(a)]). Researchers who are not part of the covered entity's workforce and are not themselves covered entities are not subject to the standards.

4. Comment: Several commenters stated that internal networks and external networks should be treated differently. One commenter asked for further clarification of the difference between what needs to be secured external to a corporation versus the security of data movement within an organization. Another stated that complying with the security standards for internal communications may prove difficult and costly to monitor and control. In contrast, one commenter stated that the existence of requirements should not depend on whether use of information is for internal or external purposes.
Another commenter argued that the regulation goes beyond the intent of the law, and while communication of electronic information between entities should be covered, the law was never intended to mandate changes to an entity's internal automated systems. One commenter requested that raw data that are only for the internal use of a facility be excluded, provided that reasonable safeguards are in place to keep the raw data under the control of the facility.

Response: Section 1173(d)(2) of the Act states: Each person described in section 1172(a) who maintains or transmits health information shall maintain reasonable and appropriate administrative, technical, and physical safeguards--(A) to ensure the integrity and confidentiality of the information; (B) to protect against any reasonably anticipated--(i) threats or hazards to the security or integrity of the information; and (ii) unauthorized uses or disclosures of the information; and (C) otherwise to ensure compliance with this part by the officers and employees of such person. This language draws no distinction between internal and external data movement. Therefore, this final rule covers electronic protected health information at rest (that is, in storage) as well as during transmission. Appropriate protections must be applied, regardless of whether the data are at rest or being transmitted. However, because each entity's security needs are unique, the specific protections determined appropriate to adequately protect information will vary and will be determined by each entity in complying with the standards (see the discussion below).

5. Comment: Several commenters found the following statement in the proposed rule (63 FR 43245) at section II.A. confusing and asked for clarification: “With the exception of the security standard, transmission within a corporate entity would not be required to comply with the standards.”

Response: In the final Transactions Rule, we revised our approach concerning the transaction and code set exemptions, replacing this concept with other tests that determine whether a particular transaction is subject to those standards (see the discussion in the Transactions Rule at 65 FR 50316 through 50318). We also note that the Privacy Rule regulates a covered entity's use, as well as disclosure, of protected health information.

6. Comment: One commenter stated that research would be hampered if proposed § 142.306(a) applied. The commenter believes that research uses of health information should be excluded or the standard should be revised to allow appropriate flexibility for research depending on the risk to patients or subjects (for example, if the information is anonymous, there is no risk, and it would not be necessary to meet the security standards).

Response: If electronic protected health information is de-identified (as truly anonymous information would be), it is not covered by this rule because it is no longer electronic protected health information (see 45 CFR 164.502(d) and 164.514(a)). Electronic protected health information received, created, or maintained by a covered entity, or that is transmitted by covered entities, is covered by the security standards and must be protected. To the extent a researcher is a covered entity, the researcher must comply with these standards with respect to electronic protected health information. Otherwise, the conditions for release of such information to researchers is governed by the Privacy Rule. See, for example, 45 CFR 164.512(i), 164.514(e) and 164.502(d). These standards would not apply to the researchers as such in the latter circumstances.

7. Comment: One commenter asked to what extent individual patients are subject to the standards. For example, some telemedicine practices support the use of diagnostic systems in the patient's home, which can be used to conduct tests and send results to a remote physician. In other cases, patients may be responsible for the filing of insurance claims directly and will need the ability to verify facts, confirm receipt of claims, and so on. The commenter asked if it is the intent of the rule to include electronic transmission to or from the patient.

Response: Patients are not covered entities and, thus, are not subject to these standards. With respect to transmissions from covered entities, covered entities must protect electronic protected health information when they transmit that information. See also the discussion of encryption in section III.G.

C. Transition to the Final Rule

The proposed rule included definitions for a number of terms that have now already been promulgated as part of the Transactions Rule or the Privacy Rule. Comments related to the definitions of “code set,” “health care” clearinghouse,” “health plan,” “health care provider,” “small health plan,” “standard” and “transaction,” are addressed in the Transactions Rule at 65 FR 50319 through 50320. Comments concerning the definition of “individually identifiable health information” are discussed below, but are also addressed in the Privacy Rule at 65 FR 82611 through 82613. In addition, a few terms were redefined in the final Standards for Privacy of Individually Identifiable Health Information (67 FR 53182), issued on August 14, 2002 (Privacy Modifications). Certain terms that were defined in the proposed rule are not used in the final rule because they are no longer necessary. Other terms defined in the proposed rule are defined within the explanation of the standards in the final rule and are discussed in the preamble discussions in [164.308] through [164.312].

Definitions of terms relevant to the security standards now appear in the regulations text provisions as indicated below:

§ 160.103: Definitions of the following terms relevant to this rule appear in

§ 160.103: “business associate,” “covered entity,” “disclosure,” “electronic media,” “electronic protected health information,” “health care,” “health care clearinghouse,” “health care provider,” “health information,” “health plan,” “individual,” “individually identifiable health information,” “implementation specification,” “organized health care arrangement,” “protected health information,” “standard,” “use,” and “workforce.” These terms were discussed in connection with the Transaction and Privacy Rules and with the exception of the terms “covered entity” “disclosure” “electronic protected health information,” “health information,” “individual,” “organized health care arrangement,” “protected health information,” and “use,” we will not discuss them in this document. We note that the definition of those terms are not changed in the final rule.

§ 162.103: We have moved the definition of “electronic media” at § 162.103 to § 160.103 and have modified it to clarify that the term includes storage of information. The term “electronic media” is used in the definition of “protected health information.” Both the privacy and security standards apply to information “at rest” as well as to information being transmitted.

We note that we have deleted the reference to § 162.103 in paragraph (1)(ii) of the definition of “protected health information,” since both definitions, “electronic media” and “protected health information,” have been moved to this section. Also, it is unnecessary, because the definitions of § 160.103 apply to all of the rule in parts 160, 162, and 164.

We have also clarified that the physical movement of electronic media from place to place is not limited to magnetic tape, disk, or compact disk. This clarification removes a restriction as to what is considered to be physical electronic media, thereby allowing for future technological innovation. We further clarified that transmission of information not in electronic form before the transmission, for example, paper or voice, is not covered by this definition. [164.103]: The following term “plan sponsor” now appears in the new [164.103], which consists of definitions of terms common to both subpart C and subpart E (the privacy standards). This definition was moved, without substantive change, from §164.501 and has the meaning given to it in that section, and comments relating to this definition are discussed in connection with that section in the Privacy Rule at 65 FR 82607, 82611 through 82613, 82618 through 82622, and 82629.

[164.304]: Definitions specifically applicable to the Security Rule appear in [164.304], and these are discussed below. These definitions are from, or derived from, currently accepted definitions in industry publications, such as, the International Organization for Standards (ISO) 7498-2 and the American Society for Testing and Materials (ASTM) E1762-95.

