Volume 2 / Paper 2 1 5/2005: rev. 3/2007
HIPAA
Security
SERIES
Compliance Deadlines
No later than April 20, 2005 for
all covered entities except small
health plans, which have until
no later than April 20, 2006.
NOTE: To download the first paper
in this series, “Security 101 for
Covered Entities,” visit the CMS
website at:
www.cms.hhs.gov/SecurityStandard/
under the “Regulation” page.
What is the Security Series?
The security series of papers will provide guidance from the Centers for
Medicare & Medicaid Services (CMS) on the rule titled “Security Standards
for the Protection of Electronic Protected Health Information,” found at 45
CFR Part 160 and Part 164, Subparts A and C, commonly known as the
Security Rule. The Security Rule was adopted to implement provisions of the
Health Insurance Portability and Accountability Act of 1996 (HIPAA). The
series will contain seven papers, each focused on a specific topic related to
the Security Rule. The papers, which cover the topics listed to the left, are
designed to give HIPAA covered entities
insight into the Security Rule and
assistance with implementation of the
security standards. This series explains
specific requirements, the thought process
behind those requirements, and possible
ways to address the provisions.
CMS recommends that covered entities read the first paper in this series,
“Security 101 for Covered Entities” before reading the other papers. The first
paper clarifies important Security Rule concepts that will help covered
entities as they plan for implementation. This second paper in the series is
devoted to the standards for
Administrative Safeguards and their
implementation specifications and
assumes the reader has a basic
understanding of the Security Rule.
Background
An important step in protecting electronic protected health information
(EPHI) is to implement reasonable and appropriate administrative safeguards
that establish the foundation for a covered entity’s security program. The
Administrative Safeguards standards in the Security Rule, at § 164.308, were
developed to accomplish this purpose.
2
Security Standards: Administrative Safeguards
Security
Topics
5.
Security Standards
- Organizational,
Policies &
Procedures, and
Documentation
Requirements
4.
Security Standards
- Technical
Safeguards
3.
Security Standards
- Physical
Safeguards
1.
Security 101 for
Covered Entities
6.
Basics of Risk
Analysis and Risk
Management
7.
Implementation for
the Small Provider
2.
Security
Standards
- Administrative
Safeguards
5.
Security Standards
- Organizational,
Policies and
Procedures and
Documentation
Requirements
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 2 5/2005: rev. 3/2007
The objectives of this paper are to:
Review each Administrative Safeguards standard and
implementation specification listed in the Security Rule.
Discuss the purpose for each standard.
Provide sample questions that covered entities may want to
consider when implementing the Administrative Safeguards.
Sample questions provided in this paper, and other HIPAA Security Series
papers, are for consideration only and are not required for implementation.
The purpose of the sample questions is to promote review of a covered
entity’s environment in relation to the requirements of the Security Rule.
The sample questions are not HHS interpretations of the requirements of the
Security Rule.
All the information presented in the Security Series is designed to further
covered entities’ understanding of the Security Rule concepts. The papers
are not intended to be the definitive guidance for covered entity compliance.
Compliance with the Security Rule will depend on a number of factors,
including those identified in § 164.306(b)(2):
“(i) The size, complexity, and capabilities of the covered
entity.
(ii) The covered entity's technical infrastructure,
hardware, and software security capabilities.
(iii) The costs of security measures.
(iv) The probability and criticality of potential risks to
EPHI.”
What are Administrative Safeguards?
The Security Rule defines administrative safeguards as, “administrative
actions, and policies and procedures, to manage the selection, development,
implementation, and maintenance of security measures to protect electronic
protected health information and to manage the conduct of the covered
entity’s workforce in relation to the protection of that information.”
The Administrative Safeguards comprise over half of the HIPAA Security
requirements. As with all the standards in this rule, compliance with the
Administrative Safeguards standards will require an evaluation of the
STANDARD
164.310(a)(1)
ADMINISTRATIVE
SAFEGUARDS
- Security Management
Process
- Assigned Security
Responsibility
- Workforce Security
- Information Access
Management
- Security Awareness
and Training
- Security Incident
Procedures
- Contingency Plan
- Evaluation
- Business Associate
Contracts and Other
Arrangements
HIPAA SECURITY
STANDARDS
PHYSICAL
SAFEGUARDS
- Facility Access
Controls
- Workstation Use
- Workstation Security
- Device and Media
Controls
TECHNICAL
SAFEGUARDS
- Access Control
- Audit Controls
- Integrity
- Person or Entity
Authentication
- Transmission Security
ORGANIZATIONAL
REQUIREMENTS
- Business Associate
Contracts and Other
Arrangements
- Requirements for
Group Health Plans
Security Standards:
General Rules
POLICIES and
PROCEDURES and
DOCUMENTATION
REQUIREMENTS
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 3 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(1)
NOTE: For a more detailed
discussion of “addressable” and
“required” implementation
specifications, see the first
paper in this series, “Security
101 for Covered Entities.”
security controls already in place, an accurate and thorough risk analysis, and a series of
documented solutions derived from a number of factors unique to each covered entity.
Security Management Process
The first standard under Administrative Safeguards section is the Security Management Process.
This standard requires covered entities to:
“Implement policies and procedures to prevent, detect, contain and
correct security violations.”
The purpose of this standard is to establish the administrative processes and procedures that a
covered entity will use to implement the security program in its environment. There are four
implementation specifications in the Security Management Process standard.
