Security Standards
III. Analysis of, and Responses to,
Public Comments on the Proposed Rule
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 (§ 164.308(a)(4))
We proposed an "information access control" requirement
for establishment and maintenance of formal, documented policies
and procedures defining levels of access for all personnel authorized
to access health information, and how access is granted and modified.
In § 164.308(a)(4)(ii)(B) and (C) below, the proposed implementation
features are made addressable specifications. We have added in §
164.308(a)(4)(ii)(A), a required implementation specification to
isolate health care clearinghouse functions to address the provisions
of section 1173(d)(1)(B) of the Act which related to this area.
a. Comment: One commenter asked that the requirement be
deleted, expressing the opinion that this requirement goes beyond
"reasonable boundaries" into regulating common business
practices. In contrast, another asked that we expand this requirement
to identify participating parties and access privileges relative
to specific data elements.
Response: We disagree that this requirement improperly imposes
upon business functions. Restricting access to those persons and
entities with a need for access is a basic tenet of security. By
this mechanism, the risk of inappropriate disclosure, alteration,
or destruction of information is minimized. We cannot, however,
specifically identify participating parties and access privileges
relative to data elements within this regulation. These will vary
depending upon the entity, the needs within the user community,
the system in which the data resides, and the specific data being
accessed. This standard is consistent with § 164.514(d) in
the Privacy Rule (minimum necessary requirements for use and disclosure
of protected health information), and is, therefore, being retained.
b. Comment: Several commenters asked that we not mandate
the implementation features, but leave them as optional, a suggested
means of compliance. The commenters noted that this might make the
rules more scalable and flexible, since this approach would allow
providers to implement safeguards that best addressed their needs.
Along this line, one commenter expressed the belief that each organization
should implement features deemed necessary based on its own risk
assessment.
Response: While the information access management standard
in this final rule must be met, we agree that the implementation
specifications at § 164.308(a)(4)(ii)(B) and (C) should not
be mandated but posed as a suggested means of compliance, which
must be addressed. These specifications may not be applicable to
all entities based on their size and degree of automation. A fully
automated covered entity spanning multiple locations and involving
hundreds of employees may determine it has a need to adopt a formal
policy for access authorization, while a small provider may decide
that a desktop standard operating procedure will meet the specifications.
The final rule has been revised accordingly.
c. Comment: Clarification was requested concerning the meaning
of "formal."
Response: The word "formal" has caused considerable
concern among commenters, as it was thought "formal" carried
the connotation of a rigidly defined structure similar to what might
be found in the Department of Defense instructions. As used in the
proposed rule, this word was not intended to convey such a strict
structure. Rather, it was meant to convey that documentation should
be an official organizational statement as opposed to
word-of-mouth or cryptic notes scratched on a notepad. While documentation
is still required (see § 164.316), to alleviate confusion,
the word "formal" has been deleted.
d. Comment: One commenter asked that we clarify that this
requirement relates to both the establishment of policies for the
access control function and to access control (the implementation
of those policies).
Response: "Information access management" does address
both the establishment of access control policies and their implementation.
We use the term "implement" to clarify that the procedures
must be in use, and we believe that the requirement to implement
policies and procedures requires, as an antecedent condition, the
establishment or adaptation of those policies and procedures.
5. Security Awareness and Training (§ 164.308(a)(5)(i))
We proposed, under the requirement "Training," that security
training be required for all staff, including management. Training
would include awareness training for all personnel, periodic security
reminders, user education concerning virus protection, user education
in the importance of monitoring login success/failure, and how to
report discrepancies, and user education in password management.
In this final rule, we adopt this proposed requirement in modified
form. For the standard "Security awareness and training,"
in § 164.308(a)(5), we require training of the workforce as
reasonable and appropriate to carry out their functions in the facility.
All proposed training features have been combined as implementation
specifications under this standard. Specific implementation specifications
relative to content are addressable. The "Virus protection"
implementation feature has been renamed "protection from malicious
software," because we did not intend by the nomenclature to
exclude coverage of malicious acts that might not come within the
prior term, such as worms.
a. Comment: One commenter believes that security awareness
training for all system users would be too difficult to do in a
large organization.