The following terms in [164.304] are taken from the proposed rule text or the glossary in Addendum 2 of the proposed rule (63 FR 43271), were not commented on, and/or are unchanged or have only minor technical changes for purposes of clarification and are not discussed below: “access,” “authentication,” “availability,” “confidentiality,” “encryption,” “password,” and “security.” [164.314]: Four terms were defined in

§164.504(a) of the Privacy Rule (“common control,” “common ownership,” “health care component,” and “hybrid entity”). Because these terms apply to both security and privacy, their definitions have been moved to [164.103] without change.

Those terms are discussed in the Privacy Rule at 65 FR 82502 through 82503 and at 67 FR 53203 through 53207.

1. Covered Entity (§ 160.103)

Comment: One commenter asked if transcription services were covered entities. The question arose because transcription is often the first electronic or printed source of clinical information. Concern was expressed about the application of physical safeguard standards to the transcribers working for transcription companies or health care providers, either as employees or as independent contractors.
Another commenter expressed concern that scalability was limited to only small providers. The commenter explained that Third Party Administrators (TPAs) allow claim processors to work at home. Some TPAs have noted that it would be impossible to comply with the security standards for home-based claims processors.

Response: A covered entity's responsibility to implement security standards extends to the members of its workforce, whether they work at home or on-site. Because a covered entity is responsible for ensuring the security of the information in its care, the covered entity must include “at home” functions in its security process. While an independent transcription company or a TPA may not be covered entities, they will be a business associate of the covered entity because their activities fall under paragraph (1)(i)(a) of the definition of that term. For business associate provisions see proposed preamble section III.E.8. and [164.308(b)(1)] and [164.314(c)] of this final rule.

2. Health Care and Medical Care (§ 160.103)

Comment: One commenter asked whether “medical care,” which is defined in the proposed rule, and “health care,” which is not, are synonymous.

Response: The term “medical care,” as used in the proposed rule (63 FR 43242), was intended to be synonymous with “health care.” The term “medical care” is not included in this final rule. It is, however, included in the definition of “health plan,” where its meaning is not synonymous with “health care.” For a full discussion of this issue and its resolution, see the Privacy Rule (65 FR 82578).

3. Health Information and Individually Identifiable Health Information 160.103)

We note that the definitions of “health information” and “individually identifiable health information” remain unchanged from those published in the Transactions and Privacy Rules.

a. Comment: A number of commenters asked that the definition of “health information” be expanded to include information collected by additional entities. Several commenters wanted the definition to include health information collected, maintained, or transmitted by any entity, and one commenter suggested the inclusion of aggregated information not identifiable to an individual. Several commenters asked that eligibility information be excluded from the definition of information. Several commenters wanted the definition broadened to include demographics.

Response: Our definition of health information is taken from the definition in section 1171(4) of the Act, which provides that health information relates to the health or condition of an individual, the provision of health care to an individual, or payment for the provision of health care to an individual. The statutory definition also specifies the entities by which health information is created or received. We note that, because “individually identifiable health information” is a subset of “health information” and by statute includes demographic information, “health information” necessarily includes demographic information. We think this is clear as a matter of statutory construction and does not require further regulatory change.

b. Comment: Several commenters asked that we clarify the difference between “health information” and “individually identifiable” and “health information pertaining to an individual” as used in the August 12, 1998 proposed rule (63 FR 43242). Additionally, commenters asked that we be more consistent in the use of these terms and recommended use of the term “individually identifiable health information.”
Two commenters stated that it is important to distinguish between “health information pertaining to an individual” and “individually identifiable health information,” as in reporting statistics at various levels there will always be a need to bring forth information pertaining to an individual. One commenter recommended that the standards apply only to individually identifiable health information. Another stated that in § 142.306(b) of the proposed rule, “health information pertaining to an individual” should be changed to “individually identifiable health information,” as nonidentifiable information can be used for utilization review and other purposes. As written, the regulation text could limit the ability to use data, for example, from a clearinghouse for compliance monitoring.

Response: In general, we agree with these commenters, and note that these comments are largely mooted by the decision, reflected in [164.306] below and discussed in section III.D.1. of this final rule, to cover only electronic protected health information in this final rule.

c. Comment: Several commenters stated that the definition of “individually identifiable health information” is not in the regulations and should be added.

Response: We note that the definition of “individually identifiable health information” appears at § 160.103, which applies to this final rule.

4. Protected Health Information (§ 160.103)

This term is moved from §164.501 to § 160.103 because it applies to both subparts C (security) and E (privacy). See 67 FR 53192 through 531936 regarding the definition of “protected health information.”

Also, the term “electronic media” is included in paragraphs (1)(i) and (ii) of the definition of “protected health information,” as specified in this section.

In addition, we added the definitions of “covered functions,” “plan sponsor,” and “Required by law” to [164.103].

5. Breach ([164.304])

Comment: One commenter asked that “breach” be defined.

Response: The term “breach” has been deleted and therefore not defined. Instead, we define the term “security incident,” which better describes the types of situations we were referring to as breaches.

6. Facility ([164.304])

This new term has been added as a result of changing the name of the

“physical access control” standard to “facility access control.” This change was made based on comments indicating that the original term was not descriptive. We have defined the term “facility” as the physical premises and interior and exterior of a building.

7. Security Incident ([164.304])

Comment: We received comments asking that this term be defined.

Response: This final rule defines “Security incident” in [164.304] as “the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.”

8. System ([164.304])

Comment: One commenter asked that “system” be defined.

Response: This final rule defines “system,” in the context of an information system, in [164.304] as “an interconnected set of information resources under the same direct management control that shares common functionality. A system normally includes hardware, software, information, data, applications, communications, and people.”

9. Workstation ([164.304])

Comment: One commenter expressed concern that the use of the term “workstation” implied limited applicability to fixed devices (such as terminals), excluding laptops and other portable devices.

Response: We have added a definition of the term “workstation” to clarify that portable devices are also included. This final rule defines workstation as “an electronic computing device, for example, a laptop or desktop computer, or any other device that performs similar functions, and electronic media stored in its immediate environment.”

10. Definitions Not Adopted

Several definitions in the proposed regulations text and glossary are not adopted as definitions in the final rule: “participant,” “contingency plan,” “risk,” “role-based access control,” and “user-based access control.” The terms “participant,” “role-based access control,” and “user-based access control” are not used in this final rule and thus are not defined. “Risk” is not defined as its meaning is generally understood. While we do not define the term, we address “contingency plan” as a standard in [164.308(a)(7)] below.

a. Comment: We received comments requesting that we define the following terms: “token” and “documentation.”

Response: These terms were defined in Addendum 2 of the proposed rule. In this final rule, we do not adopt a definition for “token” because it is not used in the final rule. “Documentation” is discussed in [164.316] below.

b. Comment: We received several comments that “small” and “rural” should be defined as those terms apply to providers. We received an equal number of comments stating that there is no need to define these terms. One commenter stated that definitions for these terms would be necessary only if special exemptions existed for small and rural providers. Several commenters suggested initiation of a study to determine limitations and potential barriers small and rural providers will have in implementing these regulations.