1. Risk Analysis (Required)
2. Risk Management (Required)
3. Sanction Policy (Required)
4. Information System Activity Review
(Required)
The Importance of Risk Analysis and Risk Management
Risk analysis and risk management are critical to a covered entity’s Security Rule compliance
efforts. Both are standard information security processes that have already been adopted by some
organizations within the health care industry.
As stated in the responses to public comment in the preamble to the Security Rule, the Security
Management Process standard and associated implementation specifications “form the
foundation upon which an entity’s necessary security activities are built.” The results from the
risk analysis and risk management processes will become the baseline for security processes
within covered entities.
This paper provides a general understanding of risk analysis
and risk management concepts and processes. CMS will
include a more detailed discussion of risk analysis and risk
management in paper 6 in the HIPAA Security Series titled,
“Basics of Risk Analysis and Risk Management.”
NOTE: Risk analysis and risk
management serve as tools to
assist in the development of a
covered entity’s strategy to
protect the confidentiality,
integrity, and availability of
EPHI.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 4 5/2005: rev. 3/2007
1. RISK ANALYSIS (R) - § 164.308(a)(1)(ii)(A)
The Risk Analysis implementation specification requires covered entities to:
“Conduct an accurate and thorough assessment of the potential risks and
vulnerabilities to the confidentiality, integrity, and availability of
electronic protected health information held by the covered entity.”
In general, a risk analysis can be viewed as:
The process of identifying potential security risks, and
Determining the probability of occurrence and magnitude of risks.
Sample questions for covered entities to consider:
How does EPHI flow throughout the organization? This includes EPHI that
is created, received, maintained or transmitted by the covered entity.
What are the less obvious sources of EPHI? Has the organization considered
portable devices like PDAs?
What are the external sources of EPHI? For example, do vendors or
consultants create, receive, maintain or transmit EPHI?
What are the human, natural, and environmental threats to information
systems that contain EPHI?
2. RISK MANAGEMENT (R) - § 164.308(a)(1)(ii)(B)
Risk Management is a required implementation specification. It requires an organization
to make decisions about how to address security risks and vulnerabilities. The Risk
Management implementation specification states that covered entities must:
“Implement security measures sufficient to reduce risks and
vulnerabilities to a reasonable and appropriate level to comply with
§164.306(a).”
Risk management is the process used to identify and implement security measures to
reduce risk to a reasonable and appropriate level within the covered entity based on the
covered entity’s circumstances. The measures implemented to comply with this required
implementation specification must also allow the covered entity to comply with §
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 5 5/2005: rev. 3/2007
164.306(a) of the Security Standards: General Rules. Covered entities will want to
answer some basic questions when planning their risk management process.
Sample questions for covered entities to consider:
What security measures are already in place to protect EPHI (i.e.,
safeguards)?
Is executive leadership and/or management involved in risk management
and mitigation decisions?
Are security processes being communicated throughout the organization?
Does the covered entity need to engage other resources to assist in risk
management?
In general, a covered entity will want to make sure its
risk management strategy takes into account the
characteristics of its environment including the
factors at § 164.306(b)(2), which are listed on page 2
of this paper. These factors will help the covered
entity to determine what potential security measures
are reasonable and appropriate for its environment.
3. SANCTION POLICY (R) - § 164.308(a)(1)(ii)(C)
Another implementation specification in the Security Management Process is the
Sanction Policy. It requires covered entities to:
“Apply appropriate sanctions against workforce members who fail to
comply with the security policies and procedures of the covered entity.”
Appropriate sanctions must be in place so that workforce members understand the
consequences of failing to comply with security policies and procedures, to deter
noncompliance.
Sample questions for covered entities to consider:
Does the covered entity have existing sanction policies and procedures to
meet the requirements of this implementation specification? If not, can
NOTE: Covered entities must
ensure that the risk analysis
and risk management
processes are on-going and
dynamic processes that can
change as the environment or
operations change.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 6 5/2005: rev. 3/2007
existing sanction policies be modified to include language relating to
violations of these policies and procedures?
Does the organization require employees to sign a statement of adherence to
security policy and procedures (e.g., as part of the employee handbook or
confidentiality statement) as a prerequisite to employment?
Does the statement of adherence to
security policies and procedures state
that the workforce member
acknowledges that violations of security
policies and procedures may lead to
disciplinary action, for example, up to
and including termination?
Does the sanction policy provide examples of potential violations of policy
and procedures?
Does the sanction policy adjust the disciplinary action based on the severity
of the violation?
4. INFORMATION SYSTEM ACTIVITY REVIEW (R) - § 164.308(a)(1)(ii)(D)
The Security Management Process standard also includes the Information System
Activity Review implementation specification. This required implementation
specification states that covered entities must:
“Implement procedures to regularly review records of information system
activity, such as audit logs, access reports, and security incident tracking
reports.”
The information system activity review enables covered entities to determine if any EPHI
is used or disclosed in an inappropriate manner.
Information system activity review procedures may be different for each covered entity.
The procedure should be customized to meet the covered entity’s risk management
strategy and take into account the capabilities of all information systems with EPHI.
NOTE: A covered entity’s
sanction policy should reinforce
its security policies and
procedures.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 7 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(2)
NOTE: The Information
System Activity Review
implementation specification
should also promote continual
awareness of any information
system activity that could
suggest a security incident.
Sample questions for covered entities to consider:
What are the audit and activity review functions of the current information
systems?