Response: We disagree with the commenter. Security awareness
training is a critical activity, regardless of an organization's
size. This feature would typically become part of an entity's overall
training program (which would include privacy and other information
technology items as well). For example, the Government Information
Systems Reform ACT (GISRA) of 2000 requires security awareness training
as part of Federal agencies' information security programs, including
Federal covered entities, such as the Medicare program. In addition,
National Institute of Standards and Technology (NIST) SP 800-16,
"Information Technology Security Training Requirements, A role
and performance base model, April 1998," (broken down into
3 PDF files: Part 1 - document, Part
2 - Appendix A-D, Part 3 - Appendix
E) provides an excellent source of information and guidance
on this subject and is targeted at industry as well as government
activities. We also note that covered entities must have discretion
in how they implement the requirement, so they can incorporate this
training in other existing activities. One approach would be to
require this training as part of employee orientation.
b. Comment: A number of commenters asked that this requirement
be made optional or used as a guideline only. Several commenters
stated that this requirement is too specific and is burdensome.
Several asked that the implementation features be removed.
Several others stated that this requirement is not appropriate
for agents or contractors. One commenter asked how to apply this
requirement to outsiders having access to data. Another asked if
this requirement included all subcontractor staff. Others stated
that contracts, signed by entities such as consultants, that address
training should be sufficient.
Response: Security training remains a requirement because
of its criticality; however, we have revised the implementation
specifications to indicate that the amount and type of training
needed will be dependent upon an entity's configuration and security
risks. Business associates must be made aware of security policies
and procedures, whether through contract language or other means.
Covered entities are not required to provide training to business
associates or anyone else that is not a member of their workforce.
c. Comment: Several commenters questioned why security awareness
training appeared in two places, under "Physical safeguards"
as well as "Administrative safeguards." Others questioned
the appropriateness of security awareness training under "Physical
safeguards."
Response: We reviewed the definitions of the proposed "Awareness
training for all personnel" ("Administrative safeguards")
implementation feature and the proposed "Security awareness
training" ("Physical safeguards") requirement. We
agree that, to avoid confusion and eliminate redundancy, security
awareness and training should appear in only one place. We believe
the appropriate location for it is under "Administrative safeguards,"
as such training is essentially an administrative function.
d. Comment: Several commenters objected to the blanket requirement
for security awareness training of individuals who may be on site
for a limited time period (for example, a single day).
Response: Each individual who has access to electronic protected
health information must be aware of the appropriate security measures
to reduce the risk of improper access, uses, and disclosures. This
requirement does not mean lengthy training is appropriate in every
instance; there are alternative methods to inform individuals of
security responsibilities (for example, provisions of pamphlets
or copies of security policies, and procedures).
e. Comment: One commenter asked that "training"
be changed to "orientation."
Response: We believe the term "training," as presented
within this rule is the more appropriate term. The rule does not
contemplate a one-time type of activity as connoted by "orientation,"
but rather an on-going, evolving process as an entity's security
needs and procedures change.
f. Comment: Several commenters asked how often training
should be conducted and asked for a definition of "periodic,"
as it appears in the proposed implementation feature "Periodic
security reminders." One asked if the training should be tailored
to job need.
Response: Amount and timing of training should be determined
by each covered entity; training should be an on-going, evolving
process in response to environmental and operational changes affecting
the security of electronic protected health information. While initial
training must be carried out by the compliance date, we provide
flexibility for covered entities to construct training programs.
Training can be tailored to job need if the covered entity so desires.
6. Security Incident Procedures (§ 164.308(a)(6))
We proposed a requirement for implementation of accurate and current
security incident procedures: formal, documented report and response
procedures so that security violations would be reported and handled
promptly. We adopt this standard in the final rule, along with an
implementation specification for response and reporting, since documenting
and reporting incidents, as well as responding to incidents are
an integral part of a security
program.
a. Comment: Several commenters asked that we further define
the scope of a breach of security. Along this same line, another
commenter stated that the proposed security incident procedures
were too vague as stated. We were asked to specify what a security
incident would be, what the internal chain for reporting procedures
would be, and what should be included in the documentation (for
example, hardware/software, personnel responses).