Response: The statute requires that we address the needs of small and rural providers. We believe that we have done this through the provisions, which require the risk assessment and the response to be assessment based on the needs and capabilities of the entity. This scalability concept takes the needs of those providers into account and eliminates any need to define those terms.

c. Comment: In the proposed rule, we proposed the following definition for the term “Access control”: “A method of restricting access to resources, allowing only privileged entities access. Types of access control include, among others, mandatory access control, discretionary access control, time-ofday, classification, and subject-object separation.” One commenter believed the proposed definition is too restrictive and requested revision of the definition to read: “Access control refers to a method of restricting access to resources, allowing access to only those entities which have been specifically granted the desired access rights.” Another commenter wanted the definition expanded to include partitioned rule-based access control (PRBAC).

Response: We agree with the commenter who suggested that the definition as proposed seemed too restrictive. In this case, as in many others, a number of commenters believed the examples given in the proposed rule provided the only acceptable compliance actions. As previously noted, in order to clarify that the examples listed were not to be considered all-inclusive, we have generalized the proposed requirements in this final rule. In this case, we have also generalized the requirements and placed the substantive provisions governing access control at [164.308(a)(4)], [164.310(a)(1)], and [164.312(a)(1)]. With respect to PRBAC, the access control standard does not exclude this control, and entities should adopt it if appropriate to their circumstances.

D. General Rules ([164.306])

In the proposed rule, we proposed to cover all health information maintained or transmitted in electronic form by a covered entity. We proposed to adopt, in § 142.308, a nation-wide security standard that would require covered entities to implement security measures that would be technology-neutral and scalable, and yet integrate all the components of security (administrative procedures, physical safeguards, technical security services, and technical security mechanisms) that must be in place to preserve health information confidentiality, integrity, and availability (three basic elements of security). Since no comprehensive, scalable, and technology-neutral set of standards currently exists, we proposed to designate a new standard, which would define the security requirements to be fulfilled.

The proposed rule proposed to define the security standard as a set of scalable, technology-neutral requirements with implementation features that providers, plans, and clearinghouses would have to include in their operations to ensure that health information pertaining to an individual that is electronically maintained or electronically transmitted remains safeguarded. The proposed rule would have required that each affected entity assess its own security needs and risks and devise, implement, and maintain appropriate security to address its own unique security needs. How individual security requirements would be satisfied and which technology to use would be business decisions that each entity would have to make. In the final rule we adopt this basic framework. In [164.306], we set forth general rules pertaining to the security standards. In paragraph (a), we describe the general requirements. Paragraph (a) generally reflects section 1173(d)(2) of the Act, but makes explicit the connection between the security standards and the privacy standards (see [164.306(a)(3)]). In [164.306(a)(1)], we provide that the security standards apply to all electronic protected health information the covered entity creates, receives, maintains, or transmits. In paragraph (b)(1), we provide explicitly for the scalability of this rule by discussing the flexibility of the standards, and paragraph (b)(2) of [164.306] discusses various factors covered entities must consider in complying with the standards.

The provisions of [164.306(c)] provide the framework for the security standards, and establish the requirement that covered entities must comply with the standards. The administrative, physical, and technical safeguards a covered entity employs must be reasonable and appropriate to accomplish the tasks outlined in paragraphs (1) through (4) of [164.306(a)]. Thus, an entity's risk analysis and risk management measures required by [164.308(a)(1)] must be designed to lead to the implementation of security measures that will comply with [164.306(a)]. It should be noted that the implementation of reasonable and appropriate security measures also supports compliance with the privacy standards, just as the lack of adequate security can increase the risk of violation of the privacy standards. If, for example, a particular safeguard is inadequate because it routinely permits reasonably anticipated uses or disclosures of electronic protected health information that are not permitted by the Privacy Rule, and that could have been prevented by implementation of one or more security measures appropriate to the scale of the covered entity, the covered entity would not only be violating the Privacy Rule, but would also not be in compliance with [164.306(a)(3)] of this rule. Paragraph (d) of [164.306] establishes two types of implementation specifications, required and addressable. It provides that required implementation specifications must be met. However, with respect to implementation specifications that are addressable, [164.306(d)(3)] specifies that covered entities must assess whether an implementation specification is a reasonable and appropriate safeguard in its environment, which may include consideration of factors such as the size and capability of the organization as well as the risk. If the organization determines it is a reasonable and appropriate safeguard, it must implement the specification. If an addressable implementation specification is determined not to be a reasonable and appropriate answer to a covered entity's security needs, the covered entity must do one of two things: implement another equivalent measure if reasonable and appropriate; or if the standard can otherwise be met, the covered entity may choose to not implement the implementation specification or any equivalent alternative measure at all. The covered entity must document the rationale behind not implementing the implementation specification. See the detailed discussion in section II.A.3.

Paragraph (e) of [164.306] addresses the requirement for covered entities to maintain the security measures implemented by reviewing and modifying the measures as needed to continue the provision of reasonable and appropriate protections, for example, as technology moves forward, and as new threats or vulnerabilities are discovered.

1. Scope of Health Information Covered by the Rule ([164.306(a)])

We proposed to cover health information maintained or transmitted by a covered entity in electronic form. We have modified, by narrowing, the scope of health information to be safeguarded under this rule from that which was proposed. The statute requires the privacy standards to cover individually identifiable health information. The Privacy Rule covers all individually identifiable information except for: (1) Education records covered by the Family and Educational Rights and Privacy Act (FERPA); (2) records described in 20 U.S.C. 1232g(a)(4)(B)(iv); and (3) employment records. (see the Privacy Rule at 65 FR 82496. See also 67 FR 53191 through 53193). The scope of information covered in the Privacy Rule is referred to as “protected health information.” Based upon the comments we received, we align the requirements of the Security and Privacy Rules with regard to the scope of information covered, in order to eliminate confusion and ease implementation. Thus, this final rule requires protection of the same scope of information as that covered by the Privacy Rule, except that it only covers that information if it is in electronic form.

We note that standards for the security of all health information or protected health information in nonelectronic form may be proposed at a later date.

a. Comment: One commenter stated that the rule should apply to aggregate information that is not identifiable to an individual. In contrast, another commenter asked that health information used for statistical analysis be exempted if the covered entity may reasonably expect that the removed information cannot be used to reidentify an individual.

Response: As a general proposition, any electronic protected health information received, created, maintained, or transmitted by a covered entity is covered by this final rule. We agree with the second commenter that certain information, from which identifiers have been stripped, does not come within the purview of this final rule. Information that is de-identified, as defined in the Privacy Rule at §164.502(d) and §164.514(a), is not “individually identifiable” within the meaning of these rules and, thus, does not come within the definition of “protected health information.” It accordingly is not covered by this final rule. For a full discussion of the issues of de-identification and re-identification of individually identifiable health information see 65 FR 82499 and 82708 through 82712 and 67 FR 53232 through 53234.

b. Comment: Several commenters asked whether systems that determine eligibility of clients for insurance coverage under broad categories such as medical coverage groups are considered health information. One commenter asked that we specifically exclude eligibility information from the standards.