Are the information systems functions
adequately used and monitored to
promote continual awareness of
information system activity?
What logs or reports are generated by
the information systems?
Is there a policy that establishes what reviews will be conducted?
Is there a procedure that describes specifics of the reviews?
Assigned Security Responsibility
The second standard in the Administrative Safeguards section is Assigned Security
Responsibility. There are no separate implementation specifications for this standard. The
standard requires that covered entities:
“Identify the security official who is responsible for the development and
implementation of the policies and procedures required by this subpart
[the Security Rule] for the entity.”
The purpose of this standard is to identify who will be operationally responsible for assuring that
the covered entity complies with the Security Rule. Covered entities should be aware of the
following when assigning security responsibility:
This requirement is comparable to the Privacy Rule standard at
§164.530(a)(1), Personnel Designations, which requires all covered entities to
designate a Privacy Official.
The Security Official and Privacy Official can be the same person, but are not
required to be.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 8 5/2005: rev. 3/2007
STANDARD
§
164.308(a)(3)
While one individual must be designated as having overall responsibility,
other individuals in the covered entity may be assigned specific security
responsibilities (e.g., facility security or network security).
When making this decision covered entities should consider some basic questions.
Sample questions for covered entities to consider:
Would it serve the organization’s needs to designate the same individual as
both the Privacy and Security Official (for example, in a small provider
office)?
Has the organization agreed upon, and clearly identified and documented,
the responsibilities of the Security Official?
How are the roles and responsibilities of the Security Official crafted to
reflect the size, complexity and technical capabilities of the organization?
Workforce Security
The third standard is Workforce Security, which states that covered entities must:
“Implement policies and procedures to ensure that all members of its
workforce have appropriate access to electronic protected health
information, as provided under [the Information Access Management
standard], and to prevent those workforce members who do not have
access under [the Information Access Management standard] from
obtaining access to electronic protected health information.”
Within a covered entity’s environment, workforce members that need access to EPHI to carry
out their duties must be identified. For each workforce member, or job function, the covered
entity must identify the EPHI that is needed, when it is needed, and make reasonable efforts to
control access to the EPHI. This will also include identification of the computer systems and
applications that provide access to the EPHI. Covered entities must provide only the minimum
necessary access to EPHI that is required for a workforce member to do his or her job.
Within Workforce Security there are three addressable implementation specifications.
1. Authorization and/or Supervision (Addressable)
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 9 5/2005: rev. 3/2007
2. Workforce Clearance Procedure (Addressable)
3. Termination Procedures (Addressable)
1. AUTHORIZATION AND/OR SUPERVISION (A) – § 164.308(a)(3)(ii)(A)
Where the Authorization and/or Supervision implementation specification is a reasonable
and appropriate safeguard for a covered entity, the covered entity must:
“Implement procedures for the authorization and/or supervision of
workforce members who work with electronic protected health
information or in locations where it might be accessed.”
Authorization is the process of determining whether a particular user (or a computer
system) has the right to carry out a certain activity, such as reading a file or running a
program. Implementation of this addressable implementation specification will vary
among covered entities, depending upon the size and complexity of the workforce, and
the information systems that contain EPHI. For
example, in a very small provider office, all staff
members may need to access all EPHI in their
information system, since they may perform multiple
functions. In this case, the covered entity might
document the reasons for implementing policies and
procedures allowing this kind of global access. If the
documented rationale is reasonable and appropriate,
this may be an acceptable approach.
To determine the most reasonable and appropriate authorization and/or supervision
procedures, covered entities may want to ask some basic questions about existing policies
and procedures.
Sample questions for covered entities to consider:
Are detailed job descriptions used to determine what level of access the
person holding the position should have to EPHI?
Who has or should have the authority to determine who can access EPHI,
e.g., supervisors or managers?
Are there similar existing processes used for paper records that could be
used as an example for the EPHI?
NOTE: The Authorization
and/or Supervision
implementation specification
provides the necessary checks
and balances to ensure that all
members of the workforce have
appropriate access (or, in some
cases, no access) to EPHI.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 10 5/2005: rev. 3/2007
Covered entities should review the authorization and supervision policies already present
in the organization’s current operating environment. Depending on the existing policies,
covered entities may need to reinforce them, make modifications for EPHI, and/or
develop corresponding documentation.
2. WORKFORCE CLEARANCE PROCEDURE (A) - § 164.308(a)(3)(ii)(B)
Covered entities need to address whether all members of the workforce with authorized
access to EPHI receive appropriate clearances. Where the Workforce Clearance
Procedure implementation specification is a reasonable and appropriate safeguard for a
covered entity, the covered entity must:
“Implement procedures to determine that the access of a workforce
member to electronic protected health information is appropriate.”
In other words, the clearance process must establish the procedures to verify that a
workforce member does in fact have the appropriate access for their job function. A
covered entity may choose to perform this type of screening procedure separate from or
as a part of the authorization and/or supervision procedure.
Sample questions for covered entities to consider:
Are there existing procedures for determining that the appropriate workforce
members have access to the necessary information?
Are the procedures used consistently within the organization when
determining access of related workforce job functions?
3. TERMINATION PROCEDURES (A) - § 164.308(a)(3)(ii)(C)
Where the Termination Procedures implementation specification is a reasonable and
appropriate safeguard for a covered entity, the covered entity must:
“Implement procedures for terminating access to electronic protected
health information when the employment of a workforce member ends or
as required by determinations made as specified in paragraph
(a)(3)(ii)(B) [the Workforce Clearance Procedure] of this section.”