Response: We define a security incident in § 164.304.
Whether a specific action would be considered a security incident,
the specific process of documenting incidents, what information
should be contained in the documentation, and what the appropriate
response should be will be dependent upon an entity's environment
and the information involved. An entity should be able to rely upon
the information gathered in complying with the other security standards,
for example, its risk assessment and risk management procedures
and the privacy standards, to determine what constitutes a security
incident in the context of its business operations.
b. Comment: One commenter asked what types of incidents
must be reported to outside entities. Another
commented that we clarify that incident reporting is internal.
Response: Internal reporting is an inherent part of security
incident procedures. This regulation does not specifically require
any incident reporting to outside entities. External incident reporting
is dependent upon business and legal considerations.
c. Comment: One commenter stated that network activity should
be included here.
Response: We see no reason to exclude network activity under
this requirement. Improper network activity should be treated as
a security incident, because, by definition, it represents an improper
instance of access to or use of information.
d. Comment: One commenter stated that this requirement should
address suspected misuse also.
Response: We agree that security incidents include misuse
of data; therefore, this requirement is addressed.
e. Comment: Several commenters asked that this requirement
be deleted. One commenter asked that we delete the implementation
features.
Response: As indicated above, we have adopted the proposed
standard and combined the implementation specifications.
7. Contingency Plan (§ 164.308(a)(7)(i))
We proposed that a contingency plan must be in effect for responding
to system emergencies. The plan would include an applications and
data criticality analysis, a data backup plan, a disaster recovery
plan, an emergency mode operation plan, and testing and revision
procedures.
In this final rule, we make the implementation specifications for
testing and revision procedures and an applications and data criticality
analysis addressable, but otherwise require that the contingency
features proposed be met.
a. Comment: Several commenters suggested the contingency
plan requirement be deleted. Several thought that this aspect of
the proposed regulation went beyond its intended scope. Another
believed that more discussion and development is needed before developing
regulatory guidance on contingency plans. Others wanted this to
be an optional requirement. In contrast, one commenter requested
more guidance concerning contingency planning. Still others wanted
to require that a contingency plan be in place but stated that we
should not regulate its contents. One comment stated that data backup,
disaster recovery, and emergency mode operation should not be part
of this requirement.
Response: A contingency plan is the only way to protect
the availability, integrity, and security of data during unexpected
negative events. Data are often most exposed in these events, since
the usual security measures may be disabled, ignored, or not observed.
Each entity needs to determine its own risk in the event of an
emergency that would result in a loss of operations. A contingency
plan may involve highly complex processes in one processing site,
or simple manual processes in another. The contents of any given
contingency plan will depend upon the nature and configuration of
the entity devising it.
While the contingency plan standard must be met, we agree that
the proposed testing and revision implementation feature should
be an addressable implementation specification in this final rule.
Dependent upon the size, configuration, and environment of a given
covered entity, the entity should decide if testing and revision
of all parts of a contingency plan should be done or if there are
more reasonable alternatives. The same is true for the proposed
applications and data criticality analysis implementation feature.
We have revised the final rule to reflect this approach.
b. Comment: One commenter believed that adhering to this
requirement could prove burdensome. Another stated that testing
of certain parts of a contingency plan would be burdensome, and
even infeasible, for smaller entities.
Response: Without contingency planning, a covered entity has no
assurance that its critical data could survive an emergency situation.
Recent events, such as September 11, 2001, illustrate the importance
of such planning. Contingency planning will be scalable based upon,
among other factors, office configuration, and risk assessment.
However, in response to the scalability issue raised by the commenter,
we have made the testing and revision implementation specification
addressable (see § 164.308(a)(7)(ii)).
c. Comment: Two commenters considered a 2-year implementation
time frame for this requirement inadequate for large health plans.