Response: We cannot accept the latter suggestion. Eligibility information will typically be individually identifiable, and much eligibility information will also contain health information. If the information is “individually identifiable” and is “health information,” (with three very specific exceptions noted in the general discussion above) and it is in electronic form, it is covered by the security standards if maintained or transmitted by a covered entity.

c. Comment: Several commenters requested clarification as to whether the standards apply to identifiable health information in paper form. Some commenters believed the rule should be applicable to paper; others argued that it should apply to all confidential, identifiable health information.

Response: While we agree that protected health information in paper or other form also should have appropriate security protections, the proposed rule proposing the security standards proposed to apply those standards to health information in electronic form only. We are, accordingly, not extending the scope in this final rule.
We may establish standards to secure protected health information in other media in a future rule, in accordance with our statutory authority to do so. See discussion, supra, responding to a comment on the definition of “health information” and “individually identifiable health information.”

d. Comment: The proposed rule would have excluded “telephone voice response” and “faxback” systems from the security standards, and we specifically solicited comments on that issue. A number of commenters agreed that telephone voice response and faxback should be excluded from the regulation, suggesting that the privacy standards rather than the security standards should apply. Others wanted those systems included, on the grounds that inclusion is necessary for consistency and in keeping with the intent of the Act. Still others specifically wanted personal computer-fax transmissions included. One commenter asked for clarification of when we would cover faxes, and another commenter asked why we were excluding them. Several commenters suggested that the other security requirements provide for adequate security of these systems.

Response: In light of these comments, we have decided that telephone voice response and “faxback” (that is, a request for information from a computer made via voice or telephone keypad input with the requested information returned as a fax) systems fall under this rule because they are used as input and output devices for computers, not because they have computers in them. Excluding these features would provide a huge loophole in any system concerned with security of the information contained and/or processed therein. It should be noted that employment of telephone voice response and/or faxback systems will generally require security protection by only one of the parties involved, and not the other. Information being transmitted via a telephone (either by voice or a DTMP tone pad) is not in electronic form (as defined in the first paragraph of the definition of “electronic media”) before transmission and therefore is not subject to the Security Rule. Information being returned via a telephone voice response system in response to a telephone request is data that is already in electronic form and stored in a computer. This latter transmission does require protection under the Security Rule.
Although most recently made electronic devices contain microprocessors (a form of computer) controlled by firmware (an unchangeable form of computer program), we intend the term “computer” to include only software programmable computers, for example, personal computers, minicomputers, and mainframes. Copy machines, fax machines, and telephones, even those that contain memory and can produce multiple copies for multiple people are not intended to be included in the term “computer.” Therefore, because “paper-to-paper” faxes, person-to-person telephone calls, video teleconferencing, or messages left on voice-mail were not in electronic form before the transmission, those activities are not covered by this rule. See also the definition of “electronic media” at § 160.103. We note that this guidance differs from the guidance regarding the applicability of the Transactions Rule to faxback and voice response systems. HHS has stated that faxback and voice response systems are not required to follow the standards mandated in the Transactions Rule. This new guidance refers only to this rule.

e. Comment: One commenter asked whether there is a need to implement special security practices to address the shipping and receiving of health information and asked that we more fully explain our expectations and solutions in the final rules.

Response: If the handling of electronic protected health information involves shipping and receiving, appropriate measures must be taken to protect the information. However, specific solutions are not provided within this rule, as discussed in section III.A.3 of this final rule. The device and media controls standard under [164.310(d)(1)] addresses this situation.

f. Comment: One commenter wanted the “HTML” statement reworded to eliminate a specific exemption for HTML from the regulation.

Response: The Transactions Rule did not adopt the proposed exemption for HTML. The use of HTML or any other electronic protocol is not exempt from the security standards. Generally, if protected health information is contained in any form of electronic transmission, it must be appropriately safeguarded.

g. Comment: One commenter asked to what degree “family history” is considered health information under this rule and what protections apply to family members included in a patient's family history.

Response: Any health-related “family history” contained in a patient's record that identifies a patient, including a person other than the patient, is individually identifiable health information and, to the extent it is also electronic protected health information, must be afforded the security protections.

h. Comment: Two commenters asked that the rule prohibit re-identification of de-identified data. In contrast, several commenters asked that we identify a minimum list or threshold of specific re-identification data elements (for example, name, city, and ZIP) that would fall under this final rule so that, for example, the rule would not affect numerous systems, for example, network adequacy and population-based clinical analysis databases. One commenter asked that we establish a means to use re-identified information if the entity already has access to the information or is authorized to have access.

Response: The issue of re-identification is addressed in the Privacy Rule at §164.502(d) and §164.514(c). The reader is referred to those sections and the related discussion in the preamble to the Privacy Rule (65 FR 82712) and the preamble to the Privacy Modifications (67 FR 53232 through 53234) for a full discussion of the issues of reidentification. We note that once information in the possession (or constructive possession) of a covered entity is re-identified and meets the definition of electronic protected health information, the security standards apply.

2. Technology-Neutral Standards

Comment: Many commenters expressed support for our efforts to develop standards for the security of health information. A number of comments were made in support of the technology-neutral approach of the proposed rule. For example, one commenter stated, “By avoiding prescription of the specific technologies health care entities should use to meet the law's requirements, you are opening the door for industry to apply innovation. Technologies that don't currently exist or are impractical today could, in the near future, enhance health information security while minimizing the overall cost.” Several other commenters stated that the requirements should be general enough to withstand changes to technology without becoming obsolete. One commenter anticipates no problems with meeting the standards. In contrast, one commenter suggested that whenever possible, specific technology recommendations should provide sufficient detail to promote systems interoperability and decrease the tendency toward adoption of multiple divergent standards. Several commenters stated that by letting each organization determine its own rules, the rules impose procedural burdens without any substantive benefit to security.

Response: The overwhelming majority of comments supported our position. We do not believe it is appropriate to make the standards technology-specific because technology is simply moving too fast, for example, the increased use and sophistication of internet-enabled hand held devices. We believe that the implementation of these rules will promote the security of electronic protected health information by (1) providing integrity and confidentiality; (2) allowing only authorized individuals access to that information; and (3) ensuring its availability to those authorized to access the information. The standards do not allow organizations to make their own rules, only their own technology choices.

3. Miscellaneous Comments

a. Comment: Some commenters stated that the requirements and implementation features set out in the proposed rule were not specific enough to be considered standards, and that the actual standards are delegated to the discretion of the covered entities, at the expense of medical record privacy. Several commenters stated that it was inappropriate to balance the interests of those seeking to use identifiable medical information without patient consent against the interest of patients. Several other commenters believe that allowing covered entities to make their own decisions about the adequacy and balance of security measures undermined patient confidentiality interests, and stated that the proposed rule did not appear to adequately consider patient concerns and viewpoints.