Termination procedures must be implemented to remove access privileges when an
employee, contractor, or other individual previously entitled to access information no
longer has these privileges. Whether the employee leaves the organization voluntarily or
involuntarily, procedures to terminate access must be in place.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 11 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(4)
The same process that is implemented for termination should also be used to change
access levels if an employee’s job description changes to require more or less access to
EPHI. The procedures should also address the complexity of the organization and the
sophistication of associated information systems.
Sample questions for covered entities to consider:
Do the termination policies and procedures assign responsibility for
removing information system and/or physical access?
Do the policies and procedures include timely communication of
termination actions to insure that the termination procedures are
appropriately followed?
Information Access Management
The fourth standard in the Administrative Safeguards section is Information Access
Management. Covered entities are required to:
“Implement policies and procedures for authorizing access to electronic
protected health information that are consistent with the applicable
requirements of subpart E of this part [the Privacy Rule].”
Restricting access to only those persons and entities with a
need for access is a basic tenet of security. By implementing
this standard, the risk of inappropriate disclosure, alteration,
or destruction of EPHI is minimized. Covered entities must
determine those persons and/or entities that need access to
EPHI within their environment.
Compliance with this standard should support a covered
entity’s compliance with the HIPAA Privacy Rule minimum necessary requirements, which
requires covered entities to evaluate their practices and enhance safeguards as needed to limit
unnecessary or inappropriate access to and disclosure of protected health information. To better
understand this standard, covered entities should review the minimum necessary standard of the
HIPAA Privacy Rule. See 45 CFR 164.502(b) and 164.514(d).
The Information Access Management standard has three implementation specifications.
1. Isolating Health Care Clearinghouse Functions (Required)
NOTE: The Information
Access Management
implementation specifications
are closely related to the
implementation specifications
under the Workforce Security
standard.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 12 5/2005: rev. 3/2007
2. Access Authorization (Addressable)
3. Access Establishment and Modification (Addressable)
1. ISOLATING HEALTH CARE CLEARINGHOUSE FUNCTIONS (R) –
§ 164.308(a)(4)(ii)(A)
The Isolating Health Care Clearinghouse Functions implementation specification states:
“If a health care clearinghouse is part of a larger organization, the
clearinghouse must implement policies and procedures that protect the
electronic protected health information of the clearinghouse from
unauthorized access by the larger organization.”
This implementation specification only applies in the situation where a health care
clearinghouse is part of a larger organization. In these situations, the health care
clearinghouse is responsible for protecting the EPHI that it is processing.
Sample questions for covered entities to consider:
Does the larger organization perform health care clearinghouse functions?
If health care clearinghouse functions are performed, are policies and
procedures implemented to protect EPHI from the other functions of the
larger organization?
Are additional technical safeguards needed to separate EPHI in information
systems, used by the health care clearinghouse, to protect against
unauthorized access by the larger organization?
2. ACCESS AUTHORIZATION (A) - § 164.308(a)(4)(ii)(B)
In the Workforce Security standard portion of this paper, authorization was defined as the
act of determining whether a particular user (or computer system) has the right, based on
job function or responsibilities, to carry out a certain activity, such as reading a file or
running a program. Where this implementation standard is a reasonable and appropriate
safeguard for a covered entity, the covered entity must:
“Implement policies and procedures for granting access to electronic
protected health information, for example, through access to a
workstation, transaction, program, process, or other mechanism.”
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 13 5/2005: rev. 3/2007
Once the covered entity has determined that the person or system is authorized, there are
numerous ways to grant access to EPHI. In general, a covered entity’s policies and
procedures must identify who has authority to grant access privileges. It must also state
the process for granting access. To create and document policies and procedures to grant
access, covered entities should address the following questions.
Sample questions for covered entities to consider:
How is authorization documented? How can it be used to grant access?
Are the policies and procedures for granting access consistent with
applicable requirements of the Privacy Rule?
Have appropriate authorization and clearance procedures, as specified in
workforce security, been performed prior to granting access?
Are access rules specific to applications and business requirements? For
example, do different workforce members require different levels of access
based on job function?
Is there a technical process in place, such as creating unique user name and
an authentication process, when granting access to a workforce member?
Once a covered entity has clearly defined who should get access to what EPHI and under
what circumstances, it must consider how access is established and modified.
3. ACCESS ESTABLISHMENT AND MODIFICATION (A) -
§ 164.308(a)(4)(ii)(C)
Where the Access Establishment and Modification implementation specification is a
reasonable and appropriate safeguard for a covered entity, the covered entity must:
“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.”
This means that a covered entity must implement and manage the creation and
modification of access privileges to workstations, transactions, programs or processes.
Responsibility for this function may be assigned to a specific individual or individuals,
which also may be responsible for terminating access privileges for workforce members.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 14 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(5)
Covered entities must evaluate existing procedures, update them (if needed), and
document procedures as necessary.
Sample questions for covered entities to consider:
Are policies and procedures in place for establishing access and modifying
access?
Are system access policies and procedures documented and updated as
necessary?
Do members of management or other workforce members periodically
review the list of persons with access to EPHI to ensure they are valid and
consistent with those authorized?
Security Awareness and Training
Regardless of the Administrative Safeguards a covered entity implements, those safeguards will
not protect the EPHI if the workforce is unaware of its role in adhering to and enforcing them.