Another commenter stated that implementation of measures against
natural disaster would be too big an issue for this regulation.
Response: The statute sets forth the compliance dates for
the initial standards. The statute requires that compliance with
initial standards is not later than 2 years after adoption of the
standards for all covered entities except small health plans for
which the compliance date is not later than 3 years after adoption.
The final rule calls for covered entities to consider how natural
disasters could damage systems that contain electronic protected
health information and develop policies and procedures for responding
to such situations. We consider this to be a reasonable precautionary
step to take since in many cases the risk would be deemed to be
low.
d. Comment: A commenter requested clarification of the term
"Emergency mode" with regard to the proposed "Emergency
mode operation plan" implementation feature.
Response: We have clarified the "Emergency mode operations
plan" to show that it only involves those critical business
processes that must occur to protect the security of electronic
protected health information during and immediately after a crisis
situation.
8. Evaluation (§ 164.308(a)(8))
We proposed that certification would be required and could be performed
internally or by an external accrediting agency. We solicited input
on appropriate mechanisms to permit an independent assessment of
compliance. We were particularly interested in input from those
engaging in health care electronic data interchange (EDI), as well
as independent certification and auditing organizations addressing
issues of documentary evidence of steps taken
for compliance; need for, or desirability of, independent verification,
validation, and testing of system changes; and certifications required
for off-the-shelf products used to meet the requirements of this
regulation. We also
solicited comments on the extent to which obtaining external certification
would create an undue burden on small or rural providers.
In this final rule, we require covered entities to periodically
conduct an evaluation of their security safeguards to demonstrate
and document their compliance with the entity's security policy
and the requirements of this subpart. Covered entities must assess
the need for a new evaluation based on changes to their security
environment since their last evaluation, for example, new technology
adopted or responses to newly recognized risks to the security of
their information.
a. Comment: We received several comments that certification
should be performed externally. A larger group of commenters preferred
self-certification. The majority of the comments, however, were
to the effect that external certification should be encouraged but
not mandated.
A number of commenters thought that mandating external certification
would create an undue financial burden, regardless of the size of
the entity being certified. One commenter stated that external certification
would not place an undue burden on a small or rural provider.
Response: Evaluation by an external entity is a business
decision to be left to each covered entity. Evaluation is required
under § 164.308(a)(8), but a covered entity may comply with
this standard either by using its own workforce or an external accreditation
agency, which would be acting as a business associate. External
evaluation may be too costly an option for small entities.
b. Comment: Several commenters stated that the certification
should cover all components of the proposed rule, not just the information
systems.
Response: We agree. We have revised this section to reflect
that evaluation would be both technical and nontechnical components
of security.
c. Comment: A number of commenters expressed a desire for
the creation of certification guides or models to complement the
rule.
Response: We agree that creation of compliance guidelines
or models for different business environments would help in the
implementation and evaluation of HIPAA security requirements and
we encourage professional associations and others to do so. We may
develop technical assistance materials, but do not intend to create
certification criteria because we do not have the resources to address
the large number of different business environments.
d. Comment: Some commenters asked how certification is possible
without specifying the level of risk that is permissible.
Response: The level of risk that is permissible is specified
by § 164.306(a). How such risk is managed will be determined
by a covered entity through its security risk analysis and the risk
mitigation activities it implements in order to ensure that the
level of security required by § 164.306 is provided.
e. Comment: Several commenters requested creation of a list
of Federally "certified" security software and off-the-shelf
products. Several others stated that this request was not feasible.
Regarding certification of off-the-shelf products, one commenter
thought this should be encouraged, but not mandated; several thought
this would be an impractical endeavor.
Response: While we will not assume the task of certifying
software and off-the-shelf products for the reason described above,
we have noted with interest that other Government agencies such
as the National Institute of Standards and Technology (NIST) are
working towards that end. The health care industry is encouraged
to monitor the activity of NIST and provide comments and suggestions
when requested (see http://www.niap.nist.gov.).
f. Comment: One commenter stated, "With HCFA's publishing
of these HIPAA standards, and their desire to retain the final responsibility
for determining violations and imposing penalties of the statute,
it also seems appropriate for HCFA to also provide certifying services
to ensure security compliance."