Response: Again, the overwhelming majority of commenters supported our approach. This final rule sets forth requirements with which covered entities must comply and labels those requirements as standards and implementation specifications. Adequate implementation of this final rule by covered entities will ensure that the electronic protected health information in a covered entity's care will be as protected as is feasible for that entity.We disagree that covered entities are given complete discretion to determine their security polices under this rule, resulting in effect, in no standards. While cost is one factor a covered identity may consider in determining whether to implement a particular implementation specification, there is nonetheless a clear requirement that adequate security measures be implemented, see 45 CFR 164.306(b). Cost is not meant to free covered entities from this responsibility.

b. Comment: Several commenters requested we withdraw the regulations, citing resource shortages due to Y2K preparation, upcoming privacy legislation, and/or the “excessive micro-management” contained in the rules. One commenter stated that, to insurers, these rules were onerous, not necessary, and not justified as cost-effective, as they already have effective practices for computer security and are subject to rigorous State laws for the safeguarding of health information. Another commenter stated that these rules would adversely affect a provider's practice environment.

Response: The HIPAA statute requires us to promulgate a rule adopting security standards for health information. Resource concerns due to Y2K should no longer be an issue. Covered entities will have 2 years (or, in the case of small health plans, 3 years) from the adoption of this final rule in which to comply. Concerns relative to effective and compliance dates and the Privacy Rule are discussed under [164.318], Compliance dates for initial implementation, below and at 65 FR 82751 through 82752. We disagree that these standards will adversely affect a provider's practice environment. The scalability of the standards allows each covered entity to implement security protections that are appropriate to its specific needs, risks, and environments. These protections are necessary to maintain the confidentiality, integrity, and availability of patient data. A covered entity that lacks adequate protections risks inadvertent disclosure of patient data, with resulting loss of public trust, and potential legal action. For example, a covered entity with poor facility access controls and procedures would be susceptible to hacking of its databases. A provider with appropriate security protections already in place would only need to ensure that the protections are documented and are reassessed periodically to ensure that they continue to be appropriate and are actually being implemented. Our decision to classify many implementation specifications as addressable, rather than mandatory, provides even more flexibility to covered entities to develop costeffective solutions. We believe that insurers who already have effective security programs in place will have met many of the requirements of this regulation.

c. Comment: One commenter believes the rule is arbitrary and capricious in its requirements without any justification that they will significantly improve the security of medical records and with the likelihood that their implementation may actually increase the vulnerability of the data. The commenter noted that the data backup requirements increase access to data and that security awareness training provides more information to employees.

Response: The standards are based on generally accepted security procedures, existing industry standards and guidelines, and recommendations contained in the National Research Council's 1997 report For The Record: Protecting Electronic Health Information, Chapter 6. We also consulted extensively with experts in the field of security throughout the health care industry. The standards are consistent with generally accepted security principles and practices that are already in widespread use.

Data backup need not result in increased access to that data. Backups should be stored in a secure location with controlled access. The appropriate secure location and access control will vary, based upon the security needs of the covered entity. For example, a procedure as simple as locking backup diskettes in a safe place and restricting who has access to the key may be suitable for one entity, whereas another may need to store backed-up information off-site in a secure computer facility. The information provided in security awareness training heightens awareness of security anomalies and helps to prevent security incidents.

d. Comment: Several commenters suggested that the proposed rule appears to reflect the Medicare program's perspective on security risks and solutions, and that it should be noted that not all industry segments share all the same risks as Medicare. One commenter stated that as future proposed rules are drafted, we should solicit input from those most significantly affected, for example, providers, plans, and clearinghouses.

Others stated that Medicaid agencies were not sufficiently involved in the discussions and debate. Still another stated that States would be unable to perform some basic business functions if all the standards are not designed to meet their needs.

Response: We believe that the standards are consistent with common industry practices and equitable, and that there has been adequate consultation with interested parties in the development of the standards. These standards are the result of an intensive process of public consultation. We consulted with the National Uniform Billing Committee, the National Uniform Claim Committee, the American Dental Association, and the Workgroup for Electronic Data Interchange, in the course of developing the proposed rule. Those organizations were specifically named in the Act to advise the Secretary, and their membership is drawn from the full spectrum of industry segments. In addition, the National Committee on Vital and Health Statistics (NCVHS), an independent advisory group to the Secretary, held numerous public hearings to obtain the views of interested parties. Again, many segments of the health care industry, including provider groups, health plans, clearinghouses, vendors, and government programs participated actively. The NCVHS developed recommendations to the Secretary, which were relied upon as we developed the proposed rule. Finally, we note that the opportunity to comment was available to all during the public comment period.

e. Comment: One commenter stated that there is a need to ensure the confidentiality of risk analysis information that may contain sensitive information.

Response: The information included in a risk analysis would not be subject to the security standards if it does not include electronic protected health information. We agree that risk analysis data could contain sensitive information, just as other business information can be sensitive. Covered entities may wish to develop their own business rules regarding access to and protections for risk analysis data.

f. Comment: One commenter expressed concern over the statement in the preamble of the proposed rule (63 FR 43250) that read: “No one item is considered to be more important than another.” The commenter suggested that security management should be viewed as most critical and perhaps what forms the foundation for all other security actions.

Response: The majority of comments received on this subject requested that we prioritize the standards. In response, we have regrouped the standards and implementation specifications in what we believe is a logical order within each of three categories: “Administrative safeguards,” “Physical safeguards,” and “Technical safeguards.” In this final rule, we order the standards in such a way that the “Security management process” is listed first under the “Administrative safeguards” section, as we believe this forms the foundation on which all of the other standards depend. The determination of the specific security measures to be implemented to comply with the standards will, in large part, be dependent upon completion of the implementation specifications within the security management process standard (see [164.308(a)(1)]). We emphasize, however, that an entity implementing these standards may choose to implement them in any order, as long as the standards are met.

g. Comment: One commenter stated that there is a need for requirements concerning organizational practices (for example, education, training, and security and confidentiality policies), as well as technical practices and procedures.

Response: We agree. Section 164.308 of this final rule describes administrative safeguards that address these topics. Section 164.308 requires covered entities to implement standards and required implementation specifications, as well as consider and implement, when appropriate and reasonable, addressable implementation specifications. For example, the security management process standard requires implementation of a risk analysis, risk management, a sanction policy, and an information system activity review. The information access management standard requires consideration, and implementation where appropriate and reasonable, of access authorization and access establishment and modification policies and procedures. Other areas addressed are assigned security responsibility, workforce security, security awareness and training, security incident procedures, contingency planning, business associate contracts, and evaluation.

h. Comment: One commenter stated that internal and external security requirements should be separated and dealt with independently.