Many security risks and vulnerabilities within covered entities are internal. This is why the next
standard, Security Awareness and Training, is so important.
Specifically, the Security Awareness and Training standard states that covered entities must:
“Implement a security awareness and training program for all members of
its workforce (including management).”
Security training for all new and existing members of the covered entity’s workforce is required
by the compliance date of the Security Rule. In addition, periodic retraining should be given
whenever environmental or operational changes affect the security of EPHI. Changes may
include: new or updated policies and procedures; new or upgraded software or hardware; new
security technology; or even changes in the Security Rule.
The Security Awareness and Training standard has four implementation specifications.
1. Security Reminders (Addressable)
2. Protection from Malicious Software (Addressable)
3. Log-in Monitoring (Addressable)
4. Password Management (Addressable)
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 15 5/2005: rev. 3/2007
NOTE: Covered entities must
document the security
reminders they implement.
Documentation could include
the type of reminder, its
message, and the date it was
implemented.
1. SECURITY REMINDERS (A) - § 164.308(a)(5)(ii)(A)
Where this implementation specification is a reasonable and appropriate safeguard for a
covered entity, the covered entity must implement:
“Periodic security updates.”
There are many types of security reminders that
covered entities may choose to implement. Examples
might include notices in printed or electronic form,
agenda items and specific discussion topics at
monthly meetings, focused reminders posted in
affected areas, as well as formal retraining on security
policies and procedures. Covered entities should look
at how they currently remind the workforce of current
policies and procedures, and then decide whether these practices are reasonable and
appropriate or if other forms of security reminders are needed.
2. PROTECTION FROM MALICIOUS SOFTWARE (A) - § 164.308(a)(5)(ii)(B)
One important security measure that employees may need to be reminded of is security
software that is used to protect against malicious software. Where this implementation
specification is a reasonable and appropriate safeguard for a covered entity, the covered
entity must implement:
“Procedures for guarding against, detecting, and reporting malicious
software.”
Malicious software can be thought of as any program
that harms information systems, such as viruses,
Trojan horses or worms. As a result of an
unauthorized infiltration, EPHI and other data can be
damaged or destroyed, or at a minimum, require
expensive and time-consuming repairs.
Malicious software is frequently brought into an organization through email attachments,
and programs that are downloaded from the Internet. Under the Security Awareness and
Training standard, the workforce must also be trained regarding its role in protecting
against malicious software, and system protection capabilities. It is important to note that
training must be an ongoing process for all organizations.
NOTE: Malicious software that
successfully invades
information systems can cause
significant damage.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 16 5/2005: rev. 3/2007
3. LOG-IN MONITORING (A) - § 164.308(a)(5)(ii)(C)
Security awareness and training should also address how users log onto systems and how
they are supposed to manage their passwords. Where the Log-in Monitoring
implementation specification is a reasonable and appropriate safeguard for a covered
entity, the covered entity must implement:
“Procedures for monitoring log-in attempts and reporting discrepancies.”
Typically, an inappropriate or attempted log-in is
when someone enters multiple combinations of
usernames and/or passwords to attempt to access an
information system. Fortunately, many information
systems can be set to identify multiple unsuccessful
attempts to log-in. Other systems might record the
attempts in a log or audit trail. Still others might
require resetting of a password after a specified
number of unsuccessful log-in attempts.
If smaller covered entities are not using, or are not familiar with, their systems
capabilities for these types of log-in attempts, they should contact their system vendor or
read their application software manuals for more information. Once capabilities are
established the workforce must be made aware of how to use and monitor them.
4. PASSWORD MANAGEMENT - § 164.308(a)(5)(ii)(D)
The last addressable specification in this standard is Password Management. Where this
implementation specification is a reasonable and appropriate safeguard for a covered
entity, the covered entity must implement:
“Procedures for creating, changing, and safeguarding passwords.”
In addition to providing a password for access, entities must ensure that workforce
members are trained on how to safeguard the information. Covered entities must train all
users and establish guidelines for creating passwords and changing them during periodic
change cycles.
Sample questions for covered entities to consider:
Are there policies in place that prevent workforce members from sharing
passwords with others?
Is the workforce advised to commit their passwords to memory?
NOTE: The purpose of the
Log-in Monitoring
implementation specification is
to make workforce members
aware of log-in attempts that
are not appropriate.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 17 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(6)
Are common sense precautions taken, such as not writing passwords down
and leaving them in areas that are visible or accessible to others?
Security Incident Procedures
The next standard is Security Incident Procedures, which states that covered entities must:
“Implement policies and procedures to address security incidents.”
The purpose of this standard is to require covered entities to address security incidents within
their environment. Addressing security incidents is an integral part of the overall security
program. Implementing the Security Rule standards will reduce the type and amount of security
incidents a covered entity encounters, but security incidents will occur. Even covered entities
with detailed security policies and procedures and advanced technology will have security
incidents.
The Security Rule defines a security incident as, “the attempted or successful unauthorized
access, use, disclosure, modification, or destruction of information or interference with system
operations in an information system.” Security incident procedures must address how to identify
security incidents and provide that the incident be reported to the appropriate person or persons.
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 Rule 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.
There is one required implementation specification for this standard.
RESPONSE AND REPORTING (R) - § 164.308(a)(6)(ii)
The Response and Reporting implementation specification states that covered entities
must:
“Identify and respond to suspected or known security incidents; mitigate,
to the extent practicable, harmful effects of security incidents that are
known to the covered entity; and document security incidents and their
outcomes.”