Response: In view of the enormous number and variety of
covered entities, we believe that evaluation can best be handled
through the marketplace, which can develop more usable and targeted
evaluation instruments and processes.
8(sic). Business Associate Contracts or Other Arrangements (§
164.308(b)(1))
In the proposed rule § 142.308(a)(2) "Chain of trust"
requirement, we proposed that covered entities be required to enter
into a chain of trust partner agreement with their business partners,
in which the partners would agree to electronically exchange data
and protect the integrity, confidentiality, and availability of
the data exchanged. This standard has been modified from the proposed
requirement to reflect, in § 164.308(b)(1) "Business associate
contracts and other arrangements," the business associate structure
put in place by the Privacy Rule.
In this final rule, covered entities must enter into a contract
or other arrangement with persons that meet the definition of business
associate in § 160.103. The covered entity must obtain satisfactory
assurances from the business associate that it will appropriately
safeguard the information in accordance with these standards (see
§ 164.314(a)(1)).
The comments received on the proposed chain of trust partner agreements
are discussed in section 2 "Business associate contracts and
other arrangements" of the discussion of § 164.314 below.
9. Proposed Requirements Not Adopted in This Final Rule
a. Security Configuration Management
We proposed that an organization would be required to implement
measures, practices, and procedures regarding security configuration
management. They would be coordinated and integrated with other
system configuration management practices for the security of information
systems. These would include documentation, hardware and/or software
installation and maintenance review and testing for security features,
inventory procedures, security testing, and virus checking.
Comment: Several commenters asked that the entire requirement
be deleted. Several others asked that the inventory and virus checking
implementation features be removed as they believe those features
are not germane to security configuration management. A number of
commenters requested that security testing be deleted because this
implementation feature is too detailed, unreasonable, impractical,
and beyond the scope of the legislation.
Others stated that the testing would be very complex and expensive.
Others wanted more clarification of what we intend by security testing,
and how much would be enough. A number of commenters asked that
all of the implementation features be deleted. Others asked that
the implementation features be made optional. Several commenters
wanted to know the scope of organizational integration required.
Several others asked if what we meant by Security Configuration
Management was change or version control.
Response: Upon review, this requirement appears unnecessary
because it is redundant of other requirements we are adopting in
this rule. A covered entity will have addressed the activities described
by the features under this proposed requirement by virtue of having
implemented the risk analysis, risk management measures, sanction
policies, and information systems criticality review called for
under the security management process. The proposed documentation
implementation feature has been made a separate standard (see §
164.316). As a result, the Security Configuration Management requirement
is not adopted in this final rule.
b. Formal Mechanism for Processing Records
The proposed rule proposed requiring a formal mechanism for processing
records, and documented policies and procedures for the routine
and nonroutine receipt, manipulation, storage, dissemination, transmission,
and/or disposal of health information. This requirement has not
been adopted in the final rule.
Comment: Several commenters thought this requirement concerned
the regulation of formal procedures for how an entity does business
and stated that such procedures should not be regulated. Others
asked for additional clarification of what is meant by this requirement.
One commenter thought the requirement too ambiguous and asked for
clarification as to whether we meant such things as "the proper
handling of storage media, databases, transmissions," or "the
clinical realm of processes."
Two commenters asked how extensive this requirement would be and
whether systems' user manuals and policies and procedures for handling
health information would suffice and what level of detail would
be expected.
Several thought this requirement could result in a significant resource
and monetary burden to develop and maintain formal procedures. Two
asked for an explanation of the benefit to be derived from this
requirement.
One asked that covered entities be required to document processes
that create a security risk only and suggested that a risk assessment
would determine the need for this documentation.
Response: We agree with the commenters that the standard
is ambiguous, and upon review, is unnecessary because the remaining
standards, for example, device and media controls, provide adequate
safeguards. Accordingly, this requirement is not adopted in this
final rule.
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