Response: The presentation of the standards within this final rule could have been structured in numerous ways, including by addressing separate internal and external security standards. We chose the current structure as we considered it a logical breakout for purposes of display within this final rule. Under our structure a covered entity may apply a given standard to internal activities and to external activities. Had we displayed separately the standards for internal security and the standards for external security, we would have needed to describe a number of the standards twice, as many apply to both internal and external security. However, a given entity may address the standards in whatever order it chooses, as long as the standards are met.

i. Comment: Two commenters stated that the standards identified in Addendum 3 of the proposed rule may not all have matured to implementation readiness.

Response: Addendum 3 of the proposed rule cross-referred individual requirements on the matrix to existing industry standards of varying levels of maturity. Addendum 3 was intended to show what we evaluated in searching for existing industry standards that could be adopted on a national level. No one standard was found to be comprehensive enough to be adopted, and none were proposed as the standards to be met under the Security Rule.

j. Comment: One commenter suggested we include a revised preamble in the final publication. Another questioned how clarification of points in the preamble will be handled if the preamble is not part of the final regulation.

Response: Preambles to proposed rules are not republished in the final rule. The preamble in this final rule contains summaries of the information presented in the preamble of the proposed rule, summaries of the comments received during the public comment period, and responses to questions and concerns raised in those comments and a summary of changes made. Additional clarification will be provided by HHS on an ongoing basis through written documents and postings on HHS's websites.

k. Comment: One commenter asked that we clarify that no third party can require implementation of more security features than are required in the final rule, for example, a third party could not require encryption but may choose to accept it if the other party so desires.

Response: The security standards establish a minimum level of security to be met by covered entities. It is not our intent to limit the level of security that may be agreed to between trading partners or others above this floor.

l. Comment: One commenter asked how privacy legislation would affect these rules. The commenter inquired whether covered entities will have to reassess and revise actions already taken in the spirit of compliance with the security regulations.

Response: We cannot predict if or how future legislation may affect the rules below. At present, the privacy standards at subpart E of 42 CFR part 164 have been adopted, and this final rule is compatible with them.

m. Comment: One commenter stated that a data classification policy, that is a method of assigning sensitivity ratings to specific pieces of data, should be part of the final regulations.

Response: We did not adopt such a policy because this final rule requires a floor of protection of all electronic protected health information. A covered entity has the option to exceed this floor. The sensitivity of information, the risks to and vulnerabilities of electronic protected health information and the means that should be employed to protect it are business determinations and decisions to be made by each covered entity.

n. Comment: One commenter stated that this proposed rule conflicts with previously stated rules that acceptable “standards” must have been developed by ANSI-recognized Standards Development Organizations (SDOs).

Response: In general, HHS is required to adopt standards developed by ANSI-accredited SDOs when such standards exist. The currently existing security standards developed by ANSIrecognized SDOs are targeted to specific technologies and/or activities. No existing security standard, or group of standards, is technology-neutral, scaleable to the extent required by HIPAA, and broad enough to be adopted in this final rule. Therefore, this final rule adopts standards under section 1172(c)(2)(B) of the Act, which permits us to develop standards when no industry standards exist.

o. Comment: One commenter stated that this regulation goes beyond the scope of the law, unjustifiably extending into business practices, employee policies, and facility security.

Response: We do not believe that this regulation goes beyond the scope of the law. The law requires HHS to adopt standards for reasonable and appropriate security safeguards concerning such matters as compliance by the officers and employees of covered entities, protection against reasonably anticipated unauthorized uses and disclosures of health information, and so on. Such standards will inevitably address the areas the commenter pointed to. The intent of this regulation is to provide standards for the protection of electronic protected health information in accordance with the Act. In order to do this, covered entities are required to implement administrative, physical, and technical safeguards. Those entities must ensure that data are protected, to the extent feasible, from inappropriate access, modification, dissemination, and destruction. As noted above, however, this final rule has been modified to increase flexibility as to how this protection is accomplished.

p. Comment: One commenter stated that all sections regarding confidentiality and privacy should be removed, since they do not belong in this regulation.

Response: As the discussion in section III.A above of this final rule makes clear, the privacy and security standards are very closely related. Section 1173(d)(2) of the Act specifically mentions “confidentiality” and authorizes uses and disclosures of information as part of what security safeguards must address. Thus, we cannot omit all references to confidentiality and privacy in discussions of the security standards. However, we have relocated material that relates to both security and privacy (including definitions) to the general section of part 164.

q. Comment: One commenter asked that data retention be addressed more specifically, since this will become a significant issue over time. It is recommended that a national work group be convened to address this issue.

Response: The commenter's concern is noted. While the documentation relating to Security Rule implementation must be retained for a period of 6 years (see [164.316(b)(2)]), it is not within the scope of this final rule to address data retention time frames for administrative or clinical records.

r. Comment: One commenter stated that requiring provider practices to develop policies, procedures, and training programs and to implement record keeping and documentation systems would be tremendously resource-intensive and increase the costs of health care.

Response: We expect that many of the standards of this final rule are already being met in one form or another by covered entities. For example, as part of normal business operations, health care providers already take measures to protect the health information in their keeping. Health care providers already keep records, train their employees, and require employees to follow office policies and procedures. Similarly, health plans are already frequently required by State law to keep information confidential. While revisions to a practice's or plan's current activities may be necessary, the development of entirely new systems or procedures may not be necessary.

s. Comment: One commenter stated that there is no system for which risk has been eliminated and expressed concern over phrases such as covered entities must “assure that electronic health information pertaining to an individual remains secure.”

Response: We agree with the commenter that there is no such thing as a totally secure system that carries no risks to security. Furthermore, we believe the Congress' intent in the use of the word “ensure” in section 1173(d) of the Act was to set an exceptionally high goal for the security of electronic protected health information. However, we note that the Congress also recognized that some trade-offs would be necessary, and that “ensuring” protection did not mean providing protection, no matter how expensive. See section 1173(d)(1)(A)(ii) of the Act. Therefore, when we state that a covered entity must ensure the safety of the information in its keeping, we intend that a covered entity take steps, to the best of its ability, to protect that information. This will involve establishing a balance between the information's identifiable risks and vulnerabilities, and the cost of various protective measures, and will also be dependent upon the size, complexity, and capabilities of the covered entity, as provided in [164.306(b)].

E. Administrative Safeguards ([164.308])

We proposed that measures taken to comply with the rule be appropriate to protect the health information in a covered entity's care. Most importantly, we proposed to require that both the measures taken and documentation of those measures be kept current, that is, reviewed and updated periodically to continue appropriately to protect the health information in the care of covered entities. We would have required the documentation to be made available to those individuals responsible for implementing the procedure.

We proposed a number of administrative requirements and supporting implementation features, and required documentation for those administrative requirements and implementation features.