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 18 5/2005: rev. 3/2007
Security incident procedures must describe how workforce members are to respond to an
incident. This may include: preserving evidence; mitigating, to the extent possible, the
situation that caused the incident; documenting the incident and the outcome; and
evaluating security incidents as part of ongoing risk management.
Covered entities must be aware of any number of possible incidents that they may have to
deal with. For example:
Stolen or otherwise inappropriately obtained passwords that are used to access
EPHI
Corrupted backup tapes that do not allow restoration of EPHI
Virus attacks that interfere with the operations of information systems with
EPHI
Physical break-ins leading to the theft of media with EPHI
Failure to terminate the account of a former employee that is then used by an
unauthorized user to access information systems with EPHI
Providing media with EPHI, such as a PC hard drive or laptop, to another user
who is not authorized to access the EPHI prior to removing the EPHI stored
on the media.
A covered entity’s security incident procedures must establish adequate response and
reporting procedures for these and other types of events.
Sample questions for covered entities to consider:
Are policies and procedures developed and implemented to address security
incidents?
Do the security incident policies and procedures list possible types of
security incidents and the response for each?
Do the security incident policies and procedures identify to whom security
incidents must be reported?
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 19 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(7)
Contingency Plan
The purpose of contingency planning is to establish strategies for recovering access to EPHI
should the organization experience an emergency or other occurrence, such as a power outage
and/or disruption of critical business operations. The goal is to ensure that organizations have
their EPHI available when it is needed. The Contingency Plan standard requires that covered
entities:
“Establish (and implement as needed) policies and procedures for
responding to an emergency or other occurrence (for example, fire,
vandalism, system failure, and natural disaster) that damages systems that
contain electronic protected health information.”
The Contingency Plan standard includes five implementation specifications.
1. Data Backup Plan (Required)
2. Disaster Recovery Plan (Required)
3. Emergency Mode Operation Plan (Required)
4. Testing and Revision Procedures (Addressable)
5. Applications and Data Criticality Analysis (Addressable)
1. DATA BACKUP PLAN (R) - § 164.308(a)(7)(ii)(A)
The Data Backup Plan implementation specification requires covered entities to:
“Establish and implement procedures to create and maintain retrievable
exact copies of electronic protected health information.”
Most covered entities may have backup procedures as part of current business practices.
Data Backup plans are an important safeguard for all covered entities, and a required
implementation specification.
Sample questions for covered entities to consider:
What is the EPHI that must be backed up?
Does the plan include all important sources of data such as patient
accounting systems, electronic medical records, health maintenance and
case management information, digital recordings of diagnostic images,
electronic test results, or any other electronic documents created or used?
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 20 5/2005: rev. 3/2007
Has the organization considered the various methods of backups, including
tape, disk, or CD?
Does the backup plan include storage of backups in a safe, secure place?
Is the organization’s frequency of backups appropriate for its environment?
2. DISASTER RECOVERY PLAN (R) - § 164.308(a)(7)(ii)(B)
The Disaster Recovery Plan implementation specification requires covered entities to:
“Establish (and implement as needed) procedures to restore any loss of
data.”
Some covered entities may already have a general disaster plan that meets this
requirement; however, each entity must review the current plan to ensure that it allows
them to recover EPHI.
Sample questions for covered entities to consider:
Does the disaster recovery plan address issues specific to the covered
entity’s operating environment?
Does the plan address what data is to be restored?
Is a copy of the disaster recovery plan readily accessible at more than one
location?
3. EMERGENCY MODE OPERATION PLAN (R) - § 164.308(a)(7)(ii)(C)
The Emergency Mode Operation Plan implementation specification requires covered
entities to:
“Establish (and implement as needed) procedures to enable continuation
of critical business processes for protection of the security of electronic
protected health information while operating in emergency mode.”
When a covered entity is operating in emergency mode due to a technical failure or
power outage, security processes to protect EPHI must be maintained.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 21 5/2005: rev. 3/2007
Sample questions for covered entities to consider:
Does the organization’s plan balance the need to protect the data with the
organization’s need to access the data?
Will alternative security measures be used to protect the EPHI?
Does the emergency mode operation plan include possible manual
procedures for security protection that can be implemented as needed?
Does the emergency mode operation plan include telephone numbers and
contact names for all persons that must be notified in the event of a disaster,
as well as roles and responsibilities of those people involved in the
restoration process?
4. TESTING AND REVISION PROCEDURES (A) - § 164.308(a)(7)(ii)(D)
Where the Testing and Revision Procedures implementation specification is a reasonable
and appropriate safeguard for the covered entity, the covered entity must:
“Implement procedures for periodic testing and revision of contingency
plans.”
It is important to point out that this implementation specification applies to all
implementation specifications under the Contingency Plan standard, including the Data
Backup Plan, Disaster Recovery Plan, and Emergency Mode Operations Plan.
Disaster recovery and emergency mode operations
plans might be tested by using a scenario-based walk-
thru (to avoid daily operations impacts) or by
performing complete live tests. The comprehensiveness
and sophistication of the testing and revision
procedures depends on the complexity of the covered entity’s organization and other
factors such as size and costs. It is expected that the frequency and comprehensiveness of
the procedures will vary among covered entities.
Sample questions for covered entities to consider:
Are the processes for restoring data from backups, disaster recovery and
emergency mode operation documented?
NOTE: Testing and revision
procedures will vary in
frequency and
comprehensiveness.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 22 5/2005: rev. 3/2007
STANDARD
§ 164.308(a)(8)
Do those responsible for performing contingency planning tasks understand
their responsibilities?
Have those responsible actually
performed a test of the procedures?
Have the results of each test been
documented and any problems with the
test reviewed and corrected?
5. APPLICATION AND DATA CRITICALITY ANALYSIS (A) -
§ 164.308(a)(7)(ii)(E)
The last implementation specification in the Contingency Plan standard is Application
and Data Criticality Analysis. Where this implementation specification is a reasonable
and appropriate safeguard for the covered entity, the covered entity must:
“Assess the relative criticality of specific applications and data in support
of other contingency plan components.”
This implementation specification requires covered entities to identify their software
applications (data applications that store, maintain or transmit EPHI) and determine how
important each is to patient care or business needs, in order to prioritize for data backup,
disaster recovery and/or emergency operations plans. A prioritized list of specific
applications and data will help determine which applications or information systems get
restored first and/or which must be available at all times.
Evaluation
It is important for a covered entity to know if the security plans and procedures it implements
continue to adequately protect its EPHI. To accomplish this, covered entities must implement
ongoing monitoring and evaluation plans. Covered entities must periodically evaluate their
strategy and systems to ensure that the security requirements continue to meet their
organizations’ operating environments.
The Evaluation standard has no separate implementation specifications. The standard requires
covered entities to:
NOTE: In most environments,
at a minimum, a covered entity
should determine if existing
contingency plans are
appropriate.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 23 5/2005: rev. 3/2007
STANDARD
§ 164.308(b)(1)
“Perform a periodic technical and nontechnical evaluation, based initially
upon the standards implemented under this rule and subsequently, in
response to environmental or operations changes affecting the security of
electronic protected health information, that establishes the extent to
which an entity’s security policies and procedures meet the requirements
of this subpart [the Security Rule].”
The purpose of the evaluation is to establish a process for
covered entities to review and maintain reasonable and
appropriate security measures to comply with the Security
Rule. Initially the evaluation must be based on the security
standards implemented to comply with the Security Rule.
Subsequent periodic evaluations must be performed in response to environmental or operational
changes that affect the security of EPHI. The on-going evaluation should also be performed on a
scheduled basis, such as annually or every two years. The evaluation must include reviews of
the technical and non-technical aspects of the security program.
Sample questions for covered entities to consider:
How often should an evaluation be done? For example, are additional
evaluations performed if security incidents are identified, changes are made
in the organization, or new technology is implemented?
Is an internal or external evaluation, or a combination of both, most
appropriate for the covered entity?
Are periodic evaluation reports and the supporting material considered in
the analysis, recommendations, and subsequent changes fully documented?
Business Associate Contracts
And Other Arrangements
The last standard in the Administrative Safeguards section is Business Associate Contracts and
Other Arrangements. The organizational requirements related to this standard are discussed in
more detail in § 164.314(a) of the Rule, which is covered in paper five of this series titled
“Security Standards – Organizational, Policies and Procedures and Documentation
Requirements.” The Business Associate Contracts and Other Arrangements standard states that:
“A covered entity, in accordance with § 164.306 [the Security Standards:
General Rules], may permit a business associate to create, receive,
NOTE: On-going evaluation of
security measures is the best
way to ensure all EPHI is
adequately protected.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 24 5/2005: rev. 3/2007
maintain, or transmit electronic protected health information on the
covered entity’s behalf only if the covered entity obtains satisfactory
assurances, in accordance with § 164.314(a) [the Organizational
Requirements] that the business associate will appropriately safeguard the
information (Emphasis added).”
Covered entities must enter into a contract or other arrangement with persons that meet the
definition of business associate in § 160.103. This standard is comparable to the Business
Associate Contract standard in the Privacy Rule, but is specific to business associates that create,
receive, maintain or transmit EPHI. To comply with this standard, covered entities must obtain
satisfactory assurances from the business associate that it will appropriately safeguard EPHI.
This standard also addresses a few situations in which a business associate contract is not
needed.
As stated at § 164.308(b)(2), the Business Associate Contracts and Other Arrangements standard
does not apply with respect to:
“(i) The transmission by a covered entity of EPHI to a health care
provider concerning the treatment of an individual.
(ii) The transmission of EPHI by a group health plan or an HMO or
health insurance issuer on behalf of a group health plan to a plan
sponsor, to the extent that the requirements of § 164.314(b) and §
164.504(f) apply and are met; or
(iii) The transmission of EPHI from or to other agencies providing the
services at § 164.502(e)(1)(ii)(C), when the covered entity is a health
plan that is a government program providing public benefits, if the
requirements of § 164.502(e)(1)(ii)(C) are met.”
In addition, § 164.308(b)(3) states, “A covered entity that violates the satisfactory assurances it
provided as a business associate of another covered entity will be in noncompliance with the
standards, implementation specifications, and requirements of this paragraph and §164.314(a).”
The standard has one implementation specification.
WRITTEN CONTRACT OR OTHER ARRANGEMENT (R) – § 164.308(b)(4)
Covered entities are required to:
“Document the satisfactory assurances required by paragraph (b)(1) [the
Business Associate Contracts and Other Arrangements] of this section
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 25 5/2005: rev. 3/2007
through a written contract or other arrangement with the business
associate that meets the applicable requirements of §164.314(a) [the
Organizational Requirements].”