In this final rule, we have placed these administrative standards in [164.308]. We have reordered them, deleted much of the detail of the proposed requirements, as discussed below, and omitted two of the proposed sets of requirements (system configuration requirements and a requirement for a formal mechanism for processing records) as discussed in paragraph 10 of the discussion of [164.308] of section III.E. of this preamble. Otherwise, the basic elements of the administrative safeguards are adopted in this final rule as proposed.

1. Security Management Process ([164.308(a)(1)(i)])

We proposed the establishment of a formal security management process to involve the creation, administration, and oversight of policies to address the full range of security issues and to ensure the prevention, detection, containment, and correction of security violations. This process would include implementation features consisting of a risk analysis, risk management, and sanction and security policies.

We also proposed, in a separate requirement under administrative procedures, an internal audit, which would be an in-house review of the records of system activity (for example, logins, file accesses, and security incidents) maintained by an entity.

In this final rule, risk analysis, risk management, and sanction policy are adopted as required implementation specifications although some of the details are changed, and the proposed internal audit requirement has been renamed as “information system activity review” and incorporated here as an additional implementation specification.

a. Comment: Three commenters asked that this requirement be deleted. Two commenters cited this requirement as a possible burden. Several commenters asked that the implementation features be made optional.

Response: This standard and its component implementation specifications form the foundation upon which an entity's necessary security activities are built. See NIST SP 800-30, “Risk Management Guide for Information Technology Systems,” chapters 3 and 4, January 2002. An entity must identify the risks to and vulnerabilities of the information in its care before it can take effective steps to eliminate or minimize those risks and vulnerabilities. Some form of sanction or punishment activity must be instituted for noncompliance. Indeed, we question how the statutory requirement for safeguards “to ensure compliance * * * by a [covered entity's] officers and employees” could be met without a requirement for a sanction policy. See section 1176(d)(2)(C) of the Act. Accordingly, implementation of these specifications remains mandatory. However, it is important to note that covered entities have the flexibility to implement the standard in a manner consistent with numerous factors, including such things as, but not limited to, their size, degree of risk, and environment. We have deleted the implementation specification calling for an organizational security policy, as it duplicated requirements of the security management and training standard. We note that the implementation specification for a risk analysis at [164.308(a)(1)(ii)](A) does not specifically require that a covered entity perform a risk analysis often enough to ensure that its security measures are adequate to provide the level of security required by [164.306(a)]. In the proposed rule, an assurance of adequate security was framed as a requirement to keep security measures “current.” We continue to believe that security measures must remain current, and have added regulatory language in [164.306(e)] as a more precise way of communicating that security measures in general that must be periodically reassessed and updated as needed.

The risk analysis implementation specification contains other terms that merit explanation. Under [164.308(a)(1)(ii)](A), the risk analysis must look at risks to the covered entity's electronic protected health information. A thorough and accurate risk analysis would consider “all relevant losses” that would be expected if the security measures were not in place. “Relevant losses” would include losses caused by unauthorized uses and disclosures and loss of data integrity that would be expected to occur absent the security measures.

b. Comment: Relative to the development of an entity's sanction policy, one commenter asked that we describe the sanction penalties for breach of security. Another suggested establishment of a standard to which one's conduct could be held and adoption of mitigating circumstances so that the fact that a person acted in good faith would be a factor that could be used to reduce or otherwise minimize any sanction imposed. Another commenter suggested sanction activities not be implemented before the full implementation and testing of all electronic transaction standards.

Response: The sanction policy is a required implementation specification because--(1) the statute requires covered entities to have safeguards to ensure compliance by officers and employees; (2) a negative consequence to noncompliance enhances the likelihood of compliance; and (3) sanction policies are recognized as a usual and necessary component of an adequate security program. The type and severity of sanctions imposed, and for what causes, must be determined by each covered entity based upon its security policy and the relative severity of the violation.

c. Comment: Commenters requested the definitions of “risk analysis” and “breach.”

Response: “Risk analysis” is defined and described in the specification of the security management process standard, and is discussed in the preamble discussion of [164.308(a)(1)(ii)](A) of this final rule. The term breach is no longer used and is, therefore, not defined.

d. Comment: One commenter asked whether all health information is considered equally “sensitive,” the thought being that, in determining risk, an entity may consider the loss of a smaller amount of extraordinarily sensitive data to be more significant than the loss of a larger amount of routinely collected data. The commenter stated that common reasoning would suggest that the smaller amount of data would be considered more sensitive.

Response: All electronic protected health information must be protected at least to the degree provided by these standards. If an entity desires to protect the information to a greater degree than the risk analysis would indicate, it is free to do so.

e. Comment: One commenter asked that we add “threat assessment” to this requirement.

Response: We have not done this because we view threat assessment as an inherent part of a risk analysis; adding it would be redundant.

f. Comment: We proposed a requirement for internal audit, the in-house review of the records of system activity (for example, logins, file accesses, and security incidents) maintained by an entity. Several commenters wanted this requirement deleted. One suggested the audit trail requirement should not be mandatory, while another stated that internal audits would be unnecessary if physical security requirements are implemented. A number of commenters asked that we clarify the nature and scope of what an internal audit covers and what the audit time frame should be. Several commenters offered further detail concerning what should and should not be required in an internal audit for security purposes. One commenter stated that ongoing intrusion detection should be included in this requirement. Another wanted us to specify the retention times for archived audit logs. Several commenters had difficulty with the term “audit” and suggested we change the title of the requirement to “logging and violation monitoring.” A number of commenters stated this requirement could result in an undue burden and would be economically unfeasible.

Response: Our intent for this requirement was to promote the periodic review of an entity's internal security controls, for example, logs, access reports, and incident tracking. The extent, frequency, and nature of the reviews would be determined by the covered entity's security environment. The term “internal audit” apparently, based on the comments received, has certain rigid formal connotations we did not intend. We agree that the implementation of formal internal audits could prove burdensome or even unfeasible, to some covered entities due to the cost and effort involved. However, we do not want to overlook the value of internal reviews. Based on our review of the comments and the text to which they refer, it is clear that this requirement should be renamed for clarity and that it should actually be an implementation specification of the security management process rather than an independent standard. We accordingly remove “internal audit” as a separate requirement and add “information system activity review” under the security management process standard as a mandatory implementation specification.

2. Assigned Security Responsibility ([164.308(a)(2)])

We proposed that the responsibility for security be assigned to a specific individual or organization to provide an organizational focus and importance to security, and that the assignment be documented. Responsibilities would include the management and supervision of (1) the use of security measures to protect data, and (2) the conduct of personnel in relation to the protection of data. In this final rule, we clarify that the final responsibility for a covered entity's security must be assigned to one official. The requirement for documentation is retained, but is made part of [164.316] below. This policy is consistent with the analogous policy in the Privacy Rule, at 45 CFR 164.530(a), and the same considerations apply. See 65 FR 82744 through 87445. The same person could fill the role for both security and privacy.

a. Comment: Commenters were concerned that delegation of assigned security responsibility, especially in large organizations, needs to be to more than a single individual. Commenters believe that a large health organization's security concerns would likely cross many departmental boundaries requiring group responsibility.

Response: The assigned security responsibility standard adopted in this final rule specifies that final security responsibility must rest with one individual to ensure accountability within each covered entity. More than one individual may be given specific security responsibilities, especially within a large organization, but a single individual must be designated as having the overall final responsibility for the security of the entity's electronic protected health information. This decision also aligns this rule with the final Privacy Rule provisions concerning the Privacy Official.

b. Comment: One commenter disagreed with placing assigned security responsibility as part of physical safeguards. The commenter suggested that assigned security responsibility should be included under the Administrative Procedures.

Response: Upon review of the matrix and regulations text, we agree with the commenter, because this requirement involves an administrative decision at the highest levels of who should be responsible for ensuring security measures are implemented and maintained. Assigned security responsibility has been removed from “Physical safeguards” and is now located under “Administrative safeguards” at [164.308].

3. Workforce Security ([164.308(a)(3)(i)])

We proposed implementation of a number of features for personnel security, including ensuring that maintenance personnel are supervised by a knowledgeable person, maintaining a record of access authorizations, ensuring that operating and maintenance personnel have proper access authorization, establishing personnel clearance procedures, establishing and maintaining personnel security policies and procedures, and ensuring that system users have proper training.

In this final rule, to provide clarification and reduce duplication, we have combined the “Assure supervision of maintenance personnel by authorized, knowledgeable person” implementation feature and the “Operating, and in some cases, maintenance personnel have proper access authorization” feature into one addressable implementation specification titled “Authorization and/or supervision.”

In a related, but separate, requirement entitled “Termination procedures,” we proposed implementation features for the ending of an employee's employment or an internal or external user's access. These features would include things such as changing combination locks, removal from access lists, removal of user account(s), and the turning in of keys, tokens, or cards that allow access. In this final rule, “Termination procedures” has been made an addressable implementation specification under “Workforce security.” This is addressable because in certain circumstances, for example, a solo physician practice whose staff consists only of the physician's spouse, formal procedures may not be necessary. The proposed “Personnel security policy/procedure” and “record of access authorizations” implementation features have been removed from this final rule, as they have been determined to be redundant. Implementation of the balance of the “Workforce security” implementation specifications and the other standards contained within this final rule will result in assurance that all personnel with access to electronic protected health information have the required access authority as well as appropriate clearances.

a. Comment: The majority of comments concerned the supervision of maintenance personnel by an authorized knowledgeable person. Commenters stated this would not be feasible in smaller settings. For example, the availability of technically knowledgeable persons to ensure this supervision would be an issue. We were asked to either reword this implementation feature or delete it.

Response: We agree that a “knowledgeable” person may not be available to supervise maintenance personnel. We have accordingly modified this implementation specification so that, in this final rule, we are adopting an addressable implementation specification titled, “Authorization and/or supervision,” requiring that workforce members, for example, operations and maintenance personnel, must either be supervised or have authorization when working with electronic protected health information or in locations where it resides (see [164.308(a)(3)(ii)](A)). Entities can decide on the feasibility of meeting this specification based on their risk analysis.

b. Comment: The second largest group of comments requested assurance that, with regard to the proposed “Personnel clearance procedure” implementation feature, having appropriate clearances does not mean performing background checks on everyone. We were asked to delete references to “clearance” and use the term “authorization” in its place.

Response: We agree with the commenters concerning background checks. This feature was not intended to be interpreted as an absolute requirement for background checks. We retain the use of the term “clearance,” however, because we believe that it more accurately conveys the screening process intended than does the term “authorization.” We have attempted to clarify our intent in the language of [164.308(a)(3)(ii)](B), which now reads, “Implement procedures to determine that the access of a workforce member to electronic protected health information is appropriate.” The need for and extent of a screening process is normally based on an assessment of risk, cost, benefit, and feasibility as well as other protective measures in place. Effective personnel screening processes may be applied in a way to allow a range of implementation, from minimal procedures to more stringent procedures based on the risk analysis performed by the covered entity. So long as the standard is met and the underlying standard of [164.306(a)] is met, covered entities have choices in how they meet these standards. To clarify the intent of this provision, we retitle the implementation specification “Workforce clearance procedure.”

c. Comment: One commenter asked that we expand the implementation features to include the identification of the restrictions that should be placed on members of the workforce and others.

Response: We have not adopted this comment in the interest of maintaining flexibility as discussed in [164.306]. Restrictions would be dependent upon job responsibilities, the amount and type of supervision required and other factors. We note that a covered entity should consider in this regard the applicable requirements of the Privacy Rule (see, for example, §164.514(d)(2) (relating to minimum necessary requirements), and §164.530(c) (relating to safeguards).

d. Comment: One commenter believes that the proposed “Personnel security” requirement was reasonable, since an administrative determination of trustworthiness is needed before allowing access to sensitive information. Two commenters asked that we delete the requirement entirely. A number of commenters requested that we delete the implementation features. Another commenter stated that all the implementation features may not be applicable or even appropriate to a given entity and should be so qualified.

Response: While we do not believe this requirement should be eliminated, we agree that all the implementation specifications may not be applicable or even appropriate to a given entity. For example, a personal clearance may not be reasonable or appropriate for a small provider whose only assistant is his or her spouse. The implementation specifications are not mandatory, but must be addressed. This final rule has been changed to reflect this approach (see [164.308(a)(3)(ii)](B)).

e. Comment: The majority of commenters on the “Termination procedures” requirement asked that it be made optional, stating that it may not be applicable or even appropriate in all circumstances and should be so qualified or posed as guidelines. A number of commenters stated that the requirement should be deleted. One commenter stated that much of the material covered under the “Termination procedures” requirement is already covered in “Information access control.” A number of commenters stated that this requirement was too detailed and some of the requirements excessive.

Response: Based upon the comments received, we agree that termination procedures should not be a separate standard; however, consideration of termination procedures remains relevant for any covered entity with employees, because of the risks associated with the potential for unauthorized acts by former employees, such as acts of retribution or use of proprietary information for personal gain. We further agree with the reasoning of the commenters who asked that these procedures be made optional; therefore, “Termination procedures” is now reflected in this final rule as an addressable implementation specification. We also removed reference to all specific termination activities, for example, changing locks, because, although the activities may be considered appropriate for some covered entities, they may not be reasonable for others.

f. Comment: One commenter asked whether human resource employee termination policies and procedures must be documented to show the types of security breaches that would result in termination.

Response: Policies and procedures implemented to adhere to this standard must be documented (see [164.316] below). The purpose of termination procedure documentation under this implementation specification is not to detail when or under which circumstances an employee should be terminated. This information would more appropriately be part of the entity's sanction policy. The purpose of termination procedure documentation is to ensure that termination procedures include security-unique actions to be followed, for example, revoking passwords and retrieving keys when a termination occurs.

4. Information Access Management (