Sample questions covered entities may want to consider:
Have all business associates been identified? Business associates may
include clearinghouses, medical billing services, vendors of hardware and
software, external consultants, lawyers, transcription contractors, or others
who have access to EPHI.
Have existing business associate contracts created and implemented for
compliance with the Privacy Rule, which involve EPHI, been reviewed to
determine if Security Rule requirements are addressed?
To minimize additional work efforts, can existing business associate
contracts, which involve EPHI, be modified to include Security Rule
requirements?
In Summary
All of the standards and implementation specifications found in the Administrative Safeguards
section refer to administrative functions, such as policy and procedures that must be in place for
management and execution of security measures. These include performance of security
management process, assignment or delegation of security responsibility, training requirements,
and evaluation and documentation of all decisions.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 26 5/2005: rev. 3/2007
Resources
The remaining papers in this series will address other specific topics related to the Security Rule.
The next paper in this series covers the Physical Safeguards section. These are the safeguards
required to protect electronic systems, equipment and the data they hold, from threats,
environmental hazards and unauthorized intrusion, as well as the measures necessary to restrict
physical access to EPHI.
Covered entities should periodically check the CMS website at www.cms.hhs.gov under
“Regulations and Guidance” for additional information and resources as they work through the
security implementation process. There are many other sources of information available on the
Internet. While CMS does not endorse guidance provided by other organizations, covered
entities may also want to check with other local and national professional health care
organizations, such as national provider and health plan associations for additional information.
Need more information?
Visit the CMS website often at www.cms.hhs.gov under “Regulations and Guidance” for the
latest security papers, checklists, and announcements of upcoming events.
Visit the Office for Civil Rights website, http://www.hhs.gov/ocr/hipaa
, for the latest
guidance, FAQs and other information on the Privacy Rule.
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 27 5/2005: rev. 3/2007
Security Standards Matrix (Appendix A of the Security Rule)
ADMINISTRATIVE SAFEGUARDS
Standards Sections
Implementation Specifications
(R)= Required, (A)=Addressable
Risk Analysis
(R)
Risk Management
(R)
Sanction Policy
(R)
Security
Management
Process
§ 164.308(a)(1)
Information System
Activity Review
(R)
Assigned Security
Responsibility
§ 164.308(a)(2)
Authorization and/or
Supervision
(A)
Workforce Clearance
Procedure
(A)
Workforce Security § 164.308(a)(3)
Termination Procedures
(A)
Isolating Health Care
Clearinghouse Functions
(R)
Access Authorization
(A)
Information Access
Management
§ 164.308(a)(4)
Access Establishment
and Modification
(A)
Security Reminders
(A)
Protection from Malicious
Software
(A)
Log-in Monitoring
(A)
Security Awareness
and Training
§ 164.308(a)(5)
Password Management
(A)
Security Incident
Procedures
§ 164.308(a)(6) Response and Reporting
(R)
Data Backup Plan
(R)
Disaster Recovery Plan
(R)
Emergency Mode
Operation Plan
(R)
Testing and Revision
Procedures
(A)
Contingency Plan § 164.308(a)(7)
Applications and Data
Criticality Analysis
(A)
Evaluation
§ 164.308(a)(8)
Business Associate
Contracts and Other
Arrangements
§ 164.308(b)(1) Written Contract or Other
Arrangement
(R)
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 28 5/2005: rev. 3/2007
PHYSICAL SAFEGUARDS
Standards Sections
Implementation Specifications
(R)= Required, (A)=Addressable
Contingency Operations
(A)
Facility Security Plan
(A)
Access Control and
Validation Procedures
(A)
Facility Access
Controls
§ 164.310(a)(1)
Maintenance Records
(A)
Workstation Use
§ 164.310(b)
Workstation Security § 164.310(c)
Disposal
(R)
Media Re-use
(R)
Accountability
(A)
Device and Media
Controls
§ 164.310(d)(1)
Data Backup and Storage
(A)
TECHNICAL SAFEGUARDS
Standards Sections
Implementation Specifications
(R)= Required, (A)=Addressable
Unique User Identification
(R)
Emergency Access
Procedure
(R)
Automatic Logoff
(A)
Access Control § 164.312(a)(1)
Encryption and Decryption
(A)
Audit Controls
§ 164.312(b)
Integrity § 164.312(c)(1) Mechanism to Authenticate
Electronic Protected Health
Information
(A)
Person or Entity
Authentication
§ 164.312(d)
Integrity Controls
(A)
Transmission
Security
§ 164.312(e)(1)
Encryption
(A)
ORGANIZATIONAL REQUIREMENTS
Standards Sections
Implementation Specifications
(R)= Required, (A)=Addressable
Business Associate
Contracts
(R)
Business associate
contracts or other
arrangements
§ 164.314(a)(1)
Other Arrangements
(R)
Requirements for
Group Health Plans
§ 164.314(b)(1) Implementation
Specifications
(R)
2 Security Standards: Administrative Safeguards
Volume 2 / Paper 2 29 5/2005: rev. 3/2007
POLICIES AND PROCEDURES AND DOCUMENTATION REQUIREMENTS
Standards Sections
Implementation Specifications
(R)= Required, (A)=Addressable
Policies and
Procedures
§ 164.316(a)
Time Limit
(R)
Availability
(R)
Documentation § 164.316(b)(1)
Updates
(R)
